Law On The Marketing Of Medicinal Products

Original Language Title: Gesetz über den Verkehr mit Arzneimitteln

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Read the untranslated law here: http://www.gesetze-im-internet.de/amg_1976/BJNR024480976.html

Law on the marketing of medicines (medicines Act - AMG) AMG Ausfertigung date: 24.08.1976 full quotation: "medicines act as amended by the notice of December 12, 2005 (BGBl. I pp. 3394), most recently by article 3 of the Act of December 17, 2014 (BGBl. I S. 2222) has been changed" stand: Neugefasst by BEK. v. 12.12.2005 I 3394;
 
Amended by art. 3 G v. 17.12.2014 I 2222 for details on the stand number you see in the menu see remarks footnote (+++ text detection from validity: 6.6.1986 +++) (+++ application cf. §§ 63j, 109, 141 +++) (+++ official note of the standard authority on EC law: implementation of EURL 84/2010 (CELEX No.: 32010 L 0084) EURL 62/2011 (CELEX No.: 32011 L 0062) EURL 24/2011 (CELEX No.: 32011 L 0024) see G v. 19.10.2012 I 2192 +++) the G was article 1 G v. 24.8.1976 I 2445 of the Bundestag with the consent of the Federal Council decided. It is with the exception of d. § 78 Pursuant article 10 of this G on the 1.1.1978 entered into force.
Legal abbreviation: Eingef. by article 1 No. 1 G v. 30.7.2004 I 2031 mWv 6.8.2004 first section table of contents purpose of Act and definitions, scope of application article 1 purpose of the Act section 2 medicinal term § 3 fabric term § 4 other definitions § 4a exceptions from the scope of application of § 4 b special provisions for medicines for advanced therapies second section requirements of § 5 medicinal ban of raised concern medicinal products article 6 empowerment to protect of the health section 6a of the bans of drugs for doping purposes in sports , Note obligations § 7 treated with ionising radiation and radioactive medicines section 8 prohibitions to protect before deception article 9 the person responsible for the placing on the market of § 10 labelling section 11 leaflet § 11a trade information article 12 empowerment for the labelling, the leaflet and the pack sizes third section pharmaceutical manufacturing section 13 of manufacturing authorization § 14 decision on the manufacturing authorization section 15 expertise section 16 limitation of the manufacturing authorization article 17 time limit for the issuance of section 18 withdrawal , Cancellation, rest of article 19 article 20 responsibilities reporting obligations section 20a approval of active substances and other substances of article 20 b permit for the extraction of tissue and the laboratory tests § 20 c permission for the loading or processing, preservation, testing, storage or putting into circulation of tissues or tissue preparations § 20 d exemption from the permit obligation for tissue and tissue preparations fourth section authorisation of medicinal products article 21 authorisation § 21a approval of tissue preparations section 22 registration documents article 23 special documents in medicinal products for animals section 24 expertises § 24a use of documents of a Vorantragen controller section 24 (b) approval a Generic, exclusivity § 24 c claims section 24 d General recovery power section 25 decision over the admission § 25a screening § 25 b the mutual recognition procedure and decentralised procedure section 25 c measures the competent federal authority to decisions or resolutions of the European Community or the European Union article 26 drug testing guidelines § 27 time limit for the issuance of section 28 of Edition power § 29 duty of disclosure, new section 30 withdrawal, cancellation, rest of article 31 termination, extension section 32 state batch testing § 33 reimbursement and fees § 34 § 35 public information appropriations concerning the authorisation and exemption of § 36 authorization for standard approvals section 37 approval the European Community or the European Union for the placing on the market, approvals of medicines from other States fifth section registration of medicinal products article 38 registration of homeopathic medicines section 39 decision on the registration of homeopathic medicines, procedures article 39a registering traditional herbal medicines section 39 b registration documents for traditional herbal medicinal products § 39 c decision on the registration of traditional herbal medicines section 39B other procedural rules for traditional herbal medicinal products sixth section of protection of people at the clinical trial section 40 General requirements of the clinical trial section 41 special requirements of the clinical trial § 42 procedures at the Ethics Commission, approval at the federal authority section 42a withdrawal, revocation and suspension of the approval or the favourable opinion section 42 b publishing the results of clinical trials seventh section drug section 43 pharmacy duty, placing on the market by veterinarians section 44 exemption from the obligation to pharmacy 45 § empowerment to further exemptions from the pharmacy requirement of § 46 authorization to extend the duty of Pharmacy section 47 distribution channel Section 47a of the special distribution channel, proof obligations § 47 b special channel section 48 diamorphine prescription paragraph 49 (dropped out) § 50 retail with over-the-counter drugs § 51 levy in the travel industry section 52 ban of self-service § 52A wholesale trade in medicinal products article 52 (b) provision of medicinal products article 52 c medicines agency article 53 hearing of experts eighth section assurance and control of the quality of article 54 operating regulations § 55 pharmaceutical book section 55a of the official collection of investigation ninth section special rules for medicinal products applied in animals be 56a § § 56 medicated feedingstuffs prescribing, dispensing and use of medicines by veterinarians § 56 b exceptions § 57 acquisition and ownership by pet owners, evidence § 57a application by pet owners section 58 application in animals , that the extraction of food serve section 58a notifications relating to livestock section 58 b notifications relating to medicinal use § 58 c determination of the frequency of therapy section 58 d reduction treatment with antibacterial active substances section 58e regulation appropriations section 58f using data § 58 g evaluation § 59 clinical testing and residue testing in animals, food-producing section 59a traffic with substances and preparations from substances § 59 b substances to carry out residue controls section 59 c proof obligations for substances , § 59d be used as veterinary medicinal products can administration of pharmacologically active substances to animals, that food serve pets § 61 section 60 powers of veterinary education tenth section pharmacovigilance section 62 organization of the pharmacovigilance system of the competent federal authority § 63 phased plan section 63a of stufenplanbeauftragter § 63 b General pharmacovigilance obligations of the holder of the authorisation section 63 c documentation and reporting obligations of the holder of the authorisation for medicinal products which are intended for use in people , for suspected cases of side effects article 63d periodic updated safety reports section 63e European procedure § 63f General requirements for non-Interventional safety testing § 63 g special conditions for arranged non-Interventional safety testing section 63 h documentation and reporting requirements for medicinal products for use in animals determined are paragraph 63i documentation and reporting requirements for blood and tissue preparations and tissue § 63j exceptions eleventh section monitoring section 64 implementation monitoring section 65 sampling section 66 Duldungs - and duty section 67 general obligation § 67a re-purposed information system section 68 notification and information obligations § 69 measures the competent authorities § 69a monitoring by Substances used as veterinary medicinal products § 69 b use of certain data may twelfth section special rules for German armed forces, federal police, riot police, civil protection article 70 application and enforcement of the Act § 71 exceptions thirteenth section imports and exports article 72 import permit § 72a certificates § 72 (b) import permits and certificates for fabric and certain section 73a tissue preparations section 73 shipment ban export section 74 involvement of customs services fourteenth section of information officer, Pharmaberater article 74a information officer § 75 expertise section 76 obligations fifteenth section determination of the authorities of the federal upper and other provisions article 77 competent federal authority § 77a independence and transparency section 78
Prices for times of crisis article 80 article 79 exception appropriations authorization process and hardship arrangements article 81 relative to other laws § 82 General administrative provisions section 83 approximation to European Union law § 83a regulations in certain cases section 83 b promulgation of regulations sixteenth section liability for drugs § 84 strict liability § 84a right to information § 85 contributory negligence § 86 extent of damages case of death § 87 extent of damages for bodily injury § 88 limits § 89 compensation through money pensions article 90 (dropped out) § 91 further liability § 92. mandatory nature of article 93 several indemnifiable § 94 cover section 94a of the territorial jurisdiction
 
