Law on the marketing of medicinal products

Original Language Title: Gesetz über den Verkehr mit Arzneimitteln

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Law on the marketing of medicinal products (Medicines Act-AMG)

Unofficial table of contents

AMG

Date of completion: 24.08.1976

Full quote:

" Medicinal Products Act, as amended by the Notice of 12 December 2005 (BGBl. 3394), the most recent of which is Article 3 of the Law of 17 December 2014 (BGBl. 2222). "

Status:	New by Bek. v. 12.12.2005 I 3394;
	Last amended by Art. 3 G v. 17.12.2014 I 2222

For more details, please refer to the menu under Notes

Footnote

(+ + + Text credits applicable: 6.6.1986 + + +) 
(+ + + For application cf.  § § 63j, 109 u.  141 + + +) 
(+ + + Official note from the norm-provider on EC law: 
 Implementation of the   
 EURL 84/2010 (CELEX No: 32010L0084) 
 EURL 62/2011 (CELEX No: 32011L0062) 
 EURL 24/2011 (CELEX No: 32011L0024) cf.  G v. 19.10.2012 I 2192 + + +)

The G was decided as Article 1 G v. 24.8.1976 I 2445 of the Bundestag with the consent of the Bundesrat. It is with the exception of d. § 78 gem. Article 10 of this G entered into force on 1 January 1978.
Legal abbreviation: Inc. by Art. 1 No. 1 G v. 30.7.2004 I 2031 mWv 6.8.2004 Unofficial table of contents

Content Summary

First section
Purpose of the law and definitions, scope
§ 1	Purpose of the law
§ 2	Pharmaceutical term
§ 3	Fabric Term
§ 4	Other definitions
Section 4a	Derogations from the scope
§ 4b	Special provisions for advanced therapy medicinal products

Second section
Requirements for medicinal products
§ 5	Prohibition of medicinal products
§ 6	Authorisation to protect health
§ 6a	Prohibition of medicinal products for doping purposes in sport, duty-related obligations
§ 7	Medicinal products treated with ionising radiation
§ 8	Prohibitions to protect against deception
§ 9	The person responsible for placing on the market
§ 10	Marking
§ 11	Package leaflet
§ 11a	Subject Information
§ 12	Authorisation for labelling, package leaflet and pack sizes

Third Section
Manufacture of medicinal products
§ 13	Manufacturing permit
§ 14	Decision on manufacturing authorization
§ 15	Expertise
§ 16	Limitation of manufacturing authorization
§ 17	Time limits for grant
§ 18	Withdrawal, Revocation, Ruhen
§ 19	Responsible areas
§ 20	Notifiable
§ 20a	Application for active substances and other substances
§ 20b	Permission for the extraction of tissue and laboratory tests
§ 20c	Permission for the processing, preservation, testing, storage or placing on the market of tissue or tissue preparations
§ 20d	Exception to the authorisation requirement for tissue and tissue preparations

Fourth Section
Authorisation of medicinal products
Section 21	Authorisation requirement
Section 21a	Authorisation of tissue preparations
Section 22	Marketing authorisation documents
Section 23	Special documents relating to medicinal products for animals
§ 24	Expert opinion
§ 24a	Use of documents from a pre-applicant
§ 24b	Authorisation of a generic medicine, protection of the underlay
§ 24c	Rerequests
§ 24d	General exploitation power
Section 25	Decision on authorisation
Section 25a	Pre-Review
§ 25b	Procedures for mutual recognition and decentralised procedure
Section 25c	Measures taken by the competent federal authority in respect of decisions or decisions of the European Community or of the European Union
Section 26	Drug testing guidelines
§ 27	Time limits for grant
§ 28	Power of deposit
§ 29	Notification requirement, new authorisation
§ 30	Withdrawal, Revocation, Ruhen
Section 31	Erasing, extension
Section 32	State Charge Review
§ 33	Expenditure on charges and charges
Section 34	Information to the public
§ 35	Authorisations for authorisation and exemption
§ 36	Authorization for standard approvals
Section 37	Authorisation of the European Community or of the European Union for the placing on the market, authorisations of medicinal products from other States

Fifth Section
Registration of medicinal products
§ 38	Registration of homeopathic medicinal products
§ 39	Decision on the registration of homeopathic medicinal products, procedural rules
Section 39a	Registration of traditional herbal medicinal products
Section 39b	Registration documents for traditional herbal medicinal products
Section 39c	Decision on the registration of traditional herbal medicinal products
Section 39d	Other procedural rules for traditional herbal medicinal products

Sixth Section
Protection of human beings in clinical trials
§ 40	General requirements for clinical examination
Section 41	Special requirements for clinical examination
§ 42	Procedure at the Ethics Committee, approval procedure with the Federal Authority
§ 42a	Withdrawal, revocation and revocation of the authorisation or the assessment to be agreed
§ 42b	Publication of the results of clinical trials

Seventh Section
Release of medicinal products
Section 43	Pharmacy duty, placing on the market by veterinarians
Section 44	Exception to pharmacy requirements
§ 45	Authorisation for further exemptions from the obligation to pharmacist
Section 46	Authorisation to extend the obligation to extend pharmacy
§ 47	Sales path
Section 47a	Special distribution route, follow-up duties
§ 47b	Special sales path Diamorphin
§ 48	Prescription
§ 49	(dropped)
§ 50	Retail sale of free-selling medicinal products
Section 51	Levy in the travel industry
Section 52	Prohibition of self-service
§ 52a	Wholesale trade in medicinal products
Section 52b	Provision of medicinal products
§ 52c	Drug delivery
Section 53	Hearing of experts

Eighth section
Quality assurance and control
§ 54	Operating Regulations
§ 55	Medicinal book
§ 55a	Official collection of investigative procedures

Ninth Section
Special provisions for medicinal products to be used in animals
§ 56	Medicated feedingstuffs
Section 56a	Prescription, delivery and use of medicinal products by veterinarians
§ 56b	Exceptions
Section 57	Acquisition and possession by animal keepers, evidence
Section 57a	Application by animal keepers
Section 58	Use in animals used for the production of foodstuffs
Section 58a	Communications on animal huskings
§ 58b	Communications on medicinal products
Section 58c	Determination of the frequency of therapy
§ 58d	Reduction of treatment with antibacterially active substances
§ 58e	Regulation
§ 58f	Use of data
§ 58g	Evaluation
§ 59	Clinical testing and residue testing in animals used for food production
§ 59a	Transport of substances and preparations of substances
§ 59b	Substances for the implementation of residue controls
Section 59c	Obligation to follow up on substances which may be used as veterinary medicinal products
§ 59d	Administration of pharmacologically active substances to animals used for the production of food
§ 60	Pets
Section 61	Powers of veterinary education

Tenth section
Pharmacovigilance
Section 62	Organisation of the pharmacovigilance system of the competent federal authority
§ 63	Stepplan
Section 63a	Level Plan Representative
Section 63b	General pharmacovigilance obligations of the holder of the authorisation
Section 63c	Documentation and reporting requirements of the holder of the marketing authorisation for medicinal products intended for use in humans, for suspected cases of adverse reactions
Section 63d	Periodic safety update reports
§ 63e	European procedure
Section 63f	General requirements for non-interventional safety tests
§ 63g	Special requirements for non-interventional safety tests
§ 63h	Documentation and reporting requirements for medicinal products intended for use in animals
Section 63i	Documentation and reporting requirements for blood and tissue preparations and tissues
§ 63j	Exceptions

Eleventh Section
Monitoring
Section 64	Implementation of monitoring
Section 65	Sampling
Section 66	Obligation to take part in and to participate
Section 67	General notification requirement
§ 67a	Database-based information system
Section 68	Participation and teaching obligations
Section 69	Measures taken by the competent authorities
§ 69a	Monitoring of substances which may be used as veterinary medicinal products
§ 69b	Use of certain data

Twelfth section
Special provisions for Bundeswehr, federal police, riot police, civil protection
Section 70	Application and enforcement of the law
Section 71	Exceptions

Thirteenth Section
Import and export
Section 72	Import permit
Section 72a	Certificates
Section 72b	Import authorisation and certificates for tissue and certain tissue preparations
Section 73	Movement ban
Section 73a	Export
Section 74	Participation of customs services

Fourteenth Section
Information Officer, Pharmaberater
Section 74a	Information Officer
§ 75	Expertise
Section 76	Obligations

Fifteenth Section
Determination of the competent federal authorities and other provisions
Section 77	Competent federal authority
§ 77a	Independence and transparency
Section 78	Prices
§ 79	Emergency appropriations for periods of crisis
§ 80	Authorisation for procedures and hardship cases
§ 81	Relationship to other laws
Section 82	General administrative provisions
Section 83	Alignment with the law of the European Union
§ 83a	Legal Regulations in certain cases
Section 83b	Proclamation of legal orders

Sixteenth section
Liability for damage to medicinal products
Section 84	Liability for liability
Section 84a	Entitlement to information
§ 85	Co-inflicted
§ 86	Extent of the replacement obligation in the case of killing
Section 87	Extent of the replacement obligation in case of bodily injury
Section 88	Maximum amounts
§ 89	Damages due to money
§ 90	(dropped)
Section 91	Further liability
§ 92	Indispensable
Section 93	Multiple surrogate
Section 94	Coverage
Section 94a	Local competence

Seventeen Section
Criminal and penal rules
§ 95	Criminal provisions
§ 96	Criminal provisions
Section 97	Fines
Section 98	Recovery
§ 98a	Extended decay

Eighteenth section
Transitional and transitional provisions

	First subsection
§ § 99 to 124	Transfer rules on the occasion of the law on the reorganisation of the pharmaceutical law

	Second subsection
§ § 125 and 126	Transitional provisions on the occasion of the First Act amending the Medicines Act

	Third Subsection
§ § 127 to 131	Transitional provisions on the occasion of the Second Act amending the Medicines Act

	Fourth subsection
Section 132	Transitional provisions on the occasion of the Fifth Act amending the Medicines Act

	Fifth Subsection
§ 133	Transitional provision on the occasion of the Seventh Act amending the Medicines Act

	Sixth subsection
Section 134	Transitional provisions on the occasion of the Transfusion Act

	Seventh-Subsection
§ 135	Transitional provisions on the occasion of the Eighth Law amending the Medicines Act

	Eighth Subsection
Section 136	Transitional provisions on the occasion of the Tenth Law amending the Medicines Act

	Ninth Subsection
Section 137	Transitional provisions on the occasion of the Eleventh Act amending the Medicines Act

	Tenth subsection
§ 138	Transitional provisions on the occasion of the Twelfth Act amending the Medicines Act

	Eleventh Subsection
Section 139	Transitional provisions on the occasion of the First Act amending the Transfusion Act and the provisions of the provisions of the law on medicinal products

	Twelfth subsection
§ 140	Transitional provisions on the occasion of the Thirteenth Act amending the Medicines Act

	Thirteenth subsection
Section 141	Transitional provisions on the occasion of the Fourteenth Act amending the Medicines Act

	Fourteenth subsection
Section 142	Transitional provisions on the occasion of the tissue law

	Fifteenth subsection
Section 143	Transitional provisions on the occasion of the law to improve the fight against doping in sport

	Sixteenth subsection
Section 144	Transitional provisions on the occasion of the law on the amendment of medicinal products and other provisions

	Seventeen subsection
§ 145	Transitional provisions on the occasion of the law on the reorganisation of the pharmaceutical market

	Eighteenth subsection
	Transitional provision
Section 146	Transitional provisions on the occasion of the Second Act on the amendment of medicinal products and other provisions

	Annex

First section
Purpose of the law and definitions, scope

Unofficial table of contents

§ 1 Purpose of the Law

It is the purpose of this Act, in the interests of the proper supply of medicinal products for human and animal health, to safety in the marketing of medicinal products, in particular for the quality, efficacy and safety of medicinal products in accordance with the conditions laid down in of the following provisions. Unofficial table of contents

§ 2 Concept of medicinal products

(1) Medicinal products are substances or preparations made of substances,

1.

which are intended for use in or on the human or animal body and are intended to be used as a means of healing or alleviation or for the prevention of human or animal diseases or pathogenic complaints, or

2.

used in or on the human or animal body, or can be administered to a human or an animal, to either:

a): to restore, correct or influence physiological functions by means of a pharmacological, immunological or metabolic action, or
b): to make a medical diagnosis.

(2) As medicinal products,

1.: articles containing a medicinal product as referred to in paragraph 1 or on which a medicinal product referred to in paragraph 1 is applied and which are intended to be brought into contact with the human or animal body in a permanent or temporary manner;
1a.: veterinary instruments in so far as they are intended for single use and the marking indicates that they have been subjected to a method of reducing the number of germs;
2.: Articles which, without being subject to items 1 or 1a, are intended to be introduced into the animal body permanently or temporarily for the purposes referred to in paragraph 1, with the exception of instruments of veterinary use,
3.: composite and surgical suture materials, to the extent that they are intended for use on or in the animal body and are not items falling within the range of 1, 1a or 2,
4.: Substances and preparations of substances which are intended to be applied without being used on or in the animal body, whether or not in cooperation with other substances or preparations, of the nature, condition or function of the substance. of the animal body, or the detection of pathogens in animals.

(3) Medicinal products are not

1.: food within the meaning of Article 2 (2) of the Food and Feed Code,
2.: cosmetic products within the meaning of Article 2 (5) of the Food and Feed Code,
3.: tobacco products within the meaning of Section 3 of the Preliminary Tobacco Act,
4.: Substances or preparations of substances which are intended exclusively to be used externally on the animal for the purpose of cleaning or caring or for influencing the appearance or the body odour, in so far as they do not contain any substances or preparations. substances which are excluded from the market outside the pharmacy,
5.: Biocidal products as defined in Article 3 (1) (a) of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 on the making available on the market and the use of biocidal products (OJ L 327, 22.5.2012, p. OJ L 167, 27.6.2012, p.1),
6.: feedingstuffs within the meaning of Section 3 (12) to (16) of the Food and Feed Code,
7.: Medical devices and accessories for medical devices within the meaning of § 3 of the Medical Devices Act, unless they are medicinal products within the meaning of § 2 (1) (2) (b),
8.: Organs within the meaning of Section 1a (1) of the Transplant Act, if they are intended for transmission to human recipients.

(3a) Medicinal products are also products which are or contain substances or preparations of substances which, taking into account all the properties of the product, fall within the definition of paragraph 1 and which are also covered by the (4) As long as an agent is authorised or registered as a medicinal product under this Act or is exempted from the authorisation or registration by means of a legal regulation, it shall be deemed to have been: Medicinal products. If the competent authority has rejected the authorisation or registration of an agent on the grounds that it is not a medicinal product, it shall not be considered as a medicinal product. Unofficial table of contents

§ 3 Concept of substance

Substances within the meaning of this Act are:

1.: chemical elements and chemical compounds as well as their naturally occurring mixtures and solutions,
2.: plants, parts of plants, plant components, algae, fungi and lichens in processed or unprocessed condition,
3.: Animal body, including live animals, as well as body parts, components and metabolic products of humans or animals in a processed or unprocessed condition,
4.: Microorganisms including viruses and their constituents or metabolic products.

Unofficial table of contents

§ 4 Other definitions

(1) Ready-to-use medicinal products are medicinal products which are produced in advance and placed on the market in a pack intended for delivery to the consumer or other medicinal products intended for the preparation thereof, in the preparation of which the product is intended for use in the manufacture of a product. in any other way, an industrial process is used or which is commercially produced, except in pharmacies. Finished pharmaceuticals are not intermediates intended for further processing by a manufacturer. (2) Blood preparations are medicinal products derived from blood, plasma or serum conserves, blood components or preparations. (3) Sera are medicinal products within the meaning of Section 2 (1), which contain antibodies, antibody fragments or fusion proteins with a functional antibody component as active substance and because of the active substance. The active substance is used. Sera shall not be considered as a blood preparation within the meaning of paragraph 2 or as a tissue preparation within the meaning of paragraph 30. (4) Vaccines are medicinal products within the meaning of § 2 (1), which contain antigens or recombinant nucleic acids and which are intended to be used for this purpose. are to be used in humans or animals for the production of specific defence and protective substances and, where they contain recombinant nucleic acids, are intended exclusively for the prevention or treatment of infectious diseases. (5) Allergens are medicinal products within the meaning of Section 2 (1), which contain antigens or haptens and are intended to be used in humans or animals for the detection of specific defence or protective substances (test allergens) or contain substances which contribute to the antigen-specific reduction of a specific immunological hypersensitivity (6) Testsera are medicinal products within the meaning of § 2 para. 2 no. 4, which are obtained from blood, organs, organ parts or organ secretions of healthy, diseased, diseased or immunisatorically pretreated living organisms, contain specific antibodies and which are intended to be used for this purpose (7) Test antigens are medicinal products within the meaning of § 2 para. 2 no. 4, which contain antigens or haptens and which are intended to be used as such. (8) Radioactive Medicinal products are medicinal products which are or contain radioactive substances and which emit ionizing radiation spontaneously and which are intended to be used on account of these properties; as radioactive medicinal products, medicinal products also apply to the medicinal products concerned. Radiomarkation of other substances prior to administration of radionuclides (precursors) and the systems intended for the production of radioactive medicinal products with a fixed parent radionuclide, which forms a daughter radionuclide (generators). (9) Advanced therapy medicinal products are gene therapeutics, somatic cell therapeutics or Biotechnologically processed tissue products as defined in Article 2 (1) (a) of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending the Directive 2001 /83/EC and Regulation (EC) No 726/2004 (OJ L 197, 21.7.2001, p. 121). (10) medicaments for medicated feedingstuffs are medicinal products manufactured from premixtures and compound feedingstuffs and intended for use in animals used for transport purposes (11) Medicinal premixtures are medicinal products intended solely for the manufacture of medicated feedingstuffs. They shall be considered as ready-to-use medicinal products. (12) The withdrawal period shall be the time when the medicinal product is administered in accordance with the last application of the medicinal product in the case of an animal to the recovery of foodstuffs obtained from that animal, on the basis of the final use of the medicinal product. the protection of public health and ensuring that residues in these foodstuffs are those listed in the Annex to Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification in respect of maximum residue limits in foodstuffs of animal origin (OJ C 139, 30.4.2004, p. 1), as amended in the current version, do not exceed the maximum permitted levels for pharmacologically active substances. (13) Side effects are harmful to medicinal products intended for use in humans. and unintended reactions to the medicinal product. Adverse reactions in medicinal products intended for use in animals are harmful and unintended reactions when used in the intended use. Serious adverse reactions are adverse reactions that are fatal or life-threatening, require hospitalisation or extension of hospitalisation, disability or severe disability, invalidity, congenital anomalies or birth defects. In the case of medicinal products intended for use in animals, serious adverse reactions are also serious, causing persistent or prolonged symptoms. Unexpected side effects are side effects, the nature, extent or result of which differs from the specialist information of the medicinal product. (14) Production is the winning, the ready, the preparation, the working or processing, the refilling including Bottling, packing, marking and release; not to be used as a production shall be the mixing of ready-made medicinal products with feedingstuffs by the keeper for direct administration to the animals kept by him. (15) Quality is the the nature of a medicinal product based on identity, content, purity, chemical, physical, biological or by the production process. (16) A batch is the same starting quantity in a single production process or in a continuous process. (17) placing on the market for sale or other delivery, holding, offering and dispensing to others. (18) The pharmaceutical An entreptitious person shall be responsible for medicinal products subject to authorisation or registration of Holder of the authorisation or registration. A marketing authorisation holder shall also be responsible for the placing on the market of medicinal products under his/her name, except in the cases of § 9 (1) sentence 2. (19) Active substances are substances intended for use in the manufacture of medicinal products for use as medicaments. (20) (20) (omitted) (21) Xenogenic medicinal products are intended for use in humans or in humans, and may be used in the manufacture of medicinal products for the medicinal products. Medicinal products that are or are contained in live animal tissues or cells. (22) Wholesale trade in medicinal products shall be carried out by any professional or professional activity for the purpose of commercial activity involving the procurement, storage, supply or export of medicinal products, with the exception of the supply of medicinal products. any consumer other than doctors, dentists, veterinarians or hospitals. (22a) The intermediary of medicinal products is any professional or commercial activity of persons who, without wholesale trade, are self-employed and in the foreign name of Medicinal products within the meaning of Article 2 (1) or (2) (1), which are used in the case of human beings (23) Clinical examination in humans is any study carried out in humans, which is intended to produce clinical or pharmacological effects of The following medicinal products should be studied or identified, or the absorption, distribution, metabolism or excretion, with a view to the safety or efficacy of the medicinal products, to be investigated or to be identified. . Sentence 1 shall not apply to an investigation which is a non-interventional examination. Non-interventional testing is an investigation into which findings from the treatment of persons with medicinal products are analysed using epidemiological methods, followed by the treatment, including diagnosis, and Monitoring not a pre-determined test plan, but exclusively the medical practice; in so far as it is a medicinal product subject to authorisation or under section 21a (1), this shall also be carried out in accordance with the procedures laid down in Approval or approval specified for its application. (24) Sponsor is a natural or legal person who assumes responsibility for the instigation, organisation and financing of a clinical trial in humans. (25) Reviewer is generally a person responsible for carrying out clinical trials in humans in a medical examination office or in justified exceptional cases, another person whose profession, on the basis of his scientific requirements and the experience of his/her exercise of his/her performance, is required to provide patient care for the Carrying out research on human beings. Where a clinical trial is carried out in a testing body by a group of persons, the auditor shall be the head of that group responsible for carrying out the clinical trial. If a test is carried out in a number of test sites, the sponsor shall appoint an auditor as the head of the clinical trial. (26) Homeopathic medicinal product shall be a medicinal product according to any one of the European Pharmacopoeia or, in the absence thereof, of: has been produced in accordance with a homeopathic method of preparation described in the official pharmacopoeias of the Member States of the European Union. A homeopathic medicinal product may also contain more than one active substance. (27) A medicinal product which is used in the application of the the risk associated with medicinal products

a): any risk related to the quality, safety or efficacy of the medicinal product to the health of patients or to public health, to medicinal products intended for human or animal health, for use in animals,
b): any risk of undesirable effects on the environment.

(28) The benefit-risk ratio shall include an assessment of the positive therapeutic effects of the medicinal product in relation to the risk referred to in paragraph 27 (a), in the case of medicinal products intended for use in animals, even in accordance with paragraph 27 (a). b. (29) Plant medicinal products are medicinal products which, as active substances, are exclusively one or more herbal substances, or one or more herbal preparations, or one or more such herbal substances in combination with one or more of them; several such herbal preparations. (30) Tissue preparations are medicinal products which are tissues within the meaning of § 1a No. 4 of the transplant law or have been manufactured from such tissues. Human semen and ova (germ cells), as well as impregnated ova and embryos are not medicinal products or tissue preparations. (31) Reconstitution of a ready-to-use product for human use is the transfer to his or her own In accordance with the information provided in the package leaflet or in the context of the clinical trial, in accordance with the provisions of the test plan. (32) Any carriage in, through or out of the scope of the law shall be provided. Importation shall be the release for free circulation of products from third countries which are not parties to the Agreement on the European Economic Area and which are covered by the Medicines Act. Products as set out in the second sentence shall be deemed to have been introduced if they have been transferred to the economic cycle contrary to the customs regulations. (33) Anthroposophic medicinal product is a medicinal product based on the anthroposophical understanding of human beings and nature. , in accordance with a homeopathic method of preparation described in the European Pharmacopoeia or, in the absence thereof, in accordance with a homeopathic method described in the official pharmacopoeias of the Member States of the European Union, or in accordance with a special anthroposophical preparation processes and which is intended to be used in accordance with the principles of the anthroposophical understanding of human beings and nature. (34) Any safety assessment of a medicinal product intended for use in humans shall be subject to any examination of: an authorised medicinal product which is carried out in order to identify, describe or quantify a safety risk, confirm the safety profile of a medicinal product or measure the efficiency of risk management measures. (35) A safety test for a medicinal product which is used in the case of animals, a pharmacoepidemiological study or clinical trial, in accordance with the conditions of authorisation, with a view to establishing a health hazard in relation to an authorised veterinary medicinal product, and to: (36) The risk management system shall include pharmacovigilance activities and measures to identify, describe, avoid or minimise the risks associated with a medicinal product, including: Evaluation of the effectiveness of such activities and activities. (37) Risk management plan is a detailed description of the risk management system. (38) The system of pharmacovigilance is a system that the holder of the authorisation and the competent authority of the Federal Republic of Germany apply, in particular to those in the Tenth Section. (39) Pharmacovigilance stock documentation shall be used to monitor the safety of authorised medicinal products and to identify any changes in the risk-benefit balance. (39) Detailed description of the pharmacovigilance system, which is the (40) A falsified medicinal product is a medicinal product with false information on the use of a medicinal product.

1.: the identity, including its packaging, its identification, its name or its composition, with regard to one or more of its constituents, including the excipients and the content of these constituents,
2.: the origin, including the manufacturer, the country of manufacture, the country of origin and the holder of the marketing authorisation or the holder of the authorisation; or
3.: the distribution channels described in records and documents.

(41) A falsified active substance is an active substance whose labelling on the container does not indicate the actual content or whose accompanying documentation does not reflect all the manufacturers involved or not the actual distribution route. Unofficial table of contents

Section 4a Exceptions to the scope of application

This law shall not apply to:

1.: medicines produced using pathogens or by biotechnical means, and intended for the prevention, detection or cure of animal diseases,
2.: the production and placing on the market of germ cells for artificial insemination in animals;
3.: Tissue removed from a person within a treatment process in order to be transferred back to the person without changing its material nature.

Sentence 1 No. 1 shall not apply to § 55. Unofficial table of contents

Section 4b Special provisions for medicinal products for advanced therapy

(1) For advanced therapy medicinal products which fall within the scope of this Act

1.: as an individual preparation for an individual patient,
2.: not routinely manufactured in accordance with specific quality standards, and
3.: used in a specialised hospital care facility under the professional responsibility of a doctor

, the Fourth Section, with the exception of § 33, and the Seventh Section of this Law shall not apply. The other provisions of the law, as well as Articles 14 (1) and 15 (1) to (6) of Regulation (EC) No 1394/2007, shall apply accordingly, with the proviso that the duties and powers referred to therein shall, in accordance with the provisions of this Regulation, be The law shall be carried out by the competent authority or the competent authority of the national authority and shall be replaced by the holder of the authorisation within the meaning of this Act or the holder of the marketing authorisation in the sense of of Regulation (EC) No 1394/2007, the holder of the authorisation referred to in the first sentence of paragraph 3 shall enter into force. (2) Not routinely produced within the meaning of the first sentence of paragraph 1, point 2, shall in particular be medicinal products,

1.: which are produced to a small extent, and where, on the basis of routine production, deviations are made in the procedure which is medically justified for an individual patient, or
2.: which have not yet been produced in sufficient numbers, so that the necessary findings for their comprehensive assessment are not yet available.

(3) Medicinal products as referred to in the first sentence of paragraph 1 may only be delivered to others if they have been approved by the competent authority of the Federal Republic of Germany. Section 21a (2) to (8) shall apply accordingly. The permit may be limited to a limited period. Where the required information and documents cannot be provided in accordance with Article 21a (2) (6), the applicant may attach the information and documents relating to the mode of operation, the likely effect and possible risks. The holder of the authorisation shall, at certain intervals by the competent federal authority, determine the extent of the production and the findings for the comprehensive assessment of the competent authority of the competent authority. to report. The authorisation shall be withdrawn if it is subsequently known that one of the conditions set out in the first sentence of paragraph 1 has not been fulfilled; it shall be revoked if one of the conditions is no longer fulfilled. Section 22 (4) shall apply accordingly. (4) In consultation with the competent authority, the competent authority shall decide on requests for the authorisation of a medicinal product for advanced therapies. Section 21 (4) shall apply accordingly.

Second section
Requirements for medicinal products

Unofficial table of contents

§ 5 Prohibition of medicinal products

(1) It is prohibited to place any serious medicinal product on the market or to apply it to another person. (2) Medications where there is a reasonable suspicion, according to the state of the scientific findings, is prohibited. that they have harmful effects in their intended use, which go beyond a measure acceptable according to the findings of medical science. Unofficial table of contents

§ 6 Authorisation to protect health

(1) The Federal Ministry of Health (Federal Ministry of Health) is authorized to use certain substances, preparations of substances or articles in the manufacture of medicinal products by means of a regulation with the consent of the Federal Council. to prohibit, restrict or prohibit the placing on the market and use of medicinal products which are not manufactured in accordance with these provisions, in so far as it is intended to prevent risks or to prevent direct or indirect use of such medicinal products; indirect risks to human or animal health caused by medicinal products is. The German Federal Ministry of Food, Agriculture and Consumer Protection (Federal Ministry of Food, Agriculture and Consumer Protection), in agreement with the Federal Ministry for Food, Agriculture and Consumer Protection, enacts the regulation in accordance with the provisions of the first sentence, as far as medicinal products intended for use in animals are The legal regulation referred to in paragraph 1 shall be adopted in agreement with the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, as far as radioactive medicinal products and medicinal products are used, in the manufacture of which ionizing radiation is used. . Unofficial table of contents

§ 6a Prohibition Of Medicinal Products for doping purposes in sport, duty of execution

(1) It is prohibited to place on the market, prescribe or otherwise use medicinal products referred to in the first sentence of paragraph 2 for the purpose of doping in sport, provided that doping in humans is or should be carried out. (2) Paragraph 1 shall apply only to: Medicinal products which are substances of the categories of prohibited substances listed in the relevant version of the Annex to the Convention against Doping (Law of 2 March 1994 on the Convention of 16 November 1989 against Doping, BGBl. 1994 II p. 334) Active substances or substances intended for use in the prohibited methods listed there . In the package leaflet and in the specialist information for these medicinal products, the following warning should be stated: "The use of the medicinal product [use designation of the medicinal product] may lead to positive results in the case of doping controls." If a health risk can follow from the misuse of the medicinal product for doping purposes, this must be provided in addition. Sentence 2 shall not apply to medicinal products which have been manufactured in accordance with homeopathic processing techniques. (2a) It is prohibited to use medicinal products or active substances which are or are included in the Annex to this Act in the absence of a medicinal product. to buy or own a small quantity for doping purposes in sport, provided that doping in humans is to be carried out. With the agreement of the Federal Council, the Federal Ministry, in agreement with the Federal Ministry of the Interior after hearing experts, shall, with the approval of the Federal Council, determine the not small quantity of the substances referred to in sentence 1. The Federal Ministry of the Interior is authorized, in agreement with the Federal Ministry of the Interior, after hearing of experts by legal regulation with the consent of the Federal Council

1.: include other substances in the Annex to this Act, which are suitable for doping purposes in sport and whose use is dangerous for non-therapeutic purposes; and
2.: to determine the not small quantity of these substances.

By means of a legal regulation according to sentence 3, substances from the appendix of this law may be deleted if the conditions of the sentence 3 No. 1 are no longer available. (3) The Federal Ministry is authorized, in agreement with the Federal Ministry of the Within the scope of the provisions of the Law Regulation, with the consent of the Federal Council, to determine other substances or preparations of substances to which paragraph 1 applies, to the extent that this is necessary in order to present a direct or indirect risk to the health of the to prevent people from doping in sport. Unofficial table of contents

Section 7 Radioactive medicinal products treated with ionising radiation

(1) It shall be prohibited to place on the market radioactive medicinal products or medicinal products which have been used for the production of ionizing radiation, unless this is permitted by the regulation referred to in paragraph 2. (2) Federal Ministry is authorized, in agreement with the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, by means of a legal regulation with the consent of the Federal Council, the placing on the market of radioactive medicinal products or in the production of to allow the use of ionizing radiation to the extent that this is done in accordance with the the state of scientific knowledge for medical purposes, and which is safe for human or animal health. The Regulation provides for the provision of distribution channels for medicinal products, as well as information on the radioactivity on the container, the outer packaging and the package leaflet. The regulation is issued by the Federal Ministry of Food, Agriculture and Consumer Protection in agreement with the Federal Ministry and the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, in so far as they are medicinal products which is intended for use in animals. Unofficial table of contents

§ 8 prohibitions on protection against deception

(1) It shall be prohibited to manufacture or place on the market medicinal products or active substances which:

1.

are not significantly reduced in quality by way of derogation from the recognised pharmaceutical rules; or

1a.

(dropped)

2.

are provided with misleading description, indication or presentation. In particular, misleading information shall be provided where:

a): Medicinal products should be attached to a therapeutic activity or an activity or active substance which they do not have,
b): it is erroneously given the impression that success can be expected with certainty or that no harmful effects occur after use has been made for the intended purpose or for a longer period of time,
c): for deception on the quality of appropriate names, indications or notices which are co-determinant for the evaluation of the medicinal product or active substance.

(2) It is prohibited to manufacture, place on the market or otherwise trade counterfeit medicines or counterfeit active substances. (3) It is prohibited to place on the market medicinal products whose expiry date has expired. Unofficial table of contents

§ 9 The person responsible for placing the market on the market

(1) Medicinal products which are placed on the market within the scope of this Act must bear the name or business name and address of the pharmaceutical entreprenter. This does not apply to medicinal products intended for clinical trial in humans. (2) Medicinal products may only be placed on the market in the scope of this Act by a marketing authorisation holder who is based in the the scope of this Act, in another Member State of the European Union or in another Contracting State of the Agreement on the European Economic Area. If the pharmaceutical contractor orders a local representative, this does not release him from his legal responsibility. Unofficial table of contents

§ 10 Labelling

(1) Ready-to-use medicinal products which are intended for medicinal products within the meaning of Article 2 (1) or (2) (1) and are not intended for clinical testing in humans or which are exempted from the authorisation requirement pursuant to section 21 (2) 1a (1b) or (6) of this Article shall be allowed within the scope of this Law shall be placed on the market only if on the containers and, where used, on the outer envelopes in good legible writing, in a general language in German and in a permanent manner and in accordance with the information in accordance with § 11a

1.: the name or business name and address of the marketing authorisation holder and, where available, the name of the local representative appointed by him,
2.: the name of the medicinal product, followed by the indication of the strength and pharmaceutical form, and where applicable, the indication that it is intended for use in infants, children or adults, unless such information is already available in the If the product contains up to three active substances, the international non-proprietary name (INN) must be listed or, if it does not exist, the common name; this shall not apply if the name is given in the name of the the active substance name referred to in paragraph 8 is included,
3.: the approval number, with the abbreviation "Zul. -Nr.",
4.: the batch designation, where the product is placed on the market in batches, with the abbreviation "Ch.-B.", insofar as it cannot be placed on the market in batches, the date of manufacture,
5.: the pharmaceutical form,
6.: the content by weight, volume of space or number of pieces,
7.: the nature of the application,
8.: the active substances according to the type and quantity and other components according to the species, to the extent that this is ordered by the competent federal authority pursuant to § 28 (2) (1) or by legal regulation pursuant to § 12 (1) (4), also in conjunction with para. 2, or in accordance with Article 36 (1); in the case of medicinal products for parenteral or topical use, including the use of the eye, all components of the type,
8a.: in the case of medicinal products derived from genetic engineering, the active substance and the name of the genetically modified micro-organism used in the production or the cell line,
9.: the expiry date with the indication "usable up to",
10.: in the case of medicinal products which may only be supplied on medical, dental or veterinary prescription, the reference to "prescription", in the case of other medicinal products which may only be delivered to consumers in pharmacies, the notice "Pharmacy requirements",
11.: in the case of patterns of reference "Unsaleable pattern",
12.: the fact that medicinal products are to be kept inaccessible to children, unless they are medicinal waters,
13.: where appropriate, special precautions for the disposal of unused medicinal products or other special precautions to avoid risks to the environment,
14.: Use of medicinal products not subject to medical prescription.

Where the information referred to in the first sentence is also reproduced in another language, the same information must be provided in that language. Provision should also be made for the indication of the prescribed dosage, which shall not apply to the containers and ampoules referred to in the third sentence of paragraph 8 and to medicinal products intended to be used exclusively by health professionals. to be made. Medicinal products which are manufactured according to a homeopathic process technique and which are authorised in accordance with § 25 are to be labelled in addition with a reference to the homeopathic condition. Other information not required by a Regulation of the European Community or of the European Union or already authorised under such a Regulation shall be admissible in so far as it is used in the application of the medicinal product in question. (1a) (omitted) (1b) For medicinal products intended for use in humans, the name of the medicinal product shall be considered to be related to the medicinal product used in humans, and the following conditions are considered to be related to the medicinal product used in humans. on the outer envelopes, also in Braille. The other information on the pharmaceutical form referred to in the first sentence of paragraph 1 and on the category of persons to which the medicinal product is intended shall not be included in the blind text, even if such information is given in the name of the person concerned. are included. Sentence 1 shall not apply to medicinal products;

1.: which are intended to be used exclusively by health professionals, or
2.: which are placed on the market in containers of no more than 20 millilitres of volume or of a content of not more than 20 grams.

(2) There are also warnings to indicate to consumers certain storage instructions and storage instructions intended for professionals, in so far as this is necessary according to the state of the scientific findings or by conditions of the (3) In the case of sera, the type of living being from which they are obtained is also the host system which is used for viral propagation. (4) For medicinal products entered in the Register of homeopathic medicinal products, In the case of medicinal products, the following information shall be provided in place of the information referred to in the first sentence of paragraph 1 (1) to (14) and in addition to the clearly visible indication 'homeopathic medicinal product':

1.: Substances according to the type and quantity and the degree of dilution, using the symbols from the officially used pharmacopoeias; the scientific name of the original substance may be supplemented by an invented name,
2.: the name and address of the marketing authorisation holder and, where available, its local representative,
3.: the nature of the application,
4.: Expiry date; paragraph 1, first sentence, No. 9 and paragraph 7 shall apply;
5.: the pharmaceutical form,
6.: the content by weight, volume of space or number of pieces,
7.: Notice that medicinal products are to be kept inaccessible to children, other special precautions for storage and warnings, including further information, to the extent that they are necessary for safe use or after paragraph 1 2 are required;
8.: batch name,
9.: Registration number with the abbreviation "Reg. -No." and the indication "Registered homeopathic medicinal product, therefore without indication of a therapeutic indication",
10.: an indication to the user to seek medical advice in the course of the application of the medicinal product,
11.: in the case of medicinal products which may only be delivered to consumers in pharmacies, the reference "pharmacies",
12.: in the case of patterns of reference "Unsaleable pattern".

Sentence 1 shall apply in accordance with medicinal products exempted from registration pursuant to § 38 (1) sentence 3; paragraph 1b shall not apply. (4a) In the case of traditional herbal medicinal products according to § 39a, in addition to the particulars referred to in paragraph 1, the following indications are included:

1.: The medicinal product is a traditional medicinal product which is registered exclusively on the basis of long-term application for the field of application; and
2.: the user should consult a doctor or other qualified person who is active in a medical profession in the event of persistent symptoms of the disease or the occurrence of side effects other than those mentioned in the Package Leaflet.

The registration number referred to in the first sentence of paragraph 1 shall replace the registration number with the abbreviation "Reg. -Nr.". (5) In the case of medicinal products intended for use in animals, paragraphs 1 and 1a shall apply with the proviso that, instead of the particulars referred to in in paragraph 1, points 1 to 14 and paragraph 1a, the following information shall be provided:

1.: the name of the medicinal product, followed by the indication of the strength, the pharmaceutical form and the animal species, unless these particulars are already included in the name; if the medicinal product contains only one active substance, the international the short name of the World Health Organisation, or, where such a name does not exist, the common name, unless the indication of the active substance is already included in the name,
2.: the active substances according to the type and quantity and other ingredients according to the species, to the extent that this is ordered by the competent federal authority in accordance with § 28 (2) (1) or by means of legal regulation pursuant to Section 12 (1) (4), also in connection with (2) or in accordance with Article 36 (1),
3.: the batch designation,
4.: the approval number, with the abbreviation "Zul. -Nr.",
5.: the name or business name and address of the marketing authorisation holder and, where available, the name of the local representative appointed by him,
6.: the animal species in which the medicinal product is to be used,
7.: the nature of the application,
8.: the withdrawal period, in the case of medicinal products intended for use in animals used for the production of foodstuffs,
9.: the expiry date referred to in paragraph 7;
10.: where necessary, special precautions for the disposal of unused medicinal products,
11.: the indication that medicinal products are to be kept inaccessible to children, other special precautions for storage and warning, including further information, where necessary for safe use or after: referred to in paragraph 2,
12.: the indication "for animals",
13.: the pharmaceutical form,
14.: the content by weight, volume of space or number of pieces,
15.: in the case of medicinal products which may only be supplied on veterinary prescription, the reference to "prescription", in the case of other medicinal products which may only be supplied to the consumer in pharmacies, the reference "liable to pharmacies",
16.: in the case of patterns of reference "Unsaleable pattern".

Medicinal products intended for use in animals entered in the Register of homeopathic medicinal products shall be accompanied by the clearly visible indication 'homeopathic medicinal product'; instead of the information provided for in the first sentence of the first sentence of the first subparagraph, the following shall be replaced by the following: the information referred to in the first sentence of paragraph 4, points 1, 9 and 10. Sentences 1 and 2 shall apply in accordance with medicinal products exempted from registration pursuant to § 38 (1) sentence 3 or § 60 (1) of the Regulation. In the case of traditional herbal medicinal products for use in animals, the registration number shall be replaced by the abbreviation "Reg. no." instead of the indication provided for in the first sentence of the first sentence of paragraph 4; the information referred to in the first sentence of paragraph 4 (1) shall also be replaced by the following: of the application in animals referred to in point 2. The particulars referred to in points 13 and 14 of the first sentence shall only be available on the outer packaging provided that there is an outer covering. (6) The following shall apply to the description of the components:

1.: For the purposes of the description of the species, the international abbreviation names of the World Health Organisation or, in so far as such names are not present, are to be used in common scientific names; the Federal Institute for Drugs and In agreement with the Paul-Ehrlich-Institut and the Federal Office for Consumer Protection and Food Safety, medical products shall determine the names to be used and publish them in a database according to § 67a;
2.: Units of measurement shall be used to describe the quantity; if biological units or other information on the value are scientifically common, they shall be used.

(7) The expiry date shall be indicated by month and year. (8) Blister packs shall be provided with the name or company of the marketing authorisation holder, the name of the medicinal product, the name of the batch and the expiry date. The name and company of a parallel importer can be omitted. In the case of containers holding no more than 10 millilitres of nominal quantities and in the case of ampoules containing only one unit of use, the particulars referred to in paragraphs 1, 2 to 5 need only be made on the external envelopes; however, it is necessary to: at least the particulars referred to in the first sentence of paragraph 1, point 2, first half-sentence, 4, 6, 7, 9 and, in accordance with paragraphs 3 and 5, first sentence 1, points 1, 3, 7, 9, 12, 14 and the use of appropriate abbreviations shall be used for the containers and ampoules. Sentence 3 shall also be applied to small containers other than those referred to therein, provided that different requirements are applied to small containers in accordance with § 25b. (8a) For fresh plasma preparations and preparations made from blood cells at least the information referred to in the first sentence of paragraph 1, point 1, 2, without the indication of the strength, pharmaceutical form and group of persons, points 3, 4, 6, 7 and 9, and the description and volume of the anticoagulant and, where available, the Additive solution, the storage temperature, the blood group and in the case of allogenic preparations from red In addition, the rhesus formula, in the case of platelet concentrates and autologous preparations of red blood cells, in addition to the rhesus factor, are given in addition to the rhesus formula. In the case of autologous blood preparations, the indication "Only for autologous blood transfusion" must be made and an additional indication of the recipient must be given in autologous and directed blood preparations. (8b) For tissue preparations, at least the information referred to in the first and second sentences of paragraph 1, without specifying the strength, the pharmaceutical form and the category of persons, the number 3 or the approval number, with the abbreviation "Gen. No", points 4, 6 and 9, and the indication "biological hazard" in the case of the established infectivity. In the case of autologous tissue preparations, the indication "Only for autologous application" must be made and, in the case of autologous and directed tissue preparations, an additional indication must be given to the recipient. (9) In the case of the information provided for in paragraphs 1 to 5 may be used in the transport of medicinal products with the usual abbreviations. The company referred to in paragraph 1 (1) may be abbreviated, provided that the company can be identified from the abbreviation in general. (10) For medicinal products intended for use in animals and for clinical testing or testing of residues, paragraph 5 shall be taken. Paragraph 1, points 1, 3, 5, 7, 8, 13 and 14, and paragraphs 8 and 9, insofar as they relate to them, shall apply. These medicinal products shall, where appropriate, be accompanied by the indication "intended for clinical trial" or "intended for the examination of residues". Press packs must be marked with the name, the batch name and the reference to the second sentence. (11) Subquantities taken from finished medicinal products intended for use in humans may be given only with a label , which shall be at least equal to the requirements of paragraph 8, first sentence. Paragraph 1b shall not apply.

Footnote

(+ + + § 10 (1): For application, see Section 109 (1) + + +) Unofficial table of contents

Section 11 Package Leaflet

(1) Ready-to-use medicinal products which are medicinal products within the meaning of Article 2 (1) or (2) (1) and which are not intended for clinical examination or residue testing or which are exempted from the obligation to be granted pursuant to section 21 (2) 1a (1b) or (6) of this Regulation shall be permitted in the The scope of this law shall be placed on the market only with a package leaflet which bears the heading "leaflet" and the following information in the following order in general, in German, in good condition Legible font and in accordance with the information according to § 11a must be included:

1.

for identification of the medicinal product:

a): the name of the medicinal product, Section 10 (1), first sentence, No 2 shall apply,
b): the substance or indication group or the mode of action;

2.

the fields of application;

3.

a list of information that must be known prior to taking the medicine:

a): contra-indications,
b): appropriate precautions for use,
c): Interactions with other medicinal products or other means, in so far as they may affect the effect of the medicinal product,
d): Warnings, in particular as far as this is ordered by the competent federal authority pursuant to § 28 (2) no. 2 or by means of a legal regulation pursuant to § 12 (1) no. 3;

4.

the instructions required for a proper application to

a): Dosage,
b): the nature of the application,
c): the frequency of administration, if necessary indicating the exact date on which the medicinal product can or must be administered,
, and, where necessary and depending on the type of medicinal product,
d): the duration of the treatment, if it is to be determined,
e): advice on the case of overdose, the discontinuation of the dose or any indication of the risk of undesirable consequences of the sedimensiation,
f): the explicit recommendation to consult the doctor or pharmacist on matters relating to the clarification of the application;

5.

a description of the adverse reactions which may occur in the intended use of the medicinal product; any countermeasures to be taken in the case of adverse reactions, to the extent that this is necessary according to the state of scientific knowledge; any medicinal product intended for use in human beings should be included in the standard text, which expressly calls on patients to have any adverse reaction to their physicians, pharmacists, relatives of Health professions or directly to the competent federal authority , where the notification can be made in any form, in particular electronic means;

6.

an indication of the expiry date stated on the packaging;

a): warning against using the medicine at the end of this date,
b): as far as necessary, special precautions for storage and storage, after opening the container or after preparation by the user of the ready-to-use preparation,
c): if necessary, warning of certain visible signs that the medicinal product is no longer to be used,
d): Full qualitative composition according to active substances and other ingredients as well as quantitative composition according to active substances using common names for each pharmaceutical form of the medicinal product, section 10 (6) application,
e): the pharmaceutical form and the content by weight, the amount of space or the number of units for each pharmaceutical form,
f): the name and address of the marketing authorisation holder and, where available, its local representative,
g): the name and address of the manufacturer or the importer who has released the medicinal product for the manufacture of the finished product;

7.

in the case of a medicinal product which is authorised under other names in other Member States of the European Union in accordance with Articles 28 to 39 of Directive 2001 /83/EC, a list of the medicinal products in the Member States approved names;

8.

the date of the last revision of the package leaflet.

For medicinal products intended for use in humans, and on the list referred to in Article 23 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the purposes of Authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 327, 30.4.2004, p. 1), as last amended by Regulation (EU) No 1027/2012 (OJ L 136, 30.4.2004, p. 38), the following statement must also be made: 'This medicinal product is subject to additional monitoring.' This declaration must be preceded by a black symbol and shall be followed by a suitable standardised explanatory text in accordance with Article 23 (4) of Regulation (EC) No 726/2004. Explanatory statements relating to the terms referred to in the first sentence shall be admissible. Where the information referred to in the first sentence of the Package Leaflet is also reproduced in another language, the same information must be provided in that language. The first sentence shall not apply to medicinal products which do not require authorisation pursuant to Article 21 (2) (1) of an authorisation. Other information not required by a Regulation of the European Community or of the European Union or already authorised under such a Regulation shall be admissible in so far as it is used in the application of the medicinal product in question. It is important for patients to be informed of health information and not to contradict the information provided for in § 11a. In the case of the information referred to in the first sentence of 1 (3) (a) to (d), where this is necessary according to the state of scientific knowledge, the specific situation of certain categories of persons, such as children, pregnant women or breastfeeding women, shall be: to enter the elderly or persons with specific diseases and, where necessary, to indicate the potential effects of the application on the ability to drive or the ability to operate certain machines. The holder of the authorisation shall be obliged to keep the package leaflet up to the latest scientific knowledge, including the conclusions of assessments and the recommendations made on the basis of the recommendations adopted pursuant to Article 26 of Regulation (EC) No A sample of the package leaflet and amended versions shall be sent without delay to the competent authority of the Federal Republic of Germany, unless the medicinal product is provided by the competent authority. Authorisation or registration is granted. (1b) The sentence referred to in paragraph 1 (2) In the package leaflet, there are also references to components whose knowledge of an effective and harmless Use of the medicinal product is required and certain storage instructions must be provided for the consumer, insofar as this is necessary according to the state of the scientific findings or by the competent federal authority pursuant to section 28 (2) no. 2 or prescribed by law (2a) In the case of radioactive medicinal products, paragraph 1 shall apply in accordance with the proviso that the precautions to be taken by the user and the patient during the preparation and administration of the medicinal product are to be taken; and special precautions for the disposal of the transport container and unused medicinal product. (3) In the case of medicinal products entered in the Register of homeopathic medicinal products, paragraph 1 shall apply in accordance with the condition that the medicinal products listed in the Register for homeopathic medicinal products are listed in § 10 (4), except for the indication of the The name and address of the manufacturer who has released the medicinal product for the placing on the market, and the name and address of the manufacturer who has released the product for the placing on the market, shall be indicated in so far as it is This is not the pharmaceutical entrepre. Sentence 1 shall apply in accordance with medicinal products exempted from registration in accordance with § 38 (1) sentence 3. (3a) In Sera, paragraph 1 shall apply accordingly, with the proviso that the type of living being from which they are obtained also applies to virusimpfsubstances. A host system which has served to increase the virus and, in the case of medicinal products from human blood plasma, to be fractionated to indicate the country of origin of the blood plasma. (3b) In the case of traditional herbal medicinal products according to § 39a, paragraph 1 shall apply accordingly: the proviso that the information referred to in the first sentence of paragraph 1 shall be given in the form of the information provided that the Medicinal product is a traditional medicinal product which is registered exclusively on the basis of a long-standing application for the field of application. In addition, the package leaflet must include the notice pursuant to § 10 (4a) sentence 1 no. 2. (3c) The holder of the authorisation shall ensure that the package leaflet, at the request of patients ' organisations, for medicinal products intended for use in the case of medicinal products, (3d) In the case of medicinal waters, without prejudice to the obligations referred to in paragraph 2, the information referred to in the first sentence of paragraph 1 (3) (b), (4) (e) and (3) of the Regulation may be available. f, No 5, insofar as the reference indicated therein is required, and No 6 (c) is deleted. In the case of medicinal waters, it may also be possible to deviate from the order laid down in paragraph 1. (4) In the case of medicinal products intended for use in animals, paragraph 1 shall apply with the proviso that, instead of the particulars referred to in the first sentence of paragraph 1, the following shall apply: The information referred to in the second sentence of paragraph 1 and 3 in the following order must be made public in the German language, in good legible writing and in accordance with the information given in section 11a:

1.: the name and address of the marketing authorisation holder, if any, of his local representative and of the manufacturer who released the medicinal product for the placing on the market;
2.: the name of the medicinal product, followed by the indication of the strength and pharmaceutical form; the common name of the active substance is listed if the medicinal product contains only a single active substance and its name is a invented name; Medicinal products which, under other names in other Member States of the European Union, in accordance with Articles 31 to 43 of Directive 2001 /82/EC of the European Parliament and of the Council establishing a Community code relating to veterinary medicinal products of 6 November 2001 (OJ C 197, 12.7.2001 EC No 1), as amended by Directive 2004 /28/EC (OJ L 311, 28.11.2004, p. EU No 58), which authorises the placing on the market of a list of names approved in each Member State;
3.: fields of application;
4.: Counter-indications and side effects, to the extent that such information is necessary for the application; for this purpose, no information can be given, the indication "no known" is to be used; the indication that the user or keeper is to be requested, to notify the veterinarian or pharmacist of any adverse reaction not listed in the package leaflet;
5.: Animal species for which the medicinal product is intended, dosage instructions for each animal species, the manner in which the medicinal product is used, as far as necessary for the purposes of its intended use;
6.: Withdrawal period in the case of medicinal products intended for use in animals used for the production of foodstuffs; whereas compliance with a waiting period is not necessary, this shall be indicated;
7.: special precautions for storage;
8.: special warnings, in particular in so far as this is ordered by the competent authority of the federal authority or is required by means of a legal regulation;
9.: in so far as this is necessary in accordance with the state of scientific knowledge, special precautions for the disposal of unused medicinal products or other special precautions to protect the environment; avoid.

The date of the last revision of the Package Leaflet shall be indicated. In the case of pre-mixtures of medicinal products, it is necessary to include indications for the appropriate production of medicated feedingstuffs and information on the duration of the shelf life of medicated feedingstuffs. Further information shall be admissible in so far as they are related to the use of the medicinal product, which are important for the user or keeper of the animals and do not contradict the information provided for in § 11a. In the case of medicinal products for use in animals entered in the Register of homeopathic medicinal products, or exempted from registration pursuant to Section 38 (1) sentence 3 or Article 60 (1), the rates 1, 2 and 4 shall apply mutatis , with the proviso that the information required by Article 10 (4) is to be provided, with the exception of the indication of the batch number, the date of the decay date and the indication required for samples. In the case of traditional herbal medicinal products for use in animals, in addition to the information referred to in the first sentence of paragraph 3b, an indication of the application in animals shall be given in accordance with Article 10 (4a), first sentence, point 2. (5) The information referred to in point 3 (a) and (c) and (5) shall not be used, the reference shall not be used for the information referred to in paragraph 3. Where further information is provided on the package leaflet, it shall be clearly set out and delimited by the information referred to in paragraphs 1 to 4. (6) The package leaflet may be omitted if the information required under paragraphs 1 to 4 is available on: the container or on the outer casing. Paragraph 5 shall apply. (7) Subquantities taken from finished medicinal products intended for use in humans may only be delivered together with a copy of the package leaflet prescribed for the medicinal product for use in the finished product. . The first sentence of paragraph 6 shall apply accordingly. By way of derogation from the first sentence, in the case of the periodic release of partial quantities taken from ready-to-use medicinal products in the context of a permanent medication, copies must be made in new, patient-individually compiled blisters of the quantities for each of the following: Package leaflets shall not be re-attached until they have been modified in relation to the last appended claims.

Footnote

Section 11 para. 1 sentence 1 Input sentence italic print: would have to be correct " No. 1a, 1b ". Unofficial table of contents

Section 11a Technical information

(1) The pharmaceutical operator shall be obliged to provide doctors, dentists, veterinary surgeons, pharmacists and, in the case of medicinal products not subject to medical prescription, other persons who are professionally engaged in the exercise of medicine or dentistry, for: Medicinal products for manufacture which are subject to the authorisation requirement or are exempted from authorisation, medicinal products within the meaning of Article 2 (1) or (2) (1) and for transport outside pharmacies shall not be released, subject to a request for a Information for professional circles (subject information) should be provided. It must bear the heading 'Summary of information' and contain the following information in a legible font, in accordance with the Summary of Product Characteristics approved in the framework of the authorisation, and in the order shown below:

1.

the name of the medicinal product, followed by the strength and the pharmaceutical form;

2.

qualitative and quantitative composition according to active substances and the other ingredients, the knowledge of which is necessary for the proper administration of the product, including the common or chemical name; § 10 (6) application;

3.

the pharmaceutical form;

4.

Clinical particulars:

a): fields of application,
b): Dosage and type of use in adults and, where the medicinal product is intended for use in children, in children,
c): contra-indications,
d): special warnings and precautions for use and for immunological medicinal products, all special precautions taken by persons who come into contact with immunological medicinal products and by persons who make these medicinal products patients, as well as precautions to be taken by the patient, in so far as this is ordered by the competent authority of the competent authority in accordance with § 28 (2) (1) (a) or required by a regulation of the law,
e): Interactions with other medicinal products or other means, in so far as they may affect the effect of the medicinal product,
f): use in pregnancy and lactation,
g): the effects on the ability to operate machinery and drive motor vehicles,
h): Adverse reactions when used in intended use,
i): Overdose: symptoms, emergency measures, antidoers;

5.

pharmacological properties:

a): pharmacodynamic properties,
b): pharmacokinetic properties,
c): pre-clinical safety data;

6.

Pharmaceutical particulars:

a): List of excipients,
b): Main incompatibilities,
c): the shelf-life and, where necessary, the shelf-life in the manufacture of a ready-to-use preparation of the medicinal product or, in the case of the first opening of the container,
d): special precautions for storage,
e): the nature and contents of the container;
f): special precautions for the disposal of broken medicinal products or of waste materials derived therefrom, in order to avoid risks to the environment;

7.

authorisation holder;

8.

Marketing authorisation number;

9.

the date of issue of the authorisation or the renewal of the authorisation;

10.

Date of revision of the technical information.

In the case of all medicinal products intended for use in humans, a standard text should be included which expressly calls on health professionals to ensure that any incident of a side-effect to the competent authority has been taken into account. The Federal Supreme Authority shall be able to report the notification in any form, in particular electronically. For medicinal products intended for use in humans and on the list referred to in Article 23 of Regulation (EC) No 726/2004, the following statement must also be made: ' This medicinal product shall be subject to an additional Monitoring. " This declaration must be preceded by a black symbol and shall be followed by a suitable standardised explanatory text in accordance with Article 23 (4) of Regulation (EC) No 726/2004. Other information not required by a Regulation of the European Community or of the European Union or already authorised under this Regulation shall be permitted if it relates to the use of the medicinal product in the context of: , and shall not be contrary to the information provided for in the second sentence; they must be clearly dismissed and delimited by the information provided for in the second sentence. The first sentence shall not apply to medicinal products which are not subject to authorization pursuant to Article 21 (2) or which are manufactured according to a homeopathic process technology. The holder of the authorisation shall be obliged to keep the information subject to the current scientific knowledge, including the conclusions of assessments and the recommendations made in accordance with Article 26 of the Regulation (EC) No 726/2004, the European Internet portal for medicinal products has been published. The standard texts required according to sentences 3 and 5 are made known by the competent federal authority in the Federal Gazette. (1a) Sera is also the type of living being from which they are obtained, the host system for virusimpfsubstances, which is the In the case of medicinal products derived from human plasma for fractionation, the country of origin of the blood plasma must be indicated. (1b) For radiolabeled medicinal products, the details of the internal radiation dosimetry shall also be provided. detailed instructions for the extemporaneous preparation and the Quality control for this preparation and, where necessary, the maximum storage period during which an intermediate preparation, such as an eluate or the ready-to-use medicinal product, complies with its specifications. (1c) For medicinal products which: for use in animals, the information provided under point 4 "clinical particulars" shall contain the following information:

a): Indication of each target species in which the medicinal product is to be used,
b): information on the application, with particular reference to target species,
c): contra-indications,
d): special warnings concerning each target species,
e): special warnings for use, including special safety precautions to be taken by the person to be administered,
f): Adverse reactions (frequency and severity),
g): use in the case of pregnancy, eggs or milk production,
h): Interactions with other medicinal products and other forms of interaction,
i): Dosage and method of administration,
j): Overdose: emergency measures, symptoms, antidoers, if necessary,
k): Waiting period for all food products, including those for which there is no waiting period.

The information referred to in the second sentence of paragraph 5 (5) (c) shall be deleted. (1d) In the case of medicinal products which may only be given on medical, dental or veterinary prescription, the reference to "prescription only", in the case of narcotic drugs, shall also be deleted. Note "Narcotic drugs", in the case of other medicinal products which may only be delivered to consumers in pharmacies, the reference "Pharmacy requirements"; in the case of medicinal products containing a substance or preparation pursuant to § 48 (1), first sentence, point 3 (1e) For authorisations of Medicinal products according to § 24b may be omitted from the information referred to in paragraph 1 relating to fields of application, dosages or other objects of a patent which are still subject to patent law at the time of placing on the market. (2) The pharmaceutical Entrepreneurs are obliged to make the changes in the subject information relevant to the therapy available to the professional circles in a suitable form. The competent federal authority may, where necessary, determine the form in which the changes are to be made available to all or certain professional circles. (3) A model of the subject information and amended versions shall be the (4) The obligation laid down in the first sentence of paragraph 1 may be made in the case of medicinal products exclusively administered by health professionals. , including the inclusion of the particulars referred to in the second sentence of paragraph 1 in the package leaflet . The package leaflet must be provided with the heading "Package Leaflet and subject information". Unofficial table of contents

§ 12 authorisation of the labelling, package leaflet and pack sizes

(1) The Federal Ministry of Economics and Technology shall be authorized, in agreement with the Federal Ministry of Economics and Technology, by means of a regulation with the consent of the Federal Council

1.

extend the provisions of § § 10 to 11a to other medicinal products and the scope of the subject-specific information to further information,

2.

require the information referred to in § § 10 and 11 to be communicated to the consumer in a different way,

3.

for certain medicinal products or groups of medicinal products to prescribe warning signs, warning signs or marks

a): the packaging, the outer wrapping, the package leaflet, or
b): of the specialist information

shall be affixed,

4.

to indicate that certain components are to be indicated on the containers and on the outer envelopes, or that they are to be indicated in the package leaflet,

in so far as it is necessary to ensure the proper handling of medicinal products and their proper application within the scope of this Act, and in order to ensure a direct or indirect risk to human or animal health as a result of a lack of information. (1a) The Federal Ministry shall also be authorized, by means of a regulation, with the consent of the Federal Council, for substances or preparations made of substances in the indication of containers and external Envelopes or in the package leaflet or in the specialist information to allow for summary names in so far as it is not an effective component and where there is no risk of direct or indirect exposure to human or animal health as a result of a lack of information. (1b) Federal Ministry of Economics and Technology is also authorized, in agreement with the Federal Ministry of Economics and Technology, by legal regulation with the consent of the Federal Council

1.: the labelling of the starting materials intended for the manufacture of medicinal products; and
2.: the labelling of medicinal products intended for clinical trials;

, in so far as it is necessary to prevent a direct or indirect risk to the health of humans or animals which may occur as a result of a lack of labelling. (2) Insofar as these are medicinal products which are used in the case of: In the cases referred to in paragraph 1, 1a, 1b or 3, the Federal Ministry of Food, Agriculture and Consumer Protection shall replace the Federal Ministry for Food, Agriculture and Consumer Protection in accordance with the provisions of this Regulation, in agreement with the Federal Ministry of Food, Agriculture and Consumer Protection. Federal Ministry. The legal regulation referred to in paragraphs 1, 1a or 1b shall be adopted in agreement with the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, as far as radioactive medicinal products and medicinal products are concerned, in the manufacture of which ionising medicinal products are to be ionised. Radiation shall be used, or in the cases referred to in paragraph 1, point 3, warnings, warning signs or identification marks with regard to information pursuant to § 10 (1) sentence 1 (13) or (5) sentence 1 (1) (10), § 11 (4) sentence 1 (9) or (11a) (1) sentence 2 No 6 (f) are required. (3) The Federal Ministry is also authorized to Regulation without the consent of the Federal Council to determine that medicinal products may be placed on the market only in certain pack sizes and from the pharmaceutical companies on the containers or, where used, on the outer packaging Envelopes must be marked accordingly. The determination of these pack sizes is carried out for certain active substances and takes into account the fields of application, the duration of the application and the form of administration. In the determination of the pack sizes, there is basically a three-division basis:

1.: Packs for short duration of use or compatibility tests,
2.: packings for average duration of use,
3.: Packs for longer application duration.

Third Section
Manufacture of medicinal products

Unofficial table of contents

§ 13 Manufacturing authorisation

(1) Who

1.: medicinal products within the meaning of Article 2 (1) or (2) (1),
2.: Test sera or test antigens,
3.: active substances which are of human, animal or microbial origin or which are produced by genetic engineering; or
4.: other substances of human origin intended for the manufacture of medicinal products

A commercial or professional manufacture requires the authorisation of the competent authority. The same shall apply to legal persons, non-legally competent associations and companies of civil law who manufacture medicinal products for the purpose of delivery to their members. The first sentence shall be applied to an examination on the basis of which the release of the medicinal product for placing on the market is declared. Article 14 (4) shall remain unaffected. (1a) Paragraph 1 shall not apply to:

1.: tissue within the meaning of Section 1a (4) of the Transplant Act, for which it requires permission in accordance with § 20b or § 20c,
2.: the extraction and laboratory examination of autologous blood for the production of biotechnologically processed tissue products, for which it is necessary to obtain permission in accordance with § 20b,
3.: tissue preparations for which a permit according to § 20c is required,
4.: the reconstitution, unless it is a medicinal product intended for clinical trial.

(2) A permit referred to in paragraph 1 shall not be required

1.

the holder of a pharmacy for the manufacture of medicinal products in the normal course of pharmacies, or for reconstitution or packaging, including the labelling of medicinal products intended for clinical trial, provided that: this corresponds to the test plan,

2.

the institution of a hospital where it may issue medicinal products in accordance with the law on pharmacy, or for reconstitution or packaging, including the labelling of medicinal products intended for clinical trial, provided that: this corresponds to the test plan,

3.

the veterinarian in the course of the establishment of a veterinary skin pharmacist for

a): the refilling, packaging or labelling of medicinal products in unaltered form,
b): the manufacture of medicinal products containing substances or preparations of such substances released exclusively for the purposes of transport outside pharmacies;
c): the manufacture of homeopathic medicinal products which, to the extent that they are intended for use in animals used for the production of foodstuffs, contain only active substances listed in the Annex to Regulation (EU) No 37/2010 as substances which are not necessary for the establishment of maximum quantities,
d): the preparation of medicinal products from a ready-to-use medicinal product and non-active medicinal products;
e): mixing ready-to-use pharmaceutical products for the immobilization of zoo, wild and farmed animals,

in so far as these activities are carried out for the animals treated by him,

4.

the wholesaler for the refilling, packaging or labelling of medicinal products in unaltered form, in so far as it is not intended to be packaged for the purpose of delivering to the consumer,

5.

the retailer, who has the expertise referred to in § 50, for the refilling, packaging or labelling of medicinal products for delivery in unaltered form directly to the consumer,

6.

the manufacturer of active substances intended for the manufacture of medicinal products which are produced according to a process technique described in the homeopathic part of the medicinal product.

(2a) The exceptions provided for in paragraph 2 shall not apply to the manufacture of blood preparations, tissue preparations, sera, vaccines, allergens, testers, test antigens, advanced therapy medicinal products, xenogens and radiopaceous medicinal products. Sentence 1 shall not apply to the bodies referred to in paragraph 2 (1) or (2), in so far as it is concerned:

1.: the refilling of the patient in an unaltered form, the packaging or identification of sera of non-human or animal origin which is authorised within the scope of this Act, or
2.: the reconstitution or refilling, packaging or labelling of medicinal products intended for clinical trial, provided that this corresponds to the test plan; or
3.: the production of test allergens

. The activities referred to in the second and third sentences of the second sentence shall be notified to the competent authority. (2b) The authorization referred to in paragraph 1 shall also not require a person who is a doctor or otherwise authorised to exercise the medicine in humans, to the extent that the medicinal products are under of their direct professional responsibility for the purpose of personal use in a particular patient. Sentence 1 shall not apply to:

1.: Advanced therapy medicinal products and xenogenic medicinal products, and
2.: Medicinal products intended for clinical trial, in so far as it is not only a reconstitution.

(2c) The first sentence of paragraph 2b shall apply to veterinarians as part of the operation of a veterinary medicinal product for the use of animals treated by them. (3) A medicinal product for the refilling of liquefied medicinal gases referred to in paragraph 1 in accordance with paragraph 1 of this Article shall be considered as The delivery container of a tank vehicle also includes the refilling of the liquefied medical gases in unaltered form from the delivery container of a tanker in containers that are at a hospital or other consumer (4) The decision on the granting of the permit shall be taken by the the competent authority of the country in which the establishment is or is to be located. In the case of blood preparations, tissue preparations, sera, vaccines, allergens, advanced therapy medicinal products, xenogenic medicinal products, genetically engineered medicinal products, and active substances and other medicinal products intended for the manufacture of medicinal products Substances which are of human, animal or microbial origin or which are produced by genetic engineering methods shall be taken by the competent federal authority in consultation with the competent authority. Unofficial table of contents

Section 14 Decision on manufacturing authorization

(1) The permission may only be refused if:

1.: does not exist at least one person with the knowledge of the material required in accordance with § 15 (knowledgeable person according to § 14), who is responsible for the activity referred to in § 19,
2.: (dropped)
3.: the knowledgeable person referred to in paragraph 1 or the applicant does not possess the reliability required for the performance of his duties,
4.: the knowledgeable person referred to in paragraph 1 is unable to comply with the obligations under which he is responsible,
5.: (dropped)
5a.: in establishments which manufacture medicated feedingstuffs from premixtures of medicinal products, the person who is entrusted with the supervision of the technical process of manufacture does not have sufficient knowledge and experience in the field of mixing technology; ,
5b.: the doctor, whose responsibility is followed by a pre-treatment of the donating person for the separation of blood stem cells or other blood components, does not have the necessary expertise,
5c.: Contrary to § 4 sentence 1 no. 2 of the Transfusion Act, no senior medical person has been appointed or that person does not possess the required material according to the status of medical science or contrary to § 4 sentence 1 no. 3 of the Transfusion Act Transfusion law, when carrying out the removal of a person from a person, is not a medical person,
6.: appropriate rooms and facilities for the intended manufacture, testing and storage of the medicinal products are not available, or
6a.: the manufacturer is not in a position to ensure that the manufacture or testing of the medicinal products according to the state of science and technology and in the production of blood and blood components, in addition to the provisions of the second Section of the Transfusion Act.

(2) (a) (2a) The senior medical person according to § 4 sentence 1 no. 2 of the transfusion law may at the same time be the knowledgeable person under paragraph 1 (1) no. 1. (2b) (omitted) (3) (omitted) (4) By way of derogation from paragraph 1, no. 6 may be partially outside the establishment of the medicinal product manufacturer

1.: the manufacture of medicinal products for clinical trials in the human person in a pharmacist,
2.: the modification of the date of failure of medicinal products for clinical trial in a laboratory by an authorised person of the manufacturer, provided that such medicinal products are intended solely for use in this test site,
3.: the examination of medicinal products in authorised establishments,
4.: the collection or testing, including laboratory testing of donor samples, of substances of human origin intended for the production of medicinal products, with the exception of tissue, in other establishments or establishments,

which do not require their own permission, are carried out in the presence of suitable spaces and facilities and ensure that the production and testing of the state of the art is carried out according to the state of science and technology, and that the (5) In the event of complaints submitted to the documents submitted, the applicant shall be given the opportunity to remedy deficiencies within a reasonable period of time. If the defect is not remedied, the granting of permission shall be refused. Unofficial table of contents

Section 15

(1) The proof of the required expertise as a knowledgeable person in accordance with § 14 shall be provided by

1.: the Approbation as a pharmacist or
2.: the certificate of examination of a university degree in pharmacy, chemistry, biology, human or veterinary medicine after completed university studies

(2) In the cases referred to in paragraph 1 (2), the competent authority must be shown to be able to demonstrate that the competent authority has a right to that the university studies have included theoretical and practical teaching in at least the following basic subjects, and that there is sufficient knowledge of this:
Experimental Physics
General and inorganic chemistry
Organic Chemistry
Analytical chemistry
Pharmaceutical chemistry
Biochemistry
Physiology
Microbiology
Pharmacology
Pharmaceutical technology
Toxicology
Pharmaceutical biology.
Theoretical and practical teaching and sufficient knowledge can be obtained from a university, even after university studies have been completed within the meaning of paragraph 1 (2) and can be proven by examination. (3) For the preparation and Paragraph 2 shall not apply to the examination of blood preparations, sera of human or animal origin, vaccines, allergens, test sera and test antigens. In place of the practical activities referred to in paragraph 1, a minimum of three years ' activity in the field of medical serology or medical microbiology must be demonstrated. By way of derogation from the second sentence, the practical activity referred to in paragraph 1 shall be replaced by

1.: for blood preparations from blood plasma for fractionation, for at least three years in the production or testing in plasma-processing plants with manufacturing authorization and in addition, a minimum of six months ' experience in the Transfusion medicine or medical microbiology, virology, hygiene or analytics,
2.: For blood preparations made from blood cells, preparations of fresh plasma and for active substances and blood components for the preparation of blood preparations, a transfusion medical experience of at least two years, which is applied to all areas of production and audit,
3.: in the case of autologous blood preparations, a transfusion medical experience of at least six months or a one-year activity in the manufacture of autologous blood preparations,
4.: at least two years of experience in this activity, in particular in the underlying technology, for blood stem cell preparations,

can be detected. For the pre-treatment of persons for the separation of blood stem cells or other blood components, the person responsible must provide evidence of sufficient knowledge and at least two years of experience in this activity. In the case of packaging and marking, the conditions set out in paragraph 1. (3a) shall remain in place for the manufacture and testing of medicinal products for advanced therapy, xenogenic medicinal products, tissue preparations, in-vivo diagnostic medicinal products Paragraph 2 shall not apply by means of marker genes, radioactive medicinal products and active substances. Instead of the practical activities referred to in paragraph 1,

1.: for gene therapeutics and medicinal products for in vivo diagnostics by means of marker genes for at least two years in a medically relevant field, in particular genetic engineering, microbiology, cell biology, virology or the Molecular biology,
2.: for somatic cell therapeutics and biotechnologically processed tissue products, for at least two years in a medically relevant field, in particular genetic engineering, microbiology, cell biology, virology or the Molecular biology,
3.: in the case of xenogenic medicinal products, at least three years of activity in a medically relevant area, comprising at least two years of activity, in particular in an area of the areas referred to in paragraph 1,
4.: in the case of tissue preparations, for at least two years in the field of the manufacture and testing of such medicinal products in establishments and establishments which require a manufacturing authorization under this law or an authorisation under the law of the European Union,
5.: in the case of radiopharmaceuticals, for at least three years in the field of nuclear medicine or radiopharmaceutical chemistry; and
6.: in the case of active substances other than those referred to in the third sentence of paragraph 3, point 2, an activity of at least two years in the manufacture or testing of active substances

(4) The practical activity referred to in paragraph 1 must be carried out in an establishment for which a licence for the manufacture of medicinal products by a Member State of the European Union, another State Party to the Agreement has been granted on the European Economic Area or by a State with which a mutual recognition of allowances is agreed in accordance with Section 72a, first sentence, No. 1. (5) The practical activity is not required for the manufacture of Medicated feedingstuffs derived from medicinal products; paragraph 2 shall not apply: Application. Unofficial table of contents

Section 16 limitation of manufacturing authorization

The licence shall be granted to the applicant for a given plant and for certain medicinal products and forms of administration, in the cases of § 14 (4) also for a particular establishment of the authorised representative or of the other holding. Where permission is granted for the examination of medicinal products or active substances, the nature of the test shall be listed. Unofficial table of contents

Section 17 Deadlines for granting

(1) The competent authority shall take a decision on the application for authorisation within a period of three months. (2) An authorisation holder requests the amendment of the authorisation in respect of the medicinal products to be produced. or in relation to the rooms and facilities within the meaning of section 14 (1) (6), the Authority shall take the decision within a period of one month. In the event of an exception, the period shall be extended by a further two months. The applicant must be informed of the reasons before the expiry of the deadline. (3) If the authority gives the applicant an opportunity to remedy shortcomings in accordance with § 14 para. 5, the time-limits until the deficiencies or until the expiry of the event shall be remedied. of the time limit laid down in accordance with section 14 (5). The inhibition shall begin with the day on which the applicant is notified of the request to remedy the deficiencies. Unofficial table of contents

Section 18 Revocation, revocation, revocation

(1) The permission shall be withdrawn if it becomes known retrospectively that one of the reasons for the failure to grant has been provided for in accordance with Section 14 (1) of the Grant. If one of the reasons for the failure has subsequently occurred, it shall be revoked; in place of the revocation, the revocation of the permit may also be ordered. (2) The competent authority may provisionally order that the manufacture of a medicinal product be discontinued if the manufacturer fails to submit the evidence to be carried out for the production and testing. The provisional arrangement can be limited to one batch. Unofficial table of contents

Section 19 Responsibility

The competent person according to § 14 is responsible for the fact that each batch of the medicinal product has been manufactured and tested in accordance with the regulations on the marketing of medicinal products. It shall certify compliance with these provisions for each batch of medicinal products in a continuous register or a comparable document before they are placed on the market. Unofficial table of contents

§ 20 Display obligations

The holder of the licence shall notify the competent authority of any change to one of the particulars referred to in Article 14 (1), on presentation of the evidence provided by the competent authority. In the event of an unforeseen change of the knowledgeable person in accordance with § 14, the notification shall be made immediately. Unofficial table of contents

Section 20a applicable to active substances and other substances

Section 13 (2) and (4) and § § 14 to 20 shall apply mutas to active substances and to substances of human origin intended for the manufacture of medicinal products, insofar as their manufacture or testing is required in accordance with § 13 para. 1 of the authorization. Unofficial table of contents

§ 20b Permission for the extraction of tissue and laboratory tests

(1) A body which, for use in humans, intends to acquire certain tissues within the meaning of Section 1a (4) of the Transplant Act (removal facility) or to carry out the laboratory tests required for the extraction, requires a Permission of the competent authority. The production referred to in the first sentence shall be the direct or extracorporeal removal of tissue, including any measures intended to obtain the tissue in a state capable of being worked or processed, to be clearly identified and to be obtained transport. Permission may only be refused if:

1.: an appropriately trained person with the necessary professional experience is not present, which, in so far as it is a removal facility, may at the same time be the medical person within the meaning of § 8d (1) sentence 1 of the Transplantation Act,
2.: other co-acting staff are not sufficiently qualified,
3.: appropriate spaces are not available for the respective tissue recovery or for the laboratory tests, or
4.: does not ensure that tissue recovery or laboratory tests are carried out in accordance with the state of medical science and technology and in accordance with the provisions of sections 2, 3 and 3a of the transplant law.

The competent authority may depart from a visit within the meaning of section 64 (3) sentence 2 before granting the permit under this provision. Permission shall be granted to the withdrawal facility by the competent authority for a given plant and for certain tissues and for the laboratory for a given plant and for certain activities. The competent authority may take part in the competent authority of the competent authority. (1a) § 20c (4) sentences 1 and 2 and paragraph 5 shall apply accordingly. (2) A separate permit referred to in paragraph 1 shall not require any person who is bound by these activities with a contractual relationship. a manufacturer or a worker who has a permit in accordance with § 13 or § 20c for the treatment or processing of tissue or tissue preparations. In such cases, the manufacturer or the processor shall indicate to the withdrawal facility or the laboratory of the competent authority for each of them, and shall attach the particulars and documents referred to in the third sentence of paragraph 1 to the display. At the end of one month after the notification referred to in the second sentence, the manufacturer or the processor shall notify the withdrawal facility or laboratory of the competent authority of the withdrawal facility, unless the equipment or laboratory for the removal equipment or laboratory is competent authority. In exceptional cases, the period after sentence 3 shall be extended for a further two months. The manufacturer or the processor shall be informed of this prior to the expiry of the period of time under the notification of the reasons. If the competent authority has objected, the time limits set out in sentences 3 and 4 shall be inhibited until the reason for the objection has been remedied. The provisions of the first sentence of paragraph 1 shall apply in accordance with the proviso that the authorization referred to in the first sentence of paragraph 1 shall be granted to the manufacturer or the processor. (3) The permission shall be withdrawn if it is subsequently known that one of the following shall be granted: The reason for failure referred to in the third sentence of paragraph 1 has been given in the case of grant. If any of these grounds of failure have subsequently occurred, the permission shall be revoked; in place of the revocation, the revocation of the permit may also be ordered. The competent authority may provisionally prohibit the production of tissue or laboratory tests if the removal equipment, laboratory or manufacturer or processors are responsible for the production of tissue or the laboratory tests. (4) Paragraphs 1 to 3 shall apply mutacally to the production and laboratory testing of autologous blood for the manufacture of biotechnologically processed tissue products. (5) The holder of the licence shall have the following: competent authority, any modification of the conditions referred to in the third sentence of paragraph 1 for: to give prior permission to the competent authority, subject to prior written permission, and to make the change before the competent authority has issued a written permit. In the event of an unforeseen change of the appropriately trained person in accordance with § 20b, the notification shall be made immediately. Unofficial table of contents

§ 20c Permission for the processing, preservation, testing, storage or placing on the market of tissue or tissue preparations

(1) a body which processes or processes tissues or tissue preparations which are not processed or processed by industrial processes and whose essential working or processing procedures are sufficiently known in the European Union, be conserved, examined, stored or placed on the market, and by way of derogation from § 13 (1) of a permit issued by the competent authority in accordance with the following provisions. This also applies with regard to tissue or tissue preparations whose working or processing methods are new, but comparable with a known method. The decision to grant permission shall be taken by the competent authority of the country in which the establishment is or is to be located, in consultation with the competent authority of the Federal Republic of Germany. (2) The permission may only be refused if:

1.: a person with the necessary expertise and experience referred to in paragraph 3 (responsible person pursuant to § 20c) is not present, who is responsible for ensuring that the tissue preparations and tissues are in accordance with the legislation in force, or processed, conserved, checked, stored or placed on the market;
2.: other co-acting staff are not sufficiently qualified,
3.: appropriate spaces and facilities are not available for the intended activities,
4.: is not ensured that the working or processing, including the marking, preservation and storage, as well as the state-of-the-art testing, shall be carried out, or
5.: a quality management system has not been established or kept up-to-date according to the principles of good professional practice.

By way of derogation from point 3 of the first sentence, outside the premises, the examination of tissues and tissue preparations in authorised establishments which do not require their own authorization may be carried out if appropriate spaces are used for this purpose, and Facilities are available and it is ensured that the examination is carried out according to the state of science and technology and that the responsible person can assume their responsibility in accordance with § 20c. (3) The proof of the required expertise of the responsible person in accordance with § 20c shall be provided by the certificate of a after-completed University studies in human medicine, biology, biochemistry or a study which has been recognised as equivalent, and at least two years ' practical work in the field of the processing of tissues or tissues Tissue preparations. (4) In the event of complaints submitted to the submitted documents, the applicant shall be given the opportunity to remedy deficiencies within a reasonable period of time. If the defect is not remedied, the granting of permission shall be refused. Permission shall be granted for a particular establishment and for certain tissues or tissue preparations. (5) The competent authority shall take a decision on the application for the grant of the permit within a period of three months. If a holder of the authorisation requests the change of authorisation, the authority shall take the decision within a period of one month. In exceptional cases, the period shall be extended by a further two months. The applicant shall be informed of this prior to the expiry of the period of time under the notification of the reasons. If the authority gives the applicant the opportunity to remedy shortcomings in accordance with the first sentence of paragraph 4, the time limits shall be suspended until the deficiencies or until the expiry of the time limit laid down in accordance with the first sentence of paragraph 4. The inhibition shall begin on the date on which the applicant is notified of the request to remedy the deficiencies. (6) The holder of the permit shall have any change to one of the particulars referred to in paragraph 2, presenting the evidence of the competent authority. to be notified in advance and may not make the change until the competent authority has given a written permit. In the event of an unforeseen change of the responsible person in accordance with § 20c, the notification shall be made without delay. (7) The permission shall be withdrawn if it is subsequently known that one of the reasons for the failure referred to in paragraph 2 in the case of grant . If any of these grounds of failure have subsequently occurred, the permission shall be revoked; in place of the revocation, the revocation of the permit may also be ordered. The third sentence of paragraph 1 shall apply accordingly. The competent authority may provisionally order the treatment or processing of tissue or tissue preparations to be discontinued if the worker or processor fails to submit the evidence to be carried out for the processing or processing. Where the working or processing of tissues or tissue preparations is discontinued, the working or processor shall ensure that fabric preparations and fabrics still stored are stored in a further quality-assured manner and that they are applied to other manufacturers, Processors or distributors shall be transferred with a permit pursuant to paragraph 1 or section 13 (1). This shall also apply to the data and information on the working or processing required for the tracing of these tissue preparations and tissues. Unofficial table of contents

Section 20d exception to the requirement for authorisation of tissue and tissue preparations

A licence pursuant to Section 20b (1) and § 20c (1) does not require a person who is a doctor or otherwise has the power to exercise the medicine in human beings and carries out the activities mentioned there, with the exception of the placing on the market, in order to obtain the tissue or to apply the tissue preparation in person to their patients. This does not apply to medicinal products intended for clinical trials.

Fourth Section
Authorisation of medicinal products

Unofficial table of contents

§ 21 Authorisation requirement

(1) Ready-to-use medicinal products which are medicinal products within the meaning of Article 2 (1) or (2) (1) may only be placed on the market within the scope of this Act if they are approved by the competent federal authority or if they are authorised by the competent federal authority. European Community or the European Union granting a marketing authorisation in accordance with Article 3 (1) or (2) of Regulation (EC) No 726/2004 also in conjunction with Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directives 2001 /20/EC and 2001 /83/EC and Regulation (EC) No 726/2004 (OJ L 327, 30.12.2004, p. 1), or Regulation (EC) No 1394/2007. This also applies to medicinal products which are not intended for use in manufacture and intended for use in animals, unless they are to be given to pharmaceutical companies which have a licence to manufacture medicinal products. (2) Authorisation shall not be required for medicinal products which:

1.

are intended for use in human beings and have been shown to be more frequently prescribable in the essential stages of manufacture in a pharmacy in a quantity of up to one hundred ready-to-release packs on a single day in the main stages of the production process. The framework of the usual pharmacy operation is established and is intended for use in the context of the existing pharmacy type-approval,

1a.

Medicinal products used in the manufacture of which substances of human origin are used and which are intended either for autologous or directed use intended for a given person or for a formula for individual persons , unless they are medicinal products within the meaning of Article 4 (4),

1b.

Medicinal products other than those referred to in paragraph 1a, and pharmacies which are prescribable for a patient, from medicinal products authorised within the scope of this Act

a): as a cytostatic preparation or for parenteral nutrition, as well as in other medically justified special needs, provided that it is necessary for the adequate care of the patient and if no authorised medicinal product is available is produced, or
b): be made from unchanged medicinal products, or
c): is bottled in unchanged form,

1c.

are intended for use in humans, have antiviral or antibacterial activity and are intended for the treatment of a menacable communicable disease, the spread of which is an immediate and substantially overly overshooting provision of specific medicinal products are produced from active substances which have been stored for these purposes by the health authorities of the federal or state governments or by those notified bodies, to the extent that their manufacture is carried out in a pharmacy; for the supply under the existing pharmacy type-approval or to the they are sent to other pharmacies,

1d.

Tissue preparations which are subject to the obligation to obtain authorisation in accordance with the provisions of section 21a (1),

1e.

Medicinal waters, bathing demos or other peloids which are not produced in advance and are not placed on the market in a pack intended for delivery to the consumer, or which are used exclusively for external use or for inhalation on site are intended to be

1f.

medical gases and the medicinal products authorised for individual persons within the scope of this Act, by bottling and labelling in undertakings authorised to retail medicinal products outside pharmacies in accordance with Section 50; are produced,

1g.

are produced as therapeutic allergens for individual patients on the basis of a prescription,

2.

are intended for clinical trials in humans,

3.

Medicated feedingstuffs intended for use in pre-mixtures of medicinal products for which authorisation is granted in accordance with § 25,

4.

shall be produced for individual animals or animals of a particular stock in pharmacies or in veterinary home pharmacies, subject to the conditions set out in paragraph 2a,

5.

are intended for clinical testing in animals or for the examination of residues; or

6.

be made available free of charge, under the conditions laid down in Article 83 of Regulation (EC) No 726/2004, for use in patients suffering from a disease leading to a serious disability or whose disease is is life-threatening and cannot be satisfactorily treated with an authorised medicinal product, including those related to medicinal products other than those referred to in Article 3 (1) or (2) of Regulation (EC) No 726/2004; Procedural rules are determined in a legal regulation according to § 80.

Medicinal products containing substances and preparations not released from pharmacies outside pharmacies may be produced in accordance with paragraph 2 (4) only if an authorised medicinal product for the treatment in question is used for the treatment of such products. The animal species or the area of application in question is not available, the necessary medical care for the animals would otherwise be seriously endangered and there is no risk of a direct or indirect risk to the health of humans and animals is. The manufacture of medicinal products as referred to in the first sentence is only permitted in pharmacies. The second sentence shall not apply to the preparation of medicinal products from a ready-to-use medicinal product and non-active ingredients and to the mixing of ready-to-use medicinal products for the purpose of immobilisation of zoo, game and animal animals. The manufacture within the meaning of the first sentence shall not apply to the refilling, packaging or labelling of medicinal products in unaltered form, to the extent that:

1.: no pre-processed medicinal products are available on the market in a case-by-case basis, or
2.: in any other case, the container or any other form of packaging which comes into direct contact with the medicinal product is not damaged.

The provisions of sentences 1 to 4 shall not apply to homeopathic medicinal products registered or exempted from the registration which, if intended for use in animals intended for the production of foodstuffs, contain only active substances, listed in the Annex to Regulation (EU) No 37/2010 as substances for which maximum quantities are not required. (3) Admission is to be requested by the pharmaceutical company. For a ready-to-use product manufactured in pharmacies or other retail establishments under uniform rules and given under a uniform name to consumers, the authorisation shall be granted by the publisher of the To apply for manufacturing instructions. Where a ready-to-use medicinal product is manufactured for several pharmacies or other retail establishments and is to be supplied to consumers under their names and under a uniform name, the manufacturer shall have the right to: (4) The competent federal authority shall also decide, irrespective of an application for authorisation pursuant to paragraph 3 or an application for authorisation in accordance with § 21a (1) or § 42 (2), at the request of a competent national authority via the Authorisation of a medicinal product, the requirement for authorisation of a tissue preparation or the authorisation requirement for a clinical trial. The competent State authority shall provide the application with a reasoned opinion on the classification of the medicinal product or the clinical trial. Unofficial table of contents

Section 21a Approval of tissue preparations

(1) tissue preparations which are not processed or processed by industrial processes and whose essential working or processing procedures are sufficiently well known in the European Union and whose effects and side effects are derived from the scientific knowledge material may only be placed on the market within the scope of this law if it has been approved by the competent federal authority in derogation from the authorisation requirement pursuant to section 21 (1) of this law . This also applies with regard to tissue preparations whose working or processing methods are new, but comparable with a known process. The first sentence shall be applicable to blood stem cell preparations intended for autologous or directed use intended for a particular person. The authorisation shall include the procedures for the collection, processing and testing, donor selection and documentation for each procedural step, as well as the quantitative and qualitative criteria for tissue preparations. In particular, the critical processing procedures should be evaluated in such a way that the procedures do not clinically render the tissues ineffective or harmful to the patients. (1a) A marketing authorisation referred to in paragraph 1 shall not be required for tissue preparations, which are intended for clinical testing in humans. (2) The application for approval shall be accompanied by the following particulars and documents from the applicant:

1.: the name or company name and address of the processor;
2.: the designation of the tissue preparation,
3.: the fields of application and the nature of the application and, in the case of tissue preparations, which are to be used for a limited period of time, the duration of the application,
4.: information on the collection and laboratory testing of tissues and on the treatment, processing, preservation, testing and storage of tissue preparation,
5.: the nature of the preservation, the duration of the shelf life and the nature of the storage,
6.: a description of the functionality and risks of tissue preparation,
7.: documents relating to the results of microbiological, chemical and physical tests and the methods used for the identification of such tests, in so far as these documents are required, and
8.: all information and documents relevant to the evaluation of the medicinal product.

Section 22 (4) shall apply accordingly. (3) For the information referred to in paragraph 2 (3), scientific knowledge material may be submitted, which may also consist of medical experience material prepared according to scientific methods. For this purpose, studies of the manufacturer of the tissue preparation, data from publications or subsequent evaluations of the clinical results of the tissue preparations produced are possible. (4) The competent federal authority has a to make a decision on the application for authorisation within a period of five months. If the applicant is given the opportunity to remedy shortcomings, the time-limits shall be suspended until the deficiencies have been remedied or until the time limit set for the correction has expired. The inhibition begins with the day on which the applicant is notified of the request to remedy the deficiencies. (5) The competent federal authority shall issue the approval in writing with the dispatch of an approval number. It may attach conditions to the permit. § 28 and § 34 shall apply. (6) The competent federal authority shall only refuse authorisation if:

1.: the documents submitted are incomplete;
2.: the tissue preparation does not correspond to the state of scientific knowledge, or
3.: The tissue preparation does not fulfil the intended function or the benefit/risk ratio is unfavourable.

(7) The applicant or, after the authorisation of the holders of the authorisation, shall immediately report to the competent federal authority, accompanied by appropriate documents, if any changes in the particulars and documents referred to in paragraph 2 and 3. In the event of a change in the documents referred to in paragraph 3, the change may not be made until the competent federal authority has agreed. (8) The authorisation shall be withdrawn if it is subsequently known that one of the reasons for the failure in accordance with paragraph 6 (2) and (3). It shall be revoked if any of these grounds of failure have subsequently occurred. In both cases, the rest of the permit may also be arranged on a temporary basis. The holder of the authorisation shall be heard before a decision taken pursuant to the sentences 1 to 3, unless there is a risk in the case of a conjus. If the authorisation is withdrawn or revoked or if the authorisation is withdrawn, the preparation of the tissue must not be placed on the market and must not be brought into the scope of this Act. (9) Notwithstanding paragraph 1, Tissue preparations which may be placed on the market in a Member State of the European Union or in another State Party to the Agreement on the European Economic Area shall, for the first time, for the purpose of their Application within the scope of this Act of a certificate issued by the competent authorities Federal Authority. Before issuing the certificate, the competent federal authority shall verify whether the processing of tissue preparations meets the requirements for the collection and processing procedures, including the donor selection procedures and the Laboratory tests, as well as the quantitative and qualitative criteria for tissue preparations, comply with the requirements of this Act and its regulations. The competent federal authority shall issue the certificate if the equivalence of the requirements set out in the second sentence is derived from the certificate of approval or another certificate issued by the competent authority of the country of origin and the certificate shall be issued by the competent authority of the country of origin. Proof of authorisation shall be provided in the Member State of the European Union or the other State Party to the Agreement on the European Economic Area. A change in the requirements set out in the second sentence shall be notified to the competent federal authority in good time before any further movement within the scope of this law. The certificate shall be withdrawn if one of the conditions laid down in the second sentence has not been fulfilled; it shall be revoked if one of the conditions set out in the second sentence has subsequently been omitted. Unofficial table of contents

Section 22 Admission documents

(1) The application for authorisation must be accompanied by the following information from the applicant:

1.: the name or name of the company and the address of the applicant and the manufacturer,
2.: the name of the medicinal product;
3.: the components of the medicinal product by type and quantity; § 10 (6) shall apply,
4.: the pharmaceutical form,
5.: the effects,
6.: the fields of application,
7.: the contra-indications,
8.: the side effects,
9.: the interactions with other means,
10.: the dose,
11.: on the preparation of the medicinal product;
12.: the nature of the application and in the case of medicinal products which are to be used for a limited period of time, the duration of the application,
13.: the pack sizes,
14.: the nature of the preservation, the duration of the shelf life, the nature of the storage, the results of shelf life tests,
15.: the methods of control of quality (control methods).

(1a) The information referred to in paragraph 1 (1) to (10) must be accompanied by German or English language; other particulars or documents may also be provided in the authorisation procedure in English (2) It shall also be provided that:

1.

the results of physical, chemical, biological or microbiological tests and the methods used for their determination (analytical testing),

2.

the results of pharmacological and toxicological tests,

3.

the results of clinical trials or other medical, dental or veterinary trials,

4.

a declaration that clinical trials carried out outside the European Union have been carried out under ethical conditions which are subject to the ethical conditions laid down in Directive 2001 /20/EC of the Parliament and of the Council of 4 April 2001 on the Approximation of the laws, regulations and administrative provisions of the Member States relating to the application of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 327, 30.4.2004 EC No 34) are equivalent,

5.

in the case of medicinal products intended for use in humans, a summary description of the pharmacovigilance system of the applicant, which shall include:

a): the evidence that the applicant has a qualified person in accordance with Section 63a, and the indication of the Member States in which that person is established and active, as well as the contact details of that person,
b): the indication of the place where the pharmacovigilance regular documentation for the medicinal product concerned is carried out; and
c): a declaration, signed by the applicant, that it has the necessary means to carry out the tasks and obligations set out in the Tenth Section;

5a.

in the case of medicinal products intended for use in humans, the risk management plan containing a description of the risk management system which the applicant will introduce for the medicinal product concerned, accompanied by a summary,

6.

in the case of medicinal products intended for use in animals, a detailed description of the pharmacovigilance system of the applicant, proof that the applicant has a qualified person in accordance with Section 63a and, where necessary, the risk management system that the applicant will introduce, as well as proof of the necessary infrastructure for reporting all suspected adverse reactions in accordance with § 63h,

7.

a copy of each designation of the medicinal product as a rare disease medicinal product in accordance with Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 378, 27.12.1999, p. EC No L 18 p. 1),

8.

in the case of medicinal products intended for use in human beings, a confirmation from the manufacturer that he or a person contracted by him is responsible for the compliance with good manufacturing practice in the manufacture of active substances by: has convinced a check on the spot; the confirmation must also include the date of the audit.

The results referred to in the first sentence of the first sentence of 1 to 3 shall be documented in such a way as to indicate the nature, extent and timing of the tests. All information and documents relevant to the evaluation of the medicinal product, whether favourable or unfavourable, shall be attached to the application. This shall also apply to incomplete or aborted toxicological or pharmacological tests or clinical trials on the medicinal product. (3) In place of the results referred to in paragraph 2 (2) and (3), other scientific evidence may be used. shall be submitted, and

1.: in the case of a medicinal product whose active substances have been used in general medical or veterinary medicinal products in the European Union for at least 10 years, the effects and adverse reactions of which have been known and from the scientific evidence of knowledge are visible,
2.: in the case of a medicinal product which is already comparable in its composition to a medicinal product as defined in point 1,
3.: in the case of a medicinal product which is a new combination of known ingredients for these ingredients; however, it may also be submitted for the combination as such other scientific knowledge material, if the efficacy and The safety of the medicinal product according to the composition, dosage, form of administration and areas of application can be determined on the basis of these documents.

(3a) If the medicinal product contains more than one active substance, it must be justified that any active substance shall contribute to the positive assessment of the medicinal product. (3b) In the case of radioactive medicinal products which are generators, a general description of the system shall be provided with a detailed description of the components of the system, which shall be the composition or quality of the medicinal products. May influence the preparation of a subsidiary radionuclide preparation, and qualitative and quantitative specificities of the eluate or sublimate. (3c) Furthermore, documentation must be provided for the assessment of possible environmental risks and, in the event that the storage of the medicinal product or its application or the disposal of its medicinal product is not available, Waste requires special precautions or safety measures in order to avoid hazards to the environment or to the health of humans, animals or plants, which is also indicated. Information on the reduction of such risks shall be annexed and justified. For medicinal products intended for use in animals, the results of the tests for the assessment of possible environmental risks shall also be submitted; the second sentence of the second sentence of paragraph 2 shall apply accordingly. (4) The authorisation shall be applied to an in- The scope of this Act applies to medicinal products produced by the manufacturer, the proof must be provided that the manufacturer is entitled to manufacture the medicinal product. This does not apply to an application in accordance with § 21 (3) sentence 2. (5) If the authorisation is requested for a medicinal product produced outside the scope of this law, proof must be provided that the manufacturer is subject to the legal requirements of the law. provisions of the country of manufacture shall have the right to manufacture medicinal products and, in the case of introduction, from a country other than the Member State of the European Union or other State Party to the Agreement on the European Economic Area, that the importer has a permit in order to bring the medicinal product into the (6) As far as an authorisation has been granted abroad, a copy of this authorisation and, in the case of medicinal products intended for use in humans, shall be a copy of the summary the safety data, including the data from the periodic safety update reports, where available, and the reports on suspected cases of suspected adverse reactions. Where an authorisation has been completely or partially failed, the details of the decision shall be communicated in the light of the reasons for the decision. Where an application for authorisation is examined in a Member State or in a number of Member States of the European Union, this shall be indicated. Copies of the summaries of the product characteristics and the package leaflets approved by the competent authorities of the Member States or, in so far as those documents are not yet available, to be submitted by the applicant in accordance with the procedure laid down in sentence 3 the proposed versions of these documents shall also be attached. In addition, provided that recognition of the authorisation of another Member State is requested, the declarations provided for in Article 28 of Directive 2001 /83/EC or in Article 32 of Directive 2001 /82/EC are to be made, and the other shall be provided. Sentence 5 shall not apply to medicinal products manufactured in accordance with homeopathic process technology. (7) The text of the particulars provided for in the container, the outer packaging and the package leaflet, and the particulars of the medicinal products referred to in paragraph 5, shall be replaced by the following: To accompany a draft summary of the product characteristics, which shall at the same time be the subject-specific information referred to in Article 11a (1), second sentence, to the extent that such a summary is required. The competent authority of the Federal Republic of Germany shall, in the case of medicinal products intended for human use, also present the results of the assessments of the package leaflet which have been carried out in cooperation with target groups of patients. The competent federal authority may require it to have one or more samples or sales models of the medicinal product, including the package leaflets, as well as the starting materials, intermediate products and substances used for the manufacture or testing of the product. This medicinal product shall be submitted in a sufficient quantity for the examination and in a condition suitable for the examination. Unofficial table of contents

Section 23 Special documents relating to medicinal products for animals

(1) In the case of medicinal products intended for use in animals intended for the production of foodstuffs, more than § 22 shall apply:

1.: to indicate the waiting time and to provide documentation on the results of the residue examination, in particular on the fate of the pharmacologically active ingredients and their transformation products in the animal body and on the influencing of the food of animal origin, to the extent that these are necessary for the assessment of waiting times, taking into account the maximum quantities fixed, and
2.: in the case of a medicinal product whose pharmacologically active ingredient is not listed in Table 1 of the Annex to Regulation (EU) No 37/2010, a certificate confirming that the European Medicines Agency is at least six months before the application for authorisation, an application pursuant to Article 3 of Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 on the establishment of a Community procedure for the establishment of maximum quantities of Residues of pharmacologically active substances in foodstuffs of animal origin Of origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001 /82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 136, 31.3.2004, p. 11), as amended, has been submitted in the current version.

Sentence 1 no. 2 shall not apply in so far as § 25 (2) sentence 5 applies. (2) In the case of pharmaceutical premixtures, the compound feedingstuffs intended as a carrier substance must be indicated under the name of the feed type. It must also be justified and substantiated by supporting documents that the pre-mixes for medicinal products are suitable for the intended manufacture of medicated feedingstuffs, and in particular that they are suitable, taking into account the Production of compound feedingstuffs for the production of the production methods shall permit a homogeneous and stable distribution of the active ingredients in the medicated feedingstuffs and shall be substantiated and substantiated by supporting documents for which: Duration of the medicated feedingstuffs can be preserved. In addition, a control method which can be carried out routinely and which is suitable for the qualitative and quantitative detection of the active ingredients in the medicated feedingstuffs is to be described and to be carried out by means of documentation on test results. (3) The documents relating to the results of the residue test and the residue detection procedure referred to in paragraph 1 as well as the evidence on the suitability of the pharmaceutical premixtures for the intended manufacture of the products Medicated feedingstuffs and the results of the tests on the control methods referred to in Paragraph 2 must be based on the nature, extent and timing of the tests. In place of the documents, evidence and test results according to the first sentence, other scientific knowledge material may be submitted. Unofficial table of contents

Section 24 Expert Reports

(1) The documents required pursuant to section 22 (1) (15), (2) and (3) and 23 (23) shall be accompanied by expert opinions in which the control methods, test results and residue detection procedures are summarised and evaluated. In particular, the opinions must be based on the following:

1.: from the analytical opinion, whether the medicinal product is of the appropriate quality in accordance with the recognised pharmaceutical rules, whether the control methods proposed are in accordance with the state of scientific knowledge, and whether the medicinal product is in accordance with the requirements of assessment of the quality,
2.: from the pharmacologically toxicological opinion, the toxic effects and the pharmacological properties of the medicinal product,
3.: from the clinical opinion, whether the medicinal product is adequately effective in the indicated areas of application, whether it is compatible, whether the dose envisaged is appropriate and what contraindications and side effects exist,
4.: from the opinion on the residue test, whether and how long after the use of the medicinal product, residues in the food obtained from the treated animals occur, how these residues are to be assessed, and whether the waiting time provided for is sufficient.

The opinion must also show that the residues present at the end of the specified waiting period fall below the maximum levels set out in the Annex to Regulation (EU) No 37/2010. (2) Insofar as scientific In accordance with § 22 (3) and § 23 (3) sentence 2, the opinion must be based on the opinion that the scientific knowledge material has been developed in the appropriate application of the drug test guidelines. (3) The expert opinion must be Information on the name, training and professional activities of the experts and their professional relationship with the applicant. The experts shall, by signature, confirm that the opinion has been drawn up by them. Unofficial table of contents

§ 24a Use of documents from a pre-applicant

The applicant may refer to documents pursuant to section 22 (2), (3), (3c) and § 23 (1) including the expert opinion pursuant to § 24 (1) sentence 2 of an earlier applicant (prior applicant), if he/she has the written consent of the applicant. The applicant, including his confirmation, submits that the documents to which reference is made comply with the requirements of the pharmaceutical inspection guidelines in accordance with § 26. The applicant has to comment on a request for consent within a period of three months. A partial reference is not permitted. Unofficial table of contents

Section 24b Approval of a generic medicine, protection of the underlay

(1) In the case of a generic medicinal product within the meaning of paragraph 2, the documents referred to in section 22 (2), first sentence, no. 2 and 3 and section 23 (1), including the expert opinions, may be submitted to the documents in accordance with § 24 (1) sentence 2 no. 2 to 4 of the The medicinal product of the pre-applicant (reference medicinal product) shall be referred to, provided that the reference medicinal product has been authorised for at least eight years or has been authorised for at least eight years; this shall also apply to authorisation in a other Member States of the European Union. A generic medicinal product authorised in accordance with this provision may not be placed on the market at the earliest after 10 years after the first authorisation has been granted for the reference medicinal product. The period referred to in the second sentence shall be extended to a maximum of eleven years if the holder of the authorisation has, within eight years since the authorisation, been granted the extension of the authorisation for one or more new fields of application at the time of the authorisation. (2) The authorisation as a generic medicinal product as referred to in paragraph 1 requires that the following should be assessed as a generic medicinal product, which is to be considered as a generic medicinal product. the same composition of the active substances according to type and quantity and the same As the reference medicinal product, bioequivalence has been demonstrated by bioavailability studies. The various salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be one and the same active substance, unless their properties differ significantly in terms of safety or safety; or of efficacy. In this case, the applicant shall be required to submit additional documents proving the safety or efficacy of the various salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of the active substance. The various oral forms of administration with immediate release of active substance are considered to be one and the same administration form. The applicant shall not be obliged to present bioavailability studies if it proves otherwise that the generic medicinal product meets the criteria relevant to bioequivalence according to the state of the art. In cases where the medicinal product does not meet the requirements of a generic medicinal product or where the bioequivalence cannot be demonstrated by bioequivalence studies or in the event of a change in the active substance, the area of application, the The results of the appropriate pre-clinical or clinical trials shall be provided on the strength, pharmaceutical form or route of administration to the reference medicinal product. In the case of medicinal products intended for use in animals, the relevant safety studies, in the case of medicinal products intended for use in animals used for the production of food, shall also be the results of the (3) Where the reference medicinal product has not been authorised by the competent authority of the Federal Republic of Germany, but by the competent authority of another Member State, the applicant shall submit the application form to the competent authority of another Member State. The Member State in which the reference medicinal product has been or is authorised . In this case, the competent authority of the competent authority of the other Member State shall request the competent authority of the other Member State to submit within one month a confirmation that the reference medicinal product has been or has been approved and that the reference medicinal product has been authorised to be The composition of the reference medicinal product and other documents, if necessary for the authorisation of the generic medicinal product. In the case of the authorisation of the reference medicinal product by the European Medicines Agency, the competent federal authority shall request the latter by the particulars and documents referred to in the second sentence. (4) Where the competent authority of another A Member State in which an application is submitted, the competent federal authority for the transmission of the particulars or documents referred to in the second sentence of paragraph 3 shall, within one month, inform the competent authority of the competent authority of the competent federal authority. , provided that at least eight years after the initial authorisation has been granted for the (5) A biological medicinal product which is similar to a reference biological medicinal product does not satisfy the generic requirements referred to in paragraph 2 because, in particular, the starting materials or the substances used in the medicinal product are not subject to the following conditions: The manufacturing process of the biological medicinal product shall be different from that of the reference biological medicinal product, and the results of appropriate pre-clinical or clinical trials shall be provided in respect of such deviations. The nature and number of additional documents to be submitted shall be in accordance with the criteria relevant to the state of the scientific community. (6) In addition to the provisions of paragraph 1, if a request for a new field of application of a known active substance is concerned, it shall not be required to present the results of any other tests carried out in accordance with the provisions of the marketing authorisation dossier of the reference medicinal product. , which has been in general medical use in the European Union for at least 10 years, grants a non-cumulative exclusivity period of one year for the data on the basis of significant pre-clinical or clinical studies in the context of the new field of application. (7) Paragraph 1 Sentence 3 and paragraph 6 shall not apply to generics intended for use in animals. The period referred to in the second sentence of paragraph 1 shall be extended

1.: in the case of medicinal products intended for use in fish or bees, for thirteen years,
2.: in the case of medicinal products intended for use in one or more of the animal species used for the production of foodstuffs, containing a new active substance which was not authorised in the Community on 30 April 2004, for each of the products which are not authorised to be used in the Community; Extension of the authorisation to another species of animal to be used for the production of food which has been granted within five years from the date of authorisation, by one year. However, this period may not exceed a total of thirteen years in the case of authorisation for four or more animal species serving for the production of foodstuffs.