Seventeenth section of criminal law and penalty provisions § 95 penal § 96 penal provisions article 97 penalty provisions article 98 recovery section 98a extended expiration eighteenth section of Überleitungs-and transitional provisions of first subsection articles 99 to 124 above management rules on the occasion of the law on the restructuring of the pharmaceutical legislation second subsection sections 125 and 126
Transitional provisions on the occasion of the first act amending the German medicines Act third subsection sections 127 to 131 transitional provisions from event of the second act to amend the medicines Act fourth subsection § 132 transitional provisions from event of the fifth Act amending the German medicines Act fifth subsection § 133 transitional provision of event of the seventh law amending the German medicines Act sixth subsection § 134 transitional rules out occasion of the transfusion law seventh subsection § 135 transitional provisions from event of the eighth law amending the German medicines Act eighth subsection § 136 transition from occasion of the tenth Law amending the German medicines Act ninth subsection § 137 transitional provisions on the occasion of the eleventh Act amending the German medicines Act tenth subsection § 138 transitional provisions on the occasion of the 12th law amending the German medicines Act eleventh subsection § 139 transitional provisions on the occasion of the first act amending the Act of transfusion and medicines legislation twelfth subsection § 140 transitional provisions on the occasion of the thirteenth law amending of the medicines Act thirteenth section 141 subsection transitional provisions on the occasion of the fourteenth law amending the German medicines Act fourteenth subsection § 142 transitional provisions on the occasion of Tissue Act fifteenth subsection § 143 transitional provisions on the occasion of the law to improve the fight against of doping in sport sixteenth section 144 subsection transitional provisions on the occasion of the law amending drug-legal and other regulations seventeenth subsection § 145 transitional provisions on the occasion of the law on the restructuring of the pharmaceutical market eighteenth subsection transitional provision of § 146 transitional provisions on the occasion of the second Act amending drug-legal and other regulations annex first section purpose of Act and definitions , Scope of application article 1 purpose of the law is the purpose of this law, in the interest of a proper supply of medicines by humans and animals for the safety of medicines, especially for the quality to ensure efficacy and safety of medicinal products in accordance with the following provisions.