The extension of the ten-year period for a medicinal product to be used for food production shall be eleven, twelve or thirteen years on condition that the holder of the authorisation originally also set the (8) Is the extension of an authorisation for a medicinal product authorised in accordance with section 22 (3) to a target animal species which is used for the production of food, which is: under the submission of new residue tests and new clinical trials , shall be granted a three-year period of exclusivity following the granting of the authorisation for the data for which the above tests have been carried out. Unofficial table of contents

Section 24c Reclaims

Where a number of identical documents have to be requested by a number of marketing authorisation holders, the competent authority shall inform each holder of the authorisation which documents are required for the further assessment, as well as the names and the names of the holders. Address of the other marketing authorisation holders involved. The competent federal authority shall give the holders of the authorisation concerned the opportunity to agree within a period to be determined by the competent authority, who shall submit the documents. In the event that an agreement is not reached, the competent federal authority shall decide and immediately inform all parties concerned. If they do not waive the authorisation of their medicinal product, they are obliged to pay a fraction of the costs for the production of the documents, each with a fraction corresponding to the number of the holders of the authorisation. , they shall be held liable as a full debtor. Sentences 1 to 4 shall apply to users of standard authorisations and, if the same documents are required by a number of applicants, in current admission procedures. Unofficial table of contents

§ 24d General exploitation power

The competent authority of the federal authority may, in the performance of its tasks under this law, exploit its present documents, with the exception of the documents pursuant to § 22 (1) No. 11, 14 and 15 as well as para. 2 no. 1 and the opinion of the opinion pursuant to § 24 para. 1 sentence 2 no. 1, provided that the first-time authorisation of the medicinal product in a Member State of the European Union is longer than eight years or a procedure in accordance with Section 24c is not yet concluded or if the provisions of § § 24a and 24b are not more specific for contain the reference to a pre-applicant's documentation. Unofficial table of contents

Section 25 Decision on admission

(1) The competent federal authority shall issue the authorisation in writing with the allocation of an authorisation number. The authorisation shall apply only to the medicinal products listed in the notification of authorisation and to medicinal products manufactured according to a homeopathic procedure, including those which are in force in accordance with the first sentence of Article 25 (7) of this Regulation in the case of medicinal products in force before 17 August 1994. (2) The competent authority of the Federal Supreme Authority may refuse authorisation only if:

1.: the documents submitted, including such documents to be submitted pursuant to a Regulation of the European Community or the European Union, are incomplete,
2.: the medicinal product has not been adequately tested on the basis of the state of scientific knowledge in each case, or the other scientific evidence material in accordance with Section 22 (3) does not have the status of scientific evidence in each case the findings,
3.: the medicinal product is not manufactured in accordance with the accepted pharmaceutical rules or does not have the appropriate quality,
4.: the medicinal product lacks the therapeutic efficacy indicated by the applicant, or the applicant is not sufficiently well-founded, in accordance with the relevant state of scientific knowledge, in each case,
5.: the benefit/risk ratio is unfavourable,
5a.: in the case of a medicinal product containing more than one active substance, there is no sufficient justification for any active substance to contribute to the positive assessment of the medicinal product, taking into account the specific characteristics of the medicinal product concerned in a medicinal product, shall be taken into account in a risk-risk assessment,
6.: the specified waiting period is not sufficient;
6a.: in the case of pre-mixtures of medicinal products, the control methods used for the qualitative and quantitative detection of the active substances in the medicated feedingstuffs are not routinely practicable,
6b.: the medicinal product is intended for use in animals used for the production of foodstuffs, and contains a pharmacologically active ingredient which is not included in Table 1 of the Annex to Regulation (EU) No 37/2010,
7.: the placing on the market of the medicinal product or its use in animals against statutory provisions or against a regulation or a directive or decision or decision of the European Community or of the European Union .

The authorisation may not be failed under the first sentence of paragraph 4, because therapeutic results have been achieved only in a limited number of cases. Therapeutic efficacy is lacking if the applicant does not show, in accordance with the state of the scientific results in each case, that therapeutic results can be achieved with the medicinal product. The medical experience of the respective treatment direction must be taken into consideration. The authorisation shall not be denied in accordance with the first sentence of paragraph 6b if the medicinal product is intended for the treatment of individual solipeds in which the conditions laid down in Article 6 (3) of Directive 2001 /82/EC are met, and the other medicinal products are intended for the treatment of individual solipeds. The conditions laid down in Article 6 (3) of Directive 2001 /82/EC are fulfilled. (3) The authorisation shall be refused for a medicinal product which is of an approved or already marketed medicinal product of the same name in the species or The amount of active substances is different. By way of derogation from the first sentence, a difference in the quantity of active substances shall be harmless if the medicinal products differ in the form of administration. (4) If the competent federal authority is of the opinion that an authorisation should be granted on the basis of the It shall inform the applicant, stating the reasons, of the documents. The applicant shall be given the opportunity to remedy any deficiencies within a reasonable time, but not more than six months. If the deficiencies are not remedied within this period, the authorisation shall be refused. After a decision on the approval of the approval, the submission of documents for the removal of the defect is excluded. (5) The admission is due to the examination of the submitted documents and on the basis of the expert opinion to the Commission. In order to assess the documents, the competent federal authority may use its own scientific results, provide expert advice or request expert opinions. The competent authority of the Federal Republic of Germany may, in establishments and facilities which develop, manufacture, verify or clinically examine medicinal products, provide for authorisation-related particulars and documents, including in the context of a marketing authorisation check in accordance with Article 3 (1) or (2) of Regulation (EC) No 726/2004. For this purpose, representatives of the competent authority of the Federal Government, in consultation with the competent authority, may enter operating and business premises at the usual business hours, consult documents and request information. The competent federal authority may, in addition, allow the assessment of the dossier by independent counterexperts, and shall submit their assessment of the authorisation decision and, in so far as they are medicinal products, the Pursuant to section 48 (2) no. 1, the obligation to make a prescription shall be based on the draft approval decision to be submitted to the Admission Commission in accordance with the first sentence of paragraph 6. The competent authority of the Bundesoberbehörde (Bundesoberbehörde) may be entrusted with the task of countering the person who has the necessary expertise and the reliability required to carry out the activity as a counter-expert. Upon request, the applicant shall be granted access to the opinions. If the applicant asks to be accompanied by expert experts, they shall also be heard. Paragraph 6, sentences 5 and 6 shall apply mutas to the appointment of experts, counterexperts and reviewers. (5a) The competent federal authority shall also draw up an assessment report on the documents submitted for quality, Safety and efficacy and shall give an opinion on the results of pharmaceutical and pre-clinical trials, clinical trials and medicinal products intended for human use, including: Risk management and pharmacovigilance system; for medicinal products for use in In the case of animals intended for the production of foodstuffs, the assessment report shall also refer to the results of the residue test. The assessment report shall be updated when new information is available for this purpose. (5b) Paragraph 5a does not apply to medicinal products manufactured in accordance with homeopathic process technology, provided that these medicinal products are used in accordance with the procedure laid down in Article 16 (2) of Directive 2001 /83/EC or Article 19 (2) of Directive 2001 /82/EC. (6) Prior to the decision on the authorisation of a medicinal product for the treatment of phytotherapy, homeopathy or anthroposophy. , and is subject to the prescription obligation pursuant to section 48 (2) No. 1, is to hear an admissions commission. The hearing shall cover the content of the documents submitted, the expert opinion, the opinions requested, the opinions of the experts who have been consulted, the outcome of the examination and the reasons for the decision on the approval is essential, or the assessment by the counterexperts. If the Federal Authority deviates from the outcome of the hearing in the decision on the application, it shall state the reasons for the divergent decision. In agreement with the Federal Ministry of Food, Agriculture and Consumer Protection, the Federal Ministry of the Environment, in agreement with the Federal Ministry of Food, Agriculture and Consumer Protection, shall convene the members of the Admissions Committee, in so far as it Consideration of proposals by the chambers of the medical professions, the professional associations of doctors, dentists, veterinarians, pharmacists, medical practitioners and the relevant leading associations of pharmaceutical companies for the perception of their interests. Entrepreneurs, patients and consumers. The specific characteristics of the medicinal products must be taken into account in the case of appeal. In the admission commissions, experts are appointed who have scientific knowledge and practical experience in the respective fields of application and in the respective therapeutic direction (phytotherapy, homeopathy, anthroposophy). Experience gained. (7) For medicinal products which are not subject to the prescription obligation pursuant to § 48 para. 2 No. 1, commissions for certain areas of application or treatment guidelines are formed at the competent Federal Office of the Federal Supreme Court. The provisions of paragraph 6, sentences 4 to 6, shall apply. In order to prepare the decision on the renewal of authorisations pursuant to § 105 (3) sentence 1, the competent federal authority may take part in the competent Commission. Where the decision in accordance with the third sentence relates to medicinal products for a given treatment (phytotherapy, homeopathy, anthroposophy), the competent Commission shall be involved, provided that a complete failure to extend the prolongation pursuant to Article 105 (3) sentence 1 , or the decision is of fundamental importance; within two months it has the opportunity to comment. To the extent that the Federal Supreme Authority does not take into account the opinion of the Commission in the decision referred to in the fourth sentence, it sets out the reasons. (7a) In order to improve the safety of medicinal products for children and young people, the Federal Institute for Medicinal products and medical devices a Commission for medicinal products for children and adolescents. The provisions of paragraph 6, sentences 4 to 6, shall apply. In order to prepare the decision on the application for authorisation of a medicinal product, which is also intended for use in children or adolescents, the competent federal authority shall take part in the Commission. The competent federal authority may also prepare the decision on the application for the authorisation of a medicinal product other than those referred to in the third sentence, which may be used in the case of children or young people, the Commission participate. The Commission has the opportunity to comment. In so far as the Bundesoberbehörde does not take into account the opinion of the Commission in the decision, it shall explain the reasons. The Commission may also establish, in respect of medicinal products which are not authorised for use in children or adolescents, the state of scientific knowledge of the conditions under which these medicinal products are intended for children or adolescents. Young people can be used. For the medicinal products of phytotherapy, homeopathy and anthroposophic medicine, the tasks and powers under sentences 3 to 7 shall be exercised by the commissions referred to in the fourth sentence of paragraph 7. (8) Sera, vaccines, blood preparations, Tissue preparations, allergenic, xenogenic medicinal products which are not medicinal products in accordance with Section 4 (9) shall be granted by the competent federal authority either on the basis of the examination of the submitted documents or on the basis of their own Investigations or on the basis of the monitoring of the manufacturer's tests. In this connection, officers of the competent federal authority may enter operating and business premises at the usual business hours in consultation with the competent authority, and surveys may be carried out in the latter and in the means of transport used for the holding. . At the request of the competent federal authority, the applicant shall inform the manufacturing process. In the case of these medicinal products, paragraphs 6, 7 and 7a shall not apply. (8a) Paragraph 8, sentences 1 to 3, shall apply to control methods pursuant to section 23 (2) sentence 3. (9) Are different strengths, pharmaceutical forms, route of administration, or If a medicinal product is requested, it may, at the request of the applicant, be the subject of a uniform comprehensive authorisation, including subsequent amendments and enlargements. A uniform authorisation number must be used, which must be added to further distinguishing marks for distinguishing the forms of administration or concentrations. For authorisations pursuant to section 24b (1), individual approvals of a reference medicinal product shall apply. (10) The authorisation shall be without prejudice to the civil and criminal liability of the pharmaceutical entrepellant.

Footnote

(+ + + § 25 (9): For application, see Section 141 (9) + + +) Unofficial table of contents

Section 25a preliminary examination

(1) The competent authority of the federal authority may allow the application for authorisation by independent experts to be carried out for completeness and to check whether the medicinal product is sufficient in accordance with the state of the scientific findings in each case. it has been examined. (2) In the case of complaints within the meaning of paragraph 1, the expert has the opportunity to give the applicant an opportunity to remedy defects within three months. (3) If the application for authorisation has expired after the expiry of the application, the applicant shall have the right to submit a complaint. In the event that the final opinion of the expert continues to be incomplete or deficient within the meaning of section 25 (2) (2), the authorisation shall be refused. Section 25 (4) and (6) shall not apply to the preliminary examination. (4) If the competent authority of the federal authority determines that an application for authorisation of the same kind is being examined in another Member State of the European Union, it shall reject the application and shall suspend the application. inform the applicant that a procedure pursuant to § 25b applies. (5) If the competent federal authority is informed in accordance with § 22 that an application for an already approved treatment in another Member State of the European Union has already been made, the If it is a medicinal product, it shall reject the application unless it has been submitted in accordance with Section 25b. Unofficial table of contents

Section 25b Procedure of mutual recognition and decentralised procedure

(1) In order to grant an authorisation or authorisation in more than one Member State of the European Union, the applicant shall submit a request based on identical documents in those Member States; this may be in English (2) If the medicinal product has already been authorised or authorised in another Member State of the European Union at the time of application, this authorisation shall be based on the date of application of the an assessment report, unless there is reason to believe that the Authorisation of the medicinal product is a serious risk to public health, and in the case of medicinal products for use in animals, a serious risk to human or animal health or to the environment. In such a case, the competent authority of the federal authority must proceed in accordance with the provisions of Article 29 of Directive 2001 /83/EC or Article 33 of Directive 2001 /82/EC. (3) If the medicinal product is not yet authorised at the time of application, the competent authority shall: the competent federal authority, insofar as it is a reference Member State within the meaning of Article 28 of Directive 2001 /83/EC or Article 32 of Directive 2001 /82/EC, draft assessment report, the summary of the characteristics of the (a) the medicinal product and the labelling and package leaflet and the competent Member States and the applicant. (4) Chapter 4 of Directive 2001 /83/EC and Chapter 4 of Directive 2001 /82/EC are applicable to the recognition of the authorisation of another Member State. (5) In the event of a different decision concerning the The authorisation, suspension or withdrawal shall apply to Articles 30, 32, 33 and 34 of Directive 2001 /83/EC and Articles 34, 36, 37 and 38 of Directive 2001 /82/EC. In the event of a decision pursuant to Article 34 of Directive 2001 /83/EC or Article 38 of Directive 2001 /82/EC, the authorisation shall be subject to the decision taken in accordance with the provisions of those Articles or of the decision taken pursuant to those Articles. Decision of the European Community or of the European Union. A preliminary procedure in accordance with § 68 of the Administrative Court Rules does not take place in the case of appeals against decisions of the competent federal authorities in accordance with sentence 2. Furthermore, Article 25 (6) does not apply. (6) Paragraphs 1 to 5 shall not apply to medicinal products manufactured in accordance with homeopathic process technology, provided that such medicinal products are referred to in Article 16 (2) of Directive 2001 /83/EC or to Article 19 (2) of Directive 2001 /82/EC. Unofficial table of contents

Section 25c Measures of the competent federal authority on decisions or decisions of the European Community or of the European Union

The competent federal authority shall take the necessary measures to implement decisions or decisions of the European Community or of the European Union in accordance with Article 127a of Directive 2001 /83/EC or Article 95b of Directive 2001 /82/EC the measures required. Unofficial table of contents

Section 26 Pharmaceutical test guidelines

(1) The Federal Ministry shall be authorized, by means of a legal regulation with the consent of the Federal Council, to request the information, documents and opinions referred to in § § 22 to 24, also in conjunction with § 38 (2) and § 39b (1), as well as their Examination by the competent authority of the Federal Republic of Germany to regulate. Whereas the rules must be consistent with the state of scientific knowledge in each case and must be adapted continuously to them; in particular, animal testing should be replaced by other testing procedures where this is in accordance with the state of the scientific knowledge with regard to the purpose of the audit is acceptable. The Regulation shall, in so far as it relates to radioactive medicinal products and medicinal products for the manufacture of which ionizing radiation is used, and which are ecotoxicological tests, shall be adopted in agreement with the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, and, in the case of medicinal products intended for use in animals, in agreement with the Federal Ministry of Food, Agriculture and Consumer Protection. § 25 (6) sentences 4 and 5 shall apply to the appointment of the experts. (2) The competent federal authority and the commissions pursuant to Section 25 (7) shall apply the pharmacovigilance guidelines in accordance with the scientific and scientific standards. Application of the recognition material in accordance with § 22 (3) and § 23 (3) sentence 2, taking into account the specificities of the respective medicinal products. As a scientific knowledge material, the medical experience that has been prepared according to scientific methods is also valid. Unofficial table of contents

Section 27 Deadlines for granting

(1) The competent federal authority shall take a decision on the application for authorisation within a period of seven months. The decision on the recognition of an authorisation shall be taken within three months of the receipt of the assessment report. An assessment report shall be drawn up within a period of three months. (2) If the competent federal authority gives the applicant an opportunity to remedy shortcomings in accordance with Section 25 (4), the time-limits until the deficiencies or until the defects are remedied shall be made available to the applicant. The expiry of the time limit laid down in accordance with section 25 (4) is suspended. The inhibition shall begin with the day on which the applicant is notified of the request to remedy the deficiencies. The same shall apply to the time limit granted to the applicant for his/her request, including through the assistance of experts. (3) In the case of proceedings pursuant to Section 25b (3), the time limit for the conclusion of the procedure shall be extended. three months in accordance with the rules laid down in Article 28 of Directive 2001 /83/EC and Article 32 of Directive 2001/82/EC. Unofficial table of contents

Section 28 Supervisory authority

(1) The competent authority of the Federal Republic of Germany may attach conditions to the authorisation. In the case of conditions laid down in paragraphs 2 to 3d for the protection of the environment, the competent federal authority shall decide, in agreement with the Federal Environment Agency, to the extent that the effects on the environment are to be assessed. To this end, the competent federal authority shall forward to the Federal Environment Agency the information and documents required to assess the impact on the environment. Conditions may also be arranged subsequently. (2) Obligations under paragraph 1 may be arranged to ensure that:

1.

the labelling of the containers and the outer wrapping shall comply with the requirements laid down in § 10; it may be necessary to indicate that they have to be indicated

a): instructions or warnings to the extent that they are necessary in order to prevent, in the use of the medicinal product, a direct or indirect risk to the health of humans or animals,
b): storage instructions for the consumer and storage instructions for professionals, provided they are required to obtain the required quality of the medicinal product;

2.

the package leaflet complies with the requirements of § 11; it may be necessary to indicate that it is necessary to indicate:

a): the notices or warnings referred to in point 1 (a),
b): the storage instructions for the consumer where they are necessary to obtain the required quality of the medicinal product;

2a.

the technical information shall be in accordance with the provisions of Section 11a, and it may be necessary to indicate that it is necessary to indicate:

a): the notices or warnings referred to in point 1 (a),
b): special storage and storage instructions to the extent that they are offered in order to obtain the required quality of the medicinal product,
c): the conditions referred to in paragraph 3,

3.

the information provided for in § § 10, 11 and 11a is in accordance with the documents submitted for admission and, in the process, the terms and terms and a uniform text, including the recommendations and opinions of the documents, are consistent and generally understood. committees of the European Medicines Agency, with the indication of further contraindications, adverse reactions and interactions being allowed; the competent federal authority may, in general, be entitled to do so on the grounds of: Pharmaceutical safety, transparency or the rational working method where it is possible to dispense with certain areas of application in the case of medicinal products subject to medical prescription if it is to be feared that the therapeutic purpose will be jeopardised by the indication of the medicinal product,

4.

the medicinal product is placed on the market in pack sizes appropriate to the areas of application and to the duration of the application,

5.

the medicinal product is placed on the market in a container of a specific form, a certain closure or any other safety precautions, to the extent that it is necessary to ensure compliance with the dosage instructions or to ensure that the risk of the To prevent abuse by children.

(2a) warnings referred to in paragraph 2 may also be arranged to ensure that the medicinal product is prescribed and controlled only by physicians in certain specialist areas, or only in clinics or specialised clinics or in cooperation with must be used in order to prevent, in the course of the application, a direct or indirect risk to human health, in particular where the use of the medicinal product is only in the presence of special specialist or special therapeutic facilities (3) The competent federal authority may, by imposing conditions, order further analytical, pharmacotoxicological or clinical trials to be carried out and to report on the results if sufficient There is evidence that the medicinal product may have a major therapeutic value and therefore there is a public interest in its immediate placing on the market, but for the full evaluation of the medicinal product further. important information is required. Each year, the competent federal authority shall review the results of these tests. The competent federal authority may, in the case of medicinal products intended for use in humans, be subject to conditions in the case of medicinal products which are intended for use in humans. also order,

1.: to take measures in the risk management system to ensure the safe use of the medicinal product, if this is necessary in the interests of safety of medicinal products;
2.: to carry out safety tests where this is necessary in the interests of safety in the pharmaceutical sector,
3.: to comply with obligations with regard to the collection or reporting of suspected cases of adverse reactions going beyond those of the Tenth Section where this is necessary in the interests of safety of medicinal products;
4.: to take other necessary measures with regard to the safe and effective use of the medicinal product, if this is necessary in the interests of safety of medicinal products,
5.: to introduce an appropriate system of pharmacovigilance where this is necessary in the interests of safety of medicinal products;
6.: where there are concerns about individual aspects of the efficacy of the medicinal product, which may not be removed until after the medicinal product has been placed on the market, to carry out efficacy tests after authorisation as set out in the first sentence of Article 21a (1) (f) of Directive 2001 /83/EC.

(3b) In the case of medicinal products intended for use in humans, the competent authority of the Federal Republic of Germany may also order, after the granting of authorisation, conditions,

1.: to introduce a risk management system and a risk management plan where this is necessary in the interest of pharmaceutical safety,
2.: to carry out safety tests where this is necessary in the interests of safety in the pharmaceutical sector,
3.: to carry out an impact assessment where knowledge of the disease or the clinical methodology suggests that earlier assessments of the efficacy must be significantly corrected; the obligation to carry out this efficacy assessment in accordance with the Authorisation must comply with the requirements laid down in Article 22a (1) (b), second sentence, of Directive 2001 /83/EC.

If the conditions for an obligation laid down in point 2 of the first sentence are for more than one medicinal product, and if such medicinal products are authorised in several Member States, the competent national authority shall, after referral to the committee, recommend: Pharmacovigilance risk assessment referred to in Article 56 (1) (a) (aa) of Regulation (EC) No 726/2004, the holders of the authorisation to carry out a common safety assessment after the authorisation. (3c) The The competent authority of the Federal Office may, by means of a requirement, order that the the manufacture and control of such medicinal products and their starting materials, which are of biological origin or are produced by biotechnical means,

1.: comply with certain requirements and apply certain measures and procedures;
2.: submitted documents justifying the suitability of certain measures and procedures, including documentation on validation,
3.: the introduction or modification of certain requirements, measures and procedures requires the prior consent of the competent federal authority,

in so far as it is necessary to ensure adequate quality or to ensure risk provision. The ordered runs are immediately enforceable. (3d) In the case of medicinal products intended for use in animals, the competent federal authority may, in duly substantiated individual cases, order further documents with which the competent authority shall be responsible for the application of the an assessment of possible environmental risks, and other results of tests to assess possible environmental risks, provided that this is necessary for the comprehensive assessment of the effects of the medicinal product on the environment is. The competent federal authority shall immediately verify the fulfilment of a requirement pursuant to the first sentence of the first sentence after expiry of the pre-payment period. (3e) The competent federal authority may, if this is necessary in the interests of safety in medicinal products, also impose conditions on medicinal products intended for use in animals. ensure that a risk management system, which describes the compilation of activities and measures in the field of pharmacovigilance, including the assessment of the effectiveness of such measures, is introduced after the authorisation, including the assessment of the effectiveness of such measures, and Following the authorisation, findings in the use of the medicinal product are systematically is collected, documented and evaluated and reported on the results of this investigation within a specified period of time. (3f) If the conditions laid down in paragraphs 3, 3a, 3b and 3e are subject to conditions, the competent authority of the federal authority may be responsible for the nature, scope and Determine the time frame of the studies or examinations, as well as activities, measures and assessments in the context of the risk management system. The results shall be substantiated by supporting documents in such a way as to result from this type, extent and timing of the studies or tests. (3g) The holder of the authorisation of a medicinal product intended for use in humans shall comply with all the conditions laid down in the following: to include paragraphs 3, 3a and 3b in its risk management system. The competent federal authority shall inform the European Medicines Agency of the authorisations granted under the conditions laid down in paragraphs 3, 3a and 3b. (3 h) The competent federal authority may, in the case of biological medicinal products, the competent authority of the competent authority of the Federal Republic of Germany. (4) If the authorisation is to be accompanied by a requirement, the time limit laid down in Article 27 (1) shall be extended to the end of a period of time until the expiry of a period of time for the purpose of the application. the applicant shall be called upon to give an opinion. Section 27 (2) shall apply. Unofficial table of contents

§ 29 Display obligation, new authorisation

(1) The applicant shall immediately report to the competent federal authority, accompanied by appropriate documents, if any changes in the particulars and documents are made in accordance with § § 22 to 24a and 25b. The obligation laid down in the first sentence shall be fulfilled after the authorisation has been granted by the holder of the authorisation. (1a) The holder of the authorisation shall immediately have all the prohibitions or restrictions imposed by the competent authorities of the competent authority of the competent authority of the to notify the country in which the medicinal product in question is placed on the market and any other new information which might influence the assessment of the benefits and risks of the medicinal product concerned. This information includes medicinal products intended for use in humans, both positive and negative results of clinical trials or other studies which are not limited to those mentioned in the authorisation, but also all indications and groups of the population, as well as information on the use of the medicinal product, which goes beyond the provisions of the authorisation. At the request of the competent authority of the Federal Republic of Germany, it shall also submit all information and documents proving that the risk-benefit balance is still to be assessed favourably. The competent federal authority may, at any time, require the submission of a copy of pharmacovigilance stock documentation in the case of medicinal products intended for use in humans. This shall be submitted by the holder of the authorisation no later than seven days after receipt of the request. The rates 1 to 3 shall not apply to the parallel importer. (1b) The holder of the authorisation shall have the date for the placing on the market of the medicinal product, taking into account the different permitted levels of the medicinal product. (1c) The holder of the authorisation shall be notified to the competent authority of the competent authority in accordance with the provisions of sentence 2, if the placing on the market of the medicinal product is temporarily or definitively discontinued. The notification shall be made no later than two months before the date on which the placing on the market is placed. This shall not apply if circumstances exist which the holder of the authorisation does not have to represent. (1d) The holder of the authorisation shall have all the data relating to the sales quantity of the medicinal product as well as all the data available to him in connection with the marketing authorisation. (1e) The holder of the authorisation shall have the responsibility of the competent federal authority in accordance with the procedure laid down in Article 107c (4), (5) or (6). as amended by Directive 2001 /83/EC, or intervals for the submission of regularly updated safety reports. Any changes to the date specified in the authorisation or the interval under the first sentence shall take effect six months after its publication on the European Internet portal. (1f) The holder of the authorisation shall be responsible for medicinal products which: are intended for use in humans, to inform the competent federal authority and the European Medicines Agency if new or altered risks exist or if the risk-benefit ratio of medicinal products is (1g) The holder of the authorisation of a medicinal product for use in in the case of human beings, the competent federal authority shall immediately have the reasons for the temporary or permanent placing on the market, the recall, the renunciation of the authorisation or the non-application of the extension of the Authorisation to be notified. In particular, he shall declare whether the measure referred to in the first sentence is based on one of the reasons for the first sentence of Article 25 (2), point 3, point 4 or point 5, the first sentence of Article 30 (2), or the second sentence of Article 69 (1), second sentence, point 4 or point 5. The notification referred to in the first sentence shall also be made when the measure is taken in a third country and is based on one of the reasons set out in the second sentence. Where a measure is based on one of the reasons set out in the second sentence of sentence 2, the holder of the authorisation shall inform the European Medicines Agency accordingly. (2) In the event of a change in the name of the medicinal product, the marketing authorisation holder shall be informed of the following: Change the letter of admission accordingly. Under the old name of the pharmaceutical company, the medicinal product may still be one year, from wholesale and retailer two years, beginning with the 1 January or 1 July period following the notice of the change in the Federal Gazette, be placed on the market. (2a) A change

1.: the particulars referred to in § § 10, 11 and 11a concerning the dosage, the type or duration of the application, the indications of use, in so far as it is not the addition of one or a change in an indication to be assigned to another therapeutic area. is, a restriction of contraindications, side effects or interactions with other means,
2.: of the active ingredients, except for the active substance,
3.: in an approved comparable form of administration,
3a.: in the treatment of ionizing radiation,
4.: in connection with significant changes in the manufacturing process, the pharmaceutical form, the specification or the impurity profile of the active substance or medicinal product, which are clearly related to the quality, safety or efficacy of the active substance or the medicinal product. In the case of sera, vaccines, blood preparations, allergens, test sera and test antigens, any modification of the manufacturing or testing procedure or an indication of a product of a genetic engineering method, may have an effect on the medicinal product. longer shelf life,
5.: the pack size and
6.: the withdrawal period of a medicinal product intended for use in animals

shall not be completed until the competent federal authority has agreed. Article 1 (1) also applies to the extension of the target species of medicinal products which are not intended for use in animals intended for the production of foodstuffs. The consent shall be deemed to have been granted if the amendment has not been contradicted within a period of three months. (2b) By way of derogation from paragraph 1, the following may be granted:

1.: the omission of a site for the manufacture of the medicinal product or its active substance or for packaging or batch release,
2.: a minor modification of an approved physico-chemical test procedure where appropriate validation studies can demonstrate that the updated test procedure is at least equivalent,
3.: an amendment to the specification of an active substance or other substance for the manufacture of medicinal products, in order to adapt it to a monograph of the pharmacopoeia, if the amendment is made exclusively for compliance with the pharmacopoeia and where: specifications with regard to product-specific properties remain unchanged,
4.: a change in the packaging material if it does not come into contact with the medicinal product and it has been shown that the release, administration, safety or durability of the medicinal product is not impaired, or
5.: a change in connection with the tightening of specification limits if the change is not a consequence of an obligation on the basis of previous assessments to check the specification limits and not to unexpected events in the the course of the production process is going back,

within 12 months of their introduction by the competent federal authority. (3) A new authorisation shall be requested in the following cases:

1.: in the event of a change in the composition of the active substances by type or quantity,
2.: in the event of a change in the form of presentation, in so far as it is not a modification referred to in paragraph 2a, point 3,
3.: in the case of an extension of the fields of application, to the extent that it is not a modification referred to in paragraph 2a, point 1, and
3a.: in the introduction of genetic engineering processes.

The competent federal authority shall decide on the authorisation requirement in accordance with the first sentence. (4) Paragraphs 1, 1a, sentences 4 and 5, paragraphs 1e to 1g, 2, 2a to 3 shall not apply to medicinal products for which the European Community or the European Community shall apply. The European Union has been granted a marketing authorisation. These medicinal products shall be subject to the obligations of the pharmaceutical operator under Regulation (EC) No 726/2004, on the understanding that, within the scope of the law, the obligation to communicate to the Member States or to the information (5) The provisions of paragraphs 2a to 3 shall not apply to medicinal products which are subject to Commission Regulation (EC) No 1234/2008 of 24 November 2008 on the examination of amendments authorisation of medicinal products for human and veterinary use (OJ L 327, 30.4.2004 7), as amended, as amended. Paragraphs 2a to 3 shall apply

1.: for homeopathic medicinal products subject to authorisation, which are intended for use in humans and which have been approved before 1 January 1998, or which have been authorised to be authorised,
2.: for the blood preparations referred to in Article 3 (6) of Directive 2001/83/EC, and
3.: in the case of tissue preparations authorised in accordance with Article 21, unless an industrial process is used in their manufacture.

Unofficial table of contents

§ 30 Withdrawal, Revocation, Ruhen

(1) The admission shall be withdrawn if it is subsequently known that one of the reasons for the failure of Section 25 (2) Nos. 2, 3, 5, 5a, 6 or 7 has been present at the grant; it shall be revoked if one of the reasons for the failure of Section 25 (2) No. 3, 5, 5a, 6 or 7 has subsequently occurred. The authorisation shall also be withdrawn or revoked if:

1.: it is found that the medicinal product lacks therapeutic efficacy,
2.: in the cases of § 28 (3), the therapeutic efficacy is insufficiently substantiated according to the state of the scientific findings.

Therapeutic efficacy is lacking if it is established that therapeutic results cannot be achieved with the medicinal product. In the cases of the first sentence, the rest of the authorisation may also be arranged for a limited period of time. (1a) The authorisation shall also be wholly or partially withdrawn or revoked, to the extent necessary, in order to take a decision or a decision of the The European Community or the European Union referred to in Article 34 of Directive 2001 /83/EC or in accordance with Article 38 of Directive 2001 /82/EC. A preliminary procedure in accordance with § 68 of the Administrative Court Rules does not take place in the case of appeals against decisions of the competent federal authority pursuant to sentence 1. In the cases of the first sentence, the rest of the authorisation may also be arranged for a limited period of time. (2) The competent authority of the Federal Republic of Germany may authorise the admission of the authorisation.

1.: if incorrect or incomplete information has been made in the documents in accordance with § § 22, 23 or 24, or if one of the reasons for the failure of Section 25 (2) (6a) or (6b) has been submitted during the grant of the grant,
2.: , if one of the reasons for the failure of Section 25 (2) No. 2, 6a or 6b has subsequently occurred or if one of the conditions arranged pursuant to § 28 is not complied with and if this defect is not within one of the competent federal authority has been remedied by a reasonable period of time, subject to conditions pursuant to section 28 (3) and (3a) of the annual review;
3.: withdraw, in consultation with the competent authority, if the quality tests prescribed for the medicinal product have not been carried out or have not been sufficiently carried out,
4.: in consultation with the competent authority, if it is found that the medicinal product has not been manufactured in accordance with the recognised pharmaceutical rules.

In such cases, the rest of the authorisation may also be arranged for a limited period of time. (2a) In the cases referred to in paragraphs 1 and 1a, the authorisation must be amended where the reason for the failure referred to in paragraph 1 is thereby eliminated or if the reason referred to in paragraph 1a is deleted. Decision is complied with. In the cases referred to in paragraph 2, the authorisation may be subject to amendment if it is sufficient to comply with the requirements of the safety of medicinal products. (3) Before a decision pursuant to paragraphs 1 to 2a, the holder of the authorisation shall: shall be heard, unless there is a risk in the case of a conjamation. This shall also apply where a decision of the competent federal authority on the amendment of the authorisation, conditions for the authorisation, withdrawal, withdrawal or revocation of the authorisation to an agreement of the coordination group pursuant to Article 107g, 107k , or Article 107q of Directive 2001 /83/EC. A preliminary procedure pursuant to Section 68 of the Administrative Court of Justice does not take place in the cases of sentence 2. In the cases of Section 25 (2) no. 5, the decision is immediately enforceable. (4) If the authorisation for a medicinal product is withdrawn or revoked or if the authorisation is to be withdrawn, it may be withdrawn,

1.: not placed on the market and
2.: are not brought into the scope of this law.

The return of the medicinal product to the pharmaceutical entrepre shall be permitted, subject to appropriate information. The return may be ordered by the competent authority. Unofficial table of contents

§ 31 Erdeleting, extension

(1) The authorisation shall be deleted

1.

if the authorised medicinal product is not placed on the market within three years after the date of issue of the authorisation or if the authorised medicinal product which has been placed on the market after the marketing authorisation has been placed on the market in three consecutive years no longer in traffic,

2.

by written renunciation,

3.

after the expiry of five years from the date of issue, unless:

a): in the case of medicinal products intended for use in humans, at the latest nine months,
b): in the case of medicinal products intended for use in animals, at the latest six months

before the expiry of the period, an application for renewal shall be made,

3a.

in the case of a medicinal product intended for use in animals which are used for the production of foodstuffs and which contains a pharmacologically active ingredient included in Table 2 of the Annex to Regulation (EU) No 37/2010, after the expiry of a period of 60 days following publication in the Official Journal of the European Union, unless within that period the fields of application in the case of animals used for the production of foodstuffs have not been waived in accordance with Article 29 (1); in the case of a change indication in accordance with section 29 (2a), which shall include the withdrawal of the relevant The 60-day period is inhibited until the decision of the competent federal authority or until the expiry of the period laid down in § 29 (2a) sentence 2 and it rests upon the authorisation after the 60-day period has expired during the period of this period; the provisions of half-sentences 1 and 2 shall apply mutatily to the extent to which Regulation (EC) No 1234/2008 applies to the modification of the medicinal product.

4.

if the renewal of the authorisation is to be denied.

In the cases referred to in sentence 1 (1) (1), the competent authority of the federal authority may allow exceptions, provided that this is necessary for reasons of health protection for humans or animals. (1a) An authorisation which is extended shall be valid without time limit, In the case of the extension referred to in the first sentence of paragraph 1, the competent federal authority shall, in accordance with the provisions of the first sentence of the first sentence of paragraph 1 in conjunction with paragraph 2, also take account of a further extension by five years in accordance with the provisions of the first sentence of paragraph 1. small number of patients in whom the medicinal product concerned, which is used in the case of (2) The application for an extension should be supplemented by a report containing information on the application of the medicinal product to be used in the course of the marketing of the medicinal product. contains, and to what extent, the assessment characteristics for the medicinal product have changed within the last five years. The holder of the authorisation shall submit to the competent national authority a revised version of the dossier in respect of the quality, safety and efficacy in which all the changes made since the granting of the authorisation , in the case of medicinal products intended for use in animals, a consolidated list of amendments shall be presented instead of the revised version. In the case of medicinal products intended for use in animals used for the production of foodstuffs, the competent federal authority may also require the report to include information on the experience of the residue detection procedure. (3) The authorisation shall be extended for five years in the cases referred to in the first sentence of paragraph 1, first sentence, point 3 or in paragraph 1a, at the request referred to in the first sentence of paragraph 2, within six months before the date of its deletion, if there is no reason for failure pursuant to Article 25 (2) Nos. 3, 5, 5a, 6, 6a or 6b, 7, or the admission is not to be withdrawn or revoked in accordance with Section 30 (1) sentence 2 or if no use is made of the possibility of withdrawal in accordance with § 30 para. 2 no. 1 or the revocation pursuant to § 30 para. 2 no. 2. The fifth sentence of Article 25 (5) and (5a) shall apply accordingly. In the decision on the extension, it shall also be necessary to verify whether there are any findings which have an effect on the submission of the prescription. (4) If the authorisation referred to in paragraph 1 (2) or (3) is obtained, the medicinal product may not be used. shall be placed on the market for a further two years, starting from 1 January or 1 July following the publication of the extinguishing notice pursuant to § 34. This shall not apply if the competent federal authority determines that a condition for the withdrawal or revocation has been provided in accordance with § 30; § 30 para. 4 shall apply.

Footnote

(+ + + § 31 (1): For application, see Section 141 (6) + + +) Unofficial table of contents

Section 32 State Charge Examination

(1) Without prejudice to authorisation, the charge of a serum, a vaccine or an allergen may be placed on the market only if it is released by the competent authority of the Federal Republic of Germany. The batch shall be released if a test (State charge test) has shown that the batch has been manufactured and tested in accordance with the methods of production and control which correspond to the state of the scientific findings. and that it has the necessary quality, efficacy and safety. The charge shall also be released in so far as the competent authority of another Member State of the European Union has found, following an experimental investigation, that the conditions set out in the second sentence are met. (1a) The competent authority of the Member State concerned shall: The Federal Authority shall take a decision under paragraph 1 within a period of two months from the receipt of the batch sample to be tested. Article 27 (2) shall apply. (2) The Federal Ministry shall, after hearing experts from the medical and pharmaceutical sciences and practice, adopt general administrative provisions concerning the provisions of the Federal Office of the Interior the methods of production and control referred to in paragraph 1 shall be made known in the Federal Gazette, and shall be known as the pharmacovigilance test guidelines. The regulations must correspond to the respective state of scientific knowledge and must be constantly adapted to them. (3) On the implementation of the state batch examination, § 25 (8) and § 22 (7) sentence 3 are applicable. Application. (4) The release referred to in the first sentence of paragraph 1 shall not be required in so far as the medicinal products referred to therein are exempted by means of a regulation pursuant to § 35 (1) (4) or by the competent federal authority; the competent federal authority shall: If the manufacturer ' s manufacturing and control methods are at a level of development in which the necessary quality, efficacy and safety are ensured. (5) The release referred to in paragraph 1 or the exemption by the competent federal authority referred to in paragraph 4 shall be withdrawn if one of its It must be revoked if one of the conditions has subsequently fallen away. Unofficial table of contents

§ 33 Fees and charges

(1) The competent authority of the Federal Republic of Germany shall apply the authorisation of tissue preparations, the authorisation of advanced therapy medicinal products, the release of batches, the authorisation of tissue preparations, the authorisation of tissue preparations, the release of batches, the authorisation of applications, for the activities in the context of the collection and evaluation of medicinal products risks, for the opposition proceedings against an administrative act adopted pursuant to this Act or against those arising from a legal regulation referred to in the first sentence of paragraph 2 of this Article or Article 39 (3), first sentence, point 2 or section 39d (9), of charges; and Claims and other individually attributable public services, including independent deliberations and self-employed information, insofar as it is not oral and simple written information within the meaning of Section 7 (1) of the The Federal Ministry of Economics and Technology is authorized to act in agreement with the Federal Ministry of Economics and Technology and, as far as it is concerned, the Federal Ministry of Economics and Technology, and the Federal Ministry of Economics and Technology. Medicinal products intended for use in animals, including with the Federal Ministry for food, agriculture and consumer protection by means of a regulation which does not require the consent of the Federal Council to determine the chargeable facts in more detail, including fixed rates or framework rates as well as the reimbursement of expenses , also by way of derogation from the provisions of the Administrative Costing Act. The level of fees for decisions on authorisation, on the authorisation of tissue preparations, on the authorisation of advanced therapy medicinal products, on the release of batches, and on other individually attributable Public services shall be determined in accordance with the personnel and material costs, in particular the cost of the authorisation procedure, sera, vaccines and allergens, and the effort required for the tests and for the development of appropriate Examination procedure belongs. The amount of the fees for the decision to release a batch shall be determined on the basis of the average amount of personnel and material involved, and the importance, economic value or other benefits of the release for the (3) By way of derogation from the first sentence of § 18 (1) of the Federal Law on Fees, the right to payment of fees and charges pursuant to § 33 (1) in conjunction with the Therapeutic Allergens Ordinal shall be forfeited in accordance with the provisions of the , three years after the date of the announcement of the final decision on the authorisation. (4) To the extent that an objection pursuant to paragraph 1 is successful, necessary expenses within the meaning of Section 80 (1) of the Administrative Procedure Act shall be expenses up to the extent of the amount of the expenses referred to in a legal regulation pursuant to the first sentence of paragraph 2 or § 39 (3) sentence 1 or § 39d paragraph 9 (5) The use of monographs for medicinal products exempted in accordance with § 36 of the obligation to authorise the authorisation, Requires the Federal Institute for Drugs and Medical Devices to pay fees. In doing so, flat-rate pay agreements can be concluded with the associations to which the users belong. In order to measure the charges, the third sentence of paragraph 2 shall apply. (6) The competent authority of the country shall reimburse the competent authority of the competent authority to the competent authority of the federal authority to pay the costs incurred in the course of the joint action under this law, insofar as these costs are borne by the polluter. Unofficial table of contents

Section 34 Information to the public

(1) The competent federal authority has to make known in the Federal Gazette:

1.: the granting and renewal of an authorisation;
2.: the withdrawal of an authorisation;
3.: the revocation of an authorisation;
4.: the rest of an authorisation;
5.: the erasing of an authorisation;
6.: the determination in accordance with § 31 (4) sentence 2,
7.: the amendment of the name in accordance with section 29 (2),
8.: the withdrawal or revocation of the release of a batch pursuant to section 32 (5),
9.: a decision to extend a protection period pursuant to section 24b (1) sentence 3 or (7) or to grant a protection period pursuant to § 24b (6) or (8).

Paragraphs 1 to 5 and 7 shall apply in accordance with decisions or decisions of the European Community or of the European Union. (1a) For medicinal products intended for use in human beings, the competent authority of the Federal Republic of Germany shall: The following information shall be immediately available to the public through an Internet portal and, if necessary, in any other way:

1.: information on the granting of the authorisation, together with the package leaflet and the technical information in the currently approved version,
2.: the public assessment report, which contains information in accordance with Article 25 (5a) for each application area requested and a general-purpose summary containing a section on the conditions for the use of the medicinal product,
3.: Summaries of risk management plans,
4.: information on conditions, together with time limits and dates for compliance,
5.: Concerns from the pharmacovigilance sector.

In the case of the information referred to in points 2 and 5 of the first sentence, operational and business secrets and personal data shall be deleted, unless their disclosure is necessary for the protection of public health. Where the pharmacovigilance concerns referred to in the first sentence of 1 (5) concern medicinal products authorised in several Member States, the publication shall be made in consultation with the European Medicines Agency. In the case of medicinal products intended for use in animals, the competent national authority shall provide the public with information on the issue of the authorisation, together with the technical information, the assessment report referred to in the first sentence of 1 (2) and, if the field of application of the medicinal product relates to animals used for the production of foodstuffs, including residue studies, with the deletion of operational and commercial secrets, immediately available. The first and fourth sentences also relate to changes in the information referred to. (1b) For medicinal products intended for use in humans, the withdrawal of an application for authorisation and the failure to obtain authorisation and the reasons therefor shall be public. to make accessible. Decisions on the revocation, withdrawal or revocation of an authorisation shall also be made publicly available. The Federal Authority shall have the power to supply, on request, information on the receipt of a proper application for authorisation in the case of medicinal products intended for use in the case of humans, the receipt of a proper application for the authorisation of a medicinal product. (1c) Paragraphs 1a and 1b, sentences 1 and 2, shall not apply to medicinal products subject to the conditions laid down in Regulation (EC) No 178/EC. 726/2004. (1d) The competent federal authority shall provide the information in accordance with the Paragraphs 1a and 1b shall be made available electronically. The competent federal authority shall provide the information referred to in paragraphs 1 and 1b with the adoption of the decision, referring to the lack of existing force. (1e) The competent federal authority shall have the Internet portal for medicinal products in accordance with Article 67a (2), in addition to the information referred to in the first sentence of paragraph 1a (1) to (4) and the second sentence of paragraph 1a, the following further information shall be published

1.: the list of medicinal products referred to in Article 23 of Regulation (EC) No 726/2004,
2.: Information on the reporting routes for suspected adverse reactions of medicinal products to the competent federal authority by health professionals and patients, including those provided by the competent authority of the Federal Supreme Court Internet forms.

(2) The competent authority of the Federal Republic of Germany may make an administrative act, which is based on this law, publicly known in the Federal Gazette if more than 50 addressees are affected by the administrative act. This administrative act shall be deemed to have been announced two weeks after the publication of the Federal Gazette. Other communications of the competent federal authority, including the letters with which the parties are given the opportunity to express their views in accordance with Section 28 (1) of the Administrative Procedure Act, can also be disclosed in the Federal Gazette (Bundesanzeiger) if more than 50 addressees are affected. Sentence 2 shall apply accordingly.

Footnote

(+ + + § 34 (1a): For application, see Section 141 (9) + + +) Unofficial table of contents

Section 35 Authorisations for admission and exemption

(1) The Federal Ministry shall be authorized by means of a regulation with the consent of the Federal Council

1.: (dropped)
2.: extend the provisions on authorisation to medicinal products which are not subject to the authorisation requirement laid down in Article 21 (1) and to medicinal products which are exempted from authorisation in accordance with Article 21 (2) (1), to the extent that it is necessary to: to prevent, directly or indirectly, the health of humans and animals;
3.: to extend the rules on the release of a batch and the state batch test to other medicinal products which are subject to fluctuations in their composition or in their active substance content, to the extent that it is necessary to provide an immediate or to prevent the health of humans or animals from a mediocre risk,
4.: to exempt certain medicinal products from the state batch test if the manufacturing process and the manufacturer ' s test procedure have reached a level of development in which the quality, efficacy and safety are guaranteed .

(2) The legal regulations referred to in paragraph 1 (2) to (4) shall be adopted in agreement with the Federal Ministry of Economics and Technology and, in the case of radioactive medicinal products and medicinal products, in the manufacture of which ionizing radiation is produced. , in agreement with the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, and, in the case of medicinal products intended for use in animals, in agreement with the Federal Ministry of Food and Food, Agriculture and consumer protection. Unofficial table of contents

Section 36 authorisations for standard approvals

(1) The Federal Ministry shall be authorized, after consultation of experts by means of a legal regulation with the consent of the Bundesrat, certain medicinal products or groups of medicinal products or medicinal products in certain forms of delivery from the obligation to obtain authorisation , in so far as there is no direct or indirect risk to the health of humans or animals, since the requirements for the necessary quality, efficacy and safety have been established. The exemption may be made subject to the protection of human or animal health from a specific production, composition, labelling, package leaflet, technical information or pharmaceutical form, as well as to certain types of use, Application areas or areas of application are restricted. The indication of further contraindications, side effects and interactions by the pharmaceutical entreprenter is permitted. (2) In the selection of medicinal products exempted from the obligation to obtain authorisation, the legitimate interests of the Pharmaceutical consumers, healthcare professionals and the pharmaceutical industry are being taken into account. In the choice of the name of the medicinal product, the pharmaceutical operator is free. (3) The legal regulation referred to in paragraph 1 shall be adopted in agreement with the Federal Ministry of Economics and Technology and, in the case of radioactive medicinal products, and medicinal products used for the production of ionizing radiation, in agreement with the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, and, where these are medicinal products, for use in animals , in agreement with the Federal Ministry of Food, (4) Before the adoption of the legal regulation referred to in paragraph 1, it is not necessary to consult experts and the consent of the Federal Council, insofar as this is necessary in order to provide information on contraindications, side effects, Interactions, dosages, pack sizes and precautions for use should be changed immediately and the period of validity of the legal regulation is limited to one year at the latest. The period may be extended up to a further year if the procedure referred to in paragraph 1 cannot be completed within the period of the year. (5) The monographs on which the legal regulation referred to in paragraph 1 are based shall be that of the competent federal authority to regularly review and to the extent necessary to adapt it to the state of science and technology at each level. In doing so, the monographs shall be examined to determine whether the requirements for the required quality, efficacy and safety, including a positive benefit/risk ratio, for the requirements exempted from the obligation to obtain authorisation, shall be assessed. medicines, continue to be shown to be proven. Unofficial table of contents

§ 37 Approval of the European Community or of the European Union for the placing on the market, authorisations of medicinal products from other States

(1) The marketing authorisation granted by the European Community or the European Union in accordance with Regulation (EC) No 726/2004, also in conjunction with Regulation (EC) No 1901/2006 or Regulation (EC) No 1394/2007, § § 11a, 13 (2a), § 21 (2) and (2a), § § 40, 56, 56a, 58, 59, 67, 69, 73, 84 or 94 shall be subject to an authorisation granted pursuant to section 25 of the authorisation. The authorisation within the meaning of § 21 shall also apply to the authorisation granted by another State for a medicinal product, insofar as this is determined by the Federal Ministry's legal decree. (2) The Federal Ministry shall be authorized to adopt a legal regulation in accordance with (1), which does not require the consent of the Bundesrat, to implement a Council Directive or to the extent that, in international treaties, the authorisation of medicinal products is mutually recognised as equivalent. The regulation is in agreement with the Federal Ministry of Food, Agriculture and Consumer Protection, as far as medicines are concerned, which are intended for use in animals.

Fifth Section
Registration of medicinal products

Unofficial table of contents

§ 38 Registration of homeopathic medicinal products

(1) Ready-to-use medicinal products which are medicinal products within the meaning of Article 2 (1) or (2) (1) may be placed on the market as homeopathic medicinal products within the scope of this Act only if they are placed on the market in a competent federal authority have been registered for homeopathic medicinal products (registration). An admission is not required; § 21 (1) sentence 2 and (3) shall apply accordingly. A registration is not required for medicinal products marketed by a pharmaceutical operator in quantities of up to 1 000 packs in one year, unless it is a medicinal product,

1.: contain preparations of substances in accordance with § 3 (3) or (4),
2.: which contain more than one hundred parts of the smallest dose used in non-homeopathic medicinal products subject to medical prescription in accordance with section 48; or
3.: where the facts of section 39 (2), (3), (4), (5), (6), (7) or (9) are available.

(2) The application for registration shall be accompanied by the particulars, documents and opinions referred to in § § 22 to 24. This shall not apply to the information on the effects and indications of use, to the documents and opinions on the clinical trial, and to the information referred to in Articles 22 (2) (5) and (5a) and (7) sentence 2. pharmacologically toxicological tests shall be submitted in so far as the safety of the medicinal product does not otherwise arise, in particular by means of an appropriately high degree of dilution. Section 22 (1a) shall apply accordingly. Unofficial table of contents

Section 39 Decision on the registration of homeopathic medicinal products, procedural rules

(1) The competent federal authority shall register the homeopathic medicinal product and assign the registration number to the applicant in writing. Section 25 (4) and (5) sentence 5 shall apply. The registration shall only apply to the homeopathic medicinal product listed in the communication and its degrees of dilution. The competent authority of the Federal Republic of Germany may link the decision to the registration with conditions. Conditions can also be arranged subsequently. Section 28 (2) and (4) shall apply. (2) The competent federal authority shall fail to register if:

1.: the documents submitted are incomplete;
2.: the medicinal product has not been adequately analysed in accordance with the state of scientific knowledge which has been established,
3.: the medicinal product does not have the appropriate quality in accordance with the recognised pharmaceutical rules;
4.: in the case of the medicinal product, there are reasonable grounds for suspecting that, in the event of intended use, it has adverse effects which go beyond what is acceptable in accordance with the findings of medical science;
4a.: the medicinal product is intended for use in animals used for the production of foodstuffs, and contains a pharmacologically active ingredient which is not listed in the Annex to Regulation (EU) No 37/2010 as a substance for which a the definition of maximum quantities is not necessary;
5.: the specified waiting period is not sufficient;
5a.: the medicinal product, if it is intended for use in humans, is not intended for use and not for external use,
5b.: the medicinal product is more than one part per ten thousand of the primary substance or in the case of medicinal products intended for use in humans, more than the hundredth part of the medicinal products subject to compulsory prescription in accordance with section 48 of this Regulation the smallest dose used,
6.: the medicinal product is subject to compulsory prescription, unless it contains only substances listed in the Annex to Regulation (EU) No 37/2010 as substances for which maximum quantities are not required,
7.: the medicinal product is not manufactured according to a process technique described in the homeopathic part of the medicinal product,
7a.: if the use of the individual active substances as a homeopathic or anthroposophic medicinal product is not generally known,
8.: authorisation is granted for the medicinal product,
9.: the placing on the market of the medicinal product or its use in animals would be contrary to statutory provisions.

(2a) If the medicinal product has already been registered in another Member State of the European Union or in another State Party to the Agreement on the European Economic Area, registration on the basis of this Decision shall be , unless there is a reason for the failure to give effect to paragraph 2. For the recognition of the registration of another Member State, Chapter 4 of Directive 2001 /83/EC and of medicinal products intended for use in animals, Chapter 4 of Directive 2001 /82/EC, shall apply; Article 29 (2) (b) of Directive 2001 /82/EC 4, 5 and 6 and Articles 30 to 34 of Directive 2001 /83/EC as well as Articles 33 (4), 5 and 6 and Articles 34 to 38 of Directive 2001 /82/EC shall not apply. (2b) The applicant shall be accompanied by the competent authority of the Federal Supreme Court shall immediately be notified if any changes have been made to the information contained in the information provided in and documents in accordance with § 38 (2) sentence 1. § 29 (1a), 1e, 1f and 2 to 2b shall apply mutatily. The obligation laid down in the first sentence shall be fulfilled after the registration of the holders of the registration. A new registration is to be requested in the following cases:

1.: in the event of a change in the composition of the active substances by type or quantity, including a change in the potency level,
2.: in the event of a change in the form of presentation, in so far as it is not a change in accordance with Article 29 (2a), first sentence, point 3.

(2c) The registration shall expire at the end of five years from the date of issue, unless an application for renewal is made no later than nine months before the end of the period. In order to delete and extend the registration procedure, § 31 shall apply in accordance with the condition that the grounds for the failure to apply pursuant to paragraph 2 (3) to (9) apply. (2d) For the withdrawal, revocation and revocation of the registration, § 30 (1) sentence 1 shall apply, Paragraph 2, 2a, 3 and 4 accordingly, with the proviso that the grounds referred to in paragraph 2 (2) to (9) shall apply. (2e) § 34 (1), first sentence, points 1 to 7, paragraph 1a, first sentence, points 1, 4 and 5, paragraph 1a, sentence 4, paragraphs 1b and 1d. (3) The Federal Ministry shall be authorized to apply to homeopathic medicinal products in accordance with the provisions of to enact the authorisation by means of a legal regulation without the consent of the Bundesrat, provisions on fees and charges and exemption from registration. The regulation is in agreement with the Federal Ministry of Food, Agriculture and Consumer Protection, as far as medicines are concerned, which are intended for use in animals. Section 36 (4) applies to the amendment of a regulation on the exemption from registration accordingly.

Footnote

(+ + + § 39 (2): For application, see Section 109 (10) + + +) Unofficial table of contents

Section 39a Registration of traditional herbal medicinal products

Medicinal products for manufacture, which are herbal medicinal products and medicinal products within the meaning of Article 2 (1), may only be placed on the market as traditional herbal medicinal products if they are registered by the competent federal authority. This shall also apply to herbal medicinal products containing vitamins or minerals, provided that the vitamins or minerals have the effect of traditional herbal medicinal products with regard to the area of application or the indications of use complement. Unofficial table of contents

Section 39b Registration documents for traditional herbal medicinal products

(1) The application for registration shall be accompanied by the following particulars and documents from the applicant:

1.: the particulars and documents referred to in Article 22 (1), (3c), (4), (5) and (7) and Article 24 (1) (1),
2.: the results of the analytical examination referred to in Article 22 (2), first sentence, point 1, point 1;
3.: the summary of product characteristics, bearing in mind the information referred to in Article 11a (1), taking into account the fact that it is a traditional herbal medicinal product,
4.: bibliographical information on the traditional application or reports of experts showing that the medicinal product in question or a corresponding medicinal product has been submitted for at least 30 years at the time of application, of which at least 15 years in the European Union, medicinal or veterinary medicinal products that are not harmful under the specified conditions of use, and that the pharmacological effects or efficacy of the medicinal product are due to the following conditions: many years of application and experience are plausible,
5.: a bibliographical overview of the information on safety together with an expert opinion in accordance with § 24 and, where necessary for the evaluation of the safety of the medicinal product, the necessary further information and documents,
6.: registrations or authorisations received by the applicant in another Member State or in a third country for the placing on the market of the medicinal product, as well as details of any possible negative decisions concerning registration or registration; or Authorisation and the reasons for these decisions.

Proof of use over a period of 30 years in accordance with the first sentence of sentence 1, point 4, may also be provided if no special authorisation has been granted for a medicinal product for placing on the market. It is also provided if the number or quantity of active substances of the medicinal product has been reduced during this period. A medicinal product is a corresponding medicinal product within the meaning of sentence 1 (4), if, irrespective of the excipients used, the same or similar active substances, the same or a similar use, an equivalent strength and Dosage and the same or similar route of administration as the medicinal product for which the application for registration is submitted. (1a) The information provided for in the first sentence of Article 22 (1) (1) to (10) must be in German, the rest of the information in German or English language; other particulars or documents may be included in the Registration procedures shall be made or submitted in English in English, except in the case of information used for the labelling, the package leaflet or the technical information. (2) Instead of the Presentation of the particulars and documents referred to in the first sentence of paragraph 1, Nos. 4 and 5, may also be referred to a Community or Union plant monograph pursuant to Article 16h (3) of the Directive in respect of medicinal products for use in humans. 2001 /83/EC or a list position referred to in Article 16f of Directive 2001 /83/EC. (3) the medicinal product, more than a herbal active substance or substance, in accordance with section 39a, second sentence, shall be provided for the combination of the particulars referred to in the first sentence of paragraph 1, point 4. If the individual active substances are not sufficiently well known, information on the individual active substances must also be provided. Unofficial table of contents

Section 39c Decision on the registration of traditional herbal medicinal products

(1) The competent federal authority shall register the traditional herbal medicinal product and inform the applicant in writing of the registration number. Section 25 (4) and 5 sentence 5 shall apply. The registration shall only apply to the traditional herbal medicinal product listed in the communication. The competent authority of the Federal Republic of Germany may link the decision to the registration with conditions. Conditions can also be arranged subsequently. § 28 (2) and (4) shall apply. (2) The competent federal authority shall fail to register if the application does not contain the particulars and documents required by section 39b or if the application is not in accordance with the requirements of the application.

1.: the qualitative or quantitative composition does not correspond to the information referred to in section 39b (1) or otherwise the pharmaceutical quality is not appropriate,
2.: the fields of application do not correspond exclusively to those of traditional herbal medicinal products which, according to their composition and the purpose of their application, are intended to be applied to humans without the need for medical supervision; with regard to the position of a diagnosis, prescription or monitoring of the treatment,
3.: the medicinal product may be harmful in the course of its intended use,
4.: the safety of vitamins or minerals contained in the medicinal product has not been established;
5.: the information on the traditional application is inadequate, in particular the pharmacological effects or the efficacy on the basis of the long-standing application and experience are not plausible,
6.: the medicinal product should not be administered exclusively in a given strength and dose,
7.: the medicinal product is not intended solely for oral or external use or for inhalation,
8.: the time required pursuant to section 39b (1) sentence 1, no. 4, is not fulfilled;
9.: the traditional herbal medicinal product or a corresponding medicinal product has been granted an authorisation in accordance with section 25 or a registration in accordance with section 39;
10.: the placing on the market of the medicinal product or its use in animals would be contrary to statutory provisions.

In the case of medicinal products intended for use in animals, the first sentence shall apply. (3) The registration shall expire after five years from the date of its grant, unless a request has been submitted no later than nine months before the expiry of the period. Extension is made. In the event of the deletion and renewal of the registration, § 31 shall apply accordingly, subject to the condition that the reasons for the failure to apply in accordance with paragraph 2 apply. Unofficial table of contents

Section 39d Other procedural rules for traditional herbal medicinal products

(1) The competent federal authority shall notify the applicant and, in the case of medicinal products intended for human use, of the European Commission and of the competent authority of a Member State of the European Union, at the request of: (2) For medicinal products which comply with Article 16d (1) of Directive 2001 /83/EC, § 25b shall apply mutatily to the provisions of Article 25b. For the medicinal products referred to in Article 16d (2) of Directive 2001 /83/EC, due account shall be taken of the registration of another Member State. (3) The competent authority of the Federal Republic of Germany may, pursuant to Article 16h of Directive 2001 /83/EC, On request, the Committee on Herbal Medicinal Products shall request an opinion on the evidence of the traditional application if there is any doubt as to the existence of the conditions laid down in § 39b (1) sentence 1 (4). (4) If a medicinal product is for use in people for less than 15 years within the European Union , but otherwise the conditions for registration in accordance with § § 39a to 39c are available, the competent federal authority shall have the procedure provided for in Article 16c (4) of Directive 2001 /83/EC with the participation of the (5) Where a herbal substance, a herbal preparation or a combination thereof is deleted in the list referred to in Article 16f of Directive 2001 /83/EC, registrations containing that substance shall be deleted. traditional herbal medicinal products intended for use in humans (6) § 34 (1) sentence 1 (1) to (7), unless within three months the particulars and documents referred to in § 39b (1) are submitted. Paragraph 1a, first sentence, points 1, 4 and 5, paragraph 1a, third sentence, (1b) and (1d) shall apply accordingly. (7) The applicant shall immediately report to the competent authority of the Federal Republic, accompanied by appropriate documents, if any changes in the Information and documents pursuant to section 39b (1), first sentence, in conjunction with paragraph 2, shall be obtained. § 29 (1a), 1e, 1f and 2 to 2b shall apply mutatily. The obligation laid down in the first sentence shall be fulfilled after the registration of the holders of the registration. A new registration is to be requested in the following cases:

1.: in the event of a change in the fields of application, in so far as it is not a change in accordance with Article 29 (2a), first sentence, point 1,
2.: in the event of a change in the composition of the active substances by type or quantity,
3.: in the event of a change in the form of presentation, in so far as it is not a change in accordance with Article 29 (2a), first sentence, point 3.

(8) For the withdrawal, revocation and revocation of the registration, § 30 (1) sentence 1, paragraphs 2, 2a, 3 and 4 shall apply accordingly, with the proviso that the grounds for failure to act pursuant to Section 39c (2) shall apply. (9) The Federal Ministry shall be authorized to: to adopt traditional herbal medicinal products, in accordance with the provisions of the authorisation, by means of a regulation without the consent of the Federal Council, to adopt rules on the fees and charges for registration. The regulation is in agreement with the Federal Ministry of Food, Agriculture and Consumer Protection, as far as medicines are concerned, which are intended for use in animals.

Sixth Section
Protection of human beings in clinical trials

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§ 40 General Conditions of Clinical Examination

(1) The sponsor, the auditor and all other persons involved in the clinical trial shall, in carrying out the clinical examination of a medicinal product in humans, have the requirements of good clinical practice in accordance with the provisions of Article 1 (1). 3 of Directive 2001 /20/EC. The clinical examination of a medicinal product in humans may only be initiated by the sponsor if the competent Ethics Commission assesses these in accordance with § 42 (1) and the competent federal authority (Bundesoberbehörde) in accordance with § 42 (1) (1) (a)). 2 approved. The clinical trial of a medicinal product may only be performed in humans if and as long as

1.

a sponsor or a representative of the sponsor who has its head office in a Member State of the European Union or in another State Party to the Agreement on the European Economic Area,

2.

the foreseeable risks and disadvantages to the benefit for the person in which it is to be carried out (data subject) and the probable significance of the medicinal product for the medicine are medically justifiable,

2a.

in accordance with the state of science, in relation to the purpose of the clinical trial of a medicinal product consisting of or containing a genetically modified organism or a combination of genetically modified organisms, harmful effects on

a): the health of third parties and
b): the environment

are not to be expected,

3.

the person concerned

a): be able to recognize the nature, significance and scope of the clinical trial and to orient its will in this way,
b): in accordance with the first sentence of paragraph 2, has been informed in writing, unless otherwise specified in paragraph 4 or in § 41, and
c): has been informed and consented in writing in accordance with the first and second sentences of paragraph 2a; the consent must also expressly refer to the collection and processing of health claims,

4.

the person concerned is not placed in a judicial or administrative order in an institution,

5.

it is carried out in a suitable facility by a suitably qualified examiner, and the examination is conducted by a examiner with at least two years of experience in the clinical trial of medicinal products;

6.

a pharmacologically toxicological examination of the medicinal product, corresponding to the state of scientific knowledge, has been carried out,

7.

each auditor has been informed by a scientist responsible for the pharmacotoxicological examination of their results and the risks likely to be associated with the clinical trial,

8.

where a person is killed or the body or the health of a person is injured in the conduct of the clinical trial, insurance shall be provided in accordance with the provisions of paragraph 3, which shall also provide benefits if no other person is responsible for: is liable to the damage, and

9.

A dentist is responsible for the medical care of the person concerned, or a dentist in the case of dental treatment.

If the person concerned cannot write, in exceptional cases, instead of the written consent required under point 3 (3) (b) and (c), oral consent may be given in the presence of at least one witness, who shall also be present at the Information of the person concerned was included. The witness shall not be a person employed by the test office and not a member of the test group. The verbally issued consent must be documented in writing, dated and signed by the witness. (1a) The examiner shall determine appropriately qualified members of the test group. It shall be responsible for directing and monitoring them, and shall provide them with the information necessary for their activities in the course of carrying out the clinical trial, in particular the test plan and the information on examiners. The examiner shall appoint at least one alternate with a comparable qualification. (1b) An insurance referred to in paragraph 1, third sentence, number 8 shall not be required in clinical trials with authorised medicinal products if the application is in accordance with the provisions of the (2) The data subject shall be provided by the person concerned by means of an additional investigation or by comparison of the therapy and the extent to which other insurance for examiners and sponsors exists. (2) an examiner, the doctor or, in the case of a dental examination, a dentist, or a member of the test group, the physician or, in the case of a dental examination, a dentist, to clarify the nature, importance, risks and scope of the clinical trial and of the right to participate in the clinical trial at any time. end; it must be handed out to a general information document. The person concerned shall also be given an opportunity to consult with an examiner or a member of the test group, the physician or, in the case of dental examinations, dentist, on the other conditions of conduct of the clinical trial. To give an examination. A consent to participation in a clinical trial, as stated in point 3 (3) (b) of the third sentence of paragraph 1, may be revoked at any time in writing or orally to the auditor or a member of the test group, without the consent of the (2a) The data subject shall be informed of the purpose and extent of the collection and use of personal data, in particular of health data. It shall, in particular, inform that:

1.

the data collected is required

a): shall be kept ready for inspection by the Sponsor ' S Supervisory Authority or the sponsor to verify the proper conduct of the clinical trial,
b): pseudonymated to the sponsor or a body commissioned by the sponsor for the purpose of scientific evaluation,
c): in the case of an application for authorisation, a pseudonym shall be passed on to the applicant and the competent authority responsible for the authorisation,
d): in the case of adverse events of the medicinal product to be examined, the sponsor and the competent authority of the Federal Republic of Germany, as well as the competent federal authority, shall be passed on to the European database,

2.

the consent referred to in the third sentence of paragraph 3 (3) (c) is irrevocable;

3.

in the event of withdrawal of the consent declared in accordance with the third sentence of paragraph 3 (3) (b), the stored data may continue to be used, to the extent that this is necessary to:

a): the effects of the medicinal product to be tested,
b): ensure that the legitimate interests of the data subject are not compromised,
c): to comply with the obligation to submit complete registration documents;

4.

the data are stored in the above-mentioned places for the time limits specified in accordance with section 42 (3).

In the event of withdrawal of the consent declared in accordance with the third sentence of paragraph 1 (3) (b), the authorities responsible shall immediately examine the extent to which the stored data may still be necessary for the purposes set out in the second sentence of paragraph 3. Data no longer required shall be deleted immediately. In addition, the personal data collected must be deleted after the expiry of the time limits specified pursuant to section 42 (3), unless statutory, statutory or contractual retention periods are in conflict. (3) The insurance referred to in paragraph 1 sentence 3 No 8 must be used for the benefit of the persons concerned by the clinical trial in respect of one in a Member State of the European Union or another State Party to the Agreement on the European Economic Area authorised insurers. Its scope shall be proportionate to the risks associated with the clinical trial and shall be determined on the basis of the risk assessment in such a way as to ensure that, in any event, the death or invalidity of the invalidity of any of the risks arising from the clinical trial must be assessed in such a way as to be the person concerned is at least 500 000 euro available to the clinical trial. (4) In the case of a clinical trial in the case of minors, paragraphs 1 to 3 shall apply, subject to the following conditions:

1.: The medicinal product must be intended for the detection or prevention of diseases in the case of minors, and the use of the medicinal product must be indicated in accordance with the findings of medical science in order to identify diseases in the case of minors. or to protect him from disease. The medicinal product is indicated if its application is medically indicated in the minor.
2.: The clinical trial of adults or other research methods must not be expected to provide sufficient test results according to the findings of medical science.
3.: The consent shall be given by the legal representative, after he has been informed in accordance with paragraph 2. It must comply with the presumed will of the minor to the extent that such a person can be identified. Prior to the clinical trial, the minor shall be a physician experienced in dealing with minors, the physician or, in the case of dental examination, a dentist, or a suitably experienced member of the test group, the physician or, in the case of a minor, the doctor or, in the case of a dental examination, a dentist is to inform about the examination, the risks and the benefits, to the extent that this is possible with regard to his age and his spiritual maturity; declares the minor not to take part in the clinical trial , or if it is to express this in any other way, it should be noted. If the minor is able to recognize the nature, meaning and scope of the clinical trial and to orient his will, his consent shall be required. In addition to the legal representative, an opportunity for an interview in accordance with the second sentence of paragraph 2 shall also be opened to the minor.
4.: The clinical trial may only be carried out if it is associated with as few burdens as possible for the person concerned and other foreseeable risks; both the degree of stress and the risk threshold must be included in the test plan. is defined and continuously checked by the auditor.
5.: Advantages with the exception of an adequate compensation may not be granted.

(5) The person concerned, their legal representative or any of their authorised representatives shall have a competent contact point available, in which information on all circumstances which are of importance for the conduct of a clinical trial is to be obtained. The contact point is to be set up with the respective competent federal authority. Unofficial table of contents

Section 41 Special requirements for clinical examination

(1) § 40 (1) to (3) shall apply to a clinical trial in the case of a full-year person suffering from a disease for which the medicinal product to be tested is to be used, with the following conditions:

1.: Whereas the use of the medicinal product to be tested must be indicated in accordance with the findings of medical science in order to save the life of that person, to restore health or to facilitate its suffering; or
2.: it must be associated with a direct benefit for the group of patients suffering from the same disease as this person.

If the consent cannot be obtained because of an emergency situation, a treatment which is necessary without delay in order to save the life of the person concerned shall be allowed to restore their health or to facilitate their suffering, immediately. Consent to further participation is to be obtained as soon as possible and reasonable. (2) A clinical trial in a minor who suffers from a disease for which the medicinal product to be tested should be used, § 40 (1) to (4) shall apply with the following conditions:

1.

Whereas the use of the medicinal product to be tested must be indicated in accordance with the findings of medical science in order to save the life of the person concerned, to restore health or to facilitate its suffering; or

2.

a): the clinical trial must be associated with a direct benefit for the group of patients suffering from the same disease as the person concerned,
b): the research must be strictly necessary for the confirmation of data obtained in clinical trials on other persons or by means of other research methods,
c): the research must relate to a clinical condition under which the minor concerned suffers and
d): the research may be linked to the person concerned only with a minimal risk and a minimal burden; research has only a minimal risk if, according to the nature and extent of the intervention, it is to be expected that it may be of a very minor and temporary impairment of the health of the person concerned; it has a minimal burden if it is to be expected that the inconvenience to the data subject may be temporarily suspended will occur and will be very small.

Sentence 1 (2) does not apply to minors for which paragraph 3 would be applied once the age of majority has been reached. (3) A clinical trial with a person who is not in a position to be able to do so, who is not capable of being, and is not capable of, the nature, meaning and scope of clinical trials. § 40 (1) to (3) shall apply in accordance with the following conditions: to recognise and to align its will and to orient it on a disease to which the medicinal product to be tested should be used:

1.: Whereas the use of the medicinal product to be tested must be indicated in accordance with the findings of medical science in order to save the life of the person concerned, to restore health or to facilitate its suffering; such research shall relate directly to a life-threatening or very weakened clinical condition in which the data subject is located, and the clinical trial shall be subject to the minimum burden and burden on the person concerned, and of other foreseeable risks; both the degree of stress and the risk threshold must be specifically defined in the test plan and kept under constant review by the auditor. The clinical trial may only be conducted if there is a reasonable expectation that the benefit of the use of the investigational medicinal product for the person concerned outweighs the risks or does not involve any risks.
2.: The consent shall be given by the legal representative or authorised representative, after he has been informed in accordance with § 40 (2). § 40 (4) (3) sentences 2, 3 and 5 shall apply accordingly.
3.: Research must be strictly necessary for the confirmation of data obtained in clinical trials on persons capable of informed consent or by means of other research methods. Section 40 (4) (2) shall apply accordingly.
4.: Advantages with the exception of an adequate compensation may not be granted.

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§ 42 Procedure at the Ethics Committee, approval procedure with the Federal Authority

(1) The additional evaluation of the Ethics Committee required in accordance with § 40 (1) sentence 2 shall be requested by the sponsor in the independent interdisciplinary Ethics Committee, which is responsible for the auditor under national law. If the clinical trial is carried out by a number of examiners, the application shall be submitted to the independent Ethics Committee responsible for the head of the clinical trial. The information on the education, composition and funding of the Ethics Committee is determined by national law. The sponsor shall submit to the Ethics Committee all the particulars and documents required for evaluation. In order to evaluate the documents, the Ethics Committee may use its own scientific findings, provide expert advice or request expert opinions. It shall consult experts or request expert opinions if it is a clinical trial in the case of minors and does not have their own expertise in the field of paediatrics, including ethical and psychosocial Questions of paediatric medicine, or if it is a clinical trial of xenogenic medicinal products or gene therapy medicinal products. The assassin evaluation may only be denied if:

1.: the documents submitted are incomplete, even after the expiry of a reasonable time limit set by the sponsor;
2.: the documents submitted, including the test plan, the audit information and the modalities for the selection of the participants, are not in accordance with the state of scientific knowledge, in particular the clinical trial is inappropriate, to demonstrate the safety or efficacy of a medicinal product, including a different mode of action in the case of women and men; or
3.: the requirements laid down in § 40 (1) sentence 3 nos. 2 to 9, para. 4 and § 41 are not fulfilled.

The details shall be determined in the legal regulation referred to in paragraph 3. The Ethics Committee shall forward a decision on the application referred to in the first sentence within a period of not more than 60 days after receipt of the required documents, which shall be extended or shortened in accordance with the provisions of the Regulation referred to in paragraph 3. For the examination of xenogenic medicinal products there is no time limit for the approval period. (2) The approval of the competent federal authority required pursuant to § 40 (1) sentence 2 shall be from the sponsor to the competent authority. Federal authority to apply. The sponsor shall submit all the particulars and documents necessary for the evaluation, in particular the results of the analytical and pharmacological toxicological tests, as well as the test plan and clinical particulars on the medicinal product. including the audit information. Authorisation may not be granted only if:

1.: the documents submitted are incomplete, even after the expiry of a reasonable time limit set by the sponsor;
2.: the documents submitted, in particular the information on the medicinal product and the test plan, including the test information, do not correspond to the state of scientific knowledge, in particular the clinical trial is unsuitable, the proof the safety or efficacy of a medicinal product, including a different mode of action in women and men,
3.: the requirements laid down in Article 40 (1), third sentence, No. 1, 2, 2a and 6, in the case of xenogenic medicinal products, are not fulfilled, in particular with regard to insurance for third parties, as regulated in point 8;
4.: the competent authority of the Bundesoberauthority (Bundesoberbehörde) has knowledge that the test facility is not suitable for carrying out the clinical trial or that it does not comply with the requirements of the clinical trial referred to in point 2 can be or
5.: the requirements laid down in Article 40 (4) or (41) are not fulfilled.

The approval shall be deemed to have been granted if the competent federal authority does not transmit any reasoned objections to the sponsor within 30 days of receipt of the application documents. If the sponsor has not amended the application for a reasoned objection within a period of not more than 90 days, the application shall be deemed to have been rejected. The details shall be determined in the legal regulation referred to in paragraph 3. By way of derogation from the fourth sentence, the clinical trial of medicinal products may,

1.: falling within the scope of point 1 of the Annex to Regulation (EC) No 726/2004,
2.: -advanced therapy medicinal products, xenogenic medicinal products,
3.: containing genetically modified organisms, or
4.: whose active substance is a biological product of human or animal origin, or contains biological components of human or animal origin, or requires such constituents to be produced,

only if the competent federal authority has issued a written authorisation to the sponsor. The competent federal authority shall take a decision on the application for the authorisation of medicinal products referred to in the second sentence of the second sentence of the second subparagraph, within a period not exceeding 60 days from the date of receipt of the required documents referred to in the second sentence, which shall: may be extended or shortened in accordance with the provisions of a regulation referred to in paragraph 3; for the examination of xenogenic medicinal products there is no time limit for the period of approval. (2a) The following for the approval of a clinical trial Paragraph 2 competent authority shall inform the competent authority referred to in paragraph 1. Ethics Commission, provided that it has information on other clinical trials relevant to the evaluation of the assessment reviewed by the Ethics Committee, in particular for information on aborted or otherwise prematurely finished exams. Furthermore, the transmission of personal data is not necessary, furthermore, business and business secrets are to be observed. (3) The Federal Ministry is empowered to comply with the provisions of the Federal Council with the consent of the Federal Council for the provision of guarantees of proper conduct of the clinical examination and the achievement of the scientific knowledge of relevant documents. In particular, provisions may be adopted in the regulation on:

1.

the tasks and responsibilities of the sponsor, the auditor or other persons performing or controlling the clinical trial, including display, documentation and reporting obligations, in particular with regard to side effects, and other adverse events which may occur during the study and which could affect the safety of the study participants or the conduct of the study,

2.

the tasks of and the procedure in the case of ethics committees, including the documents to be submitted, including information on the appropriate participation of women and men as participants in the examination, the interruption or Extension or reduction of the time limit for processing and the special requirements for the ethics committees in the case of clinical trials in accordance with § 40 (4) and § 41 (2) and (3),

3.

the tasks of the competent authorities and the regulatory approval procedure, including the documents to be submitted, including information on the appropriate participation of women and men as participants in the examination, and of the the interruption or extension or reduction of the period of processing, the procedure for the verification of documents in establishments and facilities, the conditions and the procedure for the withdrawal, revocation and revocation of the authorisation, or -a clinical trial,

4.

the requirements for testing equipment and the keeping and keeping of evidence,

5.

the transmission of the name and seat of the sponsor and of the auditor responsible and of the non-personal information on the clinical trial and the results of the clinical trial from the competent authority to a European database;

6.

the powers to collect and use personal data in so far as they are necessary for the conduct and monitoring of clinical trials; this also applies to the processing of data not processed or used in files ,

7.

where medicinal products are affected which consist of or contain a genetically modified organism or a combination of genetically modified organisms,

a): the collection and use of personal data in so far as they are necessary for the prevention of risks to the health of third parties or for the environment in their impact;
b): the tasks and powers of the authorities to avert risks to the health of third parties and to the environment in their impact,
c): the transmission of data to a publicly accessible European database; and
d): the exchange of information with the European Commission;

the forwarding of documents and copies of the decisions to the competent authorities and the ethics committees responsible for the auditor may also be determined and required for documents to be made available on electronic storage media to be submitted. The Regulation provides for derogations to be made in accordance with Directive 2001 /20/EC for authorised medicinal products. Unofficial table of contents

Section 42a Withdrawal, revocation and revocation of the approval or the assasining assessment

(1) The authorisation shall be withdrawn if it is known that a reason for the failure to grant has been provided for in accordance with Article 42 (2), third sentence, No. 1, No. 2 or No. 3; it must be revoked if facts occur subsequently which are based on the failure to claim § 2. 2, paragraph 2, point 2, point 3, point 4 or point 5 would be justified. In the cases of sentence 1, the rest of the permit may also be arranged for a limited period of time. (2) The competent federal authority may revoke the authorisation if the circumstances of the clinical trial do not contain the information in the permit application , or if facts give rise to doubts about the safety or the scientific basis of the clinical trial. In this case, the rest of the permit may also be arranged on a temporary basis. The competent federal authority shall immediately inform the other authorities and ethics committees responsible for the supervision, as well as the European Commission and the European Medicines Agency, stating the reasons. (3) The decision referred to in paragraphs 1 and 2 shall be given to the sponsor for an opinion within a period of one week. Section 28 (2) (1) of the Administrative Procedure Act applies accordingly. If the competent authority of the Federal Republic of Germany orders the immediate interruption of the examination, it shall immediately forward this order to the sponsor. Any objection or objection to the revocation, withdrawal or order of revocation of the authorisation, as well as any orders referred to in paragraph 5, shall have no suspensory effect. (4) The approval of a clinical trial shall be withdrawn, or The evaluation by the relevant Ethics Committee shall be withdrawn if the Ethics Committee becomes aware of the fact that an evaluation by the Ethics Committee of the Ethics Committee is to be withdrawn. The reason for failure pursuant to Article 42 (1) sentence 7 has been provided for; it shall be revoked if the Ethics Commission is aware of the fact that

1.: the requirements relating to the suitability of the examiner, his deputy or the inspection body are no longer met,
2.: there is no longer any proper insurance cover, or the conditions for an exemption from the insurance obligation are no longer available,
3.: the modalities for the selection of the test participants no longer correspond to the state of medical knowledge, in particular the clinical trial is not appropriate, the detection of the safety or efficacy of a medicinal product including a different mode of action in women and men, or
4.: the conditions for the inclusion of persons pursuant to § 40 (4) or (41) are no longer fulfilled.

Paragraphs 3 and 4 shall apply accordingly. The competent Ethics Committee shall immediately inform the competent authority of the Federal Republic of Germany and the other authorities responsible for the supervision. (5) When the competent authority of the Federal Republic of Germany, in the course of its activities, facts which justify the assumption that the sponsor, an auditor or any other party no longer fulfils his obligations in the course of the proper conduct of the clinical trial, the competent authority shall inform the competent authorities of the competent authorities. Federal authority shall immediately and immediately order the person concerned by that person any remedial measures to be carried out; if the measure does not concern the sponsor, the latter shall be informed of the order. Measures taken by the competent surveillance authority in accordance with Section 69 shall remain unaffected. Unofficial table of contents

§ 42b Publication of the results of clinical trials

(1) Pharmaceutical operators who, within the scope of this Act, place on the market a medicinal product which is subject to the marketing authorisation or marketing authorisation and is intended for use in humans; Provide reports on all results of confirmatory clinical trials in order to demonstrate the efficacy and safety of the competent federal authority for entry into the database in accordance with § 67a paragraph 2. These reports shall be made available within six months of the granting or modification, in so far as the change in confirmatory clinical trials is based on the authorisation or the marketing authorisation. (2) clinical trial with a medicinal product that has already been approved or approved for placing on the market and is not used as a comparative preparation, the sponsor shall have the results of the clinical trial within one year after of their termination in accordance with paragraph 1. (3) The reports shall be published in accordance with paragraphs 1 and 2 shall contain all the results of the clinical trials, whether favourable or unfavourable. It is also necessary to include statements on subsequent substantive changes in the test plan, as well as interruptions and outbreaks of the clinical trial. In addition, the results report must be drawn up in accordance with the requirements of Good Clinical Practice. With the exception of the name and address of the pharmaceutical entrepre or sponsor, as well as the name and address of investigators who agree in accordance with § 4a of the Federal Data Protection Act, the reports according to sentence 1 shall not be allowed to personal data, in particular patient-related data. The report may be written in German or English. § 63b (3) sentence 1 shall not apply. The provisions on the protection of intellectual property and on the protection of business and business secrets remain unaffected, as are § § 24a and 24b.

Seventh Section
Release of medicinal products

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Section 43 Pharmacy requirements, placing on the market by veterinarians

(1) Medicinal products within the meaning of § 2 (1) or (2) (1), which are not released by the provisions of § 44 or the legal regulation for the traffic outside of the pharmacies issued pursuant to § 45 (1), may not be released in the cases of § 47 not to be placed on the market in pharmacies and without official permission, for final consumption only in pharmacies and without authorization by the authorities; the provisions of the pharmacy law are regulated in the following. Outside pharmacies, except in the cases referred to in paragraph 4 and section 47 (1), medicinal products reserved for pharmacies by the first sentence of the first sentence may not be traded. The information on the issuing or modification of a permit for the dispatch of medicinal products in accordance with the first sentence shall be entered in the database in accordance with § 67a. (2) The medicinal products reserved for pharmacies under the first sentence of paragraph 1 may be entered by legal persons, non-legal associations and companies of civil law and of commercial law shall not be handed over to their members, unless the members concerned are pharmacies or the persons referred to in § 47 (1) and (3) shall be subject to the conditions laid down therein. (3) In the sense of § 2 (1) or (2) (1) No. 1, medicinal products may only be prescribed by pharmacies. Article 56 (1) remains unaffected. (4) Medicinal products within the meaning of § 2 (1) or (2) (1) may also be issued by veterinarians to the owners of the animals treated by them and for that purpose in the context of the holding of a veterinary skin pharmacist. held in stock. This shall also apply to the supply of medicinal products for the carrying out of veterinary medicinal products which are subject to veterinary checks and which are controlled by veterinary medicinal products, the extent of which shall be subject to the requirements established on the basis of veterinary indications shall not be allowed to exceed Furthermore, medicinal products within the meaning of Article 2 (1) or (2) (1), which are intended for the implementation of animal health measures and are not subject to medical prescription, may be used in the quantity required by veterinary authorities in the case of animal owners. shall be given. The levy shall give the keeper a written instruction on the nature, time and duration of the application. (5) For use in animals, medicinal products not released for circulation outside the pharmacies may be applied to the animal. Animal owners or other persons not referred to in § 47 (1) shall only be handed out in the pharmacy or veterinary skin pharmacies or by the veterinarian. This shall not apply to medicated feedingstuffs and to medicinal products within the meaning of the third sentence of paragraph 4. By way of derogation from the first sentence, medicinal products which are authorised exclusively for use in animals not intended for the production of foodstuffs may, by way of sale, be made by pharmacies which have a licence pursuant to paragraph 1 of this Article . In addition, the medicinal product referred to in the third sentence may, in the context of the establishment of a veterinary medicinal product, in an individual case, in a quantity necessary for a short-term follow-up treatment, for individual animals treated by the veterinarian, by way of the transfer shall be given. Other provisions concerning the supply of medicinal products by veterinarians under this Act and the Regulation on veterinary medicinal products shall remain unaffected. (6) Medicinal products may be sent to the successor in the context of the transfer of a veterinary practice in the establishment of the veterinary skin pharmacist. Unofficial table of contents

Section 44 exemption from the obligation to pharmacies

(1) Medicinal products intended to be used by the marketing authorisation holder solely for purposes other than the disposal or alleviation of diseases, suffering, bodily injury or pathogenic ailments are not intended to be used for the purposes of transport, the pharmacies are released. (2) Furthermore, they are released for the circulation outside the pharmacies:

1.

a): natural medicinal waters and their salts, also as tablets or pastilles,
b): artificial medicinal waters and their salts, whether or not as tablets or pastilles, but only if they correspond in their composition to natural medicinal waters,

2.

Healers, bath-demos and other peloids, preparations for the production of baths, soaps for external use,

3.

with their German names in traffic

a): Plants and parts of plants, also crushed,
b): mixtures of whole or cut plants or parts of plants as ready-to-use medicinal products;
c): Distillates from plants and plant parts,
d): Press juices made from fresh plants and parts of plants, provided that they are produced without solvent, with the exception of water,

4.

Plaster,

5.

Disinfectants intended exclusively or predominantly for external use, as well as mouth and throat disinfectants.

(3) Paragraphs 1 and 2 shall not apply to medicinal products which:

1.: may only be given on medical, dental or veterinary prescription, or
2.: are excluded from the traffic outside the pharmacy by means of a legal regulation pursuant to § 46.

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Section 45 authorizing further exceptions to the pharmacy obligation

(1) The Federal Ministry is authorized, in agreement with the Federal Ministry of Economics and Technology, after consultation of experts by means of a legal regulation with the consent of the Federal Council, substances, preparations made of substances or Articles intended to serve, in part or exclusively, for the elimination or alleviation of diseases, suffering, bodily harm or illness, to be released for circulation outside the pharmacies,

1.: in so far as they are not only allowed to be made available on medical, dental or veterinary prescription,
2.: in so far as they do not require the examination, storage and delivery by a pharmacy because of their composition or effect,
3.: unless, by their release, a direct or indirect risk to the health of humans or animals, in particular through improper treatment, is to be feared, or
4.: insofar as they do not endanger the proper supply of medicinal products.

The Regulation is adopted by the Federal Ministry of Food, Agriculture and Consumer Protection in agreement with the Federal Ministry for Economic Affairs and the Federal Ministry of Economics and Technology, in so far as these are medicinal products, which are are intended for use in animals. (2) The release may be limited to ready-to-use medicinal products, to certain doses, indications or forms of administration. (3) The regulation shall be adopted by agreement with the Federal Ministry for Environment, nature conservation and reactor safety, as far as radioactive waste is concerned Medicinal products and medicinal products used in the manufacture of ionizing radiation. Unofficial table of contents

Section 46 authorizing the extension of the obligation to pharmacies

(1) The Federal Ministry shall be authorized, in agreement with the Federal Ministry of Economics and Technology, after hearing of experts by means of a regulation with the consent of the Federal Council, medicinal products within the meaning of Section 44 of the Transport outside the pharmacies, to the extent that a direct or indirect risk to the health of humans or animals is to be feared, even in the case of use as intended or in the case of habitual use. The Regulation is adopted by the Federal Ministry of Food, Agriculture and Consumer Protection in agreement with the Federal Ministry for Economic Affairs and the Federal Ministry of Economics and Technology, in so far as these are medicinal products, which are are intended for use in animals. (2) The legal regulation referred to in paragraph 1 may be limited to certain dosages, indications or forms of administration. (3) The regulation shall be adopted in agreement with the Federal Ministry for the Environment, Nature conservation and nuclear safety, as far as radioactive waste is concerned. Medicinal products and medicinal products used in the manufacture of ionizing radiation. Unofficial table of contents

§ 47 Distribution pathway

(1) Pharmaceutical operators and wholesalers shall be authorised to supply medicinal products which are reserved for pharmacies, except for pharmacies.

1.

other pharmaceutical companies and wholesalers,

2.

Hospitals and doctors, as far as they are concerned,

a): blood preparations obtained from human blood or blood components produced by genetic engineering which, in the case of coagulation factor preparations, are controlled by the haemostaseologically qualified medical practitioner in the course of the medically controlled blood self-treatment of blood should be given to his patients,
b): tissue preparations or animal tissue,
c): Infusion solutions in containers of at least 500 ml intended for replacement or correction of body fluid and solutions for haemodialysis and peritoneal dialysis, which are, as far as peritoneal dialysis solutions are concerned, the prescribtion of the nephrologically qualified physician in the context of the physician-controlled self-treatment of his dialysis patients may be given to the doctor,
d): preparations intended solely for the recognition of the condition, condition or function of the body or of mental conditions,
e): medical gases, which also allow the delivery of medical practitioners,
f): radioactive medicinal products,
g): Medicinal products which are labelled "for clinical trial", provided that they are made available free of charge,
h): blood gel and fly larvae, which also allow the delivery of medicinal practitioners, or
i): medicines made available in the case of section 21 (2) (6),

3.

Hospitals, health care centres and doctors, as far as vaccines are concerned, in the case of a free-of-charge on the basis of § 20 (5), (6) or (7) of the Infection Protection Act of 20 July 2000 (BGBl. 1045), or to the extent that a release of vaccines is necessary to prevent the risk of disease or life,

3a.

special yellow fever vaccinations in accordance with § 7 of the law implementing the International Health Regulations (2005), in so far as the vaccine is yellow fever vaccine,

3b.

Hospitals and health services, in so far as they are medicinal products with an antibacterial or antiviral effect, which are intended to be used for specific prophylaxis in accordance with Section 20 (5), (6) or (7) of the Infection Protection Act. of communicable diseases,

3c.

Health authorities of the Federal Republic of Germany or of the Länder or of these bodies designated in each individual case, in so far as they are medicinal products intended for the case of a threatening communicable disease, the spread of which is an immediate and the usual measure require a significant overshoot of specific medicinal products;

4.

veterinary authorities, in so far as they are medicinal products intended for the implementation of public-law measures,

5.

Central procurement for medicinal products, established on a statutory basis or recognised by the competent authority in consultation with the Federal Ministry of the Environment,

6.

Veterinarians as part of the operation of a veterinarian's home pharmacy, to the extent that they are ready-to-use medicinal products, for use in the animals treated by them and for delivery to their holders,

7.

persons entitled to use dentistry, as far as the finished medicinal product is concerned, which is used exclusively in dentistry and is used in the treatment of patients,

8.

bodies of research and science which have been granted a permit under Section 3 of the Narcotics Act, which entitles the person to acquire the medicinal product concerned,

9.

Universities, as far as medicines are concerned, which are needed for the training of pharmacy students and veterinary medicine.

The recognition of the central procurement authority as set out in the first sentence of 1 (5) shall be carried out in consultation with the Federal Ministry of Food, Agriculture and Consumer Protection, in consultation with the Federal Ministry for Food, Agriculture and Consumer Protection. (1a) Pharmaceutical companies and wholesalers may not deliver medicinal products intended for use in animals to the consignee referred to in paragraph 1 (1) or (6) until they have provided them with a certificate issued by the competent authority, is that they have complied with their obligation to notify according to § 67. (1b) Pharmaceutical Traders and wholesalers shall have access to and the levy on the use in animals of certain medicinal products subject to medical prescription which are not intended solely for use in animals other than those used for the production of foodstuffs, , to carry out proof of evidence from which the quantity of the reference shall be shown separately for each of these medicinal products, with the indication of the supplier (s) and the quantity of the levy, with the indication of the person (s) of the person or persons who are entitled to be supplied, and to submit such evidence to the competent authority upon request. (1c) Pharmaceutical companies and wholesalers shall, by 31 March of each calendar year, electronically notify the central information system of medicinal products in accordance with Article 67a (1) in accordance with the provisions of a regulation referred to in the second sentence of sentence 2, by way of Article and quantity of medicinal products delivered by them during the previous calendar year to veterinarians,

1.: anti-microbial substances,
2.: substances listed in Table 2 of the Annex to Regulation (EU) No 37/2010, or
3.: substances listed in one of the annexes to the Regulation on substances with a pharmacological effect

. The Federal Ministry of Food, Agriculture and Consumer Protection is authorized, in agreement with the Federal Ministry, by means of a legal regulation with the consent of the Federal Council

1.

More detailed information on the content and form of the communications referred to in the first sentence, and

2.

to require that

a): to indicate in the communications the authorisation number of the medicinal product concerned,
b): the notification of the quantity of the medicinal product issued after the first two digits of the postcode shall be broken down by the address of the veterinarians.

The provisions of Article 67a (3) and (3a) may also apply in the case of the provisions of Article 67a (3) and (3a) in accordance with the provisions of the legal regulations. (2) The recipients referred to in paragraph 1 (5) to (9) may only use the medicinal products for their own use within the To carry out their duties. The central purchasing bodies referred to in paragraph 1 (5) may only be recognised if it is proved that they are under the expert guidance of a pharmacist or, in so far as they are medicinal products intended for use in animals, of a veterinarian and suitable premises and facilities for the testing, control and storage of the medicinal products are available. (3) Pharmaceutical operators may submit or release samples of a ready-made medicinal product

1.: doctors, dentists or veterinarians,
2.: other persons who are professionally engaged in medicine or dentistry, in so far as it is not a medicinal product subject to medical prescription,
3.: Training centres for the healing professions.

Pharmaceutical companies may submit or have the samples of a ready-made medicinal product available at training centres for the health professions only in a manner appropriate to the purpose of the training. Samples shall not contain substances or preparations

1.: within the meaning of Section 2 of the Narcotics Act, which are listed as such in Annex II or III of the Narcotics Act, or
2.: which, pursuant to Article 48 (2) sentence 3, may only be prescribed on a special prescription;

(4) Pharmaceutical operators shall not be allowed to present samples of a finished product to persons referred to in the first sentence of paragraph 3 only on the relevant written request, in the smallest pack size and in one year from a ready-to-use medicinal product. Leave two samples or leave them in. With the samples, the subject information is to be sent as long as it is prescribed in accordance with § 11a. The pattern is used in particular to inform the physician about the subject matter of the medicinal product. The recipients of samples, as well as the nature, scope and timing of the distribution of samples shall be accompanied by a statement of evidence for each recipient and shall be submitted at the request of the competent authority. Unofficial table of contents

Section 47a Special distribution path, follow-up duties

(1) Pharmaceutical companies may only use a medicinal product which is authorised for the purpose of a termination of pregnancy to institutions within the meaning of Section 13 of the Pregnancy Conflict Act of 27 July 1992 (BGBl). 1398), as amended by Article 1 of the Law of 21 August 1995 (BGBl I). 1050), and only to prescribe a doctor treating them. Other persons may not place on the market the medicinal products referred to in the first sentence. (2) Pharmaceutical operators shall keep a continuous numbering of the packages of the medicinal products referred to in the first sentence of paragraph 1 for the purpose of delivery; without this Labelling may not be given to the medicinal product. Pharmaceutical companies, on receipt and on the application, shall have the facility and the attending physician to carry out evidence and to submit such evidence to the competent authority for inspection at the request of the competent authority. (2a) Pharmaceutical companies and the establishment shall keep the medicinal products referred to in the first sentence of paragraph 1, which are in their possession, separately and shall secure them against unauthorised removal. (3) § § 43 and 47 shall apply to the provisions of paragraph 1 These medicinal products shall not be used. Unofficial table of contents

Section 47b Special distribution of Diamorphine

(1) Pharmaceutical entrepreneurs may only use a diamonorphine-containing medicinal product which is authorised for substitution-based treatment only to recognised facilities within the meaning of Article 13 (3), second sentence, point 2a of the Narcotics Act and only on the prescription of a doctor who is treating there. Other persons may not place on the market the medicinal products referred to in sentence 1. (2) § § 43 and 47 shall not apply to the medicinal products referred to in the first sentence of paragraph 1. Unofficial table of contents

Section 48 Prescription

(1) Medicinal products which:

1.: by means of the regulation referred to in paragraph 2, including in conjunction with paragraphs 4 and 5, certain substances, preparations of substances or objects, or to which such substances or preparations are added from substances,
2.: are not covered by point 1 and are intended for use in animals used for the production of foodstuffs, or
3.: are medicinal products within the meaning of Article 2 (1) or (2) (1), which contain substances with effects or preparations of such substances which are not generally known in medical science;

may only be delivered to consumers in the presence of a medical, dental or veterinary prescription. The first point of the first subparagraph shall not apply to the supply by pharmacies of the equipment of the passenger vessels with a view to the medicinal products which have been laid down in accordance with the provisions of the law on the protection of the health of persons on board and their immediate effect on the protection of the health of persons with a view to their immediate effect. Adequate medical care on board is required. The first subparagraph of point 3 shall also apply to medicinal products which are preparations of substances which are generally known in their effects if the effects of these preparations in medical science are not generally known, unless the effects of such preparations are not generally known. can be determined by the composition, dosage, administration form or area of application of the preparation. The first subparagraph of paragraph 3 shall not apply to medicinal products which are preparations of known effects, to the extent that they may be released outside pharmacies. The obligation to presenter the substance or preparation in question shall be replaced by the obligation to presenter the prescription referred to in the first subparagraph of point 1 of the Regulation referred to in point 1 of paragraph 2 of this Regulation. (2) The Federal Ministry is authorized, in agreement with the Federal Ministry of Economics and Technology, by means of legal regulation with the consent of the Federal Council

1.

determine substances or preparations from substances in which the conditions laid down in paragraph 1, first sentence, point 3, are also available in conjunction with the third sentence of paragraph 1,

2.

Substances, preparations of substances or articles,

a): the health of the person or, where it is intended for use in animals, the health of the animal, the user or the environment may, even in the case of intended use, directly or indirectly endanger them if they do not have a medical, dental or veterinary supervision,
b): which are often not used to a considerable extent in accordance with their intended purpose, if it is likely to jeopardise, directly or indirectly, the health of humans or animals; or
c): in so far as they are intended for use in animals, the use of which may require a prior diagnosis of veterinary medicinal products or may have an effect which complicate or superimpose subsequent diagnostic or therapeutic measures,

3.

to remove the prescription for medicinal products if, on the basis of the experience gained in the use of the medicinal product, the conditions laid down in point 2 are not or are no longer available, in the case of medicinal products as referred to in point 1, the earliest three may be: years after the date of entry into force of the relevant legal regulation, the prescription shall be repealed,

4.

to substances or preparations of substances which are to be made available only if the prescribing does not exceed certain quantitative limits for the use of the individual and the daily use or if the exceeding of the prescribing is not has been expressly indicated,

5.

to determine that a medicinal product may not be given repeatedly on prescription,

6.

to prescribe that a medicinal product may be dispensed only to prescribtion of doctors in a particular area or to the use of establishments approved for treatment with the medicinal product, or to prescribtion, dispensing and application must be conducted,

7.

To adopt rules on the form and content of the prescription, including the prescription in electronic form.

The legal regulations referred to in points 2 to 7 of the first sentence shall be adopted after hearings of experts, unless they are medicinal products which are authorised in accordance with Article 3 (1) or (2) of Regulation (EC) No 726/2004 or which have been approved by the Commission. Medicinal products with regard to active substance, indication, potency and pharmaceutical form. The legal regulation referred to in point 7 of the first sentence may require that medicinal products whose prescription requires the attention of particular safety requirements shall be laid down in order to ensure that:

1.: the prescription may only be carried out on an official form (special prescription) issued by the competent authority of the federal authority upon request of a physician,
2.: the form must contain information on the application and confirmations, in particular on the obligation to clarify the application and risks of the medicinal product, and
3.: A copy of the prescription by the pharmacy must be returned to the competent federal authority.

(3) The legal regulation referred to in paragraph 2, including in conjunction with paragraphs 4 and 5, may be limited to certain dosages, potentiations, dosage forms, ready-to-use medicinal products or areas of application. It is also possible to provide for an exemption from the obligation to presentate the levy on midwives and debindment providers, to the extent that this is necessary for a proper professional exercise. The restriction to certain ready-to-use medicinal products for human use as set out in the first sentence of the first sentence of Article 74a of Directive 2001 /83/EC shall be subject to the lifting of the prescription duty on the basis of significant pre-clinical or clinical trials (4) The Regulation shall be adopted by the Federal Ministry of Food, Agriculture and Consumer Protection in agreement with the Federal Ministry and the Federal Ministry for Food, Agriculture and Consumer Protection Federal Ministry of Economics and Technology (Federal Ministry of Economics and Technology), which are intended for use in animals. (5) The Regulation shall be adopted in agreement with the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, as far as radioactive medicinal products and medicinal products are concerned, in the case of which: (6) The Federal Ministry of Food, Agriculture and Consumer Protection is authorized, in agreement with the Federal Ministry, by means of a legal regulation with the consent of the Federal Council in the case of the Federal Ministry of Food, Agriculture and Consumer Protection. Paragraph 1, first sentence, No 2, medicinal products from the obligation to presenter to the extent that the requirements laid down in Article 67 (aa) of Directive 2001 /82/EC are complied with.

Footnote

(+ + + § 48 (1): For application, see Section 109 (11) + + +) Unofficial table of contents

§ 49

(dropped) Unofficial table of contents

Section 50 Retail trade with free-selling medicinal products

(1) Retail trade outside of pharmacies with medicinal products within the meaning of Article 2 (1) or (2) (1), which are released for circulation outside the pharmacies, may only be operated if the entreptier, one for the representation of the company has the necessary expertise or one of the entrepreneurs with the management of the company or the person responsible for the sale of the company. In the case of undertakings with a number of posts, there shall be a person who has the necessary knowledge of the knowledge and skills required for each establishment. (2) The knowledge and skills required to be completed The packaging, labelling, storage and placing on the market of medicinal products released for circulation outside pharmacies, as well as knowledge of the rules applicable to these medicinal products. The Federal Ministry is authorized, in agreement with the Federal Ministry of Economics and Technology and the Federal Ministry of Education and Research, to enact provisions on this subject with the consent of the Federal Council, with the consent of the Federal Council, as proof of the necessary expertise to ensure the proper use of medicinal products. It may recognise certificates of professional education or further training as evidence. It may also determine that the expertise is demonstrated by an examination before the competent authority or a body designated by it, and that it shall determine the details of the examination requirements and of the examination procedure. The legal regulation will, in so far as these are medicinal products intended for use in animals, are provided by the Federal Ministry of Food, Agriculture and Consumer Protection in agreement with the Federal Ministry, the Federal Ministry of Education and Research. Industry and Technology and the Federal Ministry of Education and Research (BMBF). (3) A expertise referred to in paragraph 1 does not require the placing on the market of finished pharmaceuticals in the retail sector, which

1.: may be made in the travel industry,
2.: are intended for the prevention of pregnancy or sexually transmitted diseases in humans,
3.: (dropped)
4.: Disinfectants intended exclusively for external use, or
5.: Oxygen.

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Section 51 levy in the travel industry

(1) The supply of medicinal products and the search for orders for medicinal products in the travel industry shall be prohibited, with the exception of the prohibition on finished medicinal products released for circulation outside pharmacies, which shall:

1.: by their customary German names, the effects of which are generally known plants or parts of plants or pans of fresh plants or parts of plants, provided that they are not produced in water with any other solvent , or
2.: Healing waters and their salts are in their natural mixing ratio or their reproductions.

(2) The prohibition provided for in the first half-sentence of paragraph 1 shall not apply to the extent to which the trader seeks other persons in the course of their business, unless the trader is a medicinal product for use in animals in Forestry holdings, commercial livestock holdings and farms in the vegetable, fruit, garden and viticulture sectors, the beekeeping sector and the fishing industry, or the placing on these holdings of orders for medicinal products to be delivered to the pharmacies. , is to be visited. This also applies to persons travelling for action and other persons who work on behalf of and on behalf of a trader. Unofficial table of contents

Section 52 Prohibition of self-service

(1) Medicinal products within the meaning of section 2 (1) or (2) (1) may be used

1.: not by vending machines and
2.: are not put on the market by other forms of self-service.

(2) Paragraph 1 shall not apply to ready-to-use medicinal products which:

1.: may be made in the travel industry,
2.: are intended for the prevention of pregnancy or sexually transmitted diseases in humans and are released for circulation outside of pharmacies,
3.: (dropped)
4.: Disinfectants intended exclusively for external use, or
5.: Oxygen.

(3) Paragraph 1 (2) shall also not apply to medicinal products which are released for circulation outside pharmacies where a person who has the expertise in accordance with § 50 is available. Unofficial table of contents

§ 52a wholesale trade in medicinal products

(1) Anyone who operates wholesale trade in medicinal products within the meaning of Article 2 (1) or (2) No. 1, Testsera or Test Antigens requires a permit. The medicinal products referred to in § 51 (1) (2) and released for circulation outside pharmacies shall be excluded from this requirement. (2) The applicant shall have the right to

1.: to designate the particular establishment for which permission is to be granted,
2.: to submit evidence that it has appropriate and adequate facilities, facilities and facilities to ensure proper storage and distribution and, where provided for, a proper refilling, packaging and the labelling of medicinal products;
3.: designate a responsible person who has the expertise required to carry out the activity; and
4.: to make a declaration, in which it undertakes in writing to comply with the rules applicable to the orderly operation of a wholesale trade.

(3) The decision to grant authorisation shall be taken by the competent authority of the country in which the establishment is or is to be situated. The competent authority shall take a decision on the application for authorisation within a period of three months. Where the competent authority requires the applicant to provide further information on the conditions laid down in paragraph 2, the time limit referred to in the second sentence shall be suspended until such time as the necessary additional information is provided by the competent authority. (4) Permission may only be refused if:

1.: the conditions laid down in paragraph 2 are not met;
2.: (a) the evidence justifies the assumption that the applicant or the person in charge referred to in paragraph 2 (3) does not possess the reliability required for the performance of their duties, or
3.: the wholesaler is not in a position to ensure that the rules applicable to the proper operation are complied with.