§ 2 concept of medicinal substances or preparations from fabrics, 1 are (1) medicinal to the application in the or are intended on the human or animal body and are intended as having properties to cure or relief or for the prevention of human or animal diseases or pathological symptoms or 2 the in the applied to the human or animal body or administered to a human or an animal can , to either a) the physiological functions by exerting a pharmacological, restore immunological or metabolic action, to correct, or to influence or b) to create a medical diagnosis.
(2) when medicines of are 1 items, which contain a medicinal product referred to in paragraph 1 or that a medicinal product referred to in paragraph 1 is applied and are intended to be installed, permanently or temporarily with the human or animal body in contact 1a.
veterinary instruments, intended for one-time use and the label indicating that they have undergone a procedure to reduce the bacterial count, 2 items, which, without objects referred to are intended to be 1 or 1a, for the purposes referred to in paragraph 1, in the animal's body permanently or temporarily to be brought, except veterinary instruments, 3 dressings and surgical suture materials , insofar as she applied determines am or in the animal's body and not items of number 1, 1a or 2 is that, also in combination with other substances or preparations of substances, 4. substances and preparations of substances, these are intended, without am or in the animal's body to be used, the nature, the State, or the function of the animal body recognize to leave or to serve as the detection of pathogens in animals.
(3) medicinal products are not 1 food within the meaning of § 2 para 2 of the food and feed law book, 2. cosmetic products within the meaning of § 2 5 of the food and feed law book, 3. tobacco products within the meaning of article 3 of the preliminary tobacco act, 4. outwardly animal cleaning or care, or to influence the appearance or body smell to be used in substances or preparations from substances which are intended solely to , as far as no substances or preparations of substances are subject to them, which are excluded from the traffic outside the pharmacy, 5. biocidal products referred to in article 3 (1) of Regulation (EU) No. 528 / 2012 of the European Parliament and of the Council of 22 may 2012 over the deployment on the market and use of biocidal products (OJ L 167 of the 27.6.2012, p. 1), 6 feed within the meaning of § 3 paragraph 12 to 16 of the food and feed law book, 7 medical devices and accessories for medical devices within the meaning of section 3 of the medical devices act, unless it is about drugs are referred to in § 2 paragraph 1 number 2 organs in the sense of § 1a No. 1 of the transplantation act, when determining for transfer to human recipient 3(2)(b), 8.
(3a) medicines are also products, substances, or preparations of substances are or can contain, taking into account all the properties of the product a definition of paragraph 1 qualify for and at the same time fall under the definition of a product pursuant to paragraph 3.
(4) unless a means is authorised or registered or exempted by regulation from the authorisation or registration under this act as a medicine, it is considered medicinal. The competent federal authority rejected the approval or registration of agent on the grounds, it is not a drug, it does not apply as a medicinal.

§ 3 1 chemical elements and chemical compounds as well as their naturally occurring mixtures and solutions, 2 plants, parts of plants, plant parts, algae, mushrooms and lichens in a processed or unprocessed state, 3. animal body, also live animals, as well as body parts, components and metabolites from humans or animals in processed or unprocessed state, are material term substances within the meaning of this Act 4 micro-organisms including viruses and their components or metabolites.