(5) The permission shall be withdrawn if it is subsequently known that one of the reasons for the failure referred to in paragraph 4 has been present at the time of issue. Permission is to be revoked if the conditions for granting permission are no longer available; instead of revocation, the permission may also be ordered. (6) A permit pursuant to § 13 or § 72 also includes permission to use the permission. (7) The provisions of paragraphs 1 to 5 shall not apply to the activities of pharmacies within the framework of the usual pharmacy operation. (8) The holder of the licence shall have any change in the the information referred to in paragraph 2, as well as any major change in the wholesale trade activity, presentation of the evidence to the competent authority in advance. In the event of an unforeseen change of the responsible person referred to in paragraph 2, point 3, the notification shall be made without delay. Unofficial table of contents

Section 52b Provision of medicinal products

(1) Pharmaceutical operators and operators of major medicinal products which, within the scope of this Act, distribute medicinal products actually placed on the market and intended for use in or on human beings, by the competent authorities responsible for the treatment of medicinal products. The Federal Supreme Authority has been approved or has been granted a marketing authorisation in accordance with Article 3 (1) or (2) of Regulation (EC) No 726/2004 by the European Community or by the European Union ensure adequate and continuous supply of the medicinal product, in order to meet the needs of patients within the scope of this law. (2) Pharmaceutical entrepreneurs must, within the framework of their responsibility, be able to deliver on-demand and continuous supply of fully-fleeced pharmaceutical products . Wholesale drug operations are major acts that maintain a complete, manufacturer-neutral range of pharmacovigilant medicinal products, which are designed to meet the needs of: Patients from the pharmacies working in the wholesale business can be covered daily within a reasonable period of time; the medicinal products to be held must be at least equal to the average requirement for two weeks. Sentence 1 shall not apply to medicinal products which are subject to the distribution route of section 47 (1) (1) (2) to (9) or (47a) or which, for other legal or actual reasons, cannot be extradited via the wholesale trade. (3) Full-service pharmaceutical wholesalers must, within the framework of their responsibility, ensure that the pharmacies that are in business relationship with them are supplied in a way that is appropriate and continuous. The provisions of the Act against restrictions on competition shall remain unaffected by the provisions of the first sentence of paragraph 1 of this Article. Unofficial table of contents

§ 52c Pharmaceutical mediation

(1) A pharmaceutical agent may only act within the scope of this Act if it has its registered office within the scope of this Act, in another Member State of the European Union or in another State Party to the Agreement on (2) The mediator may not enter into a public database in accordance with Article 67 (1), first sentence, with the competent authority and registration by the Authority, in accordance with Section 67 (a), first sentence, or a Database of another Member State of the European Union or of another Member State Contracting State of the Agreement on the European Economic Area. The notification shall indicate the nature of the activity, the name and the address of the mediator. The competent authority referred to in the first sentence shall be the authority within the jurisdiction of which the intermediary is established. (3) Do not fulfil the provisions of this Act or of the provisions adopted pursuant to this Act. Regulation, the competent authority may refuse or delete the registration in the database. Unofficial table of contents

Section 53 Consultation of experts

(1) To the extent that experts are to be consulted before the enactings of legal orders pursuant to § 36 (1), § 45 (1) and § 46 (1) before the adoption of legal regulations, the Federal Ministry shall establish an expert committee without the consent of the Federal Council. The committee is to be composed of experts from medical and pharmaceutical science, hospitals, medical professions, economic circles and social security institutions. The legal regulation may determine the details of the composition, the appointment of the members and the procedure of the committee. The regulation is issued by the Federal Ministry of Food, Agriculture and Consumer Protection in agreement with the Federal Ministry, in so far as it is a medicine intended for use in animals. (2) Insofar as according to § 48 (2) before the adoption of the legal regulation, paragraph 1 shall apply mutatily, with the proviso that experts from the medical and pharmaceutical sciences, as well as experts of the Pharmaceutical commissions of doctors, veterinarians and pharmacists are to be members. The representatives of the medical and pharmaceutical practice and the pharmaceutical industry participate in the meetings without voting rights.

Eighth section
Quality assurance and control

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Section 54 Operating Regulations

(1) The Federal Ministry is authorized, in agreement with the Federal Ministry of Economics and Technology, to adopt, by means of a legal regulation with the consent of the Federal Council, operating regulations for establishments or facilities, the medicinal products the scope of this Act or in which medicinal products are developed, manufactured, tested, stored, packaged or placed on the market, or in which trade is otherwise carried out with medicinal products, to the extent that it is necessary to: proper operation and the required quality of the medicinal products as well as pharmacovigilance, as appropriate for active substances and other substances intended for the manufacture of medicinal products, and for tissues. The Regulation is adopted by the Federal Ministry of Food, Agriculture and Consumer Protection in agreement with the Federal Ministry for Economic Affairs and the Federal Ministry of Economics and Technology, in so far as these are medicinal products, which are are intended for use in animals. The Regulation shall be adopted in agreement with the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, as far as radioactive medicinal products or medicinal products are concerned, in the manufacture of which ionizing radiation is used. (2) In the legal regulation referred to in paragraph 1, provisions may in particular be adopted on:

1.: Development, manufacture, testing, storage, packaging, quality assurance, acquisition, supply, stockpiling and placing on the market,
2.: the management and retention of evidence of the operations referred to in point 1;
3.: the maintenance and control of the animals used in the manufacture and testing of medicinal products and the evidence thereof;
4.: staff requirements;
5.: the nature, size and furnishing of the rooms,
6.: requirements for hygiene,
7.: the nature of the containers,
8.: labelling of containers in which medicinal products and their starting materials are held in stock;
9.: Willingness to work for pharmaceutical wholesalers,
10.: Repositioning of batch samples and their volume and duration of storage,
11.: the identification, disposal or destruction of non-marketable medicinal products;
12.: Conditions for and requirements for the activities referred to in paragraph 1 by the veterinarian (establishment of a veterinary medicinal product) and the requirements for the use of medicinal products by the veterinarian in the treatment of the veterinary medicinal products treated by the veterinarian. Animals.

(2a) (3) The rules set out in paragraphs 1 and 2 shall also apply to persons who engage in professional activities as referred to in paragraph 1. (4) Paragraphs 1 and 2 shall apply to pharmacies within the meaning of the law on pharmacy, insofar as these require a permission in accordance with § 13, § 52a or § 72. Unofficial table of contents

Section 55 Pharmacopoeia

(1) The Pharmacopoeia is a collection of recognised pharmaceutical products made known by the Federal Institute for Medicinal Products and Medical Devices in agreement with the Paul-Ehrlich-Institut and the Federal Office for Consumer Protection and Food Safety Rules relating to the quality, testing, storage, supply and designation of medicinal products and the substances used in their manufacture. The pharmacopoeia also contains rules for the constitution of containers and envelopes. (2) The rules of the pharmacopoeia are decided by the German Pharmacopoeia Commission or by the European Pharmacopoeia Commission. The publication of the rules may be rejected or reversed for legal or professional reasons. (3) The German Pharmacopoeia Commission has the task of deciding on the rules of the Pharmacopoeia and the competent authority of the competent authorities of the United States of Germany. (4) The German Pharmacopoeia Commission shall be established at the Federal Institute for Drugs and Medical Devices. The Federal Institute for Drugs and Medical Devices, in agreement with the Paul-Ehrlich-Institut and the Federal Office of Consumer Protection and Food Safety, convenes the members of the German Pharmacopoeia Commission from experts of the medical and pharmaceutical science, medical professions, the participating business circles and the monitoring of medicinal products in the same proportion, shall be chaired by and shall adopt its rules of procedure. The Rules of Procedure require the approval of the Federal Ministry in agreement with the Federal Ministry of Food, Agriculture and Consumer Protection. The members are obliged to secrecy. (5) The German Pharmacopoeia Commission shall, in principle, decide unanimously on the rules of the Pharmacopoeia. Decisions which have not been approved by more than three quarters of the members of the Commission shall be ineffective. (6) Paragraphs 2 to 5 shall apply to the activities of the German Homeopathic Pharmacopoeia Commission. (7) The notice shall be published in the Federal Gazette (Bundesanzeiger). It may confine itself to pointing out the reference source of the version of the pharmacopoeia and the beginning of the application of the recast. (8) Only substances and containers and envelopes may be used in the manufacture of medicinal products in so far as they are intended to be used in the manufacture of medicinal products. Medicinal products which come into contact with medicinal products are used and only forms of administration which comply with the accepted pharmaceutical regulations are produced. The first sentence of paragraph 1 shall apply to medicinal products manufactured exclusively for export, with the proviso that the rules in force in the beneficiary country may be taken into account. (9) By way of derogation from the first sentence of paragraph 1, the notice shall be published: by the Federal Office for Consumer Protection and Food Safety in agreement with the Federal Institute for Drugs and Medical Devices and the Paul-Ehrlich-Institut, in so far as they are medicinal products intended for use in animals . Unofficial table of contents

§ 55a Official Collection of Investigation Procedures

The competent federal authority shall publish an official collection of methods of sampling and testing of medicinal products and their starting materials. The procedures will be established with the participation of experts from the fields of surveillance, science and pharmaceutical entrepreneurs. The collection must be kept up-to-date.

Ninth Section
Special provisions for medicinal products to be used in animals

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Section 56 medicated feedingstuffs

(1) By way of derogation from § 47 (1), but only on prescription of a veterinary surgeon, medicated feedingstuffs may only be delivered directly to the keeper of the animal; this shall also apply where the medicated feedingstuffs in another Member State of the European Union, or in another State Party to the Agreement on the European Economic Area, using medicinal products premixtures or such pre-mixtures approved in the scope of this Act, which are the same as qualitative and comparable quantitative composition Medicinal products which have been approved in the scope of this Act, have been manufactured, comply with other medicinal products legislation in force within the scope of this Act, and have a medicinal product for medicated feedingstuffs. Accompanying certificate according to the model published by the Federal Ministry of Food, Agriculture and Consumer Protection is attached. In the case of the second sentence of sentence 1, the prescribing veterinarian shall immediately make a copy of the prescription to the competent authority in accordance with § 64 (1) for the supervision of compliance with the provisions of the veterinary medicinal products by the keeper of the animal. submit. The repeated submission to a prescription is not permitted. The Federal Ministry of Food, Agriculture and Consumer Protection is empowered, in agreement with the Federal Ministry and the Federal Ministry of Economics and Technology, to comply with the provisions of the law on the form and content of the (2) For the manufacture of a medicated feedingstuff, only a pre-mix approved in accordance with section 25 (1) or exempted under section 36 (1) from the obligation to authorise the feeding of the medicated feedingstuffs may be used. By way of derogation from the first sentence, a medicated feedingstuff may be produced on prescription from a maximum of three pre-mixtures, each of which is authorised for use in the animal species to be treated, provided that:

1.: an authorised pre-mix is not available for the area of application in question,
2.: in individual cases in the medicated feedingstuffs, no more than two pre-mixtures containing an antimicrobially active substance, or at most one pre-mixture containing medicinal products containing a number of such substances, are included, and
3.: a homogeneous and stable distribution of the active ingredients in the medicated feedingstuff is ensured.

(3) Where medicated feedingstuffs are produced, the compound feedingstuffs used must comply with the food legislation before and after mixing, and no antibiotic or coccidiostat may be used as a feed additive. (4) The manufacturer of the medicated feedingstuff shall ensure that the daily dose of the medicinal product is contained in the compound feedingstuffs containing the daily feed ration of the treated animals, and in the case of ruminants the daily needs Supplementary feedingstuffs, other than mineral feed, at least Half of them. The manufacturer of the medicated feedingstuff shall label the ready-to-feed mixture before delivery in such a way as to indicate on the label the word 'medicated feedingstuffs' and the percentage of the feed requirement in the case of the first sentence of the (5) The veterinarian may only prescribe medicated feedingstuffs,

1.

if they are intended for use in the animals treated by him,

2.

if they are intended for the animal species and indications referred to in the package leaflets of the premixtures of the medicinal products,

3.

if their application is justified according to the field of application and quantity according to the state of veterinary science in order to achieve the treatment objective; and

4.

if the amount of medicated feedingstuffs prescribed for use in animals used for the production of foodstuffs, the

a): subject to letter (b), prescription-only medicinal product premixtures, for use within the 31 days following the delivery, or
b): contain antimicrobially active substances, for use within the seven days following the release,

provided that the authorisation conditions for pre-mix medicinal products do not provide for a longer period of application.

Section 56a (2) shall apply accordingly to the prescription of medicated feedingstuffs. In the case of prescribtion of medicated feedingstuffs in accordance with the first sentence of sentence 1, no. 4, Section 56a (1) sentence 2 shall apply mutatily. Unofficial table of contents

Section 56a prescription, delivery and use of medicinal products by veterinarians

(1) The veterinarian may, subject to specific provisions on the grounds of paragraph 3, only prescribe or deliver to the keeper for transport outside of pharmacies, subject to special provisions, only if:

1.

they are intended for the animals treated by him,

2.

they are admitted or they may be placed on the market pursuant to section 21 (2) no. 4 in conjunction with paragraph 1, or fall within the scope of a legal regulation pursuant to § 36 or § 39 (3) sentence 1 no. 2 or they may be placed under the terms of section 38 (1) in the be allowed to be transported,

3.

they are intended for use in the treated species after approval for the field of application;

4.

their application by field of application and quantity according to the state of veterinary science is justified in order to achieve the treatment objective in the case in question; and

5.

which are used in animals which are used for the production of foodstuffs,

a): , subject to the letter (b), prescribed or prescribed quantity of medicinal products subject to medical prescription, for use within the 31 days following the delivery, or
B: the quantity of medicinal products which contain antimicrobial agents and which are not exclusively intended for local use in accordance with the conditions of authorisation, shall be used within the seven following the seven-year period of application of the days is determined,

provided that the authorisation conditions do not provide for a longer period of application.

The veterinarian may re-submit or prescribe prescription-only medicinal products for use in the case of animals used for the production of foodstuffs, for the treatment in question, provided that the veterinary medicinal product is administered in a period of 31 days before the date of the day of the has examined the treated animals or the treated animal stock in accordance with its treatment instructions for the final application of the medicinal products to be dispensed or prescribable. The application by the veterinarian shall be deemed to be equivalent to the provisions of the first sentence of paragraph 2 to By way of derogation from the first sentence, the veterinarian may not prescribe or give to the keeper of any premix medicinal product. (1a) Paragraph 1, sentence 3 shall not apply to the extent that a veterinarian applies medicinal products to an animal treated by him and that the medicinal products are used in the veterinary medicinal product. (2) In so far as the necessary medical care of the animals would otherwise be seriously threatened and an immediate or indirect risk to human and animal health not to be , the veterinarian may, in the case of single animals or animals, be entitled to By way of derogation from the first sentence of paragraph 1, point 3, including in conjunction with the third sentence of the first sentence of paragraph 1, prescribting, applying or releasing authorised medicinal products or medicinal products exempted from the authorisation:

1.: if an authorised medicinal product is not available for the treatment of the species concerned and the area of application in question, a medicinal product containing the authorisation for the species concerned and another area of application;
2.: where a medicinal product suitable in accordance with point 1 is not available for the species in question, a medicinal product authorised for another animal species;
3.: where a medicinal product suitable for use in accordance with point 2 is not available, a medicinal product authorised for use in human beings or, notwithstanding the first sentence of paragraph 1, point 2, also in conjunction with the third sentence of paragraph 1, a medicinal product which is used in a medicinal product, Member State of the European Union or any other State Party to the Agreement on the European Economic Area is authorized for use in animals; in the case of animals used for the production of foodstuffs, however, only those animals Medicinal products from other Member States of the European Union or of other States Parties to the Agreement on the European Economic Area authorised for use in the production of food products;
4.: where a medicinal product suitable in accordance with point 3 is not available, a medicinal product produced in a pharmacy or by the veterinarian in accordance with section 13 (2) sentence 1 (3) (d).

However, in the case of animals used for the production of foodstuffs, the medicinal product may only be administered by the veterinarian or administered under its supervision and may contain only pharmacologically active substances, which are listed in Table 1 of the Annex to the Regulation (EU) No 37/2010. The veterinarian will have to indicate the waiting period and the details of the Regulation on veterinary medicinal products shall be laid down. The provisions of sentences 1 to 3 shall apply in accordance with medicinal products manufactured in accordance with Section 21 (2) no. 4 in conjunction with paragraph 2a. Homeopathic medicinal products registered or exempted from registration may be prescribed, dispensed and applied by way of derogation from the first sentence of paragraph 1, sentence 1 (3), for medicinal products intended for use in animals which are the subject of: Only if they contain only active substances listed in the Annex to Regulation (EU) No 37/2010 as substances for which maximum quantities are not required. (2a) By way of derogation from paragraph 1 2 sentence 2 may provide medicinal products for single-hovers used for the production of foodstuffs and for the nothing other than the provisions of Section IX II of the Equiden-Pass within the meaning of Commission Regulation (EC) No 504/2008 of 6 June 2008 implementing Council Directive 90 /426/EEC as regards methods of identification of equidae (OJ L 327, 30.4.2008, p. 3), as amended, must also be prescribed, submitted or applied if they are substances as defined in Commission Regulation (EC) No 1950/2006 of 13 December 2006 on the preparation of a List of substances essential for the treatment of equidae in accordance with Directive 2001 /82/EC of the European Parliament and of the Council establishing a Community code relating to veterinary medicinal products (OJ L 327, 30.4.2001, p. 33). (3) The Federal Ministry of Food, Agriculture and Consumer Protection is authorized, in agreement with the Federal Ministry, by legal regulation with the consent of the Federal Council.

1.

to lay down requirements for the supply and prescribtion of medicinal products for use in animals, including with regard to the treatment,

2.

in the case of medicinal products intended for use in animals which contain antimicrobially active substances, subject to a regulation referred to in paragraph 5, subject to the provisions of Article 11 (4), first sentence, In so far as this is necessary for the prevention of direct or indirect exposure to human or animal health by the use of these medicinal products, the information referred to in points 3 and 5 shall be derailed,

3.

require that, in the context of the treatment of certain animals, the veterinarian should, in certain cases, establish a determination of the susceptibility of the pathogen causing a disease to certain antimicrobially active substances; or have been created,

4.

to require that

a)

Veterinarians of the supply, prescription and use, including with regard to the treatment, of medicinal products not released for circulation outside pharmacies, must lead to proof,

b)

certain medicinal products may only be used by the veterinarian themselves if these medicinal products are

aa): the health of humans or animals may, even in the course of their intended use, directly or indirectly endanger them, provided that they are not properly applied,
bb): is repeatedly not used to a considerable extent in accordance with its intended purpose and, as a result, the health of humans or animals can be directly or indirectly endangered,

5.

to prescribe that, by way of derogation from paragraph 2, the veterinarian only contains certain medicinal products containing certain antimicrobially active substances,

a): for the animal species or fields of application provided for in the authorisation, or to prescribe or
b): in the case of the animal species provided for in the authorisation, or in the fields of application provided for in that authorisation

, where necessary, in order to ensure the effectiveness of antimicrobially active substances for the treatment of humans and animals.

In accordance with the provisions of the first sentence,

1.

in the case of the first sentence of sentence 1, the requirements for sampling, the samples to be taken, the examination procedure and the detection procedure shall be determined,

2.

in the case of sentence 1 (4) (a)

a): the nature, form and content of the evidence and the duration of storage;
b): to ensure that evidence of an order issued by the competent authority is brought together by the veterinarian and made available to the competent authority in order to ensure adequate monitoring of the use of medicinal products in the case of animals which are used for the production of foodstuffs.

In order to ensure that the animals receive the necessary medical care at all times, the rules laid down in paragraphs 2, 3 and 5 of the first sentence of the first sentence of the first sentence shall apply. The obligation to provide proof of proof may be restricted to certain medicinal products, fields of application or forms of administration. (4) The veterinarian may not prescribe or write to the keeper by means of a regulation referred to in the first sentence of paragraph 3 (2) of the animal keeper (5) The Federal Ministry of Food, Agriculture and Consumer Protection is authorized, in agreement with the Federal Ministry, to obtain a veterinary medicinal product application commission with the approval of the Federal Council. set up. The Veterinary Medicinal Product Application Commission describes in guidelines the state of veterinary science, in particular for the use of medicinal products containing antimicrobially active substances. The legal regulation provides for details of the composition, the appointment of the members and the procedure of the Veterinary Medicinal Product Application Commission. In addition, further tasks may be entrusted to the Veterinary Medicinal Product Application Commission by means of a legislative decree. (6) It is presumed that a justification according to the status of veterinary science within the meaning of the first sentence of paragraph 1 is not required. or Section 56 (5), first sentence, No 3, provided that the guidelines of the Veterinary Medicinal Product Application Commission have been complied with in accordance with the second sentence of paragraph 5.

Footnote

(+ + + § 56a (2a)): For application, see Section 109 (12) + + +) Unofficial table of contents

Section 56b Exceptions

The Federal Ministry of Food, Agriculture and Consumer Protection is authorized, in agreement with the Federal Ministry, to allow exceptions to § 56a with the consent of the Federal Council, in so far as the necessary medicinal products are The supply of animals would otherwise be seriously endangered. Unofficial table of contents

Section 57 Acquisition and possession by keepers, evidence

(1) The keeper of animals may only use medicinal products which are not released for circulation outside pharmacies for use in animals only in pharmacies, in the case of the veterinarian treating the animal or in the cases of § 56 (1) of the manufacturer. Other persons who are not mentioned in § 47 (1) may only acquire such medicinal products in pharmacies. Sentence 1 shall not apply to medicinal products within the meaning of Section 43 (4) sentence 3. The provisions of sentences 1 and 2 shall not apply to the extent to which medicinal products which are authorised exclusively for use in animals not used for the production of foodstuffs are authorised,

a): by the keeper in accordance with § 43 (5) sentence 3 or 4, or
b): by persons other than those mentioned in Article 47 (1), by the person referred to in § 43 (5) sentence 3

or in accordance with Section 73 (1) (1a). By way of derogation from the first sentence, the keeper may not acquire pre-mixtures of medicinal products. (1a) Animal keepers may not possess medicinal products which are prescribed by means of the regulation that they may only be used by the veterinarian himself. . This does not apply where the medicinal products are intended for a different purpose than for use in animals, or if they are owned by Council Directive 96 /22/EC of 29 April 1996 on the prohibition of the use of certain substances with hormonal agents or thyrostatic effect, and of β-agonists in animal production and repealing Directives 81 /602/EEC, 88 /146/EEC and 88 /299/EEC (OJ L 327, 22.12.1988, p. EC No 3). (2) The Federal Ministry of Food, Agriculture and Consumer Protection is authorized, in agreement with the Federal Ministry, to prescribe, with the consent of the Federal Council, by means of a legal regulation that:

1.: establishments or persons holding animals which are used for the production of foodstuffs, and which place them on the market, or products originating from them, and
2.: persons other than those referred to in Article 47 (1),

(a) evidence of the acquisition, storage and retention of the medicinal products and registers or evidence of the use of the medicinal products, to the extent that it is necessary to ensure the proper use of medicinal products; and in the case of establishments or persons referred to in point 1, which is necessary for the implementation of acts of the European Community or of the European Union in this area. The legal regulation may regulate the nature, form and content of the registers and evidence and the duration of their retention. The Regulation may also require that evidence of the order of the competent authority be summed up by the keeper and made available to the competent authority in so far as this is necessary to ensure that the competent authority has sufficient information to ensure that the competent authority is properly managed. (3) The Federal Ministry of Food, Agriculture and Consumer Protection is empowered to monitor the use of medicinal products in animals that are used for the production of food. Federal Ministry of Justice with the consent of the Federal Council to prescribe that establishments or persons who:

1.: animals kept in an animal shelter or in a similar facility, or
2.: commercial vertebrate animals, excluding animals used for the production of foodstuffs, breeding or holding or temporarily serving for other holdings or persons,

to carry out evidence of the purchase of medicinal products subject to medical prescription which have been obtained for the treatment of the animals referred to in points 1 and 2. The legal regulation may regulate the nature, form and content of the evidence and the duration of its retention. Unofficial table of contents

§ 57a Application by animal keepers

Animal keepers and other non-veterinarians may only use medicinal products subject to medical prescription in animals where the medicinal products have been prescribed or submitted by the veterinarian in which the animals are treated in the treatment of animals. . Unofficial table of contents

Section 58 Application in the case of animals used for the production of foodstuffs

(1) In addition to the requirement of § 57a, animal owners and other non-veterinarians, medicinal products subject to medical prescription or other medicinal products prescribed or acquired by the veterinarian, shall be allowed to use medicinal products in animals which are subject to a measure taken by the competent authority in accordance with Article 58d (3), second sentence, point 2, shall be used only after a veterinary treatment instruction for the case in question. Medicinal products not subject to medical prescription, which are not released for circulation outside the pharmacies and whose use does not take place on the basis of a veterinary treatment instruction, may only be used,

1.: if they are admitted or are subject to the scope of a legal regulation according to § 36 or § 39 (3) sentence 1 no. 2 or they may be placed on the market pursuant to § 38 paragraph 1,
2.: for the animal species and indications referred to in the labelling or package leaflet of the medicinal products, and
3.: in an amount corresponding to the labelling of the medicinal product after the dose and the duration of the application.

By way of derogation from sentence 2, medicinal products within the meaning of section 43 (4) sentence 3 may only be used in accordance with the veterinary instructions provided for in § 43 (4) sentence 4. (2) The Federal Ministry of Food, Agriculture and Consumer Protection is authorized to: prohibit, in agreement with the Federal Ministry, with the consent of the Federal Council, that medicinal products intended for use in animals used for the production of foodstuffs for certain fields of application, or areas are placed on the market or used for these purposes, to the extent that: (3) The Federal Ministry of Food, Agriculture and Consumer Protection is also authorized, in agreement with the Federal Ministry, by means of a regulation of the law of the Federal Republic of Germany , with the consent of the Federal Council, details of technical installations for the oral use of medicinal products in animals, the maintenance and purification of these plants and the duty of care of the keeper to be laid down in order to carry out a disappearance to reduce antimicrobially active substances. Unofficial table of contents

Section 58a Communications on animal huskings

(1) If the bovine animals (Bos taurus), pigs (Sus scrofa domestica), chickens (Gallus gallus) or turkeys (Meleagris gallopavo) are employed or professional, the competent authority shall, in accordance with paragraph 2, have the holding of these animals in relation to the the animal species in question and the holding in which the animals are kept (livestock holding), at the latest 14 days after the start of the holding. The communication shall also contain the following information:

1.

the name of the keeper,

2.

the address of the holding and the registration number issued for the holding of livestock in accordance with animal health requirements relating to the movement of livestock;

3.

in keeping with the

a): of bovine animals, supplemented by an indication of whether they are fattening calves up to an age of eight months or of fattening children aged eight months or more,
b): of pigs supplemented by the indication of whether it is piglets up to and including 30 kg or fattening pigs over 30 kg

(type of use).

(2) The notification obligation referred to in the first sentence of paragraph 1 shall apply:

1.: For the purpose of meat production (fattening), certain chickens or turkeys and from the time of the respective hatching of such animals and
2.: bovine animals or swine intended for the purpose of fattening, and from the date on which the animals in question are withdrawn from the mother.

(3) The person who holds animals within the meaning of the first sentence of paragraph 1 on 1 April 2014 shall make the notification referred to in the first and second sentences of paragraph 1 at the latest by 1 July 2014. (4) Any person under the obligation to notify pursuant to paragraph 1 or 3 shall be subject to changes in respect of the information subject to the notification, to be notified within 14 working days. The notification referred to in paragraph 1 or 3, also in conjunction with the first sentence, shall be made by electronic means or in writing. The required notifications may be made by third parties, to the extent that the keeper has indicated this under the name of the third party of the competent authority. The provisions of paragraphs 1 and 3 and of the first sentence shall not apply to the extent to which the information requested has been communicated in accordance with the animal health rules relating to the movement of livestock. In such cases, the authority responsible for the implementation of paragraphs 1 and 3 and the first sentence of the first sentence shall transmit the required information to the competent authority for the implementation of paragraphs 1 and 3 of the animal health rules. The transfer according to sentence 5 can be carried out in accordance with § 10 of the Data Protection Act in the automated retrieval procedure. Unofficial table of contents

Section 58b Communications on the use of medicinal products

The competent authority shall have, in respect of medicinal products containing antibacterially active substances and used in the animals held by him, animals which are to be notified of their posture pursuant to Section 58a of this Regulation; for each livestock holding in respect of which a registration number has been assigned in accordance with the animal health rules relating to the circulation of livestock, and taking into account the type of use, to be notified twice a year for each treatment

1.

the name of the medicinal product used;

2.

the number and type of animals treated,

3.

subject to the provisions of paragraph 3, the number of days of treatment,

4.

the total amount of medicinal products used which contain antibacterially active substances,

5.

for each half of the year, the number of animals of the species concerned,

a): held at the start of the holding in each half-year,
b): in the course of each half-year,
c): delivered from the holding in the course of each half-year

The communications referred to in the first sentence of point 5 (b) and (c) shall be made by indicating the date of the action in question. The notification shall be published at the latest by the 14. The day of the month following the last month of the half-year in which the treatment has been carried out. Article 58a (4), sentences 2 and 3 shall apply. (2) By way of derogation from the first sentence of paragraph 1, the information referred to in the first sentence of paragraph 1 of the first sentence of paragraph 1 may be replaced by the following information:

1.: the name of the medicinal product obtained or prescribed for the treatment of the veterinarian;
2.: the number and type of animals for which a treatment instruction from the veterinarian has been issued,
3.: the identity of the animals for which a treatment instruction of the veterinarian has been issued, provided that the indication of the type of use is obtained,
4.: subject to the provisions of paragraph 3, the duration of the prescribed treatment in days,
5.: the total amount of the medicinal product applied or delivered by the veterinarian.

The first sentence shall apply only if the person holding animals is:

1.: in writing to the veterinarian at the time of purchase or prescription of the medicinal products, not to depart from the treatment instructions without consultation with the veterinarian, and
2.: in the case of the submission to the competent authority of the notification referred to in the first sentence of paragraph 1, in writing, ensure that the treatment has not deviated from the treatment instructions of the veterinarian.

In the case of medicinal products containing antibacterial substances and having a therapeutic active substance level of more than 24 hours, the veterinarian shall inform the keeper of the number of medicinal products containing antibacterial agents and shall be subject to the following conditions: the period of treatment referred to in the first sentence of paragraph 1, point 3, supplemented by the number of days in which the medicinal product concerned retains its therapeutic active substance level. In addition to the first sentence of paragraph 1, point 3, the keeper shall also communicate these days as a treatment day. Unofficial table of contents

§ 58c Determination of the frequency of therapy

The competent authority shall determine, for each six-month period, the average number of treatments with antibacterially active substances in relation to the holding in question for which the animal health rules governing the movement of livestock a registration number has been assigned, and the respective type of animals kept, taking into account the type of use, in accordance with the calculation procedure for the determination of the frequency of therapy of 21 February 2013 (BAnz AT 22.02.2013 B2)

1.: for each active substance used, the number of treated animals multiplied by the number of days of treatment and the number thus calculated added to each of the active substances of the half-year administered, and
2.: the number determined in accordance with point 1 shall then be divided by the number of animals of the species concerned, which have been kept on average in the six-month period

(2) At the latest by the end of the second month of the half-year following the communications of the preceding half-year pursuant to § 58b (1) sentence 1, the competent authority shall inform the Federal Office of Consumer protection and food safety for the purposes of paragraph 4 and the second sentence of § 77 (3) in an anonymised form, the half-yearly occupational therapy frequency determined in each case as referred to in paragraph 1. In addition, the competent authority shall inform the Federal Institute for Risk Assessment, at the request of the Federal Institute for Risk Assessment, in anonymized form, in each case, the half-yearly frequency of therapy determined in accordance with paragraph 1, as well as those in section 58b (1), first sentence, point 4 , to the extent that this is necessary for carrying out a risk assessment of the Federal Institute for Risk Assessment in the field of antimicrobial resistance. The notifications pursuant to sentences 1 and 2 may be made in accordance with § 10 of the Federal Data Protection Act in the automated retrieval procedure. (3) As far as the countries establish a common position for the purposes of paragraph 1, those in the § § 58a and 58b, which shall determine the half-yearly operational frequency of therapy in accordance with the calculation procedure referred to in paragraph 1 for determining the frequency of treatment and shall notify the decision referred to in the second sentence of paragraph 2 1 and 2. (4) The Federal Office for Consumer Protection and Food Safety shall determine from the information communicated to it on the respective half-yearly occupational therapy frequency

1.: as indicator 1 the median (value below which 50 per cent of all recorded half-yearly treatment cases are) and
2.: Figure 2 is the third quartile (value below which 75 per cent of all recorded half-yearly occupational therapy cases are located)

the nationwide half-yearly therapy frequency for each species referred to in § 58a (1). The Federal Office of Consumer Protection and Food Safety makes these measures up to the end of the third month of the half-year following the communications of the preceding half-year in accordance with Section 58b (1), for the respective past half-year (5) The competent authority or the joint body referred to in paragraph 3 shall inform the keeper of the half-yearly therapeutic frequency determined in accordance with paragraph 1 of this Article for the respective species of the animals which it holds within the meaning of section 58a (1) , taking into account the type of use. The keeper may also request information about the stored or otherwise processed data collected, stored or otherwise processed in accordance with § § 58a and 58b, insofar as they relate to his holding. (6) The data collected in accordance with § § 58a and 58b or communicated in accordance with paragraph 5 of this Article and shall be kept for a period of six years, in each case with the competent authority or the joint body referred to in paragraph 3. The period shall begin at the end of the 30 June or 31 December of the six-month period in which the national half-yearly frequency of therapy referred to in paragraph 4 has been announced. At the end of this period, the data shall be deleted. Unofficial table of contents

§ 58d Reduction of treatment with antibacterially active substances

(1) In order to contribute to the effective reduction of the use of medicinal products containing antibacterially active substances, the person holding the animals referred to in the first sentence of paragraph 58a (1) shall be subject to professional or commercial activity;

1.: two months after a notice of the indicators of the nationwide half-yearly frequency of therapy according to § 58c (4) sentence 2, whether during the past period, its operating half-yearly therapy frequency at the respective animal species of the animals kept by him, taking into account the type of use referred to in the livestock holding, for which a registration number has been assigned to him in accordance with the animal health rules relating to the movement of livestock, above the Measure 1 or measure 2 of the nationwide half-yearly therapy frequency,
2.: to record the determination referred to in point 1 immediately after it has been established in its operational documents.

(2) The half-yearly operating frequency of an animal keeper in relation to the holding of livestock for which a registration number has been assigned to him in accordance with the animal health rules relating to the movement of livestock, shall be:

1.: above the figure 1 of the national half-yearly frequency of therapy, the keeper of the animal has to examine, with the use of a veterinarian, the reasons for this breach and the treatment of the animals kept by him. may be reduced in the sense of Section 58a (1) with medicinal products containing antibacterially active substances, or
2.: above the measure 2 of the national half-yearly frequency of therapy, the keeper, on the basis of a veterinary consultation, shall have a written plan within two months of the date referred to in paragraph 1 (1). , which shall contain measures aimed at reducing the treatment of medicinal products containing antibacterially active substances.

Where the examination of the keeper of animals as set out in the first subparagraph of point 1 shows that the treatment with the medicinal products concerned can be reduced, the animal keeper shall take steps which may lead to a reduction. The keeper shall ensure that the measure referred to in point 1 of the first sentence and the steps set out in the plan referred to in point 2 of the first sentence are carried out with the guarantee of the necessary medicinal supply to the animals. The plan referred to in point 2 of the first sentence shall be supplemented by a timetable if the measures to be taken in accordance with the plan cannot be fulfilled within six months. (3) The plan referred to in paragraph 2, first sentence, point 2 shall be the competent authority not to be requested not later than two months after the date referred to in paragraph 1 (1). To the extent that it is necessary for the effective reduction of treatment with medicinal products containing antibacterially active substances, the competent authority may, in relation to the keeper,

1.

order that the plan should be amended or supplemented,

2.

Taking into account the state of veterinary science to reduce the treatment of medicinal products containing antibacterially active substances, in particular with regard to:

a): the observance of generally accepted guidelines on the use of medicinal products containing antibacterially active agents, or parts thereof, and
b): vaccination of the animals,

3.

, with a view to preventing diseases, taking into account the state of good professional practice in agriculture or good hygienic practice in animal husbandry, order requirements for the animals ' husbandry, in particular: with regard to feeding, hygiene, the method of fattening, including the duration of the mast, the fitting of the stables and their establishment and the stocking density,

4.

order that medicinal products containing antibacterially active substances may only be used by the veterinarian for a given period in a livestock holding if the animal species held by an animal keeper, under Taking into account the type of use, the semi-annual treatment frequency observed twice in a row is considerably higher than the measure 2 of the nationwide therapeutic frequency.

The aim of the amendment or supplement to the plan shall be indicated in the order referred to in the second sentence of paragraph 1. In order to ensure that the animals receive the necessary medical care at all times, the provisions of points 2, 3 and 4 of the second sentence of the second sentence shall be taken. The competent authority may also order the keeper to take the measures referred to in the second sentence of the second sentence if those rights of the keeper are withdrawn from administrative acts or restrict it from other legislation, provided that the necessary Reduction of treatment with medicinal products containing antibacterially active substances cannot be achieved by other effective measures, and the competent authority shall have real knowledge of the effectiveness of the measures to be taken further exist. Sentence 5 shall not apply to the extent to which existing legislation of the European Community or of the European Union is in conflict. (4) Where the keeper of the animal referred to in the second sentence of the second sentence of the second sentence of paragraph 3, in the case of point 3, also in connection with: Sentence 5, is not complied with and is therefore repeatedly above the number 2 of the national animal species for each species held by an animal keeper, taking into account the type of use observed. Frequency of therapy, the competent authority may maintain the holding of the livestock holding in operation of the Arrange an animal holder for a certain period of time, for a maximum period of three years. The order of fame shall be lifted as soon as it is ensured that the arrangements referred to in the first sentence are complied with. Unofficial table of contents

Section 58e Regulation

(1) The Federal Ministry of Food, Agriculture and Consumer Protection is authorized, in agreement with the Federal Ministry, with the consent of the Federal Council, by means of a regulation with the consent of the Federal Council, to further information on the nature, form and content of the communications The animal holder shall be regulated in accordance with § 58a (1) or § 58b. The legal regulation referred to in the first sentence may provide that:

1.: the communications referred to in paragraph 58b (1) or (3) may be replaced by the transmission of information or records to be carried out on the basis of other regulations on the use of medicinal products, in particular on the basis of a regulation pursuant to section 57 (2) ,
2.: Holdings up to a certain stock size shall be exempted from the requirements laid down in § 58a and § 58b.

A legal regulation referred to in the first subparagraph of paragraph 2 may be adopted only where:

1.: by the exception of farms, the attainment of the objective of reducing treatment with medicinal products containing antibacterially active substances will not be jeopardised; and
2.: the representativeness of the calculation of the measures of the nationwide half-yearly therapy frequency is maintained.

(2) The Federal Ministry of Food, Agriculture and Consumer Protection is authorized, in agreement with the Federal Ministry, by means of a legal regulation with the consent of the Federal Council

1.

to determine the requirements and details of the calculation of the indicators for the purpose of determining the median and the quartiles of the nationwide half-yearly therapy frequency,

2.

the details, including the procedure,

a): Exchange of information in accordance with § 58c (5),
b): Deletion of the data in accordance with § 58c (6)

(3) The Federal Ministry of Food, Agriculture and Consumer Protection is authorized, in agreement with the Federal Ministry, with the approval of the Federal Council, with the consent of the Federal Council, the more detailed information on

1.: the recording in accordance with Section 58d (1) (2),
2.: The content and scope of the plan referred to in § 58d (2), second sentence, point 2, to reduce the treatment of medicinal products containing antibacterially active substances, and
3.: the requirement for transmission, including the procedure referred to in Article 58d (3), first sentence

(4) The Federal Ministry of Food, Agriculture and Consumer Protection is authorized, in agreement with the Federal Ministry, by means of a legal regulation with the consent of the Federal Council, to fish that are used for the production of foodstuffs, within the scope of Articles 58a to 58f and the legal regulations adopted for the implementation of these provisions, to the extent that this is the case for the attainment of the objective of reducing treatment with medicinal products which are antibacterially effective Substances are required. A legal regulation pursuant to the first sentence may be adopted for the first time if the results of a national research project carried out on behalf of an authority throughout Germany on the treatment of medicinal products which have been carried out nationwide contain antibacterially active substances, in the case of fish used for the production of foodstuffs, have been published in the Federal Gazette. Unofficial table of contents

§ 58f Use of data

The data in accordance with § § 58a to 58d may be used solely for the purpose of determining and calculating the frequency of therapy, monitoring compliance with § § 58a to 58d and for the prosecution and prosecution of infringements of medicinal product law Regulations are processed and used. By way of derogation from the first sentence, the competent authority may, in so far as it has reason to believe that there is a breach of the food and feed law, animal welfare legislation or animal health law, the data referred to in § § 58a to 58d to the data referred to in , to the extent that such data are necessary for the prosecution of the infringement, to the authorities responsible for the prosecution of infringements. Unofficial table of contents

§ 58g Evaluation

Five years after the entry into force of this law, the Federal Ministry of Food, Agriculture and Consumer Protection reports to the German Bundestag on the effectiveness of the measures taken in accordance with sections 58a to 58d. Unofficial table of contents

Section 59 Clinical examination and examination of residues in animals used for the production of food

(1) By way of derogation from § 56a (1), a medicinal product within the meaning of section 2 (1) or (2) (1) may be used by the manufacturer or on the behalf of the manufacturer for the purpose of clinical examination and examination of the residue, if the application is to be tested for (2) Food must not be obtained from the animals in which the tests are carried out. Sentence 1 shall not apply if the competent federal authority has established a reasonable waiting period. The wait time must be

1.: comply with at least the withdrawal period laid down in the Regulation on veterinary medicinal products and, where appropriate, include a safety factor which takes into account the nature of the medicinal product; or
2.: , when maximum residue limits have been laid down in the Annex to Regulation (EU) No 37/2010, ensure that these maximum levels are not exceeded in the food produced by the animals.

The manufacturer must submit test results to the competent federal authority on residues of the medicinal products used and of their transformation products in foodstuffs, indicating the detection methods used. (3) Will a clinical trial In the case of animals which are used for the collection of foodstuffs, the indication in accordance with § 67 (1) sentence 1 must also contain the following information:

1.: the name and address of the manufacturer and of the persons carrying out tests on his behalf;
2.: the nature and purpose of the audit,
3.: the nature and number of animals intended for the test;
4.: the place, the beginning and the probable duration of the examination;
5.: Information on the intended use of animal products obtained during or after completion of the test.

(4) The tests carried out shall keep records which shall be submitted to the competent authority upon request. Unofficial table of contents

Section 59a Transport of substances and preparations of substances

(1) Persons, establishments and bodies listed in Article 47 (1) shall be authorised to use substances or preparations of substances which may not be used in the manufacture of medicinal products for animals, pursuant to Article 6 of the Regulation. Manufacture of such medicinal products or for use in animals, and do not offer, store, package, carry on or place on the market for such manufacture or use. Animal owners and other persons, establishments and establishments not listed in Article 47 (1) shall not acquire, store, package or carry on such substances or preparations, unless they are required to do so by means of a legal regulation (2) veterinarians may only obtain substances or preparations from substances not released for circulation outside the pharmacies for use in animals, and may not use such substances or preparations for the purpose of applying them to animals. Preparations may only be given to veterinarians if they are used as medicinal products , or may be placed on the market pursuant to section 21 (2) (3) or (5) or pursuant to a legal regulation pursuant to § 36 without authorisation. Animal owners may only acquire or store them for use in animals if they have been prescribed by a veterinarian as a medicinal product or have been delivered by a veterinarian. Other persons, establishments and institutions which are not listed in Article 47 (1) may not acquire, store, pack, carry out or place on the market certain substances or preparations of substances by means of a regulation in accordance with section 48 of this Regulation, unless the substances or preparations are intended for a different purpose than for use in animals. (3) The provisions of the futures legislation shall remain unaffected. Unofficial table of contents

Section 59b Substances to carry out residue checks

In the case of medicinal products intended for use in animals intended for the production of foodstuffs, the pharmaceutical operator shall, at the request of the competent authority, carry out the substances necessary for the carrying out of residue checks in to be left to adequate compensation for adequate compensation. In the case of medicinal products which are no longer marketed by the marketing authorisation holder, the obligations laid down in the first sentence of the first sentence shall be valid for three years after the date of the last placing on the market by the pharmaceutical The operator shall not exceed the date of expiry of the last batch placed on the market until the expiry date specified in accordance with section 10 (7). Unofficial table of contents

Section 59c obligation to follow up on substances which may be used as veterinary medicinal products

Establishments and establishments which may use substances or preparations of substances which may be used as veterinary medicinal products or for the manufacture of veterinary medicinal products and which are anabolic, anti-infective, anti-parasitic, anti-inflammatory, hormonal or Have psychotropic properties, produce, store, import or place on the market, have evidence of the reference or release of these substances or preparations from substances from which the supplier or recipient and the in each case obtained or given quantity, this evidence shall at least three years and, at the request of the competent authority, to be submitted. The first sentence shall also apply to persons who carry out these activities in a professional manner. In the case of substances or preparations of substances having a thyrostatic, oestrogenic, androgenic or gestagenic effect or β-agonists with an anabolic effect, such evidence shall be carried out in the form of a register in which the produced substances or preparations are produced. or the quantities obtained or used for the manufacture of medicinal products or quantities used for the manufacture of medicinal products, accompanied by the chronological indication of the supplier and the recipient. Unofficial table of contents

§ 59d Administration of pharmacologically active substances to animals used for the production of food

Pharmacologically active substances which

1.: as prohibited substances in Table 2 of the Annex to Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification as regards maximum residue limits in foodstuffs of animal origin (OJ L 378, 27.12.2009, p. 1), as last amended by the implementing Regulation (EU) No 489/2013 (OJ L 327, 28.12.2013, p. OJ L 141 of 28.5.2013, p.
2.: not in the Annex to Regulation (EU) No 37/2010

, shall not be given to any animal serving food production. The first sentence shall not apply in the cases of Article 56a (2a) and Article 16 (2) of Regulation (EC) No 470/2009 and for the administration of feedingstuffs containing authorised feed additives. Unofficial table of contents

§ 60 Pets

(1) For medicinal products intended solely for use in ornamental fish, ornamental or songbirds, pigeons, terrarids, small-food rabbits, ferrets or non-food-producing rabbits, and for transport outside of the Pharmacies are not subject to the provisions of § § 21 to 39d and 50. (2) The rules on the manufacture of medicinal products shall apply with the proviso that the proof of a two-year practical activity according to § 15 1. (3) The Federal Ministry of Food, Agriculture and Food Consumer protection is authorized, in agreement with the Federal Ministry of Economics and Technology and the Federal Ministry, with the consent of the Federal Council, with the consent of the Federal Council, the rules on the authorisation of medicinal products for the in- (4) The competent authority may allow exceptions to the first sentence of Article 43 (5) of this Regulation, in so far as it is concerned with the the supply of medicinal products to the animals referred to in paragraph 1. Unofficial table of contents

Section 61 Powers of veterinary education centres

Establishments of veterinary educational establishments in the higher education sector, which serve the supply of medicinal products for the animals treated there and are managed by a veterinarian or pharmacist, shall have the rights and obligations of a veterinarian in accordance with the Regulations of this law.

Tenth section
Pharmacovigilance

Unofficial table of contents

§ 62 Organisation of the pharmacovigilance system of the competent federal authority

(1) In order to prevent an immediate or indirect risk to the health of humans or animals, the competent federal authority shall have the risks associated with the use of medicinal products, in particular side effects, interactions with , other means, falsifications and potential risks to the environment on the basis of the use of a veterinary medicinal product, to be centrally recorded, to be evaluated and to coordinate the measures to be taken in accordance with this Act. In doing so, it cooperates with the services of the World Health Organisation, the European Medicines Agency, the pharmaceutical authorities of other countries, the health and veterinary authorities of the Federal States, the pharmaceutical commissions of the Chambers of the Medicinal products, national pharmacovigilance centres and other bodies which, when carrying out their tasks, cover medicinal products risks. The competent federal authority may inform the public about the risks of medicinal products and the measures they intend to take. The Federal Supreme Authority operates a pharmacovigilance system. In so far as it is responsible for medicinal products intended for human use, it shall regularly carry out audits of its pharmacovigilance system and shall report to the European Commission every two years, for the first time on 21 September 2013. (2) The competent federal authority shall record all suspected cases of adverse reactions, of which they become aware. Notifications from patients and health professionals can be made in any form, especially electronically. Notifications from holders of the authorisation pursuant to § 63c shall be made electronically. (3) The competent authority of the federal authority shall have, in the case of medicinal products intended for use in the case of humans, any reported case of a suspicity that has occurred within the territory of the Member State. serious side effect within 15 days and any suspected case of a non-serious side effect within 90 days of a non-serious adverse reaction to the database referred to in Article 24 of Regulation (EC) No 726/2004 (Eudravigilance database) and, if necessary, to the holder of the authorisation shall be transmitted. In the case of medicinal products intended for use in animals, the competent authority of the Federal Republic of Germany shall immediately, and at the latest within 15 days, have a serious adverse reaction to any suspected serious adverse effect that has occurred in the territory of the country. after notification, to the European Medicines Agency and to the holder of the authorisation, if it has no knowledge yet. The competent federal authority shall cooperate with the European Medicines Agency and the holder of the authorisation to establish, in particular, duplicate versions of suspitions of suspitions. The competent federal authority shall, if necessary, also involve patients, health professionals or the holder of the authorisation in the follow-up to the notifications received. (4) The competent federal authority shall control the Management of resources for pharmacovigilance activities, the operation of communications networks and market surveillance, in order to ensure their independence in the implementation of these pharmacovigilance activities. (5) Medicinal products intended for use in humans shall be subject to the following conditions: In cooperation with the European Medicines Agency, in particular the following measures shall be taken:

1.: monitor the results of risk minimisation activities, which are part of risk management plans, and the conditions laid down in Article 28 (3), (3a) and (3b),
2.: assess updates to the risk management system,
3.: it evaluates data in the EudraVigilance database to determine whether there are new or changed risks and whether the risk/benefit ratio of medicinal products is influenced by it.

(6) The competent authority of the Federal Republic of Germany may be responsible for the collection and evaluation of medicinal products risks and the coordination of necessary measures in establishments and facilities that manufacture or place medicinal products on the market or clinically. check. For this purpose, officers of the competent federal authority in consultation with the competent authority may enter operating and business premises at the usual business hours, documents including pharmacovigilance, see the main documentation as well as information. The first sentence shall also apply to undertakings commissioned by establishments and establishments in accordance with the provisions of the first sentence. A report is to be drawn up on the inspection. The report shall be submitted to the establishments and bodies referred to in the first sentence for their opinion. Leads an inspection to the conclusion that the marketing authorisation holder does not meet the requirements of the pharmacovigilance system, as described in the pharmacovigilance stock documentation, and in particular the requirements of the Tenth Section, the competent authority of the Bundesoberbehörde (Bundesoberbehörde) shall draw the authorisation holder for the deficiencies identified and shall give him the opportunity to comment. In such cases, the competent authority of the federal authority shall inform the competent authorities of the competent authorities of other establishments and establishments which manufacture, place on the market or examine medicinal products for human use. Member States, the European Medicines Agency and the European Commission.

Footnote

(+ + + Tenth Section (§ § 62 to 63j): For application see Section 63j (1) + + +) Unofficial table of contents

§ 63 Step plan

The Federal Government, with the approval of the Federal Council, shall draw up a plan for the implementation of the tasks in accordance with Section 62. In this case, the cooperation of the authorities and bodies involved at the various security levels, the involvement of the pharmaceutical companies as well as the participation of the Federal Government Commissioner for the interests of the Patients and patients are determined in detail and the measures to be taken in accordance with the provisions of this law are determined. In addition, information means and ways can be determined in the step plan. Unofficial table of contents

Section 63a Step plan officer

(1) Anyone who, as a marketing authorisation holder, is placing on the market manufactured medicinal products which are medicinal products within the meaning of Article 2 (1) or (2) (1), has a qualified person established in a Member State of the European Union with the Commission a pharmacovigilance system to establish a system of pharmacovigilance, and to provide for information on the risk of medicinal products to be carried out in accordance with the provisions of this Regulation, to be required to carry out its activities (step plan officer); collect, assess, and coordinate the necessary measures. Sentence 1 shall not apply to persons in so far as they do not require a manufacturing authorization in accordance with the first sentence of Article 13 (2), first sentence, points 1, 2, 3, 5 or (2b). The stepped planner shall be responsible for the performance of notification obligations in so far as they relate to medicinal product risks. It shall also ensure that, at the request of the competent federal authority, further information is available immediately and fully for the assessment of the risk-benefit balance of a medicinal product, including its own assessments. shall be forwarded. Further details are provided for the pharmaceutical and active substance manufacturing regulations. Persons other than those referred to in sentence 1 may not carry out an activity as a step plan officer. (2) The graduated planner may at the same time be a knowledgeable person in accordance with § 14 or responsible person in accordance with § 20c. (3) The pharmaceutical The operator shall inform the competent authority and the competent authority of the competent authority of the stepped planner and any change in advance. In the event of an unforeseen change of the phased planning officer, the notification shall be made without delay. Unofficial table of contents

Section 63b General pharmacovigilance-Obligations of the holder of the authorisation

(1) The holder of the authorisation shall be obliged to establish and operate a pharmacovigilance system. (2) The holder of the authorisation shall be obliged to use medicinal products intended for use in human beings,

1.: to assess, on the basis of its pharmacovigilance system, all information on a scientific basis, to consider ways of minimising risk and to avoid risks, and, if necessary, to take immediate measures to minimise and prevent risks,
2.: to regularly subject its pharmacovigilance system to audits at appropriate intervals, including the main results of its pharmacovigilance stock documentation and ensuring that corrective action is taken to eliminate the risk of malfunction If the measures for the elimination of defects have been carried out in full, the endorsement may be deleted,
3.: to maintain a pharmacovigilance stock documentation and to make it available on request,
4.: to run a risk management system for each individual drug, which is after the 26. , or in respect of which an edition has been issued in accordance with section 28 (3b), first sentence, point 1,
5.: monitor the results of risk minimisation operations which are part of the risk management plan or which have been referred to as requirements in accordance with Article 28 (3), (3a) to (3c), and
6.: to update the risk management system and to monitor pharmacovigilance data to determine whether there are new risks, to change existing risks or to change the risk-benefit balance of medicinal products.

(3) The holder of the authorisation may not provide pharmacovigilance with regard to the authorised medicinal product without prior or simultaneous notification to the competent authority of the Federal Republic of Germany, and to medicinal products which may be used for the treatment of medicinal products. Use in humans, including the European Medicines Agency and the European Commission, are also publicly known. It shall ensure that such information is presented in an objective and non-misleading manner.

Footnote

(+ + + Tenth Section (§ § 62 to 63j): For application see Section 63j (1) + + +)
(+ + + § 63b para. 2: For the application, see Section 63j (2) + + +) Unofficial table of contents

Section 63c Documentation and reporting requirements of the holder of the marketing authorisation for medicinal products intended for use in humans, for suspected cases of adverse reactions

(1) The holder of the authorisation shall keep records of all suspected adverse reactions as well as information on the quantities delivered. (2) The holder of the authorisation shall also:

1.: to record any suspected case of a serious side effect that has occurred in the country and to the competent authority of the Federal Republic of Germany without delay, but no later than 15 days after the date of the notification;
2.: to record any suspected case of a serious adverse effect that has occurred in a third country, and without delay to the competent national authority and to the European Medicines Agency, but no later than from 15 days after notification

electronically. The competent federal authority may require the holder of the authorisation to also cover suspected cases of non-serious side effects that have occurred in the country, and immediately, but no later than 90 days after (3) The marketing authorisation holder must ensure that all suspected adverse reactions to medicinal products intended for use in humans are reported at a central point in the company in which: (4) Paragraphs 1 to 3, § 62 (6) and § 63b apply corresponding

1.: for the holder of the registration pursuant to § 39a,
2.: for a pharmaceutical entrepellant who is not the holder of the registration or holder of the registration in accordance with § 39a and who has a right of admission or a traditional herbal medicinal product, or a traditional herbal medicinal product, is put on the market.

Paragraphs 1 to 3 shall apply in accordance with

1.: for the holder of the registration pursuant to § 38,
2.: for a pharmaceutical entrepre who is not the holder of the registration pursuant to § 38, and who places on the market a homeopathic medicinal product which is subject to registration or exempted from the obligation to register,
3.: for the applicant prior to the granting of the authorisation.

Paragraphs 1 to 3 shall apply irrespective of whether the medicinal product is still on the market, or whether the authorisation or registration is still in place. The fulfilment of the obligations laid down in paragraphs 1 to 3 may, by written agreement between the holder of the authorisation and the marketing authorisation holder, which is not the holder of the authorisation, be wholly or partly based on the holder of the (5) paragraphs 1 to 4 shall not apply to medicinal products for which a marketing authorisation has been granted by the European Community or the European Union. These medicinal products shall be subject to the obligations of the pharmaceutical operator under Regulation (EC) No 726/2004, as amended, provided that, within the scope of the law, the obligation to communicate to the Member States or to inform the Member States of the respective competent federal authority. In the case of medicinal products subject to the approval of the competent authority of the federal authority, or in respect of which a federal authority is the rapporteur in an arbitration procedure under Article 32 of Directive 2001 /83/EC, the competent federal authority shall be responsible for the analysis and monitoring of all suspected cases of serious adverse reactions occurring in the European Union, including medicinal products in the decentralised procedure. may have been approved.

Footnote

(+ + + Tenth Section (§ § 62 to 63j): For application see Section 63j (1) + + +) Unofficial table of contents

§ 63d Regular updated safety reports

(1) The holder of the authorisation shall forward periodic updates of the safety report containing the following:

1.: Summaries of data relevant to the assessment of the benefits and risks of a medicinal product, including the results of all tests that may have an impact on the authorisation,
2.: a scientific assessment of the risk-benefit balance of the medicinal product, based on all available data, including data from clinical trials for indications and populations not conforming to the authorisation,
3.: all data relating to the sales volume of the medicinal product and all the data available to it in relation to the volume of presenter, including an estimate of the number of persons applying the medicinal product.

(2) The safety reports shall be submitted electronically to the competent federal authority. (3) The pre-lay interval for periodic updates of safety reports referred to in paragraph 1 shall be indicated in the authorisation. The date of submission of the submission shall be calculated from the date of issue of the authorisation. The pre-seizure interval and dates may be established in the European Union in accordance with the procedure laid down in Article 107c (4) of Directive 2001 /83/EC. The holder of the authorisation may apply to the Committee for Medicinal Products for Human Use, or to the coordination group referred to in Article 27 of Directive 2001 /83/EC, for a single cut-off date referred to in Article 107c (6) of Directive 2001 /83/EC to be applied in the The European Union or the pre-seizure interval of regular updated safety reports shall be amended. For medicines called before the 26. The holder of the authorisation shall provide regular information to the authorities of the European Parliament and of the Council of the European Union for the period and dates of the pre-seizure interval and dates not specified in the authorisation or in accordance with Article 107c (4), (5) or (6) of Directive 2001 /83/EC. updated safety reports referred to in paragraph 1 as soon as possible after request or in the following cases:

1.: if a medicinal product has not yet been placed on the market: at least every six months after the authorisation and until the placing on the market,
2.: if a medicinal product has been placed on the market: at least every six months during the first two years following the first placing on the market, once a year in the following two years and thereafter at a distance of three years.

(4) By way of derogation from paragraph 1, regular updated safety reports shall be submitted for medicinal products authorised in accordance with Article 22 (3) or in accordance with Article 24b (2) only in the following cases:

1.: if an edition has been issued in accordance with Article 28 (3) or (3a),
2.: if it is updated by the competent authority for an active substance after the authorisation has been granted on the basis of concerns relating to pharmacovigilance data or because of concerns due to non-sufficiently existing regular updates. Safety reports are requested or
3.: where intervals and dates have been determined for the submission of periodic updates of safety reports pursuant to Article 107c (4) of Directive 2001 /83/EC in the authorisation.

The competent federal authority shall submit to the Pharmacovigilance Risk Assessment Committee the assessment reports on the periodic safety update reports referred to in point 2 of the first sentence of the first sentence of the first sentence of the first subparagraph of point 2, which shall examine whether the pharmacovigilance committee is Initiation of the procedure referred to in Article 107c (4) of Directive 2001 /83/EC is necessary. The provisions of paragraphs 2 and 3 shall apply mutagentily to the holder of registrations pursuant to § 38 or § 39a and to the marketing authorisation holder who is not the holder of the registration or the holder of the registration pursuant to § 38 or § 39a and who is an authorisation holder of the registration procedure. or a traditional herbal medicinal product or a traditional herbal medicinal product or a traditional herbal medicinal product which is subject to registration or registration. (5) The competent authority of the Federal Republic shall assess the regular updated safety reports as to whether there are new or changed risks; or the risk-benefit balance of medicinal products has changed and shall take the necessary measures. For medicinal products for which a single cut-off date or a uniform pre-seizure interval has been established in accordance with Article 107c (4) of Directive 2001 /83/EC and for medicinal products which are authorised in several Member States and for which: periodic safety reports shall be subject to the evaluation of the procedures referred to in Articles 107e and 107g. (6) The fulfilment of the obligations referred to in paragraphs 1 to 4 may be carried out by written Agreement between the holder of the authorisation and the marketing authorisation holder, who shall: is not the holder of the authorisation, in whole or in part, shall be transferred to the holder of the authorisation. Paragraphs 1 to 5 shall not apply to a parallel importer.

Footnote

(+ + + Tenth Section (§ § 62 to 63j): For application see Section 63j (1) + + +)
(+ + + § 63d: For application cf. Section 63j (2) + + +) Unofficial table of contents

§ 63e European procedure

In the cases referred to in Article 107i of Directive 2001 /83/EC, the competent federal authority shall take the measures laid down therein. Articles 107i to 107k of Directive 2001 /83/EC shall apply to the procedure.

Footnote

(+ + + Tenth Section (§ § 62 to 63j): For application see Section 63j (1) + + +)
(+ + + § 63e: For application cf. Section 63j (2) + + +) Unofficial table of contents

Section 63f General requirements for non-interventional safety tests

(1) Non-interventional safety tests carried out by the holder of the authorisation on their own initiative shall be notified to the competent authority of the Federal Republic of Germany. The competent federal authority may request the approval of the protocol and the progress reports from the holder of the authorisation. Within one year of the completion of the data collection, the holder of the approval of the competent federal authority shall submit the final report. (2) For non-interventional safety tests, which are carried out by the holder of the authorisation on the basis of the procedure in accordance with § 28 (3), 3a or 3b shall apply, the procedure in accordance with § 63g. (3) The conduct of safety tests in accordance with paragraphs 1 and 2 shall not be permissible if:

1.: it is intended to promote the use of a medicinal product,
2.: Remuneration for the participation of health professionals in such audits shall not be limited to the amount of time and costs incurred or to the costs incurred, or
3.: an incentive for a preferential prescription or recommendation of certain medicinal products.

(4) The holder of the authorisation shall also carry out safety checks in accordance with paragraphs 1 and 2 of the Federal Association of Statutes of the Federal Republic of Germany, the Federal Association of the Health Insurance Funds and the Association of Private Health Insurance (Bundesvereinigung der Privaten Krankenversicherung e). V. immediately. The place, time, objective and protocol of the examination, as well as the name and life-long doctor's number of the doctors involved, shall be indicated. Where physicians provide services to the detriment of statutory health insurance, the type and amount of the compensation actually paid to them must also be indicated in the case of advertisements in accordance with the first sentence and a copy of the compensation shall be given in each case. to submit contracts concluded with them and a presentation of the expenditure for the doctors involved and a justification for the adequacy of the compensation. Changes to the information referred to in the third sentence shall be submitted within four weeks of each quarter; the compensation actually paid shall be assigned to the doctors involved, including the life-long periods of the year. Doctor's number to be transmitted. Within one year of the completion of the data collection, the total number of patients and the type and amount of compensation paid shall be transmitted, indicating the total number of patients involved and the total amount of compensation paid. The information referred to in this paragraph shall be transmitted electronically.

Footnote

(+ + + Tenth Section (§ § 62 to 63j): For application see Section 63j (1) + + +)
(+ + + § 63f: For application cf. Section 63j (2) + + +) Unofficial table of contents

§ 63g Special requirements for non-interventional safety tests

(1) The holder of the authorisation shall, in the case of non-interventional safety tests arranged in accordance with Article 28 (3), 3a or 3b, submit the draft audit protocol before implementation

1.: the competent authority of the Federal Republic of Germany, if it is an audit carried out only in the country concerned,
2.: The Pharmacovigilance Risk Assessment Committee, if it is an audit carried out in several Member States of the European Union,

(2) A non-interventional safety assessment as referred to in paragraph 1 may only be initiated if the draft protocol has been approved by the competent authority of the federal authority in the case of tests referred to in paragraph 1 (1) or in the case of tests referred to in paragraph 1 The Pharmacovigilance Risk Assessment Committee has been approved by the Pharmacovigilance Risk Assessment Committee and the draft protocol is available from the competent federal authority. After submitting the draft protocol, the competent federal authority shall decide within 60 days of the approval of the examination. An authorisation shall be refused if the use of the medicinal product is to be promoted, the objectives cannot be achieved with the design of the examination or a clinical trial in accordance with § 4 (23) sentence 1. (3) After the start of a The examination referred to in paragraph 1 shall be substantive amendments to the Protocol before they are implemented,

1.: in the case of an audit carried out only domestily, by the competent federal authority,
2.: if it is an audit carried out in several Member States of the European Union, the Pharmacovigilance Risk Assessment Committee

to the Commission. If the test is carried out domestily in the cases referred to in point 2 of the first sentence, the holder of the authorisation shall inform the competent authority of the competent federal authority of the approved amendments. (4) After the conclusion of an examination as referred to in paragraph 1, the final Audit Report

1.: in the cases referred to in paragraph 1 (1) of the competent federal authority,
2.: in the cases referred to in paragraph 1 (2), the Pharmacovigilance Risk Assessment Committee

shall be submitted within 12 months of the completion of the data collection, unless the body responsible for the submission referred to in the first or second sentence of the first sentence of paragraph 1 or 2 has not been submitted. The final report shall be transmitted electronically together with a short presentation of the results of the examination.

Footnote

(+ + + Tenth Section (§ § 62 to 63j): For application see Section 63j (1) + + +)
(+ + + § 63g: For application cf. Section 63j (2) + + +) Unofficial table of contents

§ 63h Documentation and reporting requirements for medicinal products intended for use in animals

(1) The holder of the authorisation shall provide a dossier for medicinal products intended for use in animals relating to all suspected adverse reactions occurring in the European Union or in a third country, as well as information on the results of the (2) The holder of the authorisation shall also be responsible for medicinal products intended for use in animals.

1.

to record any suspected case of a serious side effect that has occurred within the scope of this Act and to the competent authority of the Federal Republic of Germany

2.

a): any suspected case of a serious unexpected adverse reaction which has not occurred in a Member State of the European Union, made known to him by a health professional,
b): in the case of medicinal products containing ingredients derived from human or animal feedstock, any suspected case of an infection which is a serious side effect and which is contaminated by contamination of these medicinal products by: disease caused by pathogens and has not occurred in a Member State of the European Union,

without delay and at the latest within 15 days after the notification, the competent authority of the Federal Republic of Germany and the European Medicines Agency, and

3.

frequent or, in individual cases, a significant degree of abuse, if it is likely to endanger health directly, the competent authority of the Federal Republic of Germany shall immediately

. The obligation to notify in accordance with the first sentence of 1 and 2 (a) shall be applicable to adverse reactions in man on the basis of the use of a medicinal product intended for use in animals. (3) The holder of the authorisation, who shall be admitted by the be recognised in the case of medicinal products intended for use in the case of animals, and shall ensure that any suspicion of any suspicion is not

1.: a serious side effect, or
2.: of a side effect in humans due to the use of a medicinal product intended for use in animals,

which has occurred within the scope of this Act, is also accessible to the competent authority of the Member State whose authorisation was the basis of the recognition or which, in the framework of an arbitration procedure referred to in Article 36 of Directive 2001 /82/EC (4) The competent authority of the Federal Republic of Germany shall be the competent authority for medicinal products intended for use in animals, all documents available for the assessment of suspicion or observed misuse, as well as a scientific (5) The holder of the authorisation shall have a medicinal product for medicinal products which are Use in the case of animals, unless otherwise provided for by the obligation or in the fifth or sixth sentence, on the basis of the obligations of the competent federal authority referred to in paragraph 1 and in § 63a (1), shall be subject to a regular to submit an updated report on the safety of the medicinal product immediately after the request or at least every six months after the marketing authorisation has been submitted. It shall also submit such reports immediately after the invitation or at least every six months during the first two years following the first placing on the market and once a year in the following two years. Thereafter, it shall submit the reports at intervals of three years or immediately upon request. The periodic safety update of medicinal products shall include a scientific assessment of the benefits and risks of the medicinal product concerned. The competent federal authority may, upon request, extend the reporting intervals. In the case of medicinal products exempted from the authorisation in accordance with Article 36 (1), the competent federal authority shall determine the date of submission of the periodic updated reports on the safety of the medicinal product in a Notice published in the Federal Gazette (Bundesanzeiger). The provisions of paragraphs 1 to 6 shall not apply to the parallel importer. (6) Paragraphs 1 to 5, Article 62 (6) and Section 63b (3) shall apply in accordance with

1.: for the holder of the registration pursuant to § 39a,
2.: for a pharmaceutical entrepellant who is not the holder of the registration or holder of the registration in accordance with § 39a and who has a right of admission or a traditional herbal medicinal product, or a traditional herbal medicinal product, is put on the market.

Paragraphs 1 to 4 shall apply in accordance with

1.: for the holder of the registration pursuant to § 38,
2.: for a pharmaceutical entrepre who is not the holder of the registration pursuant to § 38, and who places on the market a homeopathic medicinal product which is subject to registration or exempted from the obligation to register,
3.: for the applicant prior to the granting of the authorisation.

Paragraphs 1 to 4 shall apply irrespective of whether the medicinal product is still on the market or whether the authorisation or registration is still in place. The fulfilment of the obligations laid down in paragraphs 1 to 5 may, by written agreement between the holder of the authorisation and the marketing authorisation holder, which is not the holder of the authorisation, apply in whole or in part to the holder of the (7) paragraphs 1 to 6 shall not apply to medicinal products for which a marketing authorisation has been granted by the European Community or the European Union. These medicinal products shall be subject to the obligations of the pharmaceutical operator in accordance with Regulation (EC) No 726/2004 and its obligations under Regulation (EC) No 540/95, as amended, provided that: The scope of the law is the obligation to communicate to the Member States or to inform the Member States of the competent authority of the Federal Republic of Germany. In the case of medicinal products subject to the approval of the competent national authority, or in respect of which a federal authority is the rapporteur in an arbitration procedure provided for in Article 36 of Directive 2001 /82/EC, the competent federal authority shall be responsible for the analysis and monitoring of all suspected cases of serious adverse reactions occurring in the European Union, including medicinal products in the decentralised procedure. may have been approved.

Footnote

(+ + + Tenth Section (§ § 62 to 63j): For application see Section 63j (1) + + +) Unofficial table of contents

§ 63i Documentation and reporting requirements for blood and tissue preparations and tissues

(1) The holder of an authorisation or authorisation for blood preparations within the meaning of Article 3 (6) of Directive 2001 /83/EC or of a authorisation for tissue preparations as defined in Section 21a shall have documents relating to suspected cases of serious incidents or serious adverse reactions which have occurred in the Member States of the European Union or in the States Parties to the Agreement on the European Economic Area or in a third country, and on the number of the call for recalls. (2) The holder of an authorisation or authorisation for blood or tissue preparations as referred to in paragraph 1 shall, in addition, document any suspicion of a serious incident and any suspicion of a serious adverse reaction, and shall immediately, and at the latest within 15 days of Notification shall be notified to the competent authority of the Federal Republic of Germany. The display shall contain all the necessary information, in particular the name or company and address of the pharmaceutical operator, name and number or code of blood or tissue preparation, day and documentation of the occurrence. the suspicion of a serious incident or serious adverse reaction, day and place of blood component or tissue withdrawal, any establishments or facilities supplied, and information on the person to be donated. The incidents or reactions referred to in the first sentence shall be examined and evaluated for their cause and effect, and shall be notified without delay to the competent authority of the Federal Republic of Germany, as well as the measures to be followed for tracing and for the purpose of: Protection of donors and recipients. (3) Blood and plasma donors or tissue establishments shall have any blood or tissue preparations not subject to approval or authorisation, as well as blood and blood components and tissues; Suspicion of a serious incident and any suspicion of a serious adverse reaction without delay to the competent authority. The notification shall include all necessary information such as name or company name and address of the donation or tissue establishment, name and number or identification code of the blood or tissue preparation, day and documentation of the occurrence of the suspicion of the serious adverse events or the serious adverse reaction, day of manufacture of the blood or tissue preparation, as well as information on the person to be donated. The third sentence of paragraph 2 shall apply accordingly. The competent authority shall forward the notifications in accordance with the first and second sentences and the communications provided for in the third sentence to the competent federal authority. (4) The holder of an authorisation or authorisation for blood or tissue preparations as referred to in paragraph 1. shall, on the basis of the obligations referred to in paragraph 1, submit an updated report on the safety of medicinal products to the competent authority of the BundesoberAuthority immediately upon request or, in so far as recalls or cases or suspected cases have been suspected, serious adverse events or serious adverse reactions shall be submitted at least once a year. Sentence 1 shall not apply to the parallel importer. (5) § 62 (6) shall apply to blood and plasma donors or to tissue establishments; § 63b (3) shall apply to the holders of an authorisation of blood or tissue preparations accordingly. (6) Serious incident within the meaning of the above rules shall be any undesirable event relating to the collection, inspection, processing, processing, preservation, storage or release of tissues or tissues, or blood preparations which are responsible for the transmission of a contagious disease, death or life-threatening condition, disability or loss of ability of patients, or may require or prolong hospitalisation, or may lead to or prolong a disease. As a serious incident, any erroneous identification or confusion of germ cells or impregnated egg cells within the framework of measures of medically assisted fertilisation is also valid. (7) Serious adverse reaction in the sense of the above provisions shall be an unintended reaction, including a communicable disease, the donor or recipient in connection with the production of tissue or blood, or the transmission of tissue or blood preparations which: is fatal or life-threatening, a disability or a Loss of capacity may result in or require hospitalization, or may result in a disease or a disease or prolongation.

Footnote

(+ + + Tenth Section (§ § 62 to 63j): For application see Section 63j (1) + + +) Unofficial table of contents

Section 63j Exceptions

(1) The provisions of the Tenth Section shall not apply to medicinal products used as investigational medicinal products within the framework of a clinical trial. (2) § 63b, except for paragraphs 1 and 3, § § 63d, 63e, 63f and 63g shall not apply on medicinal products intended for use in animals.

Footnote

(+ + + Tenth Section (§ § 62 to 63j): For application see Section 63j (1) + + +)

Eleventh Section
Monitoring

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Section 64 Implementation of monitoring

(1) establishments and facilities in which medicinal products are manufactured, tested, stored, packaged or placed on the market or in which trade is otherwise carried out shall be subject to the supervision by the competent authority; The same shall apply to establishments and establishments which develop, clinically test medicinal products, undergo a residue examination or acquire or use medicinal products as defined in § 47a (1) sentence 1 or for use in animals. The development, production, testing, storage, packaging and placing on the market of active substances and other substances and tissues intended for the manufacture of medicinal products, as well as the other trade in these active substances and substances, shall be subject to the following: Supervision, insofar as they are governed by a legal regulation according to § 54, § 12 of the Transfusion Act or § 16a of the Transplantation Act. In the case of Section 14 (4) (4) and (2) (2) (2), the collection facilities and the laboratories shall be subject to supervision by the competent authority of the local authority. The provisions of the first sentence shall also apply to persons who carry out these activities professionally or do not carry medicinal products exclusively for their own use, for the sponsor of a clinical trial or his representative pursuant to § 40 (1) sentence 3 (1) and for Persons or associations of persons who collect medicinal products for others. Sentence 1 shall not apply to reconstitution, unless it is a medicinal product intended for clinical trial. (2) The persons responsible for monitoring must carry out this activity as a main occupation. The competent authority shall be able to provide expert advice. It is intended to involve members of the competent federal authority as experts in the field of blood preparations, tissue and tissue preparations, radioactive medicinal products, genetically engineered medicinal products, sera, vaccines, allergens, Advanced therapy medicinal products, xenogenic medicinal products or active substances or other substances which are human, animal or microbial origin or which are produced by genetic engineering. In the case of pharmacies which are not hospital pharmacies or who do not require a permit pursuant to § 13, the competent authority may commission experts to monitor them. (3) The competent authority has to satisfy itself that the Provisions relating to medicinal products, active substances and other substances intended for the manufacture of medicinal products, on advertising in the field of healing, the second section of the Transfusion Act, sections 2, 3 and 3a of the Law on Transplantation and the pharmacy system is being observed. It shall carry out, on the basis of a monitoring system, with particular regard to possible risks at appropriate intervals and on an appropriate scale and, if necessary, unannounced inspections, and effective To define follow-up measures. (3a) establishments and facilities which require a permit in accordance with § § 13, 20c, 72 or § 72b (1), as well as veterinary skin pharmacies are usually every two years pursuant to paragraph 3. check. The competent authority shall not grant permission in accordance with § § 13, 20c, 52a, 72 or § 72b (1) only if it has been satisfied by an inspection that the conditions for granting the permit are fulfilled. (3b) The competent authority shall: the inspections carried out in accordance with the guidelines of the European Commission referred to in Article 111a of Directive 2001 /83/EC, in accordance with the guidelines of the European Commission, to monitor the rules on the marketing of medicinal products intended for use in humans, in so far as it is not concerned the monitoring of the conduct of clinical trials. It shall cooperate with the European Medicines Agency through the exchange of information on planned and carried out inspections, and in the coordination of inspections of establishments and facilities in countries not Member States of the European Union or other States Parties to the Agreement on the European Economic Area. (3c) inspections may also be carried out at the request of another Member State, the European Commission or the European Commission. Medicinal products are to be carried out. Without prejudice to any agreements between the European Union and countries other than Member States of the European Union or other States Parties to the Agreement on the European Economic Area, the competent authority may: in the country which is not a Member State of the Union or State Party to the Agreement on the European Economic Area, to submit to an inspection in accordance with the requirements of the European Union. (3d) The inspection shall be subject to a report to create. The competent authority which carried out the inspection shall communicate the contents of the draft report to the establishments, bodies or persons examined and shall give them an opportunity to comment before finalisation thereof. (3e) the inspection, after evaluation of the opinion referred to in the second sentence of paragraph 3, to the effect that the establishments, establishments or persons do not comply with the legal provisions, that information shall be provided, in so far as the principles and guidelines of the Good manufacturing practice or good sales practice of the law of the European Union Union for medicinal products for human use, or the principles and guidelines of good manufacturing practice of the European Union's law on medicinal products for use in animals, shall be entered in the database in accordance with § 67a. (3f) Within 90 days of an inspection for the verification of good manufacturing practice or good sales practice, a certificate shall be issued to the inspected establishments, establishments or persons, if the inspection is carried out to the result to comply with the relevant principles and guidelines. The validity period of the certificate shall not exceed three years. The certificate shall be withdrawn if it becomes known subsequently that the conditions have not been fulfilled; it must be revoked if the conditions are no longer fulfilled. (3g) The information on the exhibition, the failure, the withdrawal or the revocation of the certificate referred to in paragraph 3f shall be entered in a database according to § 67a. This also applies to the granting, withdrawal, revocation or revocation of a permit in accordance with § § 13, 20b, 20c, 52a, 72 or § 72b (1) as well as for the registration and deletion of drug intermediaries or of businesses and institutions, (3h) Paragraphs 3b, 3c and 3e to 3g shall not apply to veterinary medicinal products, as well as to establishments and establishments which: only produce medicated feedingstuffs. In addition, the second sentence of paragraph 3d shall not apply to the veterinary medicinal products ' pharmacies. (4) The persons responsible for monitoring shall be entitled to:

1.: To enter, inspect and, in business premises, land, business premises, premises, means of transport and, in order to prevent the urgent danger to public security and order, also living spaces at the usual business hours, make up-premises and means of transport for documentation purposes in which an activity referred to in paragraph 1 is carried out; the fundamental right of Article 13 of the Basic Law to the inviolability of the dwelling shall be restricted to the extent that:
2.: Documents relating to the development, production, testing, clinical testing or residue testing, acquisition, storage, packaging, placing on the market and other whereabelts of the medicinal products, as well as on the advertising material on the market and on the information referred to in § 94 to provide for the necessary financial security,
2a.: Copies or copies of documents referred to in point 2, or prints or copies of data carriers on which documents are stored in accordance with point 2, or to be requested in so far as it is not personal data of patients ,
3.: to request all necessary information from natural and legal persons and non-legal persons associations, in particular the operations referred to in paragraph 2,
4.: provisional arrangements, including the closure of the holding or establishment, in so far as it is necessary for the prevention of urgent threats to public safety and order.

(4a) In so far as it is necessary for the implementation of this law or of the legal regulations adopted pursuant to this Act or of Regulation (EC) No 726/2004, the experts of the Member States of the European Union may also, where appropriate: (5) The person responsible for the information may refuse to answer any such questions, the answers to which he or she himself or one of his or her in § 383 (1) (1) (1) of the German language of the until 3 of the Code of Civil Procedure of the Member of the European Parliament (6) The Federal Ministry is empowered to regulate the exercise of supervisory functions in the where medicinal products are placed on the market by a pharmaceutical operator within the scope of the law which does not have a registered office within the scope of the Act, in so far as it is required to implement the provisions relating to: Transport of medicinal products and advertising in the field of healing is required. In so doing, the responsibility for monitoring tasks resulting from the introduction of a medicinal product from a particular Member State of the European Union may be the responsibility of a particular country or country, or be assigned to the system. The regulation is issued by the Federal Ministry of Food, Agriculture and Consumer Protection in agreement with the Federal Ministry, in so far as it is a medicine intended for use in animals. Unofficial table of contents

§ 65 sampling

(1) As far as the implementation of the rules on the marketing of medicinal products, advertising in the field of healing, the Second Section of the Transfusion Act, Sections 2, 3 and 3a of the Transplant Law and on the Pharmacy is required, the persons responsible for monitoring are authorised to request or withdraw samples for their selection for the purpose of the investigation, in return for receipt of the certificate. This power shall, in particular, cover the collection of samples of feedingstuffs, drinking water and live animals, including the necessary procedures for the intervention of such animals. In so far as the pharmaceutical company does not expressly dispense with it, a part of the sample or, if the sample is not partially or without endangering the purpose of the examination, is not part of the same quality, a second piece of the same The type of sample taken as a sample should be withdrawn. (2) Samples to be returned must be officially closed or sealed. They shall be marked with the date of the sampling and the date of the day after which the closure or sealing shall be deemed to have been withdrawn. (3) For samples not taken from the pharmaceutical contractor, the date of expiry of the closure or sealing shall be determined by the (4) As a private expert for the examination of samples left in accordance with the second sentence of paragraph 1, it is only possible to order them, who

1.: the expertise in accordance with § 15. In place of the practical activities referred to in Article 15 (1) and (4), a practical activity may be carried out in the examination and evaluation of medicinal products in drug investigation centres or in other similar medicinal products establishments,
2.: possess the reliability required to carry out the activity as an expert in the examination of official samples, and
3.: have suitable premises and facilities for the intended examination and evaluation of medicinal products.

Unofficial table of contents

§ 66 Dulunding and obligation to participate

(1) Those who are subject to the supervision in accordance with § 64 paragraph 1 shall be obliged to tolerate the measures in accordance with § § 64 and 65 and to assist the persons involved in the monitoring in the performance of their duties, in particular to them upon request the rooms and transport means, to open spaces, containers and containers, to supply information and to enable the samples to be taken. The same obligation exists for the knowledgeable person in accordance with § 14, the responsible person in accordance with § 20c, the step planning officer, information officer, the responsible person according to § 52a and the head of the clinical trial as well as their (2) The duty to take part and the joint action referred to in paragraph 1 shall apply to measures taken by the federal authorities pursuant to Article 25 (5) (4) or (8) sentence 2 and 3, or in accordance with Article 62 (6). Unofficial table of contents

Section 67 General notification requirement

(1) Holds and establishments which develop, manufacture, clinically check or undergo a residue test, test, store, package, place on the market or otherwise trade with them, have this prior to the establishment of the Activities of the competent authority, in the case of a clinical trial in the case of humans, shall also be reported to the competent authority. The provisions of the first sentence shall apply to establishments which obtain tissues which carry out the laboratory examination required for the production, working or processing tissue, conserving, testing, storing or placing on the market. The development of medicinal products shall be notified in so far as it is governed by a regulation in accordance with Section 54. The same shall apply to persons who carry out these activities independently and professionally, as well as to persons or persons ' associations collecting medicinal products for others. The indication shall indicate the nature of the activity and the premises; if medicinal products are collected, the details of the nature of the collection and of the place of storage shall be indicated. If a clinical trial in humans is to be reported in accordance with the first sentence, the competent authority shall also be its sponsor, if any, the representative of the competent authority in accordance with Section 40 (1), third sentence, point 1, as well as the examiner and his deputy, if necessary, also with indication of the position as the head of the clinical trial, in particular to name. The provisions of sentences 1 to 4 shall apply mutaly to establishments and establishments producing, testing, storing, packaging or otherwise trading active substances or other substances intended for the manufacture of medicinal products, to the extent that such substances are not Activities are governed by a legal regulation according to § 54. Sentence 1 shall not apply to reconstitution unless it is a medicinal product intended for clinical trial. (2) If the manufacture of medicinal products is intended for which it is not required to obtain a licence pursuant to § 13, such medicinal products shall not be used for the purposes of the medicinal products shall be indicated with their name and composition. (3) Changes in the case of night shall also be indicated. In the case of establishments and establishments which manufacture, import or otherwise trade active substances, an annual notification shall be sufficient, provided that the changes cannot have an effect on the quality or safety of the active substances. (3a) (4) paragraphs 1 to 3 shall apply. (4) paragraphs 1 to 3 shall be communicated to the competent authority of the Federal Republic of Germany in accordance with the provisions of paragraph 42. not for those who have permission in accordance with § 13, § 20b, § 20c, § 52a or § 72, and for pharmacies according to the law on pharmacy. Paragraph 2 shall not apply to veterinary medicinal products. (5) Anyone who, as a pharmaceutical entreprent, is placing on the market a medicinal product which is exempted from the obligation to be admitted pursuant to Article 36 (1) has previously been the competent authority of the Federal Republic of Germany. and to the competent authority. On the display, the manufacturer, the name used, the non-active ingredients used, insofar as they are not laid down in the Regulation in accordance with Article 36 (1), and the actual composition of the medicinal product, shall be provided to the extent that: Regulation in accordance with Article 36 (1) allows to indicate differences in this respect. It shall also indicate any change in the particulars and the termination of the placing on the market. (6) Anyone who carries out studies intended to collect information on the use of authorised or registered medicinal products shall have the following information: the federal authority responsible, the Federal Association of Statesmen and Health Insurance, the top association of the health insurance companies and the Association of Private Health Insurance (BfB). V. immediately. The place, time, destination and monitoring plan of the application observation shall be stated, and the doctors involved shall be named to the Federal Association of Statespersons and the Association of the Federal Government of the Health Insurance Funds, in particular with indication of the life-long periods. Name the doctor's number. Compensation paid to doctors for their participation in the studies referred to in the first sentence shall be calculated on the basis of their nature and level in such a way as to ensure that there is no incentive for a preferential prescription or recommendation of certain medicinal products. Where physicians provide services to the detriment of statutory health insurance, the type and amount of the compensation actually paid to them must also be indicated in the case of advertisements in accordance with the first sentence and a copy of the compensation shall be given in each case. to submit contracts concluded with them and a presentation of the expenditure for the doctors involved and a justification for the adequacy of the compensation. Changes to the information referred to in the fourth sentence shall be submitted within four weeks of each end of the quarter; the compensation actually paid shall be assigned to the doctors involved, including the life-long periods of the year. Doctor's number to be transmitted. Within one year of the completion of the data collection, the total number of patients and the type and amount of compensation paid shall be transmitted, indicating the total number of patients involved and the total amount of compensation paid. A final report shall be submitted to the competent federal authority within one year of the completion of data collection in the case of studies of medicinal products intended for use in human beings. § 42b (3) sentence 1 and 4 shall apply accordingly. The particulars referred to in this paragraph shall be transmitted electronically in the case of studies of medicinal products intended for use in humans. For this purpose, the competent federal authorities are aware of electronic format requirements; the competent federal authority has to make available to the public via an Internet portal its submitted advertisements and final reports. § 42b (3) sentence 4 shall apply mutas to the publication of the advertisements. The sentences 4 to 6 shall not apply to advertisements in relation to the competent federal authority. For medicinal products intended for use in animals, the advertisements in accordance with the first sentence shall only be reimbursed to the competent authority of the Federal Republic of Germany. The rates 1 to 13 do not apply to safety tests in accordance with § 63f. (7) Who intends to use medicinal products on a commercial or professional basis who are placed on the market in another Member State of the European Union by another pharmaceutical For the first time from that Member State, entrepreneurs are admitted to the scope of the law for the purpose of placing on the market within the scope of the law, this has to indicate to the holder of the authorisation prior to the commencation of the activity. In the case of medicinal products for which a marketing authorisation has been granted in accordance with Regulation (EC) No 726/2004, the first sentence shall apply on the condition that the notification shall be submitted to the holder of the marketing authorisation and to the European Medicines Agency. shall be transmitted. A fee must be paid to the Agency for the verification of compliance with the conditions laid down in the EU legislation on medicinal products and the marketing authorisations; the assessment of the fee shall be governed by the legislation of the Union. Unofficial table of contents

Section 67a Database-based information system

(1) The federal and state authorities responsible for the implementation of this law shall cooperate with the German Institute for Medical Documentation and Information (DIMDI) in order to provide a jointly usable central information system on to establish medicinal products, active substances and tissues, as well as their manufacturers or importer. This information system summares the information necessary for the fulfilment of the respective tasks across the authorities. The German Institute for Medical Documentation and Information shall establish this information system on the basis of the data provided by the competent authorities or the federal authorities in accordance with the legal regulation referred to in paragraph 3, and ensures its ongoing operation. Data from the information system shall be transmitted to the competent authorities and federal authorities for the performance of their tasks regulated by the law and to the European Medicines Agency. In addition, the competent authorities and federal authorities shall obtain access to the current data from the information system for their tasks regulated by law. Transmission to other bodies shall be permitted, provided that this is provided for by the regulation referred to in paragraph 3. The German Institute for Medical Documentation and Information can request fees for its services. The German Institute for Medical Documentation and Information (Deutsches Institut für Medizinische Documentation und Information) provides generally available databases with information on medicinal products via the German Federal Ministry of Education and Research (Bundesministry). Internet portal ready. The Internet portal shall be linked to the European Internet portal established by the European Medicines Agency, in accordance with Article 26 of Regulation (EC) No 726/2004 for medicinal products. In addition, the German Institute for Medical Documentation and Information provides information on the mail order of medicinal products intended for use in humans via a generally accessible Internet portal. This Internet portal is linked to the Internet portal operated by the European Medicines Agency, which contains information on the mail order and the common mail order logo. The German Institute for Medical Documentation and Information provides the addresses of the Internet portals in the Federal Gazette (Bundesanzeiger). (3) The Federal Ministry is empowered to exercise powers for the processing and use of data for the purposes of paragraphs 1 and 2 and for the collection of data for the purposes of paragraph 2 in agreement with the Federal Ministry of the Interior and the Federal Ministry of Economics and Technology by means of a regulation with the consent of the Federal Council and regulations to be met with regard to the transmission of data by federal authorities and the Countries to the German Institute of Medical Documentation and Information, including the personal and operational data for the purposes regulated in this Act, and the nature, scope and requirements of the data. This Regulation may also require advertisements to be or must be made on electronic or optical storage media, in so far as this is necessary for the proper implementation of the rules governing the marketing of medicinal products is required. The Regulation is adopted by the Federal Ministry of Food, Agriculture and Consumer Protection in agreement with the Federal Ministry, the Federal Ministry of the Interior and the Federal Ministry for Economic Affairs and Technology, to the extent that: (3a) The Federal Ministry of Food, Agriculture and Consumer Protection is authorized, in agreement with the Federal Ministry, the Federal Ministry of the Interior and the Federal Ministry of the Interior and the Federal Republic of Germany, to Federal Ministry of Economics and Technology With the consent of the Federal Council, regulations are to be taken with regard to the transmission of data by the German Institute for Medical Documentation and Information to Federal and State authorities, including the personal and data-related data, for the purpose of repeated observations, investigations and assessments for the detection of risks to human and animal health by the use of certain medicinal products intended for use in animals, (veterinary medicinal product monitoring) and the nature and extent of the data; and the requirements for the data. (4) The legal regulation referred to in paragraphs 3 and 3a shall be adopted in agreement with the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, as far as radioactive medicinal products or medicinal products are concerned, (5) The German Institute for Medical Documentation and Information shall take the necessary measures to ensure that data are transmitted only to the persons authorised to do so and only this access to the data is available. receive this data. Unofficial table of contents

Section 68 Part-time and teaching obligations

(1) The authorities and authorities of the Federal Government and the Länder responsible for the implementation of this law have

1.: to communicate to the authorities, bodies and experts responsible for the enforcement of the law, and
2.: in the event of infringements and in the event of suspicion of infringements of the provisions of the pharmaceutical law, medicinal products or pharmacy law for the respective areas of responsibility, to be informed without delay and in the case of investigative activities mutually supporting each other.

(2) The authorities referred to in paragraph 1

1.: provide information to the competent authority of another Member State of the European Union or to medicinal products intended for use in the case of humans, on the basis of a reasoned request, provide information and provide information to the competent authorities of the European Medicines Agency Documents and documents required for the supervision of compliance with the medicinal products, medicinal products and pharmacopoietic provisions, or for the prevention or defence of medicinal products is,
2.: check all the facts notified by the applicant authority of another Member State and inform it of the outcome of the examination.

The authorities referred to in paragraph 1 shall communicate to the competent authorities of another Member State and to the European Medicines Agency or to the European Commission all the information necessary for the monitoring of compliance with the medicinal products, medicinal products and pharmacopoietic provisions in this Member State, or for the prevention or prevention of drug risks. In cases of infringements or suspicion of infringements, the competent authorities of other Member States, the Federal Ministry, in so far as they are medicinal products intended for use in animals, shall also be able to: Federal Ministry of Food, Agriculture and Consumer Protection as well as the European Medicines Agency and the European Commission are informed. (4) The authorities referred to in paragraph 1 may, to the extent that this is necessary to ensure compliance with the Medicinal products, medicinal products and apothecary requirements or in order to prevent or avert the risk of medicinal products, including the competent authorities of other States and the competent bodies of the Council of Europe. Paragraph 2 (1) shall apply mutatily. In the case of information to States Parties to the Agreement on the European Economic Area which are not Member States of the European Union, the latter shall be informed by the European Commission. (5) Transport with the competent authorities of others. States, bodies of the Council of Europe, the European Medicines Agency and the European Commission are the responsibility of the Federal Ministry. The Federal Ministry may, with the consent of the Federal Council, delegate this power to the competent federal authorities or by means of a legal regulation to the competent supreme state authorities. In addition, the Federal Ministry may delegate the power to the competent supreme state authority, provided that it agrees to its agreement. The supreme state authorities may transfer the powers after sentences 2 and 3 to other authorities. In the case of medicinal products intended for use in animals, the Federal Ministry of Food, Agriculture and Consumer Protection is replaced by the Federal Ministry for Food, Agriculture and Consumer Protection. In this case, the regulation pursuant to the second sentence shall be adopted in agreement with the Federal Ministry. (5a) In the case of the monitoring of the advertising of medicinal products intended for use in humans, the Federal Office for Consumer Protection and Consumer Protection shall be responsible for the application of this Regulation. Food safety for transport with the competent authorities of other Member States of the European Union and of the European Commission implementing Regulation (EC) No 2006/2004 of the European Parliament and of the Council of 27 June 2004 on the implementation of Regulation (EC) No 2006/2004 of October 2004 on cooperation between the national authorities responsible for the enforcement of consumer protection laws (OJ L 327, 28.12.2004, p. EU No 1), as amended by Article 16 (2) of Directive 2005 /29/EC of the European Parliament and of the Council of 11 May 2005 (OJ L 364, 27.11.2005, p. EU No 22) as a central liaison body. (6) In the cases referred to in the second sentence of paragraph 3 and in paragraph 4, the transfer of personal data shall not, in so far as they are adversely affected by the interests of the persons concerned, be adversely affected, in particular: if an adequate data protection standard is not guaranteed at the recipient. Personal data may also be transmitted if the recipient does not have a reasonable standard of data protection, insofar as this is necessary for reasons of health protection. Unofficial table of contents

Section 69 Measures taken by the competent authorities

(1) The competent authorities shall take the necessary measures to eliminate the infringements identified and the arrangements necessary for the prevention of future infringements. They may, in particular, prohibit the placing on the market of medicinal products or active substances whose recall order and ensure that such medicinal products are revocation, if

1.: the necessary authorisation or registration for the medicinal product is not available or its resting place is arranged,
2.: the medicinal product or the active substance is not manufactured in accordance with the recognised pharmaceutical rules or does not have the appropriate quality in accordance with the recognised pharmaceutical rules,
3.: the medicinal product lacks therapeutic efficacy,
4.: there are reasonable grounds for suspecting that the medicinal product has adverse effects that go beyond a measure acceptable to medical science,
5.: the prescribed quality controls are not carried out,
6.: the required permission for the manufacture of the medicinal product or the active substance or the movement within the scope of the law is not available, or a reason for the withdrawal or revocation of the permission is given in accordance with § 18 para. 1, or
7.: the required permission to operate a wholesale trade in accordance with § 52a is not available, or a reason for the withdrawal or revocation of the permission pursuant to Section 52a (5) is given.

In the case of sentence 2 (2) and (4), the competent federal authority may order the recall of a medicinal product, provided that its action in connection with measures pursuant to § 28, § 30, § 31 (4) sentence 2 or § 32 (5) for the prevention of risks to the Human or animal health is provided by medicinal products. The decision of the competent federal authority pursuant to sentence 3 is immediately enforceable. To the extent that the medicinal products referred to in point 4 of the second sentence are those intended for use in animals, the use of medicinal products intended for use in animals is limited. (1a) In the case of medicinal products for which a marketing authorisation is granted for the Marketing or marketing authorisation

1.: pursuant to Regulation (EC) No 726/2004, or
2.: in the case of recognition in accordance with Chapter 4 of Directive 2001 /83/EC or Chapter 4 of Directive 2001 /82/EC, or
3.: On the basis of an opinion from the Committee referred to in Article 4 of Directive 87 /22/EEC of 22 December 1986, before 1 January 1995

, the competent national authority shall inform the Committee for Medicinal Products for Human Use or the Committee for Medicinal Products for Veterinary Use of any infringements of medicinal products in accordance with the conditions laid down in the above Procedures provided for in this Regulation, specifying an in-depth explanatory statement and the procedure proposed. In the case of these medicinal products, the competent authorities may, before informing the Committee referred to in the first sentence, take the necessary arrangements for the disposal and prevention of future infringements, provided that they are intended for the protection of the health of Human or animal or for the protection of the environment are urgently needed. In the cases referred to in the first sentence of sentence 1 (2) and (3), the competent authorities shall inform the European Commission and the other Member States, in the cases referred to in the first sentence of paragraph 1, of the European Commission and of the European Medicines Agency, of the ' Bundesoberbehörde ' shall be responsible for the reasons for these measures no later than the following working day In the case referred to in the second sentence of paragraph 1, point 4, the competent federal authority may also order the revocation of the authorisation or order the recall of a medicinal product, provided that its action is urgently required for the protection of the legal goods referred to in the second sentence. (2) The competent authorities may prohibit the collection of medicinal products if a proper storage of the medicinal products is not guaranteed or if there is a reasonable suspicion that the medicinal products concerned are are used in an abusive way. Collected medicinal products can be ensured if the health of humans and animals is threatened by inadequate storage or delivery. (2a) The competent authorities may also use medicinal products for use in animals. , as well as substances and preparations of substances within the meaning of Section 59a, if facts justify the assumption that the provisions relating to the marketing of medicinal products have not been complied with. (3) The competent authorities may be advertising material to ensure that the rules on the marketing of medicinal products and on the (4) In the case of the third sentence of paragraph 1, a public warning may also be issued by the competent authority of the federal authority. (5) The competent authority may, in consultation with the competent authority, be responsible for the Federal authority in the case of a medicinal product intended for use in human beings and which has been banned or which has been withdrawn from circulation, because:

1.: the conditions for placing on the market are not available or are no longer available,
2.: the medicinal product does not have the specified composition according to type and quantity, or
3.: the controls on the medicinal products or the ingredients and the intermediate products have not been carried out or any other requirement or condition for the issue of the manufacturing authorization has not been fulfilled,

in exceptional cases, allowing patients who are already treated with this medicinal product to be dispensed during a transitional period, if this is medically justifiable and indicated for the person concerned. Unofficial table of contents

Section 69a Monitoring of substances which can be used as veterinary medicinal products

Sections 64 to 69 shall apply in accordance with the establishments, facilities and persons referred to in § 59c, as well as to such establishments, facilities and persons, the substances listed in Table 2 of the Annex to Commission Regulation (EU) No 37/2010 of 22 June 2007, of the European Parliament and of the Council of the European Communities. 1 December 2009 on pharmacologically active substances and their classification as regards maximum residue limits in foodstuffs of animal origin (OJ L 327, 28.12.2009, p. 1), as amended, are to be produced, manufactured, stored, imported or placed on the market. Unofficial table of contents

§ 69b Use of certain data

(1) The competent authorities responsible for the collection of data for the display and registration of livestock holdings for the food, feed, animal welfare and animal health rights shall transmit to the authorities responsible for the supervision referred to in Article 64 (1) sentence 1 (2) The data may be kept for a period of three years. (2) The data may be kept for a period of three years. The period shall begin at the end of the year in which the data have been transmitted. After the expiry of the period, the data shall be deleted, provided that it is not allowed to be kept for longer on the basis of other provisions.

Twelfth section
Special provisions for Bundeswehr, federal police, riot police, civil protection

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Section 70 Application and enforcement of the law

(1) The provisions of this Act shall apply to bodies serving the supply of medicinal products to the Bundeswehr, the Federal Police and the riot police of the Länder, as well as to the supply of medicinal products for the protection of civil protection. Application. (2) In the field of the Bundeswehr, the enforcement of this law is the responsibility of the competent authorities and experts of the Bundeswehr in the supervision of the transport of medicinal products. In the area of the Federal Police, he is responsible for the competent authorities and experts of the Federal Police. In the field of the supply of medicinal products for civil protection, it is the responsibility of the Federal Ministry of the Interior to determine the position of the Federal Ministry of the Interior; in so far as national offices are determined, it is necessary to obtain the approval of the Federal Council Unofficial table of contents

Section 71 Exceptions

(1) The indication of the decay date prescribed in Section 10 (1) no. 9 can be dispensed with in the case of medicinal products which are handed over to the Bundeswehr, the Federal Police and for the purposes of civil and civil protection to the federal or state governments. The competent federal ministries or, as far as medicinal products are supplied to countries, the competent authorities of the Länder ensure that the quality, efficacy and safety of such medicinal products are also ensured. (2) The Federal Ministry is authorized, by means of law, exceptions to the provisions of this Act and the legal regulations issued pursuant to this Act for the area of the Bundeswehr, the Federal Police, the riot police of the to allow countries and civil and civil protection to the extent that The implementation of the specific tasks in these areas is justified and the protection of human or animal health is maintained. The Regulation is adopted by the Federal Ministry of Food, Agriculture and Consumer Protection in agreement with the Federal Ministry for the application of medicinal products intended for use in animals. (3) The German Federal Ministry of Food, Agriculture and Consumer Protection Legal Regulation, insofar as it affects the area of the Bundeswehr, in agreement with the Federal Ministry of Defence, and, insofar as it touches the area of the Federal Police and Civil Protection, in agreement with the Federal Ministry of the Interior, in each case without the consent of the Federal Council; to the extent that the legal regulation provides The Federal Ministry of the Interior, with the agreement of the Federal Council, is in agreement with the Federal Ministry of the Interior in order to deal with the area of riot police in the countries or the civil protection.

Thirteenth Section
Import and export

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Section 72 Import permit

(1) Who

1.: medicinal products within the meaning of Article 2 (1) or (2) (1),
2.: active substances which are of human, animal or microbial origin or which are produced by genetic engineering; or
3.: other substances of human origin intended for the manufacture of medicinal products

In order to introduce into the scope of this Act, for commercial or professional purposes, from countries which are not Member States of the European Union or other States Parties to the Agreement on the European Economic Area, a permit shall be required by: competent authority. Article 13 (4) and § § 14 to 20a shall apply accordingly. (2) The provisions of paragraph 1 shall apply to persons and entities wishing to introduce medicinal products of human origin for direct use in humans, with the following: Application that the authorisation may be refused only if the applicant does not show that the quality and safety of the medicinal products is assessed and that the medicinal products are transferred to their Application-capable form according to the state of science and technology qualified personnel and (3) The provisions of paragraphs 1 and 2 shall not apply to:

1.: tissue within the meaning of Section 1a (4) of the Transplant Act, for which it requires permission in accordance with Section 72b,
2.: autologes of blood for the production of biotechnologically processed tissue products, for which it requires permission in accordance with § 72b,
3.: Tissue preparations as defined in § 20c, for which it requires permission in accordance with § 72b, and
4.: Active substances which are intended for the preparation of medicaments to be prepared according to a process technology described in the homeopathic part of the medicinal product.

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§ 72a Certificates

(1) The importer may only introduce medicinal products within the meaning of § 2 (1) and 2 (1), (1), (1a), (2) and (4) or active substances if:

1.: the competent authority of the country of manufacture has certified, by a certificate, that the medicinal products or active substances are subject to recognised basic rules for the production and safety of their quality of the European Union or by standards, which are equivalent to these, are manufactured regularly, the manufacturing site is regularly monitored, the monitoring is carried out by adequate measures, including repeated and unannounced inspections, and in the event of substantial deviations inform the competent authority of the recognised basic rules , and such certificates for medicinal products within the meaning of Article 2 (1) and 2 (1), which are intended for use in humans, and active substances which are of human, animal or microbial origin, or active substances which are genetically modified by genetic engineering; , are mutually recognised,
2.: the competent authority has certified that the basic rules mentioned in the manufacture and safeguarding of the quality of the medicinal products and of the active substances used for this purpose, insofar as they are of human, animal or microbial origin, or active substances produced by genetic engineering, or in the manufacture of active substances, or
3.: the competent authority has certified that the import is in the public interest.

The competent authority may issue a certificate in accordance with

1.: in paragraph 1, only if a certificate referred to in the first sentence of paragraph 1 is not present and if it or a competent authority of a Member State of the European Union or of another Contracting State of the Agreement on the European Union is not present in the country of manufacture, the economic area has regularly verified that the basic rules referred to above are complied with in the manufacture of the medicinal products or active substances;
2.: Substitute 1 (3) only if a certificate referred to in the first sentence of paragraph 1 is not available and a certificate referred to in the first sentence of 1 (2) is not provided for or is not possible.

(1a) The first sentence of paragraph 1 shall not apply to:

1.: Medicinal products intended for clinical trials in humans or for use in the context of a hardship case programme,
2.: Medicinal products of human origin for direct use or blood stem cell preparations intended for the intended use intended for a specific person,
3.: active substances which are of human, animal or microbial origin and which are intended for the production of medicinal products to be produced according to a process technology described in the homeopathic part of the medicinal product,
4.: active substances which are substances in accordance with Article 3 (1) to (3), in so far as they are not subject to the requirements of good manufacturing practice in accordance with the principles and guidelines of the European Commission;
5.: Tissue within the meaning of Section 1a (4) of the transplant law, for which a certificate or a certificate according to § 72b is required,
6.: autologes of blood for the production of biotechnologically processed tissue products, for which a certificate or a certificate according to § 72b is required,
7.: Tissue preparations as defined in § 20c, for which a certificate or a certificate according to § 72b is required, and
8.: Active substances manufactured in and imported from a Member State which is not a Member State of the European Union or another State Party to the Agreement on the European Economic Area and which is established in the European Union The Commission has published a list in accordance with Article 111b of Directive 2001 /83/EC.

(1b) The provisions of the first sentence of paragraph 1, first and second sentence, of active substances which are of human, animal or microbial origin, or active substances produced by genetic engineering, shall apply mutagenically to others. (1c) medicinal products and active substances which are of human, animal or microbial origin, or active substances produced by genetic engineering, as well as other substances which may be used in the manufacture of medicinal products. Manufacture of medicinal products Certain substances of human origin, other than those referred to in paragraph 1a (1) (1d) 1 sentence 1 shall be applied to the importation of active substances and other substances intended for the manufacture of medicinal products; Origin Application, insofar as its supervision is governed by a legal regulation according to § 54. (2) The Federal Ministry is authorized to determine by means of law with the consent of the Federal Council that substances and preparations of substances which are may be used as a medicinal product or for the manufacture of medicinal products, should not be introduced, provided that this is necessary for the prevention of risks to human health or for the prevention of risks. (3) The Federal Ministry is also authorized, by means of a legal regulation, with the consent of the Federal Council, to: the conditions for importation of the medicinal products referred to in paragraph 1a (1) and (2), where necessary in order to ensure the proper quality of the medicinal products; It may, in particular, make provisions on the examinations to be carried out by the competent person in accordance with § 14 and the possibility of supervision in the country of manufacture by the competent authority. (4) (omitted) Unofficial table of contents

Section 72b Import authorisation and certificates for tissue and certain tissue preparations

(1) Anyone who wants to import tissue within the meaning of § 1a No. 4 of the Transplant Act or tissue preparations within the meaning of § 20c for the purpose of delivery to others or for processing or processing, requires the permission of the competent authority. § 20c (1) sentence 3 and (2) to (7) shall apply accordingly. Article 72 (2) shall apply to the importation of tissue preparations for direct application. (2) The importer referred to in paragraph 1 may only import the tissue or tissue preparations if:

1.: the authority of the country of origin has confirmed, by means of a certificate, that the collection, laboratory inspection, processing, preservation, storage or testing have been carried out in accordance with the standards laid down by the European Union at least equivalent standards of good professional practice, and such certificates are mutually recognised; or
2.: the competent authority responsible for the importer has certified that the standards of good professional practice are complied with in the production, laboratory inspection, processing, preservation, storage or testing, after they have been or have been responsible for where the authority of another Member State of the European Union or of another Contracting State of the Agreement on the European Economic Area has been satisfied in the country of manufacture, or
3.: the authority responsible for the importer has certified that the import is in the public interest if a certificate referred to in point 1 is not available and a certificate as referred to in point 2 is not possible.