§ 4 other definitions are (1) medicinal pharmaceutical, in whose preparation in any other way, an industrial process will be applied, or which are produced commercially except in pharmacies, certain medicinal products which are manufactured in advance and placed in a package destined for delivery to the consumer in the traffic or others for sale to consumers. Finished medicinal product are not intermediate products intended for further processing by a manufacturer.
(2) blood preparations are medicines are obtained blood, plasma or serum canned, blood components, or preparations of blood components blood or containing as active ingredients.
(3) sera are medicines in the sense of article 2, paragraph 1, with a functional part of the antibody as the active ingredient containing fusion proteins, antibodies and antibody fragments and be applied for this active substance. Sera are not considered blood preparations within the meaning of paragraph 2 or as a tissue preparations within the meaning of paragraph 30 (4) vaccines are medicines in the sense of § 2 para 1, which contain antigens or recombinant nucleic acids and which are intended to be applied on humans or animals for the production of specific defensive and protective substances and, insofar as they contain recombinant nucleic acids, solely for the prevention or treatment of infectious diseases are.
(5) allergens are drugs in the sense of § 2 para 1, which contain antigens or haptens and destined are, in humans or animals to detect specific defensive or protective substances applied to be included (test allergens) or substances, which applied to the Antigen-specific reduction of specific immunological hypersensitivity (therapy allergens).
(6) Testsera are medicinal products within the meaning of § 2 para 2 No. 4, which obtained body parts or body secretions of healthy, sick, sick before or immunisatorisch previously treated animals, contain specific antibodies from blood, organs, and which are intended to be used, because of this antibody, as well as the corresponding Ngal.
(7) test antigens are medicinal products within the meaning of § 2 para 2 No. 4, containing antigens or haptens and intended to be used as such.
(8) radiopharmaceuticals are medicinal products that are radioactive substances or contain and spontaneously emit ionizing radiation and intended to be applied because of these features; produced radionuclides (precursors), as well as the systems specific to the production of radioactive medicines with a fixed parent radionuclide which forms a daughter radionuclide, considered radioactive drugs also for other substances prior to administration radio marking (generators).
(9) medicinal products for advanced therapies are gene therapy medicinal products, somatic cell therapy medicinal products or biotechnologically, paragraph 1(a) of Regulation (EC) edited tissue products referred to in article 2 no 1394/2007 of the European Parliament and of the Council of 13 November 2007 on orphan medicinal products for advanced therapies and amending Directive 2001/83/EC and Regulation (EC) No 726 / 2004 (OJ OJ L 324, December 10, 2007, p. 121).
(10) medicated feedingstuffs are medicines in the form of ready-to-feed, which are made of medicinal premixes and feedingstuffs and which are intended to be installed for use in animals on the market.
(11) drug premixes are medicinal products intended only for the purpose to be used for the manufacture of medicated feedingstuffs. You apply as a finished product.
(12) the wait time is the time that to comply with the protection of public health is under intended use of the medicinal after the last application of the medicinal product with an animal to recruitment of foods obtained from this animal, and that ensures that residues in these foods in the annex of Regulation (EU) No. 37/2010 of the Commission of 22 December 2009 on pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin (OJ OJ L 15 of the 20.1.2010, S. 1) not exceed the set maximum levels for pharmacologically active substances in amended.
(13) side effects are harmful and unintended reactions to the medicinal of medicinal products which are intended for use in people. Side effects are harmful and unintended reactions intended for medicinal products which are intended for use in animals. Serious side effects are adverse reactions that are fatal or life-threatening, require a hospitalization or extension of inpatient treatment congenital anomalies, to permanent or serious disability, invalidity, or cause birth defects. For medicinal products intended for use in animals, are serious side effects, which cause constantly occurring or long-lasting symptoms. Unexpected side effects are side effects, which type, extent, or result differ from the technical information of the medicinal product.
(14) is winning, the making of, the preparation, the working or processing, transfer including filling, packing, marking and sharing; Mixing of finished medicinal products with feed through the livestock farmers for direct administration to animals held by him is not considered manufacturing.
(15) quality is the nature of a medicinal product which is determined according to content, purity, identity, other chemical, physical and biological properties or the production process.
(16) a batch is each from the same initial quantity in a single production process or in a continuous manufacturing process in a given period produced lot of medicinal.
(17) placing on the market is holding for sale or other distribution, offering for sale, the offer for sale, and disposal of to others.
(18) the pharmaceutical entrepreneur is subject to registration or approval - medicines of the holder of the authorisation or registration. It is also pharmaceutical entrepreneur who brings drugs under his name in the traffic, except in the cases of § 9 para 1 sentence 2 (19) active substances are substances which are intended for the production of medicinal products pharmacologically active constituents to be used as or to be effective components of medicines to active when they are used in the manufacture of medicinal products.
(20) (lapsed) (21) Xenogene are medicines for use in the medicinal certain human living animal tissue or cells or containing or.
(22) wholesale of medicines is any professional or commercial activity exercised for the purpose of commercial activity, which consists in the procurement, storage, delivery or export of medicines, with the exception of distribution of medicinal products to other consumers as doctors, dentists, veterinary surgeons or hospitals.
(22a) drugs is any vocational or professional experienced activity of people, who, without number 1, wholesale, independently and on behalf of foreign medicines in the sense of article 2, paragraph 1 or paragraph 2 are intended for use in people act without to gain actual control over this drug.
(23) clinical trial in humans is any survey carried out on humans, which is intended to explore clinical or pharmacological effects of drugs or to prove or to determine side effects or to investigate the absorption, distribution, metabolism or excretion, aiming to check that the safety or efficacy of the medicinal. Sentence 1 does not apply to an investigation, which is a non-Interventional trial. Non-Interventional examination is a study which analyzes findings from treating people with drugs on the basis of epidemiological methods; the treatment including diagnostic and monitoring following not a predetermined Protocol, but only the medical practice; insofar as medicinal products requires a zulassungspflichtiges or according to article 21, paragraph 1, this is also in accordance with the specifications laid down in the authorization or the approval for its