By way of derogation from the first sentence of paragraph 1, the competent authority may, if the documents submitted by the importer do not give rise to any complaints or their facilities, shall not be able to visit the collection facilities in the country of origin. (3) The Federal Ministry is authorized, by means of a regulation with the consent of the Federal Council, to grant the further conditions for the following: the importation of tissues or tissue preparations referred to in paragraph 2 shall be determined in order to: to ensure the proper quality of the tissue or tissue preparations. The competent authority may, in particular, make arrangements for the examinations to be carried out by the responsible person in accordance with § 20c and the implementation of the surveillance in the country of origin. (4) The first sentence of paragraph 2 shall apply to the importation of Tissue and tissue preparations as referred to in paragraph 1, insofar as their supervision is governed by a legal regulation pursuant to § 54, § 12 of the Transfusion Act or § 16a of the Transplantation Act. (5) Paragraphs 1 to 4 shall apply Corresponding to autologous blood for the production of biotechnologically processed Tissue products. Unofficial table of contents

Section 73 Movement prohibition

(1) Medicinal products which are subject to the obligation to approve or approve pursuant to § 21a or to register may only be brought within the scope of this Act if they are admitted to transport within the scope of this Act, according to § 21a approved, registered or exempted from the authorisation or registration; and

1.: the consignee is a pharmacist in the case of being brought from a Member State of the European Union or another State Party to the Agreement on the European Economic Area of Pharmaceutical Entrepreneurs, wholesalers or veterinarians. or, as the institution of a hospital, is supplied with medicinal products by a pharmacy of a Member State of the European Union or of another Contracting State to the Agreement on the European Economic Area, in accordance with the provisions of the pharmacies Act;
1a.: in the case of the sale to the final consumer, the medicinal product from a pharmacy of a Member State of the European Union or of another Contracting State to the Agreement on the European Economic Area, which shall be responsible for the mail-order trade after the national law, in so far as it complies with German pharmacy law with regard to the rules on mail order trading, or in accordance with the German law on pharmacies, in accordance with the German rules on mail order or electronic mail order trade is dispatched or
2.: the recipient, in the case of being brought from a country other than the Member State of the European Union or another State Party to the Agreement on the European Economic Area, has a permit in accordance with Section 72.

The medicinal products referred to in § 47a (1) sentence 1 may only be brought within the scope of this Act if the recipient is one of the facilities mentioned therein. The Federal Ministry shall publish at regular intervals an updated overview of the Member States of the European Union and the other Contracting States of the European Economic Area, in which the mail order and the (1a) medicated feedingstuffs may be brought within the scope of this law only if they are

1.: comply with the provisions of the legislation in force within the scope of this Act; and
2.: the consignee is one of the persons referred to in paragraph 1, or is an animal keeper in the case of § 56 (1) sentence 1.

(1b) It is prohibited to place falsified medicinal products or counterfeit active substances within the scope of this Act. In justified cases, in particular for the purpose of investigation or prosecution, the competent authority may grant exemptions. (2) The first sentence of paragraph 1 shall not apply to medicinal products which:

1.: in individual cases, in small quantities for the supply of medicinal products to certain animals at animal shows, tournaments or similar events,
2.: are intended for the own needs of research and scientific institutions and are required for scientific purposes, with the exception of medicinal products intended for clinical trials in humans,
2a.: is required in small quantities by a pharmaceutical operator, an establishment with a permit pursuant to § 13, or by a test laboratory as a viewing pattern or for analytical purposes,
2b.: from a holding with the permission provided for in § 13, either for the purpose of working or processing and subsequent reintroduction or reintroduction or for the purpose of the manufacture of an approved or approved placing on the market within the scope of this Directive a medicinal product from a Member State of the European Union or any other State Party to the Agreement on the European Economic Area,
3.: be transported under customs control by the scope of the law or transferred to a customs warehousing procedure or a free zone of type II control, or to a free zone of control type I or a free warehouse,
3a.: are authorised in a Member State of the European Union or in another State Party to the Agreement on the European Economic Area, and also, after intermediate storage, with a pharmaceutical operator, manufacturer or wholesaler Reexported or respent or respent,
4.: are brought in for the head of an external State or his/her companion and are intended for use during his/her stay within the scope of this Act,
5.: for personal use or consumption by the members of a diplomatic mission or consular post within the scope of this Act or officials of international organisations established there, and their members of the family, provided that these persons are not permanently resident in Germany or within the scope of this Act,
6.: in the case of entry into the scope of this Act, they shall be brought into a quantity corresponding to the normal personal requirements or the usual requirements of the animals not included in the entry into the country of the production of foodstuffs,
6a.: may be placed on the market in the country of origin and, without any commercial or professional mediation, in a quantity corresponding to the normal personal requirements of a Member State of the European Union or of another State Party to the Agreement on the European Economic Area,
7.: are carried out in transport and are intended solely for the use or consumption of the persons transported by such means of transport,
8.: are intended for use or consumption on seagoing ships and are consumed on board the ships,
9.: be sent as samples from the competent federal authority for the purpose of the authorisation or the state batch examination,
9a.: as samples for analytical purposes, are required by the competent authority in the context of pharmacovigilantics,
10.: by federal or state authorities in the field of interstate transport.

(3) By way of derogation from the first sentence of paragraph 1, ready-to-use medicinal products intended for use in humans and not admitted to the market within the scope of this Act may be approved, registered or registered in accordance with Section 21a shall be brought within the scope of this Act, if:

1.: they are ordered by pharmacies on the order of individual persons in small quantities and supplied by these pharmacies within the framework of the existing pharmacy type-approval,
2.: they may be lawfully placed on the market in the State from which they are brought within the scope of this Act, and
3.: are not available to them in the scope of the law with regard to the active substance identical medicinal products for the field of application in question which are comparable with respect to the potency of the active substance

or if they are to be kept in stock for emergencies in accordance with the provisions of the German pharmacist law or in the field of business of the Federal Ministry of Defence, or if they have to be procured in the short term if the The scope of this law shall not be available for the relevant field of application. The order and delivery shall be subject to medical or dental prescription for medicinal products not obtained from Member States of the European Union or other States Parties to the Agreement on the European Economic Area. . (3a) By way of derogation from the first sentence of paragraph 1, medicinal products which are not authorised or registered for circulation within the scope of this Act, or which have been exempted from registration or registration, may not be admitted to the market in the area of the marketing of such products. for the purposes of the application in the case of animals, to the scope of this Act only if:

1.: they are appointed by pharmacies for veterinarians or keepers of animals and supplied by these pharmacies under the existing pharmacy type-approval or by the veterinarian as part of the establishment of a veterinary medicinal product for the treatment of the veterinary medicinal products treated by the veterinary medicinal product. animals are ordered,
2.: they are authorised for use in animals in a Member State of the European Union or in another State Party to the Agreement on the European Economic Area; and
3.: , within the scope of this Act, no authorised medicinal product intended for use in animals is available for the purpose of achieving the objective of the treatment.

The order and delivery in pharmacies may only be made if there is a veterinary prescription. The third sentence of paragraph 3 shall apply accordingly. Veterinarians who order medicinal products in accordance with the first sentence or relating to pharmacies or prescribe them shall immediately notify the competent authority of this. The indication shall indicate the type of animal and the area of application of the medicinal product, the State from which the medicinal product is brought into the scope of this Act, the name and the order of the medicinal product concerned. The quantity of the medicinal product and its active substances by type and quantity. (4) The provisions of this Act shall not apply to medicinal products referred to in paragraphs 4 and 5 of paragraph 2. The provisions of this Act shall not apply to medicinal products referred to in points 1 to 3 and 6 to 10 and paragraph 3 of this Article, except for the provisions of Articles 5, 6a, 8, 13 to 20a, 52a, 64 to 69a and 78, and in the cases referred to in paragraph 2, point 2, and of the Paragraph 3, even with the exception of sections 48, 95 (1) (1) and (3a), (2) to (4), 96 (3), (10) and (11), and (97) (1), (2) (1) and (9), and (3). The provisions of this Act shall not apply to medicinal products referred to in paragraph 3a except for the provisions of § § 5, 6a, 8, 48, 52a, 56a, 57, 58 (1) sentence 1, § § 59, 64 to 69a, 78, 95 (1), points 1, 2a, 2b, 3a, 6, 8, 9 and 10, paragraph 2 to 4, § 96 Points 3, 13, 14 and 15 to 17, Articles 97 (1), 2 (1), 21 to 24, 31 and 3, and the provisions of Articles 12 (1) (1) and (2) and (2), 48 (2) (4) and (4), 54 (1), (2) and (3), and the Article 56a (3) of the Regulation on veterinary medicinal products and the regulation adopted pursuant to Articles 12, 54 and 57 of this Regulation on Obligation to follow up on medicinal products intended for use in animals. (5) Doctors and veterinarians may, in the exercise of their profession, in small border traffic within the meaning of Regulation (EC) No 1931/2006 of the European Parliament and of the Council of 20 December 2006 laying down rules on local border traffic at the external land borders of the Member States and amending the provisions of the Schengen Agreement (OJ L 327, 30.12.2006, p. 1), only medicinal products which are authorised or registered for the purpose of transport within the scope of this Act or which are exempt from registration or registration. By way of derogation from the first sentence of paragraph 1, doctors who have received a healthcare service within the meaning of Directive 2011 /24/EU of the European Parliament and of the Council of 9 March 2011 on the exercise of patients ' rights in cross-border Health care 45), on the place where they are established, medicinal products authorised in small quantities in a quantity which is essential for the provision of cross-border healthcare in the original packaging, if: and to the extent that medicinal products of the same composition and for the same fields of application are authorised within the scope of this Act; the doctor may only use these medicinal products themselves. In addition, by way of derogation from the first sentence of paragraph 1, veterinarians who, as nationals of a Member State of the European Union or of another Contracting State to the Agreement on the European Economic Area, are entitled to a service within the meaning of Directive 2006 /123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market (OJ L 376, 27.12.2006, p. 36), medicinal products authorised at the place where they are established in small quantities in an extent essential to the provision of the service in the original packaging, if and to the extent that medicinal products are of the same composition and for the same fields of application, also within the scope of this law; the veterinarian may only use these medicinal products themselves. It shall draw the attention of the keeper to the withdrawal period laid down for the corresponding medicinal product authorised within the scope of this Act. (6) For the customs clearance of free circulation in the case of paragraph 1 (2) and of the paragraph 1a No 2, in conjunction with paragraph 1 (2), shall require the submission of a certificate of the competent authority competent for the addressee in which the medicinal products are designated and confirmed that the conditions laid down in paragraph 1 or paragraph 1a are fulfilled. . At the cost of the customs operator, the customs office shall send the certificate issued by the authority which issued the certificate. (7) In the case referred to in paragraph 1 (1), a consignee who is a wholesaler or who operates a pharmacy shall have the existence of the Proof of coverage in accordance with § 94. Unofficial table of contents

Section 73a Export

(1) By way of derogation from § § 5 and 8 (1), the medicinal products referred to therein may be exported or brought out of the scope of the law if the competent authority of the country of destination has approved the import or the transfer. The authorization provided for in the first sentence must show that the competent authority of the country of destination is aware of the grounds of failure to prevent the placing on the market within the scope of this Act. (2) At the request of the pharmaceutical The operator, the manufacturer, the exporter or the competent authority of the country of destination shall provide the competent authority or the competent authority of the Federal Republic of Germany to the competent authority in so far as it relates to authorisation-related information and to the holder of the authorisation of the competent authority of the country Seat outside the scope of the Medicines Act, a certificate in accordance with the certificate system of the World Health Organization. If the application is submitted by the competent authority of the country of destination, the manufacturer ' s agreement shall be obtained before issuing the certificate. Unofficial table of contents

Section 74 Participation of customs services

(1) The Federal Ministry of Finance and the customs services designated by it shall be involved in the monitoring of the introduction of medicinal products and active substances within the scope of this Act and of export. The said authorities may

1.: hold consignments of the type referred to in the first sentence and their means of transport, containers, loading and packaging means for surveillance purposes,
2.: inform the competent administrative authorities of any suspicion of any prohibition or restriction of this law or of the laws enacted pursuant to this Act which arise in the performance of their duties;
3.: in the cases referred to in point 2, arrange for the consignments of the species referred to in the first sentence to be presented at the expense and risk of the person entitled to dispose of a competent authority for the supervision of medicinal products.

The letter and postal secrecy referred to in Article 10 of the Basic Law shall be restricted in accordance with the provisions of sentences 1 and 2. (2) The Federal Ministry of Finance shall, in agreement with the Federal Ministry, regulate by means of a decree law which does not give the consent of the Federal Ministry of Finance. The details of the procedure referred to in paragraph 1 shall be required by the Federal Council. It may, in particular, be subject to obligations relating to advertisements, notifications, information and to the performance of ancillary services, as well as to the payment of inspection in commercial documents and other documents, and for the purpose of carrying out surveys and the taking of charges. for free samples. The Regulation shall be adopted in agreement with the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, as far as radioactive medicinal products and active substances or medicinal products and active substances are concerned, in the manufacture of which ionizing agents are to be ionised. Radiation shall be used, and in agreement with the Federal Ministry of Food, Agriculture and Consumer Protection, as far as medicinal products and active substances are concerned, intended for use in animals.

Fourteenth Section
Information Officer, Pharmaberater

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Section 74a Information officer

(1) Anyone who, as a marketing authorisation holder, is placing on the market manufactured medicinal products which are medicinal products within the meaning of Article 2 (1) or (2) No 1 shall have a person with the necessary expertise and the necessary means to carry out their duties. To carry out the task of providing scientific information on the medicinal products (information officer). In particular, the Information Officer is responsible for ensuring that the prohibition of § 8 (1) No. 2 is respected and that the labelling, the package leaflet, the subject information and the advertising with the content of the admission or registration or, if the medicinal product is exempt from registration or registration, with the contents of the regulations on the exemption from the authorisation or from the registration according to § 36 or § 39 (3). Sentence 1 shall not apply to persons in so far as they do not require a manufacturing authorization pursuant to § 13 (2) sentence 1, no. 1, 2, 3 or 5. Persons other than those referred to in the first sentence shall not carry out an activity as an information officer. (2) The information officer may be a step plan officer at the same time. (3) The pharmaceutical contractor shall have the competent authority to: Information officers and any change in advance. In the event of an unforeseen change of the information officer, the notification shall be made without delay. Unofficial table of contents

Section 75

(1) Pharmaceutical companies may only hire persons who have the expertise referred to in paragraph 2 to seek medical professionals ' professional members in order to provide them with medical care for the purposes of § 2 (1) or (2) (1). to be informed (Pharmaberater). The first sentence shall also apply to teleoral information. Persons other than those referred to in the first sentence shall not be allowed to carry out an activity as a Pharmaberater. (2) The expertise shall be

1.: a pharmacist or person with a certificate of an examination completed after a university degree in pharmacy, chemistry, biology, human or veterinary medicine,
2.: Pharmacists ' assistants and persons with completed training as technical assistants in pharmacy, chemistry, biology, human or veterinary medicine,
3.: Pharmareferent.

(3) The competent authority may recognise as sufficient an examination or completed training which is at least equivalent to one of the training of the persons referred to in paragraph 2. Unofficial table of contents

Section 76 obligations

(1) The Pharmaberater, in so far as it informs relatives of the medical professions through individual medicinal products, has to submit the specialized information according to § 11a. He has to record in writing communications from health professionals about side effects and counter-indications or other risks in the case of medicinal products and to inform the client in writing. (2) Insofar as the pharmaceutical An operator shall be instructed to submit samples of ready-made medicinal products to the persons entitled under section 47 (3), he shall carry out evidence of the recipients of samples, as well as on the nature, scope and time of delivery of samples, and shall, on request, to the competent authority.

Fifteenth Section
Determination of the competent federal authorities and other provisions

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Section 77 Federal Supreme Authority

(1) The Federal Agency for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte), unless the Paul-Ehrlich-Institut or the Federal Office for Consumer Protection and Food Safety is responsible. (2) The Paul-Ehrlich-Institut is responsible for the responsible for Sera, vaccines, blood preparations, bone marrow preparations, tissue preparations, tissues, allergens, medicinal products for advanced therapies, xenogens and genetically engineered blood components. (3) The Federal Office for Consumer protection and food safety is responsible for Medicinal products intended for use in animals. For the purpose of monitoring the effectiveness of antibiotics, the Federal Office for Consumer Protection and Food Safety conducts repeated observations, investigations and assessments of resistances of animal pathogens against substances with antimicrobial activity, which are contained as active substances in veterinary medicinal products (resistance monitoring). The monitoring of resistance also includes the creation of reports. (4) The Federal Ministry is empowered to exercise the competence of the Federal Institute for Medicinal Products and Medical Devices and the Federal Republic of Germany by means of a regulation without the consent of the Federal Council. Paul-Ehrlich-Institut, if necessary in order to take account of recent scientific developments or if reasons for the uniform workload require such a change. Unofficial table of contents

Section 77a Independence and transparency

(1) The competent federal authorities and competent authorities shall ensure, with a view to ensuring independence and transparency, that the authorisation and supervision of officials of the regulatory authorities or of other authorities responsible for the authorisation and supervision of the competent authorities shall be subject to the following conditions: competent authorities or experts responsible for their neutrality do not have any financial or other interests in the pharmaceutical industry. These persons shall declare each year a declaration. (2) In carrying out their duties under this Act, the competent federal authorities and the competent authorities shall make the rules of their committees, agendas and agendas, as well as the competent authorities, the the minutes of the proceedings of their meetings shall be made publicly available, with the secrets of operations, services and business being kept. Unofficial table of contents

§ 78 Prices

(1) The Federal Ministry of Economics and Technology is hereby authorized, in agreement with the Federal Ministry and, in the case of medicinal products intended for use in animals, in agreement with the Federal Ministry for Economic and Monetary Affairs Nutrition, agriculture and consumer protection through legal regulation with the consent of the Federal Council

1.: Price margins for medicinal products sold in wholesale, pharmacies or by veterinarians in resale,
2.: prices for medicinal products manufactured and delivered in pharmacies or by veterinarians, and for dispensing vessels,
3.: Prices for the special services of pharmacies in the supply of medicinal products

to be fixed. By way of derogation from the first sentence, the Federal Ministry of Economics and Technology is authorized, in agreement with the Federal Ministry, by means of a decree law which does not require the approval of the Federal Council, the share of the fixed surcharge which does not include the To promote the provision of emergency services in accordance with the cost development of pharmacies in the event of economic management. The price rules applicable to wholesalers pursuant to the first subparagraph of point 1 shall also apply to pharmaceutical companies or other natural or legal persons who carry out an activity in accordance with Article 4 (22) in the supply of pharmacies to pharmacies, which shall be responsible for the sale of such products. Refer to medicinal products for delivery to the consumer. The Regulation on medicinal products, adopted pursuant to the first sentence, shall also apply to medicinal products which are brought into the scope of this Act in accordance with Article 73 (1), first sentence, point 1a. (2) Prices and price margins must be the subject of: to take account of the legitimate interests of pharmaceutical consumers, veterinarians, pharmacies and wholesalers. A single dispensing price for medicinal products for medicinal products excluded from the market outside pharmacies shall be guaranteed. The second sentence of paragraph 2 shall not apply to medicinal products which are not subject to medical prescription. (3) For medicinal products as referred to in the second sentence of paragraph 2, for which the prices and price ranges referred to in paragraph 1 are subject to the regulation referred to in paragraph 2. , the pharmaceutical companies have to ensure a uniform dispensing price; for non-prescription-only medicinal products which are delivered at the expense of the statutory health insurance, the pharmaceutical companies shall have the right to Entrepreneurs for the purpose of accounting for pharmacies with the health insurance companies uniform delivery price, from which the levy may be dismissed on a case-by-case basis. Social security institutions, private health insurance companies and their respective associations may, together with pharmaceutical companies, on the prescription price of the medicinal product subject to the prescription of the medicinal product subject to the obligation to pay the costs of the medicinal product, can be used for the uniform dispensing price of the medicinal (3a) Applies for a medicinal product a refund amount according to § 130b of the Fifth Book of Social Code, the pharmaceutical entrepre shall issue the medicinal product to the refund amount. By way of derogation from the first sentence, the pharmaceutical operator may surrender the medicinal product at an amount below the refund amount, without prejudice to the obligation laid down in the first sentence of paragraph 3 of this Article. The rate of surcharge as set out in the first sentence or the second sentence shall also apply to persons who do not receive the medicinal product as insured persons in a statutory health insurance scheme. (4) In the case of medicinal products which are in the event of a threatening communicable disease, the spread of which makes it necessary to provide for the supply of specific medicinal products immediately and to the usual extent, by means of pharmacies, which have been stored for this purpose in accordance with Article 47 (1), first sentence, No. 3c, shall be applied as the basis for the prices and price margins to be fixed in accordance with paragraph 2 of Country discharge price. The same applies to medicinal products which are produced in pharmacies and delivered in such cases from active substances which have been correspondingly stored for this purpose. In these cases, the second sentence of paragraph 2 shall apply at the country level. Unofficial table of contents

Section 79 Emergency appropriations for crisis periods

(1) The Federal Ministry is authorized, in agreement with the Federal Ministry of Economics and Technology, with the consent of the Federal Council, to make exceptions to the provisions of this Act and to the provisions of this Act with the consent of the Federal Council. if the necessary supply of medicinal products to the population would otherwise be seriously threatened and if there is no risk of a direct or indirect risk to the health of human beings by medicinal products , in particular, rules may be adopted to ensure the dissemination of (2) The Federal Ministry of Food, Research and Energy, the Federal Ministry of Food, Research and Energy, the Federal Ministry of Food, Agriculture and consumer protection are authorized, in agreement with the Federal Ministry and the Federal Ministry of Economics and Technology, by means of a legal regulation which does not require the consent of the Federal Council, exceptions to the Provisions of this Act and of the provisions adopted pursuant to this Act If the necessary supply of veterinary medicinal products is otherwise seriously threatened, and if there is no risk of a direct or indirect risk to the health of humans or animals by medicinal products, (3) The legal regulations referred to in paragraph 1 or 2 shall be adopted in agreement with the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, in so far as they are concerned with radioactive medicinal products and medicinal products in the manufacture of which ionizing agents are to be ionised Radiation is used, or regulations to prevent hazards from ionizing radiation. (4) The period of validity of the regulation referred to in paragraph 1 or 2 shall be limited to six months. (5) In the event of a shortage of the population with medicinal products for prevention or treatment, the period of validity of the legal regulation shall be limited to six months. , or in the case of a threatening communicable disease, the spread of which requires an immediate and a normal level of delivery of specific medicinal products, the competent authorities may, on a case-by-case basis, allow medicinal products which are not traffic within the scope of this Act is authorised or registered,

1.: shall be placed on the market, and
2.: by way of derogation from Section 73, paragraph 1, into the scope of this Act.

Sentence 1 shall apply if the medicinal products may be lawfully placed on the market in the State from which they are brought into the scope of this Act. The refund by the competent authority shall also be deemed to be a certificate in accordance with Section 72a (1), first sentence, point 3 or in accordance with section 72b (2), first sentence, point 3, that the import is in the public interest. In the event of a shortage or a threatening communicable disease within the meaning of the first sentence, the competent authorities may, on a case-by-case basis, also provide for a temporary derogation from permit or authorisation requirements or from other prohibitions. in accordance with this law. The Federal Ministry has found that there is a shortage of supply or a threatening communicable disease within the meaning of sentence 1 or is no longer available. The statement shall be made by means of a notice published in the Federal Gazette. The notice shall be published in agreement with the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, as far as radioactive medicinal products and medicinal products are concerned, in the manufacture of which ionizing radiation is used. (6) Measures taken by the competent authorities referred to in paragraph 5 shall be limited to the necessary level and shall be proportionate to address the health risks caused by the shortage of supply or the threatening communicable disease . Any objection and action taken against action under paragraph 5 shall not have suspensive effect. Unofficial table of contents

§ 80 authorization for procedure and hardship case regulations

The Federal Ministry is authorized to provide further details on the procedure by means of a regulation which does not require the approval of the Federal Council.

1.: the authorisation, including the renewal of the authorisation,
2.: the state batch examination and the release of a batch,
3.: the notification of the amendment of the registration documents;
3a.: the competent federal authority and the persons involved in the case of placing on the market in cases of hardship in accordance with Article 21 (2) sentence 1 no. 6 in conjunction with Article 83 of Regulation (EC) No 726/2004,
4.: the registration, including the renewal of registration,
4a.: the publication of the results of clinical trials in accordance with § 42b,
5.: the reporting of drug risks; and
6.: the electronic submission of documents referred to in points 1, 3, 4, 4a and 5, including the formats to be used

; it may determine the forwarding of copies to the competent authorities, and require that documents be submitted in multiple copies and on electronic or optical storage media. The Federal Ministry may transfer this authorisation to the competent federal authority without the consent of the Federal Council. The legal regulation referred to in the first sentence of paragraph 1 (3a) may, in particular, include the tasks of the competent national authority with a view to the participation of the European Medicines Agency and the Committee for Medicinal Products for Human Use in accordance with Article 83 of the Regulation (EC) No 726/2004 as well as the responsibilities of the attending physicians and the pharmaceutical companies or sponsors, including display, documentation and reporting requirements, in particular for side effects in accordance with Article 24 (1) and Article 25 of Regulation (EC) No 726/2004. In this context, provisions may also be made on medicinal products which relate to medicinal products under the conditions laid down in Article 83 of Regulation (EC) No 726/2004 which do not relate to the products referred to in Article 3 (1) or (2) of this Regulation. belong. The legal regulations referred to in sentences 1 and 2 shall be adopted in agreement with the Federal Ministry of Food, Agriculture and Consumer Protection, as far as medicinal products intended for use in animals are concerned. Unofficial table of contents

§ 81 Relationship with other laws

The provisions of the narcotics and nuclear law and the animal protection law remain unaffected. Unofficial table of contents

§ 82 General administrative provisions

The Federal Government, with the consent of the Federal Council, shall adopt the general administrative provisions necessary for the implementation of this Act. Insofar as these are addressed to the competent federal authority, the general administrative provisions shall be adopted by the Federal Ministry. The general administrative provisions referred to in the second sentence shall be adopted in agreement with the Federal Ministry of Food, Agriculture and Consumer Protection, as far as medicinal products intended for use in animals are concerned. Unofficial table of contents

Section 83 approximation to the law of the European Union

(1) Legal regulations or general administrative provisions adopted pursuant to this Act may also be adopted for the purpose of the approximation of the laws, regulations and administrative provisions of the Member States of the European Union, to the extent that this is necessary for the implementation of: Regulations, directives, decisions or decisions of the European Community or of the European Union concerning the subject matter of this Act are required. (2) (omitted) Unofficial table of contents

Section 83a Legal orders in certain cases

The Federal Ministry is authorized, by means of law, without the consent of the Federal Council, to refer to provisions in legal acts of the European Community or of the European Union in this Act or in accordance with this Act , in so far as it is necessary to adapt to amendments to those provisions. In the case of rules on medicinal products or substances intended for use in animals, the Federal Ministry of Food, Agriculture and Consumer Protection is replaced by the Federal Ministry for Food, Agriculture and Consumer Protection, which is the Federal Ministry of Food, Agriculture and Consumer Protection, which is responsible for the Agreement with the Federal Ministry. Unofficial table of contents

Section 83b Announcement of legal regulations

By way of derogation from § 2 (1) of the German Federal Gazette (Federal Gazette), legal orders under this Act may be announced.

Sixteenth section
Liability for damage to medicinal products

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Section 84 Risk liability

(1) Where a medicinal product intended for use in humans has been applied to the consumer within the scope of this Act and is subject to the obligation to be admitted or is subject to authorisation by the law of the Member States , if a person is killed or the body or the health of a person is not infringed insignificantly, the pharmaceutical operator who has placed the medicinal product on the market within the scope of this Act shall be the pharmaceutical company which has placed the medicinal product on the market, is obliged to replace the injured person with the damage resulting from it. The replacement obligation shall apply only if:

1.: the medicinal product has adverse effects in its intended use which go beyond a measure acceptable in accordance with the findings of medical science; or
2.: the damage has occurred as a result of a marking, specialist information or package leaflet which did not correspond to the findings of medical science.

(2) If the medicinal product used is suitable, in accordance with the circumstances of the individual case, to cause the damage, it shall be presumed that the damage caused by this medicinal product is caused. The suitability in individual cases shall be assessed on the basis of the composition and the dose of the medicinal product used, according to the nature and duration of its intended use, after the time-related relationship with the occurrence of damage, after the Damage image and health condition of the injured person at the time of the application, as well as all other conditions which speak for or against the causation of the damage in individual cases. The presumption shall not apply if a different circumstance is appropriate according to the circumstances of the individual case to cause the damage. Another circumstance does not lie in the use of other medicinal products which, according to the circumstances of the individual case, are likely to cause the damage, unless the use of these medicinal products is based on claims made in accordance with this provision. (3) The obligation to replace the pharmaceutical carrier referred to in the second sentence of paragraph 1 shall be excluded if, in the circumstances, it must be assumed that the harmful effects of the damage caused by the damage to the the effects of the medicinal product, not in the area of development and Manufacture. Unofficial table of contents

Section 84a entitlement to information

(1) If there are facts which justify the assumption that a medicinal product has caused the damage, the injured party may request information from the marketing authorisation holder, unless it is necessary to determine whether a claim has been made to Compensation in accordance with § 84 is not required. The claim is directed at the pharmaceutical entreprenchal known effects, side effects and interactions as well as suspected suspected cases of side effects and interactions and all other findings that are known for the Evaluation of the representability of harmful effects can be of importance. § § § 259 to 261 of the Civil Code shall be applied accordingly. A claim for information does not exist insofar as the data are to be kept secret due to legal regulations or the secrecy corresponds to a predominant interest of the pharmaceutical entrepre or a third party. (2) A Entitlement to information shall also apply to the authorities responsible for the authorisation and supervision of medicinal products, subject to the conditions set out in paragraph 1. The Authority shall not be obliged to provide the information in so far as information is to be kept secret on the basis of statutory provisions or the secrecy corresponds to a overriding interest of the pharmaceutical entreptite or a third party. Claims under the Freedom of Information Act shall remain unaffected. Unofficial table of contents

§ 85 Co-indebtedness

If, in the course of the occurrence of the damage, a fault of the injured party has been involved, § 254 of the Civil Code shall apply. Unofficial table of contents

Section 86 Scope of the obligation to spare in the event of killing

(1) In the case of the killing, compensation shall be made by reimbursement of the costs of an attempted cure and of the asset disadvantage suffered by the killed by the fact that, during the illness, its earning capacity is lifted or reduced. or a proliferation of his needs. In addition, the person liable for replacement shall reimburse the costs of the burial to the person who is responsible for the obligation to bear such costs. (2) The status of the person killed at the time of the injury to a third party in a proportion, of which he is liable, was subject to maintenance or maintenance obligations under the law, and if the third party is deprived of the right to subsistence as a result of the killing, the person liable to pay compensation shall pay compensation to the third party in so far as the killed person has been killed committed during the presumed duration of his life for the purpose of subsisting would have been. The replacement obligation occurs even if the third party was created at the time of the injury, but was not yet born. Unofficial table of contents

Section 87 Scope of the replacement obligation in the event of bodily injury

In the event of injury to the body or health, the compensation shall be made by replacing the costs of the healing and the property disadvantage suffered by the injured person in that, as a result of the injury, his or her injury shall be temporary or permanent. Working capacity has been cancelled or diminished or a multiplication of its needs has occurred. In this case, a cheap compensation in money can also be required because of the damage that is not property damage. Unofficial table of contents

Section 88 Maximum amounts

The liable person shall be liable

1.: in the event of the killing or injury of a person, only up to a capital amount of EUR 600,000 or up to a pension amount of EUR 36,000 per annum,
2.: in the event of the killing or injury of more than one person by the same medicinal product, without prejudice to the limits set out in point 1, up to a capital amount of EUR 120 million or up to a pension of EUR 7.2 million per annum.

If, in the case of the first sentence of sentence 1, point 2, the compensation to be paid to the various injured parties exceeds the maximum amounts laid down therein, the individual compensation shall be reduced in proportion to the total amount of the compensation in respect of the maximum amount. is. Unofficial table of contents

Section 89 Compensation of damages by money

(1) The compensation for compensation for the cancellation or reduction of the earning capacity and for the multiplication of the needs of the injured person and the compensation to be granted to a third party pursuant to § 86 (2) shall be for the future by payment of a financial pension. (2) The provisions of § 843 (2) to (4) of the Civil Code and Section 708 (8) of the Code of Civil Procedure shall apply. (3) If the pledge of the pledge is not to be paid, the provisions shall not apply to the payment of a fee. Security performance has been identified, the beneficiary may nevertheless be entitled to security if the assets of the pledge have deteriorated significantly; under the same condition, it may require an increase in the security specified in the judgment. Unofficial table of contents

§ 90

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Section 91 Additional liability

This shall be without prejudice to statutory provisions which, pursuant to § 84, shall be liable to a further extent than under the provisions of this Section or after which another person is responsible for the damage. Unofficial table of contents

§ 92 Inaliability

The replacement obligation under this section shall not be excluded or limited in advance. Contrary agreements are void. Unofficial table of contents

Section 93 Multiple substitutes

If there are more than one subject, they shall be liable as the total debtor. In proportion to each other, the obligation to replace and the extent of the revenue to be paid depends on the circumstances, in particular on the extent to which the damage was mainly caused by one or the other part. is. Unofficial table of contents

Section 94 Cover provision

(1) The pharmaceutical operator must ensure that he is able to comply with his legal obligations to compensate for damage caused by the use of a person placed on the market for use in human beings. A medicinal product which is subject to the obligation to be admitted or which has been exempted from the authorisation by means of a legal regulation (financial security cover). The cover provisions must be provided at the level of the amounts referred to in Article 88, first sentence. It can only

1.: a liability insurance cover for an independent insurance undertaking authorised to operate within the scope of this law, for which, in the case of reinsurance, a reinsurance contract shall be provided only with a Reinsurance undertaking which is situated within the scope of this Act, in another Member State of the European Union, in another State Party to the Agreement on the European Economic Area or in a Member State of the European Union, or in any other Member State of the European Union Commission on the basis of Article 172 of Directive 2009 /138/EC of the European Parliament and of the Council of 25 November 2009 on the taking up and pursuit of the business of insurance and reinsurance (Solvency II) (OJ L 136, 31.7.2009, p. 1) is recognised as being equivalent to the State of the European Union, or
2.: by an exemption or guarantee obligation of a national credit institution or a credit institution of another Member State of the European Union or of another Contracting State of the Agreement on the European Union Economic Area

(2) If the insurance cover is provided by a liability insurance, Section 113 (3) and § § 114 to 124 of the Insurance Contract Law shall apply mutationally. (3) By means of an exemption or warranty obligation of a Credit institutions may only be provided with a financial guarantee if it is guaranteed that the credit institution will be able, as long as it is expected to take advantage of its use, to fulfil its obligations under the financial provisions of the credit institution . § 113 (3) and § § 114 to 124 of the Insurance Contract Law apply to the exemption or warranty obligation. (4) The responsible body within the meaning of Section 117 (2) of the Insurance Contract Law is the responsible party for the Implementation of the supervision according to § 64 competent authority. (5) The Federal Republic of Germany and the Länder are not obligated to cover the financial security referred to in paragraph 1. Unofficial table of contents

Section 94a Local competence

(1) The court in whose district the plaintiff is domicated, in the absence of such a place of habitual residence, shall also be responsible for proceedings brought under Section 84 or Section 84a (1) of the Court of First Instance. (2) Paragraph 1 shall not be taken into consideration in the determination of the international jurisdiction of the courts of a foreign state pursuant to Section 328 (1) (1) of the Code of Civil Procedure.

Seventeen Section
Criminal and penal rules

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Section 95 Criminal Code

(1) With a custodial sentence of up to three years or a fine shall be punished, who

1.: , contrary to Article 5 (1), placing a medicinal product on the market or applying it to others,
2.: a regulation in accordance with Article 6 prohibiting the placing on the market of medicinal products, insofar as it refers to such penal provisions in respect of a particular case;
2a.: , contrary to the provisions of Article 6a (1), medicinal products for the purpose of doping in sport are placed on the market, prescribing or applied to others;
2b.: , contrary to the first sentence of Article 6a (2a), acquire or possess a medicinal product or an active substance,
3.: , contrary to Section 7 (1) of the radioactive medicinal product or medicinal product used for the manufacture of which ionizing radiation has been used, puts into circulation:
3a.: in accordance with Article 8 (1) (1) or (2), including in conjunction with Section 73 (4) or § 73a, the manufacture of medicinal products or active substances, placing on the market or trading them otherwise,
4.: Contrary to Article 43 (1), second sentence, second sentence, sentence 1, with medicinal products which may only be delivered to consumers on prescription, trade or give off these medicinal products,
5.: Medicinal products which may only be issued on prescription to consumers, contrary to § 47 (1), to persons or bodies other than those designated there, or to paragraph 47 (1a) or to apply contrary to § 47 (2) sentence 1,
5a.: , contrary to Article 47a (1), a medicinal product referred to there shall be sent to, or placed on the market, other facilities other than those designated therein,
6.: Article 48 (1) sentence 1 in conjunction with a regulation pursuant to section 48 (2) (1) or (2) of medicinal products intended for use in animals intended for the production of foodstuffs,
7.: Article 56 (1) without the required prescription to animal keepers,
8.: , contrary to the first sentence of Article 56a (1), including in conjunction with sentence 3, or the second sentence, medicinal products which are intended for use in animals intended for the production of foodstuffs and which are intended for use only on prescription to the consumer may be delivered,
9.: Medicinal products which may only be issued on prescription to the consumer, contrary to Article 57 (1) of the present application,
10.: Contrary to the first sentence of Article 58 (1), medicinal products which may only be delivered to consumers on prescription shall apply to animals used for the production of foodstuffs, or
11.: Contrary to § 59d sentence 1, point 1, a prohibited substance shall be administered to an animal referred to therein.

(2) The trial is punishable. (3) In particularly serious cases, the penalty is a term of imprisonment of one year to ten years. A particularly serious case is usually present when the perpetrator

1.

by one of the acts referred to in paragraph 1

a): the health of a large number of people is at risk,
b): other than the risk of death or serious injury to body or health, or
c): obtained from gross self-interest for itself or another asset advantage of a large scale, or

2.

in the cases referred to in paragraph 1 (2a)

a): medicines for doping purposes in sport to persons under the age of 18 years of age or who apply them to such persons; or
b): commercial or as a member of a gang which has committed itself to the continuing commission of such acts, or

3.

, in the cases referred to in paragraph 1 (3a), manufacture or place counterfeit medicinal products or active substances on the market, in the commercial or as a member of a gang, which has committed itself to the continuing commission of such acts.

(4) If the offender is negligent in the cases referred to in paragraph 1, the penalty shall be a custodial sentence of up to one year or a fine. Unofficial table of contents

Section 96 Criminal Code

A custodial sentence of up to one year or a fine shall be punished.

1.

in the case of a medicinal product contrary to Article 4b (3) sentence 1

2.

a legal regulation in accordance with § 6, which prescries, restricts or prohiposes the use of certain substances, preparations of substances or objects in the manufacture of medicinal products, in so far as it applies to a specific case this penal provision refers,

3.

Manufacture or place on the market, contrary to Article 8 (1) (2), also in conjunction with Section 73a, medicinal products or active substances,

4.

manufactures or imports a medicinal product, an active substance or a substance referred to in the first sentence of Article 13 (1) sentence 1 or the first sentence of Article 72 (1) (1), without the authorisation,

4a.

, without permission pursuant to § 20b, paragraph 1, sentence 1 or paragraph 2, sentence 7 of tissue wins or laboratory tests carried out or without permission in accordance with § 20c (1) sentence 1 of the tissue or tissue preparations processed, preserved, checked, stored or placed on the market ,

5.

Article 21 (1) of the finished medicinal product or medicinal product intended for use in animals or in a regulation referred to in § 35 (1) (2) or (3) or § 60 (3), without authorisation or without authorisation of the European the Community or the European Union,

5a.

shall place tissue preparations on the market without authorisation pursuant to Article 21a (1) sentence 1,

5b.

a tissue preparation for the first time without a certificate in accordance with § 21a (9) sentence 1,

6.

a claim required pursuant to section 22 (1) no. 3, 5 to 9, 11, 12, 14 or 15, subsection 3b or 3c sentence 1 or § 23 para. 2 sentence 2 or 3 does not make it complete or not correct, or a claim required pursuant to section 22 (2) or (3), section 23 (1), para. 2 sentence 2 or 3, para. 3, also, in conjunction with Section 38 (2), the required document or the enforceable arrangement referred to in Article 28 (3), (3a), (3b) or (3c) sentence 1 (2) of the required document shall not be presented in full or with non-correct content,

7.

, contrary to § 30 (4) sentence 1 no. 1, also in connection with a regulation pursuant to section 35 (1) (2), a medicinal product is placed on the market,

8.

Contrary to § 32 (1) sentence 1, also in conjunction with a regulation pursuant to section 35 (1) no. 3, a charge shall be placed on the market without release,

9.

, contrary to Article 38 (1), sentence 1 or section 39a, sentence 1 of the final medicinal product as homeopathic medicinal products or as a traditional herbal medicinal product, without registration,

10.

Contrary to Article 40 (1) sentence 3, point 2, 2a (a), 3, 4, 5, 6 or 8, the clinical examination of a medicinal product shall also be carried out in conjunction with paragraph 4 or 41, respectively,

11.

the clinical examination of a medicinal product begins, contrary to Article 40 (1) sentence 2,

12.

contrary to § 47a (1) sentence 1, if the act is not punishable by punishment in accordance with Article 95 (1) (5a), a medicinal product referred to there shall be issued without a prescription,

13.

in accordance with Article 48 (1), first sentence, in connection with a legal regulation pursuant to § 48 para. 2 nos. 1, 2 or 7 medicinal products, if the act is not punishable by penalty in § 95 para. 1 no.

14.

, without permission pursuant to § 52a (1) sentence 1, wholesale trade,

14a.

, contrary to Article 52c (2), first sentence, an activity as a mediator,

15.

Pursuant to § 56a (4) medicinal products,

16.

Contrary to Section 57 (1a) sentence 1 in conjunction with a regulation pursuant to section 56a (3) sentence 1 no. 2, a medicinal product referred to therein is in possession of a medicinal product,

17.

Contrary to the second sentence of Article 59 (2) of the Food

18.

, contrary to the provisions of paragraph 59a (1) or (2), the acquisition, supply, storage, packaging, supply or placing on the market of substances or preparations of substances,

18a.

in the case of an animal referred to in point 2 of the first sentence of paragraph 59d,

18b.

in accordance with Article 72a (1), first sentence, also in conjunction with paragraph 1b or paragraph 1d, or contrary to Article 72a (1c), a medicinal product, an active substance or a substance other than those referred to in the said paragraphs,

18c.

shall introduce tissue or tissue preparations without the permission of Section 72b (1) sentence 1,

18d.

, contrary to § 72b (2) sentence 1, tissue or tissue preparations shall be introduced,

18e.

Contrary to Article 73 (1b), first sentence, a counterfeit medicinal product or a counterfeit active substance shall be placed within the scope of this Act,

19.

a medicinal product intended for use in human beings is placed on the market, although the liability insurance or exemption or warranty obligation as required under section 94 does not exist or is no longer available, or

20.

against Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Community Pharmaceutical Agency (OJ L 327, 28. 1), as last amended by Regulation (EU) No 1027/2012 (OJ L 136, 30.4.2004, p. OJ L 316, 14.11.2012, p. 38), by:

a): contrary to the first sentence of Article 6 (1) of the Regulation in conjunction with the first subparagraph of Article 8 (3) (c) to (e), (h) to (iaa) or (ib) of Directive 2001 /83/EC of the European Parliament and of the Council of 6 November 2001 on the establishment of of a Community code relating to medicinal products for human use (OJ L 327, 28. 67), as last amended by Directive 2012 /26/EU (OJ L 311, 28.11.2012, p. 1), an indication or a document is not correctly or incompletely attached, or
b): pursuant to Article 31 (1), first sentence, of the Regulation in conjunction with the first sentence of the first subparagraph of Article 12 (3), second sentence, point (c) to (e), (h) to (j) or (k) of Directive 2001 /82/EC of the European Parliament and of the Council of 6 November 2001 on the creation of Community code relating to veterinary medicinal products (OJ L 136, 30.4.2004 EC No 1), as amended by Directive 2004 /28/EC of the European Parliament and of the Council of 31 March 2004 (OJ L 311, 28.11.2004, p. EU No 58), an indication is not correct or is not fully enclosed.

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Section 97 Rules of fines

(1) An administrative offence is to be found in the

1.: Section 96, points 1 to 5b, 7 to 18e, or point 19, or
2.: Section 96 (6) or (20)

(2) Contrary to the order of order, the person concerned also acts intentionally or negligently.

1.

, contrary to Article 8 (3), placing a medicinal product on the market,

2.

, contrary to Article 9 (1), medicinal products which do not bear the name or the company of the pharmaceutical company,

3.

, contrary to Article 9 (2), sentence 1, medicinal products shall be placed on the market without its registered office within the scope of this Act or in another Member State of the European Union or in another State Party to the Agreement on the European Union economic area,

4.

Contrary to § 10, also in connection with § 109 para. 1 sentence 1 or a legal regulation pursuant to § 12 para. 1 no. 1, medicinal products without the prescribed mark is placed on the market,

5.

Contrary to § 11 (1) sentence 1, also in conjunction with paragraphs 2a to 3b or 4, in connection with a legal regulation pursuant to § 12 para. 1 no. 1, medicinal products without the prescribed package leaflet are placed on the market,

5a.

, contrary to Article 11 (7) sentence 1, a subset of the

6.

an enforceable arrangement in accordance with section 18 (2),

7.

against

a): § § 20, 20b (5), § 20c (6), also in conjunction with Section 72b (1) sentence 2, contrary to § 52a (8), § 67 (8) sentence 1, or § 73 (3a) sentence 4,
b): Article 21a, paragraph 7, sentence 1, § 29, paragraph 1, sentence 1, also in conjunction with sentence 2, contrary to § 29 (1c) sentence 1, § 63c (2), § 63h (2), § 63i (2) sentence 1, or
c): Article 67 (1), first sentence, also in conjunction with sentence 2, also in conjunction with § 69a, contrary to § 67, paragraph 5, sentence 1 or paragraph 6, sentence 1

an indication not, not correct, not fully or not reimbursed in time,

7a.

Contrary to Section 29 (1a) sentence 1, para. 1b or 1d, does not make a notice, not correct, not complete or not in good time,

8.

, contrary to § 30 (4) sentence 1 (2) or § 73 (1) or (1a), medicinal products within the scope of this Act,

9.

, contrary to Article 40 (1) sentence 3, point 7, the clinical examination of a medicinal product,

9a.

without having appointed a deputy in accordance with the third sentence of Article 40 (1a), conduct a clinical trial,

9b.

, contrary to § 42b (1) or (2), the reports shall not be made available, not correct, in full or in a timely manner,

10.

, contrary to Article 43 (1), (2) or (3), placing on the market of medicinal products on a professional or professional basis, or with medicinal products which may be sold to consumers without prescription, trade or supplies these medicinal products,

11.

in accordance with § 43 (5), first sentence, on the use in animals of certain medicinal products which are not released for circulation outside the pharmacies, in a manner which is not correct,

12.

Medicinal products which may be delivered to consumers without prescription, contrary to § 47 (1), to persons or bodies other than those designated there or to paragraph 47 (1a) or to apply contrary to § 47 (2) sentence 1,

12a.

-in accordance with § 47 (4) sentence 1 of the specimen without written request, in a format other than the smallest pack size or beyond the permissible quantity, or leave it to be delivered,

13.

the evidence required by Section 47 (1b) or (4) sentence 3 or in the second sentence of Article 47a (2) sentence 2 does not or is not properly carried out by the competent authority at its request,

13a.

Contrary to § 47a (2) sentence 1, a medicinal product referred to there without the prescribed labelling,

14.

Contrary to Section 50 (1), the retail trade of medicinal products

15.

, contrary to Section 51 (1), haggles or orders to purchase products in the travel industry,

16.

Contrary to Section 52 (1), medicinal products shall be placed on the market by means of self-service,

17.

In accordance with Article 55 (8), first sentence, also in connection with sentence 2, a substance, a container or a wrapping, or a form of presentation,

17a.

Contrary to Article 56 (1) sentence 2, a copy of a prescription shall not be sent or not sent in due time,

18.

manufacture, in accordance with the first sentence of Article 56 (2), the first sentence, or the first sentence, of the first sentence, or the second sentence,

19.

Contrary to Article 56 (4), second sentence, a mixture of ready-to-use feedingstuffs is not marked, not in full, in the prescribed manner or not in due time,

20.

, contrary to Article 56 (5) sentence 1, prescribable a medicated feedingstuffs,

21.

1, 2, 3 or 4, also in combination with sentence 3, medicinal products,

a): which are intended for use in animals which are not used for the production of foodstuffs, and which may only be given on prescription to consumers,
b): which may be delivered to consumers without prescription,

, by writing, issuing or applying,

21a.

, contrary to § 56a (1) sentence 4, prescribe or release pre-mixes of medicinal products,

22.

Medicinal products which may be delivered to consumers without prescription shall, contrary to § 57 (1), be acquired,

22a.

contrary to § 57a of medicinal products,

23.

, contrary to § 58 (1) sentence 2 or 3, medicinal products used in animals used for the production of foodstuffs,

23a.

contrary to § 58a (1) sentence 1 or 2 or paragraph 3, paragraph 4, sentence 1, sentence 2 or sentence 3 or § 58b (1) sentence 1, 2 or 3 or paragraph 2, second sentence, point 2 or paragraph 3, a notice not, not correct, not complete, not in the in a prescribed manner or not in time,

23b.

shall not record, not correct or not in good time, a determination referred to in point 58d (1) (2),

23c.

Contrary to Article 58d (2), first sentence, point 2, the plan referred to in paragraph 2 above shall not be drawn up, not in full, not in the prescribed manner or in a timely manner,

23d.

an enforceable arrangement in accordance with § 58d (3) or (4) sentence 1,

24.

an obligation to record or file a claim in accordance with section 59 (4),

24a.

Contrary to § 59b sentence 1, substances are not left, right or not in good time,

24b.

Contrary to § 59c sentence 1, even in connection with the second sentence, the proof referred to in the first sentence of the first sentence does not, either correctly or incompletely, does not, or not, or not, kept for at least three years, or not presented in good time,

24c.

Contrary to § 63a (1) sentence 1, a stepped planner is not commissioned or, contrary to § 63a (3), a communication is not reimbursed, not fully or not reimbursed in good time,

24d.

Contrary to § 63a (1) sentence 6, an activity is carried out as a stepped plan officer,

24e.

Contrary to Article 63b (1), a pharmacovigilance system is not operating,

24f.

shall not take any action referred to in paragraph 63b (2) (1) or shall not take it in due time,

24g.

, contrary to Section 63b (2) (3), a pharmacovigilance stock documentation does not, or is not correct or complete, does not provide the correct, complete or non-timely disposal of the pharmacovigilance stock,

24h.

Contrary to Article 63b (2) (4), a risk management system for each individual medicinal product does not operate, does not operate correctly or does not fully operate,

24i.

Contrary to Section 63b (3), first sentence, the information referred to in this paragraph shall be published without the prior or simultaneous notification referred to therein,

24j.

Contrary to Section 63d (1), even in conjunction with the first sentence of paragraph 3 or the fourth sentence of paragraph 3, a safety report shall not be presented in a timely manner, not in full or in a timely manner,

24k.

the third sentence of Article 63f (1) does not transmit a final report or does not submit it in good time;

24l.

Contrary to Section 63g (1), a draft audit protocol is not submitted correctly or in good time,

24m.

contrary to § 63g (2), first sentence, with a safety test,

24n.

, contrary to § 63g (4) sentence 1, does not submit an audit report, not correct, not complete or not in good time,

24o.

shall not submit a report, not correct, in full or in time, in accordance with the provisions of the first sentence of Article 63h (5), (2) or (3);

24p.

Contrary to § 63i (3) sentence 1, does not make a notification, not correct or not in good time,

24q.

Contrary to the first sentence of Article 63i (4), a report shall not be presented, not correct or not in good time,

25.

an enforceable order pursuant to section 64 (4) (4), also in conjunction with § 69a,

26.

a duty to take up a duty or compaction pursuant to § 66, also in conjunction with § 69a,

27.

contrary to a fully-enforceable order pursuant to § 74 (1) sentence 2 no. 3, a consignment is not presented,

27a.

Contrary to § 74a (1) sentence 1, an information officer is not commissioned or, contrary to § 74a (3), a communication is not reimbursed, not completely or not reimbursed in due time,

27b.

, contrary to Section 74a (1) sentence 4, an activity as an information officer,

28.

Contrary to § 75 para. 1 sentence 1, a person is assigned to be a Pharmaberater,

29.

, contrary to Article 75 (1) sentence 3, an activity as a Pharmaberater,

30.

an obligation to record, share or proof in accordance with section 76 (1) sentence 2 or 2 (2),

30a.

(dropped)

31.

a legal regulation pursuant to § 7 (2) sentence 2, § 12 (1) No. 3 (a), § 12 (1b), § 42 (3), § 54 (1), § 56a (3), § 57 (2) or (3), § 58 (2) or § 74 (2) or a enforceable order on the basis of such a regulation Regulation of the law on a particular case refers to this fine.

32.

(dropped)

33.

(dropped)

34.

(dropped)

35.

(dropped)

36.

(dropped)

(2a) Contrary to the provisions of Article 1 of Commission Regulation (EC) No 540/95 of 10 March 1995 laying down the rules for the notification of suspected unexpected, non-serious Adverse reactions to be found within or outside the Community in medicinal products for human or veterinary use authorised in accordance with Regulation (EEC) No 2309/93 (OJ L 136, 31.3.1993, p. 5), in conjunction with Article 63h (7), second sentence, by failing to ensure that the European Medicines Agency and the competent authority of the Federal Republic of Germany are notified of a side effect referred to therein. (2b) Those who violate Regulation (EC) No 726/2004 by intentionally or negligently acting

1.: contrary to the first sentence of Article 16 (2) or the second sentence of Article 8 (3), first subparagraph, point (c) to (e), (h) to (iaa) or (ib) of Directive 2001 /83/EC, or in conjunction with Article 41 (4), first sentence, or (2) in conjunction with Article 12 (2), The first sentence of the first subparagraph of paragraph 2 (c) to (e), (h) to (j) or (k) of Directive 2001 /82/EC, in conjunction with Article 29 (4), second sentence, of the European Medicines Agency or of the competent authority of the Federal Republic of Germany, does not include a communication referred to in that paragraph, does not make it right, not complete or not in time,
2.: , contrary to Article 28 (1), in conjunction with the second subparagraph of Article 107 (1) of Directive 2001 /83/EC, it does not ensure that a notification is available at a place referred to therein,
3.: contrary to the first sentence of Article 49 (1) or the first sentence of Article 49 (2), in each case in conjunction with the second sentence of Article 29 (4), it shall not ensure that the competent authority or the European Medicines Agency has notified a side effect referred to in that paragraph ,
4.: , contrary to Article 49 (3), first sentence, a document referred to therein does not lead, not properly or incompletely.

(2c) In breach of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directives 2001 /20/EC and 2001 /83/EC and Regulation (EC) No 726/2004 (OJ L 136, 30.4.2004, p 1), by deliberately or negligently:

1.: , contrary to the first sentence of Article 33, a medicinal product referred to therein is not placed on the market in good time or in a timely manner
2.: a fully-enforceable arrangement referred to in the fourth sentence of Article 34 (2),
3.: the report referred to in Article 34 (4), first sentence, shall not be submitted in due time,
4.: , contrary to the provisions of the first sentence of Article 35, the marketing authorisation shall not, or not be transferred in time, to a third party referred to in that paragraph, and shall not, or shall not allow it, to use the documents referred to above
5.: , contrary to Article 35, second sentence, information shall not be provided, not correct or not in good time, or
6.: , contrary to the second sentence of Article 41 (2), a result of the examination referred to in that paragraph shall not be presented, not correctly or in time

(3) The administrative offence may be punishable by a fine of up to EUR 25 000. (4) The administrative authority within the meaning of Section 36 (1) (1) of the Code of Administrative Offences shall be liable in the cases where:

1.: paragraph 1 (2), point 7 (b), (7a), (9b) and (24e) to (24q), (2a) to (2c), and
2.: Point 7 (c) of paragraph 2, in so far as the act is committed against the competent authority of the Federal Republic of Germany,

the competent federal authority in accordance with § 77. Unofficial table of contents

Section 98 Einattracting

Items to which a criminal offence pursuant to § 95 or § 96 or an administrative offence pursuant to § 97 relates may be collected. Section 74a of the Criminal Code and Section 23 of the Law on Administrative Offences shall apply. Unofficial table of contents

§ 98a Extended decay

In the cases of § 95 (1) (2a) and the production and placing on the market of counterfeit medicines pursuant to § 95 (1) (3a) in conjunction with Section 8 (2), § 73d of the Criminal Code shall apply if the offender is commercially or as a member of a gang that has committed itself to continuing the commission of such acts.

Eighteenth section
Transitional and transitional provisions

First subsection
Transfer rules on the occasion of the law on the reorganisation of the pharmaceutical law

Unofficial table of contents

Section 99 of the Medicines Act 1961

The Medicines Act 1961 within the meaning of this Act is the Law on the Transport of Medicinal Products of 16 May 1961 (BGBl. 533), as last amended by the Law of 2 July 1975 (BGBl I). I p. 1745). Unofficial table of contents

§ 100

(1) A permit which has been granted in accordance with Section 12 (1) or § 19 (1) of the Medicines Act 1961 and which was valid on 1 January 1978 shall continue to apply to the previous extent as a permit within the meaning of Section 13 (1) sentence 1. (2) A permit which shall In accordance with § 53 (1) or § 56 of the Medicines Act 1961 as granted and valid on 1 January 1978, the previous extent shall be deemed to have been granted in accordance with Section 13 (1) sentence 1. (3) The manufacture of medicinal products after the In 1961, the Act on Medicinal Products does not depend on a permit, but in accordance with Section 13 (1) sentence 1 of a permit, it shall apply. the person who has been authorized to carry out the activities of the manufacture of medicinal products on 1 January 1978 for at least three years, but only in so far as the manufacture of such medicinal products has been carried out on or on the basis of the composition of the same Medicinal products are limited. Unofficial table of contents

§ 101

(dropped) Unofficial table of contents

Section 102

(1) Anyone who has the power to carry out the activities of the Head of Production on 1 January 1978 shall continue to carry on this activity to date. (2) Who, on 1 January 1978, possesses the expertise in accordance with Section 14 (1) of the Medicines Act 1961 and the activity as the production manager, shall be authorised to carry out the activity as head of production if he can demonstrate a two-year activity in the manufacture of medicinal products. If the practical activity is before 10 June 1965, it is necessary to prove a further year of practical activity before the start of the activity. (3) Anyone who started a university degree in accordance with § 15 para. 1 before 10 June 1975 acquires the expertise as a Head of production, if he completed his university studies until 10 June 1985 and pursued an activity in accordance with § 15 (1) and (3) for at least two years. Paragraph 2 shall remain unaffected. (4) Paragraphs 2 and 3 shall apply mutatily to a person who wishes to carry out the activity as a control officer. Unofficial table of contents

§ 102a

(dropped) Unofficial table of contents

Section 103

(1) For medicinal products which are authorised in accordance with § 19a or § 19d in conjunction with § 19a of the Medicines Act 1961 on 1 January 1978 or for which on 1 January 1978 an authorisation pursuant to Article 4 (1) of the Law on the Establishment of a Medicinal Products Act (Act) Federal Office of Sera and Vaccines of 7 July 1972 (BGBl. 1163), an authorisation in accordance with § 25 shall be deemed to have been granted. § § 28 to 31 apply to the admission procedure. (2) (omitted) Unofficial table of contents

Section 104

(dropped) Unofficial table of contents

Section 105

(1) Ready-to-use medicinal products which are medicinal products within the meaning of Article 2 (1) or (2) (1) and which are on the market on 1 January 1978 shall be deemed to be approved if they are on the market on 1 September 1976 or on the basis of a request which is up to (2) The medicinal product referred to in paragraph 1 shall, within a period of six months from 1 January 1978, be subject to the competent authority of the competent authority of the Federal Republic of Germany , the name of the active ingredients according to type and quantity and the Application areas are displayed. In the case of homeopathic medicinal products, the notification of the indications may be omitted. A copy of the notification shall be sent to the competent authority, together with a notification of the required information. The ready-to-use medicinal products may only be placed on the market if the notification is received on time. (3) By way of derogation from § 31 (1) (3) on 30 April 1990, the authorisation of a medicinal product indicated in accordance with paragraph 2 shall be issued on 30 April 1990. because an application is made for renewal of the authorisation or on registration before the date of the erasure, or the medicinal product is exempted from the authorisation or registration by means of a regulation. Section 31 (4) sentence 1 shall apply to the authorisation pursuant to the first sentence of the first sentence, provided that the declaration is made pursuant to § 31 (1) sentence 1 no. 2 to 31 January 2001. (3a) For the finished medicinal product as referred to in paragraph 1, until the first renewal of the authorisation an amendment pursuant to section 29 (2a), first sentence, insofar as it concerns the fields of application, and No 3 admissible only if it is effective or not, in order to remedy the deficiencies communicated to the applicant by the competent national authority, No safety is required and, in addition, for finished products referred to in paragraph 1, until the first time Extension of the authorisation § 29 (2a), first sentence, no. 1, 2 and 5, no application. A medicinal product as referred to in paragraph 1 which is manufactured in accordance with a process technique described in the homeopathic part of the medicinal product may, by way of derogation from § 29 (3), be allowed to continue until the first renewal of the authorisation.

1.: in a modified composition of the active substance by type and quantity, if the change is limited to the fact that one or more of the active substances present so far are no longer or less after the change quantity,
2.: with a modified quantity of the active substance and within the scope of the present application, with a modified indication, if the medicinal product as a whole is known to the version in force before 17 August 1994, pursuant to section 25 (7) sentence 1 the result is adjusted,
3.: (dropped)
4.: with a modified quantity of the active substance, in so far as it is a medicinal product with a number of active ingredients, the number of which has been reduced, or
5.: with a modified type or quantity of the active substance, without increasing its number within the same range of applications and the same treatment, if the medicinal product as a whole is in accordance with § 25 (7) sentence 1 in the preceding 17. (a) adapted from the date of application of the Directive in force or to a model for a medicinal product submitted by the Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Medicinal Products and Medical Devices) and which will not be subject to prescription by the adjustment,

shall be placed on the market; any amendment shall be admissible only if it is necessary to remedy the deficiencies in efficacy or safety notified to the applicant by the competent authority of the Federal State. The pharmaceutical operator shall indicate the change and, in the event of a change in the composition, shall indicate the name of the medicinal product to date, for at least five years, with a distinctly different addition to the composition of the medicinal product. Confusion with the previous designation has to be excluded. After a period of six months from the date of notification, the pharmaceutical company may only place the medicinal product on the market in the modified form. If the competent authority of the federal authority for certain medicinal products requires the use of a package leaflet with a uniform wording in accordance with section 28 (2) (3), the medicinal product may, by way of derogation from § 2, No. 2, be used in the case of amendments to the provisions of sentence 2 (4) By way of derogation from § 31 (2), the documents referred to in § 22 (1) (1) to (6) shall be attached to the application for the renewal of the authorisation. The date of submission of the documents pursuant to § 22 (1) No. 7 to 15, Section 2 (1) and (3a), in the case of pharmaceutical premixes, the documents in accordance with § 23 (2) sentence 1 and 2 as well as the analytical opinion according to § 24 (1) shall determine the The competent authority of the Federal Supreme Court. At the request of the competent federal authority, documents must also be submitted which demonstrate the sufficient biological availability of the active substance of the medicinal product, provided that the medicinal product is available in accordance with the relevant state of the scientific knowledge is required. An evaluative expert opinion shall be attached. Section 22 (2), second sentence, (4) and (4) to (7) and section 23 (3) are applicable. The documents in accordance with sentences 2 to 5 must be submitted within four months of the request of the competent federal authority. (4a) The application for renewal of the authorisation in accordance with paragraph 3 shall be the documents in accordance with section 22 (2) (2) and (3), and to submit the opinions pursuant to section 24 (1), second sentence, no. 2 and 3, until 1 February 2001, provided that these documents have not already been submitted by the applicant; § 22 (3) shall apply mutas to the relevant application. Sentence 1 does not apply to medicinal products which are produced according to a process technique described in the homeopathic part of the medicinal product. For whole blood, plasma and blood cells of human origin, by way of derogation from the first sentence, the documents shall not be required in accordance with Section 22 (2), No. 2, and the opinion referred to in Article 24 (1), second sentence, No. 2, unless there are substances contained therein which are not included in the the human body. Except in the cases of § 109a, the authorisation shall not be granted if the documents referred to in sentences 1 to 3 have not been submitted within the time limit. (4b) When submitting the documents in accordance with Section 22 (2) (2), the following may be granted in the case of veterinary medicinal products which: contain pharmacologically active substances as listed in Table 1 of the Annex to Regulation (EU) No 37/2010, to which documents submitted in accordance with the provisions of an act based on Article 13 of Regulation (EC) No 470/2009 In so far as a veterinary medicinal product is used with this pharmacologically active substance, The medicinal product is already authorised in a Member State of the European Union and the conditions for a reference in accordance with Article 24a are fulfilled. (4c) The medicinal product referred to in paragraph 3 is already in another Member State of the European Union. or any other State Party to the Agreement on the European Economic Area, in accordance with Directive 2001 /83/EC or Directive 2001 /82/EC, the renewal of the authorisation shall be granted if:

1.

the medicinal product is placed on the market in the other Member State, and

2.

the applicant

a): all information provided for in Article 22 (6) shall be made and shall be accompanied by the copies required thereafter; and
b): in writing, declares that the documents submitted in accordance with paragraphs 4 and 4a are in accordance with the approval documents on which the authorisation is based in the other Member State,

unless the renewal of the authorisation of the medicinal product may pose a risk to public health, in the case of medicinal products intended for use in animals, a risk to human or animal health or to the environment. (4d) By way of derogation from Section 38 (2), the application for registration shall be accompanied by the documents in accordance with § 22 (1) Nos. 1 to 4. The documents in accordance with § 22 (1) No. 7 to 15 and paragraph 2 no. 1 as well as the analytical report according to § 24 paragraph 1 are to be submitted to the competent federal authority on request. Section 22 (4) to (7), with the exception of the draft of a technical information, shall be applicable. The documents referred to in sentences 2 and 3 shall be submitted within two months of the request of the competent federal authority. (4e) For the decision on the application for renewal of the authorisation or registration as referred to in the first sentence of paragraph 3, shall be found § 25 (5) sentence 5 and § 39 (1) sentence 2 corresponding application. (4f) The authorization referred to in paragraph 1 shall be extended by five years at the request pursuant to paragraph 3, sentence 1, if there is no reason for failure pursuant to section 25 (2); for further renewals, § 31 Application. The peculiarities of a particular treatment direction (phytotherapy, homeopathy, anthroposophy) must be taken into account. (4g) In the case of medicinal products which are blood preparations, § 25 (8) is applicable. (5) In the event of complaints, the Applicants within a reasonable period of time, but not more than 12 months after notification of the complaints, to remedy the defects; the removal of the defect shall be stated in a pleadings. If the deficiencies are not remedied within this period, the authorisation shall be refused. After a decision on the failure of the authorisation, the submission of documents for the removal of the defect is excluded. In all appropriate cases, the competent federal authority shall not issue a complaint in accordance with the first sentence of the first sentence, but shall, on the basis of the first and second sentences of paragraph 5a, link the renewal of the authorisation with a requirement to apply the requirement to: (5a) The competent federal authority may link the renewal of the authorisation referred to in the first sentence of paragraph 3 with obligations. In addition to ensuring the requirements referred to in § 28 (2), conditions may also be subject to the guarantee of quality, safety and efficacy requirements, unless due to serious deficiencies of the the pharmaceutical quality, the efficacy or the safety concerns referred to in paragraph 5 must be notified or the renewal of the authorisation must be denied. Sentence 2 shall apply in accordance with the requirement for documents pursuant to section 23 (1) no. 1. The notice of the extension shall indicate whether the condition must be complied with immediately or up to a date specified by the competent authority of the Federal Republic of Germany. Compliance with the requirements shall be communicated to the competent authority of the Federal Republic of Germany, with an afficial declaration of an independent counterexpert confirming that the quality of the medicinal product is in accordance with the status of the competent authority. scientific knowledge. § 25 (5) sentence 5, 6 and 8 as well as § 30 (2) sentence 1 no. 2 second alternative apply accordingly. The first sentence of the first sentence of the first sentence of paragraph 3 of the first sentence of the first sentence of paragraph 3 of the first sentence of the first sentence of paragraph 3 shall not apply to the first sentence of the first sentence of paragraph 3 of the Administrative Court. instead. The immediate enforcement shall be ordered pursuant to Section 80 (2) (4) of the Administrative Court, unless the authorisation for the pharmaceutical entrepellant is an unfair hardship which is not provided by overriding public interests (5c) By way of derogation from the first sentence of paragraph 3, the authorisation of a medicinal product, which is indicated in due time in accordance with paragraph 2, for which the pharmaceutical company has declared until 31 December 1999 to submit the application for renewal of the medicinal product, shall be granted on time. The authorisation referred to in the first sentence of paragraph 3 shall be withdrawn on 1 February 2001, unless the procedure the renewal of the authorisation shall be resumed in accordance with the second sentence. After a request made before 17 August 1994, the pharmaceutical contractor had submitted, in accordance with the second sentence of paragraph 4, the documents required in accordance with paragraph 4 within the time limit laid down or the date of submission of the relevant documents had been submitted for the Medicinal products after this date, or if the requirement for the medicinal product concerned has not been issued until after that date, the procedure for the renewal of the authorisation shall be re-submitted by the competent authority of the Federal Republic of Germany to the competent authority of the competent authority of , the application shall be made up to 31 January 2001 on the submission of the documents referred to in paragraph 4a (5d) The second sentence of paragraph 3 and paragraphs 3a to 5c shall apply in accordance with medicinal products for which the provisions of Section 4 (2) of the EC-Law Transfer Ordinance of 18 December 1990 (BGBl. 2915) Annex 3 to Section 2 (2), Chapter II, No 1 and 2 to 30 June 1991, an application for renewal was made. (6) (7) Paragraphs 1 to 5d also apply to medicinal products intended for use in animals which do not contain any medicinal products for manufacture in so far as they are subject to the obligation to register or register and are on the market on 1 January 1978. Unofficial table of contents

Section 105a

(1) (omitted) (2) (omitted) (3) The competent authority of the federal authority may, in the case of ready-to-use medicinal products not subject to the prescription obligation pursuant to § 49, first of all to check the information provided and the pharmaceutical To exempt entrepreneurs from the obligations under § 11a and the Pharmaberater from the obligation pursuant to § 76 (1) sentence 1 until the uniform wording of a subject information for corresponding medicinal products is ordered by obligation in accordance with § 28 para. 2 no. 3. (4) Paragraphs 1 to 3 shall not apply to medicinal products intended for use in animals. or which fall within the competence of the Paul-Ehrlich-Institut. Unofficial table of contents

Section 105b

The right to payment of fees and charges pursuant to § 33 (1) in connection with a legal regulation pursuant to § 33 para. 2 or a legal regulation pursuant to § 39 (3) for the renewal of the authorisation or the registration of a ready-to-use medicinal product in the sense of Section 105 (1), shall be statute-barred by the end of the fourth year following the announcement of the final decision on the renewal of the authorisation or the registration to the applicant. Unofficial table of contents

Section 108a

The charge of a serum, a vaccine, a test allergen, a test serum or a test antigen which, when the accession becomes effective, is in accordance with § 16 of the Second Implementing Regulation to the Medicinal Products Act of 1 December 1986 (GBl. No 36 p. 483) shall be deemed to have been released within the meaning of section 32 (1) sentence 1 in the territory referred to in Article 3 of the Agreement. Article 32 (5) shall apply to the release. Unofficial table of contents

Section 108b

(dropped) Unofficial table of contents

§ 109

(1) In the case of finished medicinal products which are medicinal products within the meaning of Article 2 (1) or (2) (1) and have been placed on the market on 1 January 1978, § 10 shall apply with the proviso that, instead of the first sentence of Article 10 (1) (1) (3), Registration number, if available, the register number of the speciality register in accordance with the Medicines Act 1961 with the abbreviation "Reg. -Nr." occurs. The first sentence shall apply until the renewal of the authorisation or registration. (2) The texts on labelling and package leaflet shall be submitted no later than 31 July 2001. Until that date, medicinal products referred to in the first sentence of paragraph 1 may be placed on the market by the pharmaceutical operator, after that date, by wholesalers and retailers, with a labelling and package leaflet, which shall be the date set out in the first sentence of sentence 1. (3) Ready-to-use medicinal products which have been released for circulation outside pharmacies within the meaning of section 105 (1) and section 44 (1) or (2) (1) to (3) or (45); and (a) to (e) shall be subject to the provisions of paragraphs 1 and 2 as from 1 January 1992 are only placed on the market by the marketing authorisation holder if they bear one or more of the following information on the container and, where used, the outer packaging and a package leaflet:
" Traditionally applied:

a): for strengthening or strengthening,
b): for the improvement of the population,
c): to support organ function,
d): on prevention,
e): as a mildly active medicinal product. "

Sentence 1 shall not apply in so far as the fields of application are held within the scope of an authorisation pursuant to section 25 (1) or of a result made known in accordance with section 25 (7) sentence 1 in the version in force before 17 August 1994. Unofficial table of contents

Section 109a

(1) For the medicinal products referred to in Article 109 (3) and for medicinal products which are not subject to medical prescription and not by means of a legal regulation pursuant to § 45 or § 46 because of their ingredients, because of their form of administration or because they are chemical compounds with certain pharmacological effects are or are added to them, are excluded from the traffic outside the pharmacies, may the renewal of the approval pursuant to § 105 (3) and then under § 31 in accordance with the paragraphs 2 and 3. (2) The requirements for the required quality shall be met; if the documents are available in accordance with § 22 (2) (1) and the analytical opinion according to § 24 (1) and are insured by the pharmaceutical entreptite on oath, that the medicinal product is in accordance with the general conditions laid down in The administrative provision according to § 26 is tested and has the required pharmaceutical quality. The form and content of the oath insurance are determined by the competent federal authority. (3) The requirements for effectiveness are fulfilled if the medicinal product claims fields of application, which are in one of the competent authorities of the competent authority of the competent authority. Federal authority after hearing of a commission appointed by the Federal Ministry of Labour, for which Article 25 (6) sentences 4 to 6 are applied, the list of application areas for substances or combinations of substances is recognized. These fields of application are defined taking into account the specificities of the medicinal products and the traditional and documented experience, and are given the addition: "traditionally used". Such fields of application are: "To strengthen or strengthen the ...", "In order to improve ...", "In order to support the organ function of ...", "For the prevention of ...", "As a mildly active medicinal product at ...". Areas of application which have the effect of excluding medicinal products from the outside of pharmacies shall not be recognised. (4) Paragraphs 1 to 3 shall apply only if documents are not submitted pursuant to Section 105 (4a) (4a) By way of derogation from paragraph 4, paragraphs 2 and 3 shall apply to medicinal products as referred to in paragraph 1, if the extension of the authorisation would be to be refused because a sentence 1 in accordance with § 25 (7) sentence 1 in the preceding 17 It may not be recognised as a result of evidence of efficacy in the version in force in force in August 1994. Unofficial table of contents

§ 110

In the case of medicinal products which are subject to registration pursuant to section 21 of the obligation to register or are required to register on 1 January 1978, the competent federal authority may impose warnings on conditions to the extent that: in order to prevent, in the course of the use of the medicinal product, a direct or indirect risk to humans or animals. Unofficial table of contents

Section 111

(dropped) Unofficial table of contents

Section 112

Anyone who, on 1 January 1978, medicinal products within the meaning of Article 2 (1) or (2) (1), which are released for circulation outside the pharmacies, shall be placed on the market in the retail trade outside of the pharmacies may continue to carry out this activity in so far as it is referred to in the Law on Professional Training in the Retail Trade of 5 August 1957 (BGBl. 1121), as amended by Article 150 (2) (15) of the Law of 24 May 1968 (BGBl I). 503), was entitled to do so. Unofficial table of contents

Section 113

By way of derogation from § 58 (1), medicinal products may be used if the labelling or accompanying documents show that the medicinal product may be placed on the market in accordance with section 105 (1). Unofficial table of contents

Section 114

(dropped) Unofficial table of contents

§ 115

A person who carries out the activities of a Pharmaberater according to § 75 on 1 January 1978 does not require the training certificate required there. Unofficial table of contents

Section 116

Doctors who, on 1 January 1978, have the right to produce and supply medicinal products to the persons treated by them under national law, may continue to carry on this activity to the extent to which they have been treated. Section 78 shall apply. Unofficial table of contents

Section 117

(dropped) Unofficial table of contents

Section 118

§ 84 shall not apply to any damage caused by medicinal products which have been delivered before 1 January 1978. Unofficial table of contents

§ 119

Medicinal products for manufacture which are medicinal products within the meaning of Article 2 (1) or (2) (1) and are placed on the market in the area referred to in Article 3 of the Agreement on entry into effect of accession may not be required without the provisions of Article 11 of this Regulation. Package leaflet shall still be placed on the market by wholesalers and retailers, provided that they comply with the provisions of the German Democratic Republic, which apply before the date of entry into force of the accession. The competent authority of the Federal Republic of Germany may, by means of conditions, order warnings in so far as it is necessary to prevent the use of the medicinal product in a direct or indirect risk to humans or animals. Unofficial table of contents

§ 120

In the case of a clinical trial, which will be carried out in the area referred to in Article 3 of the agreement on entry into effect, the insurance shall be concluded in accordance with section 40 (1) no. Unofficial table of contents

Section 121

(dropped) Unofficial table of contents

§ 122

The obligation to notify in accordance with § 67 shall not apply to establishments, establishments and to persons in the territory referred to in Article 3 of the Agreement, which, in the event of their entry into effect, are already engaged in an activity within the meaning of that provision. Unofficial table of contents

§ 123

The necessary expertise as a Pharmaberater pursuant to Section 75 (2) No. 2 also possesses the fact that, in the area referred to in Article 3 of the Einigungscontracges, he has completed an apprenticeship as a pharmacist, a pharmacy assistant or a veterinary engineer. Unofficial table of contents

Section 124

§ § 84 to 94a shall not apply to medicinal products which have been delivered to the consumer in the area referred to in Article 3 of the agreement before the date of entry into force of the accession.

Second subsection
Transitional provisions on the occasion of the First Act amending the Medicines Act

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§ 125

(1) The competent authority of the federal authority, after consultation of the Commissions pursuant to § 25 (6) and (7) for medicinal products authorised on 2 March 1983, shall determine the time limit within which the documents relating to the control method referred to in Article 23 (2) sentence 3 (2) For medicinal products for which an application for authorisation has been requested after 1 March 1983 and before 4 March 1998, the provisions of Section 23 shall apply, provided that the documents relating to the control methods do not appear before the application of paragraph 1 (3) is a time-limit for the submission of documents relating to the The control method referred to in paragraph 1 has been determined and documents are not submitted or are not in accordance with the requirements of section 23 (2) sentence 3, the authorisation may be revoked. Unofficial table of contents

§ 126

§ 125 (1) and (3) shall apply to medicinal products intended for use in animals and which are authorised to enter into the territory referred to in Article 3 of the agreement on accession.

Third Subsection
Transitional provisions on the occasion of the Second Act amending the Medicines Act

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§ 127

(1) Medicinal products which are on the market on 1 February 1987 and are subject to the labelling requirements laid down in § 10 must, one year after the first renewal of the authorisation to 1 February 1987, or after the exemption from the Marketing authorisation, or, in so far as they are homeopathic medicinal products, are placed on the market for five years after 1 February 1987 by the pharmaceutical operator in accordance with the provisions of Section 10 (1) (9). Until that date, medicinal products referred to in the first sentence of the Marketing Authorisation Holder, after that date may continue to be placed on the market by wholesalers and retailers without an indication of an expiry date, if the duration of the shelf life is more than three years or in the case of medicinal products for which the regulation of § 109 is applicable, more than two years. § 109 remains unaffected. (2) Medicinal products which are on the market on 1 February 1987 and are subject to the labelling requirements of section 10 (1a) may still be used by the pharmaceutical company until 31 December 1988, by wholesalers and retailers. shall be placed on the market even after that date without the information provided for in Article 10 (1a). Unofficial table of contents

§ 128

(1) The pharmaceutical operator shall have the first application for renewal of the authorisation or registration of the competent federal authority for finished medicinal products on the market on 1 February 1987, submitted to 1 February 1987. to provide the text of the subject information. Sentence 1 shall not apply in so far as the competent federal authority has exempted from the obligations pursuant to Section 11a until further medicinal products which are not subject to the prescription obligation pursuant to § 49; in this case the draft of the technical information shall be subject to: (2) In the cases referred to in paragraph 1, § § 11a, 47 (3) sentence 2 and § 76 (1) shall apply from the date of the renewal of the admission or registration or the establishment of a specialist information by Article 36 (1) or in the cases referred to in the first sentence of paragraph 1, six months after the decision of the competent federal authority on the content of the specialist information. Until that date, ready-to-use medicinal products may be placed on the market where the package leaflet does not comply with the provisions of Section 11 (1) as amended by the Second Act amending the Medicinal Products Act. Unofficial table of contents

Section 129

Article 11 (1a) shall apply to medicinal products placed on the market on 1 February 1987, subject to the proviso that their package leaflet must be sent after the next renewal of the authorisation or registration of the competent authority. Unofficial table of contents

§ 130

Anyone appointed as a private expert for the examination of samples pursuant to section 65 (2) on 1 February 1987 may continue to carry on this activity to the present extent. Unofficial table of contents

Section 131

Section 128 applies to medicinal products which are placed on the market in the area referred to in Article 3 of the Agreement on Accession, in order to submit or send a specialist information in accordance with Section 11a.

Fourth subsection
Transitional provisions on the occasion of the Fifth Act amending the Medicines Act

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Section 132

(1) Medicinal products which are on the market on 17 August 1994 and which are subject to the requirements of § § 10 and 11 must be extended one year after the first renewal of the authorisation to 17 August 1994 or, where they are admitted to the authorisation shall be exempt from the date referred to in the regulation pursuant to paragraph 36 or, insofar as they are homeopathic medicinal products, five years after 17 August 1994 by the pharmaceutical company in accordance with the provisions of Sections 10 and 11 of this Regulation in the Transport is brought. Until that date, medicinal products referred to in the first sentence of the pharmaceutical company, after that date, may continue to be placed on the market by wholesalers and retailers with a labelling and package leaflet to be placed on the market until 17 August. The provisions in force in 1994. § 109 shall remain unaffected. (2) The pharmaceutical operator shall, on the basis of the first application submitted on 17 August 1994, apply for the renewal of the authorization of the competent authorities for finished medicinal products on the market on 17 August 1994. To submit the text of the subject information corresponding to § 11a in the version of this Act. Section 128 (1) sentence 2 shall remain unaffected. (2a) A manufacturing authorization which does not comply with § 16 shall be adapted to § 16 by 17 August 1996. Sentence 1 shall apply in accordance with § 72. (2b) Who on 17 August 1994 carries out the activity as the production manager for the manufacture or as a control manager for the examination of blood preparations and the conditions of § 15 (3) in the up to 17 August 1994 (3) (3) (omitted) (4) § 39 (2) (4a) and (5a) does not apply to medicinal products which have been registered by 31 December 1993, or to the registration thereof up to that date. Date of application has been filed or which have been indicated in accordance with section 105 (2) and in accordance with § 38 (1) sentence 3 in , the version in force before 11 September 1998. Section 39 (2) (4a) shall not apply to medicinal products as defined in the first sentence for which a new registration is requested because a component is to be removed or a number of constituents are to be removed or the degree of dilution of components should be increased. Section 39 (2) (4a) and (5a) shall also not apply to medicinal products which, in the manner and quantity of the ingredients and with regard to the pharmaceutical form referred to in the first sentence, are taken into account in the case of decisions relating to the registration or renewal of the product. Medicinal products are identical. Section 21 (2a) sentence 5 and section 56a (2) sentence 5 shall also apply to medicinal products intended for use in animals, the degree of dilution of which is less than the sixth decimal potency, provided that they have been registered in accordance with the first or second sentence, or if they are registered by the registration is free.

Fifth Subsection
Transitional provision on the occasion of the Seventh Act amending the Medicines Act

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§ 133

The obligation to notify according to § 67 in conjunction with § 69a shall apply to the establishments, institutions and persons referred to in § 59c which already carry out an activity within the meaning of Section 59c on 4 March 1998 with the proviso that the display shall be valid no later than 1 April 1998. 1998.

Sixth subsection
Transitional provisions on the occasion of the Transfusion Act

Unofficial table of contents

Section 134

Who at the entry into force of the Transfusion Act of 1 July 1998 (BGBl. 1752), as the head of production for the manufacture or control of blood preparations or sera from human blood, and the conditions set out in Article 15 (3) in the period up to and including the date mentioned above. , this activity may continue to be carried out. Those who, on the date set out in the first sentence, carry out the activities of the pre-treatment of persons for the separation of blood stem cells or other blood components in accordance with the state of science and technology, may continue to carry out this activity.

Seventh-Subsection
Transitional provisions on the occasion of the Eighth Law amending the Medicines Act

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§ 135

(1) Medicinal products which are on the market on 11 September 1998 and are subject to the requirements of § § 10 and 11 must be renewed one year after the first renewal of the authorisation to 11 September 1998 or, in so far as they have been approved by the shall be exempted from the date referred to in Article 36 of the Regulation or, in so far as they are homeopathic medicinal products, on the 1. In accordance with the provisions of § § 10 and 11, the pharmaceutical company shall be placed on the market in October 2003. Until that date, medicinal products referred to in the first sentence of the pharmaceutical company, after that date may continue to be placed on the market by wholesalers and retailers with a labelling and package leaflet which may be placed on the market until the end of the period of 11 years. The Directive is in force in September 1998. § 109 shall remain unaffected. (2) Anyone who has the power to carry out the activity as a production or control manager for the medicinal products or active substances referred to in § 15 para. 3a on 11 September 1998 may continue to carry on this activity to the present extent. Section 15 (4) is to be found up to 1. (3) Homeopathic medicinal products, which are on the market on 11 September 1998 and for which up to the first of these two years are to be used. By way of derogation from the third sentence of Article 38 (1) until the date of the decision on registration, an application for registration may be placed on the market by way of derogation from the first sentence of Article 38 (1), provided that the application is in force until 11 September 1998. (4) § 41 no. 6 does not apply in the amended version to declarations of consent issued before 11 September 1998.

Eighth Subsection
Transitional provisions on the occasion of the Tenth Law amending the Medicines Act

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Section 136

(1) For medicinal products in respect of which the extension requested pursuant to § 105 (3) sentence 1 has already been granted, the documents referred to in § 105 (4a) sentence 1 shall be submitted at the latest with the application in accordance with § 31 (1) no. 3. In the case of these medicinal products, the authorisation should be extended if there is no reason for failure in accordance with section 25 (2); for further extensions § 31 application. (1a) On medicinal products according to § 105 para. 3 sentence 1, which according to a not in the homeopathic part of the pharmacopoeia described in the pharmacopoeia, the second sentence of Article 105 (3) of this Regulation shall apply in the version valid until 12 July 2000 pending a decision of the Commission pursuant to Section 55 (6) on the inclusion of this process technology, if up to 1. (2) For medicinal products in respect of which the applicant has been notified of defects in the efficacy or safety before 12 July 2000 § 105 shall apply. (2a) § 105 (3a) sentence 2 shall apply until 31 January 2001 in force until 31 January 2001, subject to the condition that there is no need for a defect in the defect and that there is no need for a Change is permitted only if it is limited to the fact that one or more of the (3) For medicinal products which have been manufactured according to a process technique described in the homeopathic part of the medicinal product, § 105 (5c) shall continue to apply in the of the version in force before 12 July 2000.

Ninth Subsection
Transitional provisions on the occasion of the Eleventh Act amending the Medicines Act

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Section 137

By way of derogation from § 13 (2), § 47 (1) (6), § 56 (2) sentence 2 and (5) sentence 1, medicated feedingstuffs may still be manufactured, placed on the market and applied until 31 December 2005 after the regulations in force until 1 November 2002. By 31 December 2005, by way of derogation from the first sentence of Article 56 (2), the manufacture of a medicated feedingstuffs may be made up of a maximum of three pre-mixtures, each of which is authorised for use in the animal species to be treated, provided that:

1.: an authorised pre-mix is not available for the area of application in question,
2.: in individual cases in the medicated feedingstuffs, no more than two antibiotic-containing pre-mixtures are contained; and
3.: a homogeneous and stable distribution of the active ingredients in the medicated feedingstuff is ensured.

By way of derogation from the second sentence of paragraph 2, only one antibiotic-containing pre-mixture may be present in the medicated feedingstuffs provided that these substances contain two or more antibiotic substances.

Tenth subsection
Transitional provisions on the occasion of the Twelfth Act amending the Medicines Act

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§ 138

(1) For the manufacture and import of active substances of microbial origin and other substances of human origin intended for the manufacture of medicinal products, manufactured or professionally produced for the purpose of delivery to others, or in § § 13, 72 and 72a shall apply in the version valid up to 5 August 2004 until 1 September 2006, unless the blood is intended for the manufacture of medicinal products; and Blood components of human origin. If blood is taken from autologous body cells for tissue regeneration in the course of tissue engineering, and no manufacturing authorization has been requested for this purpose, § 13 shall not apply until 1 September 2006. (2) Anyone who has the power to exercise the activities of the head of production or control on 5 August 2004 may continue to carry out this activity by way of derogation from Article 15 (1). (3) For clinical trials of medicinal products in humans, for which the following shall be applied before 6 August 2004. in accordance with Article 40 (1), second sentence, in the version valid up to 6 August 2004 The documents of the ethics committee responsible for the head of the clinical trial have been submitted. § § 40 to 42, 96 No. 10 and § 97 (2) No. 9 are applicable in the version valid until 6 August 2004. (4) Anyone who is responsible for the work of the Wholesale trade with medicinal products on 6 August 2004 has the power to exercise and until 1 December 2004, pursuant to Section 52a (1), an application for the granting of a licence to operate a wholesale trade with medicinal products may, by way of derogation from Article 52a (1) to the Decision on the application submitted to carry out the activities of wholesale trade in medicinal products; § 52a (3) Sentence 2 to 3 shall not apply. (5) An official recognition granted pursuant to Section 54 (2a) for the wholesale trade of medicinal products intended for use in animals pursuant to Section 54 (2a) shall be deemed to be a permit within the meaning of Section 52a for the Wholesale trade in medicinal products intended for use in animals. Until 1 March 2005, the holder of the recognition shall provide the competent authority with documents and explanations in accordance with section 52a (2). (6) Anyone who is active in the field of human or animal origin, or on genetic engineering, other substances If, on 6 August 2004, it is authorised to enter into the scope of this Act without the import licence in accordance with § 72, this activity may continue until 1 September 2005. (7) Medicinal products which are before the 30. By way of derogation from § 10 (1b) of pharmaceutical companies, by way of derogation from § 10 (1b) until the next renewal of the authorisation, however no longer than 30 October 2005, the competent authority of the competent federal authority shall not be allowed to apply the authorisation. The Commission continued to place on the market in October 2007. By way of derogation from § 10 (1b), medicinal products which have been placed on the market by pharmaceutical companies in accordance with the first sentence may continue to be placed on the market.

Eleventh Subsection
Transitional provisions on the occasion of the First Act amending the Transfusion Act and the provisions of the provisions of the law on medicinal products

Unofficial table of contents

Section 139

Those who, on the entry into force of Article 2 (3) of the First Law amending the Transfusion Act and the Pharmaceutical Legislation of 10 February 2005 (BGBl. 234), as the head of production or as a control manager for the examination of blood stem cell preparations, and which fulfils the conditions set out in Article 15 (3) in the version applicable up to that date, this activity may continue to be carried out exercise.

Twelfth subsection
Transitional provisions on the occasion of the Thirteenth Act amending the Medicines Act

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§ 140

By way of derogation from section 56a (2) and section 73 (3), medicinal products may not be used in animals which are not used for the production of foodstuffs, until 29. The European Parliament and the Council of the European Parliament and of the Council of the European Parliament and of the Council of the European Parliament and of the Council of the European Parliament and of the Council of 19 October

Thirteenth subsection
Transitional provisions on the occasion of the Fourteenth Act amending the Medicines Act

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Section 141

(1) Medicinal products which are on the market on 5 September 2005 and are subject to the requirements of § § 10 and 11 shall, two years after the first renewal of the authorisation or registration following the 6 September 2005 period, or, where they are shall be exempted from the date of admission or registration, in respect of the date referred to in § 36 or § 39, or, in so far as they do not require an extension, on 1 January 2009 by the pharmaceutical operator in accordance with the provisions of § § 10 and 11 shall be placed on the market. Up to the respective dates referred to in the first sentence, medicinal products may be placed on the market by wholesalers and retailers after these dates with a labelling and package leaflet which may be placed on the market until the end of the period of 5 years. The provisions of this Directive are in force. § 109 shall remain unaffected. (2) The pharmaceutical company shall have the first application submitted after 6 September 2005 for the renewal of the authorisation of the competent authorities for finished medicinal products which are on the market on 5 September 2005. (3) A person who does not have the expertise in accordance with § 15, but on the 5th of January 2009, the Federal Supreme Authority shall submit the text of the information which corresponds to § 11a. The activities of a knowledgeable person, as described in § 19, shall be authorized in September 2005. shall be considered as an informed person in accordance with § 14. (4) Ready-to-use medicinal products, which are on the market on 5 September 2005 and are subject to the authorisation requirement pursuant to § 21 for the first time after 6 September 2005 pursuant to § 4 (1), may continue to be placed on the market if an application for authorisation has been submitted for them by 1 September 2008. (5) The periods for the protection of the underlay under section 24b (1), (4), (7) and (8) shall not apply to reference medicinal products, the authorisation of which before the 30. These medicinal products are subject to the protection periods in accordance with § 24a in the version valid until 5 September 2005 and is the period in section 24b (4) 10 years. (6) For medicinal products, the authorisation of which is prior to the 1. The provisions of Section 31 (1) (3) shall apply in the version valid until 5 September 2005; Section 31 (1a) shall not apply to these medicinal products until they have been extended after 6 September 2005. In the case of authorisations for which the five-year period of validity ends until 1 July 2006, the period laid down in Article 31 (1) (3) shall continue to apply in the version in force before 6 September 2005. The competent federal authority may order the requirement for a further extension for medicinal products for which authorisation has been renewed after 1 January 2001 and before 6 September 2005, provided that this is necessary in order to ensure that the Marketing of the medicinal product shall continue to be ensured. Applications submitted before 6 September 2005 for the renewal of authorisations which no longer require an extension pursuant to this paragraph shall be deemed to have been completed. The rates 1 and 4 apply accordingly for registrations. Renewal of authorisation or registration of medicinal products which are deemed to be authorised in accordance with Section 105 (1) shall be considered to be an extension within the meaning of this paragraph. Section 136 (1) shall remain unaffected. (7) The holder of the authorisation shall immediately notify the competent federal authority for a medicinal product which is authorised on 5 September 2005 but is not on the market at that date to indicate that the (8) For inconsistencies which were levied before 5 September 2005, § 33 shall apply in the version valid until 5 September 2005. (9) § 25 (9) and § 34 (1a) are not applicable to Medicinal products which have been requested prior to 6 September 2005. (10) Medicinal products which have been registered as homeopathic medicinal products until 6 September 2005 or whose registration has been requested before 30 April 2005 shall continue to apply the provisions in force until that date. The same applies to medicinal products which have been indicated in accordance with Section 105 (2) and which have been placed on the market in accordance with § 38 (1) sentence 3 in the version valid before 11 September 1998. Section 39 (2) (5b) shall also not apply to medicinal products which, in the manner and quantity of the ingredients and with regard to the pharmaceutical form referred to in the first sentence, referred to in the first sentence, are not applied to medicinal products. (11) § 48 (1) sentence 1 no. 2 shall only apply from the date on which a legal regulation has entered into force in accordance with § 48 (6) sentence 1, but no later than 1 January 2008. The Federal Ministry of Food, Agriculture and Consumer Protection (Federal Ministry of Food, Agriculture and Consumer Protection) is aware of the day after sentence 1 of the Federal Law Gazprom. (12) Section 56a (2a) is to be applied only after the list referred to there is drawn up and the Federal Ministry of Food Agriculture and consumer protection are published in the Federal Gazette or, if it is part of a directly applicable act of the European Community or the European Union, has been published in the Official Journal of the European Union (13) For medicinal products on the market on 5 September 2005 and Article 63b (5) sentence 3 shall apply after the next report to be submitted to the 6th September 2005. (14) The authorisation shall apply. (14) The following shall apply. of a traditional herbal medicinal product, which has been extended in accordance with § 105 in conjunction with § 109a, shall be issued on 30 April 2011, unless an application for admission or registration pursuant to Section 39a has been submitted before 1 January 2009. The admission in accordance with § 105 in conjunction with § 109a shall also be issued after a decision on the application for admission or registration in accordance with § 39a. After the decision, the medicinal product may be placed on the market for a further 12 months in the form to date.

Fourteenth subsection

Unofficial table of contents

Section 142 Transitional provisions on the occasion of the tissue law

(1) A person who, as a knowledgeable person on 1 August 2007, possesses the expertise referred to in Article 15 (3a) in the version valid up to that date, may continue to carry on the activity as an informed person. (2) Who is responsible for tissue or Tissue preparations up to 1. 1 or § 20c para. 1 or a manufacturing authorization pursuant to § 13 para. 1 or until February 1, 2008 a permit pursuant to § 21a (1) or until 30 September 2008 an authorisation pursuant to § 21 (1) (1) or (1) (1) (1) or (1) until 30 September 2008. , the tissue or tissue preparations must be further obtained, examined in the laboratory, processed, processed, preserved, stored or placed on the market until a decision has been taken on the application. (3) Who on 1 August 2007 for tissue or Tissue preparations as defined in § 20b (1) or § 20c (1) a manufacturing authorization pursuant to Section 13 (1) or (1) or for tissue preparations within the meaning of section 21a (1) of an authorisation pursuant to section 21 (1), no new application must be submitted in accordance with § 20b, paragraph 1, § 20c (1) or § 21a (1).

Fifteenth subsection

Unofficial table of contents

Section 143 Transitional provisions on the occasion of the law to improve the fight against doping in sport

(1) Ready-to-use medicinal products which have been approved by the competent federal authority before 1 November 2007 and are subject to the requirements of section 6a (2) sentence 2 to 4 may also be used without the references prescribed in § 6a (2) sentences 2 and 3 in the package leaflet of pharmaceutical companies is placed on the market until the next renewal of the authorisation, but no longer than until 31 December 2008. (2) A substance or group of substances is included in the Annex to the Convention against Doping of 16 November 1989 (BGBl. 334), medicinal products authorised at the time of publication of the amended Annex to the Bundesgesetzblatt (Bundesgesetzblatt) and containing one of these substances may also be used without the references prescribed in § 6a (2) sentences 2 and 3 in the package leaflet of pharmaceutical companies until the next renewal of the authorisation, but no longer than until the end of one year after the notice of the Annex in the Bundesgesetzblatt (Federal Law Gazans) is put into circulation. The first sentence shall apply to substances intended for use in prohibited methods. (3) Medicinal products which have been placed on the market by pharmaceutical companies in accordance with paragraph 1 may continue to be used by wholesalers and retailers without the (4) The time limits referred to in paragraphs 1 and 2 shall apply in accordance with the adaptation of the wording of the subject information.

Sixteenth subsection
Transitional provisions on the occasion of the law on the amendment of medicinal products and other provisions

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Section 144

(1) Anyone who has the power to manufacture the advanced therapy medicinal products referred to in Section 4b (1) on 23 July 2009 and to apply for a manufacturing authorization by 1 January 2010 shall continue to apply those medicinal products until the decision has been taken on the submitted application. (2) Anyone who has the power to market the advanced therapy medicinal products referred to in Section 4b (1) with the exception of biotechnologically processed tissue products on 23 July 2009 and, until 1 August 2010, authorise a marketing authorisation in accordance with § 4b The first sentence of paragraph 3 may be applied until the date on which the medicinal product is submitted to the decision (3) Anyone who has the authority to place biotechnologically processed tissue products on the market under Section 4b (1) on 23 July 2009 and, until 1 January 2011, applies for a permit in accordance with § 4b (3) sentence 1, may this (4) A person who, as a knowledgeable person on 23 July 2009, has the expertise referred to in Article 15 (3a) in the version valid up to that date, shall be entitled to: (4a) A person who is an informed person prior to 23 July 2009 If the person has the expertise in accordance with § 15 (1) and (2) for medicinal products which, by recasting § 4 (3) in the version valid as of 23 July 2009, are Sera and require a professional knowledge in accordance with § 15 (3), the activity was allowed to be knowledgeable person from 23 July 2009 to 26. Continue to be held in October 2012. This also applies to a person who, as a knowledgeable person, possessed the expertise in accordance with § 15 (1) and (2) for these medicinal products as of 23 July 2009. (5) Who on 23 July 2009 for the production or the laboratory examination of autologous blood to the Manufacture of biotechnologically processed tissue products has a manufacturing authorization in accordance with § 13 paragraph 1, requires no new permission in accordance with § 20b, paragraph 1 or 2. (6) The notification requirement in accordance with § 67 (5) shall apply from 1 January 2010 for Medicinal products which are already placed on the market on 23 July 2009. (7) Who on 23 July 2009 medicinal products according to § In accordance with § 67 of the first sentence of paragraph 3, which is in force until 23 July 2009, the competent authority must indicate this in accordance with § 67 bis 1 February 2010. Anyone exercising on 23 July 2009 an activity in accordance with § 4a sentence 1, point 3 in the version valid until 23 July 2009, for which it requires permission in accordance with § § 13, 20b or § 20c, and has applied for permission until 1 August 2011, may this Continue to work until the decision on the application is made.

Seventeen subsection

Unofficial table of contents

Section 145 Transitional provisions on the occasion of the law on the reorganisation of the pharmaceutical market

For medicinal products already authorised at the time of entry into force, the pharmaceutical company and the sponsor shall, for the first time not later than 18 months after the entry into force of the law, have the reports required pursuant to § 42b (1) and (2) of the Act of to the competent authority of the Federal Republic of Germany. Sentence 1 shall apply to clinical trials in respect of which § § 40 to 42 have been applied in the version in force as of 6 August 2004.

Eighteenth subsection
Transitional provision

Unofficial table of contents

Section 146 Transitional provisions on the occasion of the Second Act on the amendment of pharmaceutical and other provisions

(1) Medicinal products which are available on the market In the case of the first paragraph of Article 10 (1) of the first paragraph of Article 10 (1) of the Directive, two years after the first on the 26th of October 2012, the The following extension of the registration or registration or as far as they are exempted from registration or registration, or if they do not require an extension, on 26 October 2012, on 26 October 2012. The marketing authorisation shall be placed on the market by the pharmaceutical operator in accordance with the provisions of Section 10 (1) (2) of this Regulation. Up to the respective dates referred to in the first sentence, medicinal products may be placed on the market by wholesalers and retailers after these dates, with a marking on the market which is up to 26 years. (2) Medicinal products, which are in force on 26 October 2012. In accordance with Article 11 (1) sentence 1, point 5, two years after the first on the notice pursuant to Section 11 (1) (b) of the standard text shall be subject to the standard text in accordance with § 11 (1) (5) of the Code. in accordance with § 11 (1) sentence 1, point 5, the following renewal of the admission or registration or, if they are exempted from the admission, or, if they do not require an extension, two years, or, insofar as they are registered in accordance with § 38 or according to § 38 or 39 (3) are medicinal products exempted from registration, five years after the date of the Notice pursuant to Section 11 (1b) of the standard text pursuant to Section 11 (1) sentence 1, point 5, shall be placed on the market by the pharmaceutical operator in accordance with the provision of § 11. Up to the respective dates referred to in the first sentence, medicinal products may be placed on the market by wholesalers and retailers after these dates with a package leaflet which may be placed on the market until the end of the period of 26 years. (2a) Those on 26 October 2012. Article 13 (2a) sentence 2 (1) or (3) shall notify the competent authority in accordance with Section 13 (2a), sentence 3 to 26 February 2013. (3) The pharmaceutical company shall have the right to include the Standard text in accordance with § 11a (1), third sentence, for pre-processed medicinal products, which is based on the 26. The first sentence of Article 11a (1) sentence 9 to the standard text referred to in Article 11a (1) sentence 3 shall be placed on the market with the first application for an extension of the authorisation of the competent authority of the Federal Republic of Germany to the text of the application. (4) For authorisations or registrations, the five-year period of validity up to the age of 26 shall be submitted to the Commission for the period of validity of the contract. The first sentence of § 31 (1) (3), § 39 (2c) and § 39c (3) sentence 1 shall continue to apply in the period up to 26 October 2013. (5) The obligation under Article 22 (2), first sentence, point 5a, shall not apply to medicinal products that are before the 26. have been approved or have already been approved before 26 October 2012, or for which a proper application for authorisation has already been submitted before 26 October 2012. (6) Those who are engaged in the activity of wholesale trade until the 26th of October 2012. By way of derogation from Section 52a (1) to the decision on the submitted application, the competent authority shall, by way of derogation from § 52a (1), exercise the power to grant a licence for the operation of a wholesale trade in medicinal products until 26 February 2013. (7) The obligation under Section 63b (2) (3) shall apply to medicinal products prior to the 26th paragraph of Article 6 (3) of the Regulation. From 21 July 2015, or, if earlier, from the date on which the authorisation is renewed, the date of entry into force shall be 21 July 2015 or, if sooner, the date on which the authorisation is renewed The obligation under Section 63b (2) (3) shall apply to medicinal products for which prior to the 26. (8) § § 63f and 63g apply to exams, which are based on the date of the 26th of July 2015. (9) Anyone who has the power to carry out an activity as a drug mediator on 2 January 2013 and indicates his activity with the competent authority until 2 May 2013, may carry out this activity until the decision on registration in accordance with § 52c. (10) Companies and institutions which otherwise trade with active substances must display their activities to the competent authority by 26 April 2013. (11) For the purpose of retail trade, medicinal products which are used for the purposes of People are destined to be offered via the Internet via the mail order, its Indicate the activity of the competent authority, indicating the information required in Article 67 (8) by ... [insert date four months after the date of entry into force in accordance with Article 15 (4)]. ^*) (12) The requirements referred to in Article 94 (1), third sentence, point 1 shall apply for reinsurance contracts as of 1 January 2014.

*): Editor's note: The European Commission's implementing act, as referred to in Article 15 (4), has not yet been adopted.

Nineteen subsection
Transitional provision

Unofficial table of contents

Section 147 Transitional provision on the occasion of the Third Law amending pharmaceutical and other regulations

For non-interventional safety tests in accordance with § 63f and investigations pursuant to § 67 (6), which were initiated before 13 August 2013, § 63f (4) and § 67 (6) shall be valid until 31 December 2013 in the period up to 12 August 2013 in force. Version application. Unofficial table of contents

Annex (to § 6a (2a))

(Fundstelle des Originaltextes: BGBl I 2007, 2511-2512;
with regard to of the individual amendments. Footnote) Substances according to § 6a (2a) sentence 1 are:

I.

Anabolic substances

1.

Anabol-androgenic steroids

a): Exogenous anabol-androgenic steroide1 androstendiol
1-Androstendion
Bolanediol
Bolasteron
Boldenon
Boldion
Calusterone
Clostebol
Danazol
Dehydrochlormethyltestosterone
Desoxymethyltestosterone
Drostanolon
Ethylestrenol
Fluoxymesterone
Formebolone
Furazabol
Gestrinon
4-hydroxytestosterone
Mestanolon
Mesterolon
Metandienon
Metenolon
Methandriol
Methasterone
Methyldienolone
Methyl-1-testosterone
Methylnortestosterone
Methyltestosterone
Metribolon, synonym methyltrienolone
Miboleron
Nandrolon
19 -Norandrostendion
Norboleton
Norclostebol
Norethandrolon
Oxabolon
Oxandrolon
Oxymesterone
Oxymetholone
Prostanozole
Quinbolon
Stanozolol
Stenbolon
1-Testosterone
Tetrahydrogestrinon
Trenbolone
Other substances related to anabol-androgenic steroids
b): Endogenous anabol-androgenic steroideandrostenediol
Androstendion
Androstanolon, synonym dihydrotestosterone
Prasterone, synonymous with dehydroepiandrosterone (DHEA)
Testosterone

2.

Other anabolic StoffeClenbuterol
Selective Androgen Receptor Modulators (SARMs)
Tibolon
Zeranol
Zilpaterol

II.

Peptide hormones, growth factors and related substances

1.: Erythropoiesis stimulatory substances
Erythropoietin human (EPO)
Epoetin alfa, beta, delta, omega, theta, zeta and analogue recombinant human erythropoietin
Darbepoetin alfa (dEPO)
Methoxy-polyethylene glycol-epoetin beta, synonymous with PEG-epoetin beta, Continuous Erythropoiesis Receptor Activator (CERA)
Peginesatid, synonyms Hematid
2.: Chorionic gonadotrophin (CG) and Luteinizing Hormon (LH) Chorionic gonadotrophin (HCG) Choriogonadotropin alfaLutropin alfa
3.: Corticotropins
Corticotropin
Tetracosactide
4.: Growth hormone, release factors, release peptides and growth factor somatropin, synonymous growth hormone human, growth hormones (GH) somatrem, synonymous somatotropin (methionyl), human growth hormone release factors, synonymous growth hormone releasing Hormones (GHRH) SermorelinSomatorelinGrowth hormone release peptides, synonyms Growth Hormones Releasing Peptides (GHRP) Mecasermin, synonym insulin-like growth factor 1, Insulin-like growth Factor-1 (IGF-1) IGF-1-analogues

III.

Hormones and Metabolic Modulators

1.: Aromatasehemmeraminoglutethimidanastrozolandrosta-1,4,6-trien-3, 17-dione, synonym Androstatriendion4-Androsten-3,6, 17-trione (6-oxo) ExemestanFormestanLetrozolTestolactone
2.: Selective Estrogen Receptor Modulators
(SERMs) Raloxifen
Tamoxifen
Toremifene
3.: Other antiestrogen-active substance clomiens
Cyclofenil
Fulvestrant
4.: Myostatin functions changing substance myostatin inhibitors
Stamulumab
5.: Metabolism-ModulatorenInsulinePPARδ (Peroxisome Proliferator Activated Receptor Delta)-Agonist, synonym PPAR-delta-AgonistenGW051516, synonym GW 1516AMPK (PPARδ-AMP-activated protein kinase)-Axis-AgonistenAICAR.

IV)

(dropped)

The enumeration includes the various salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives.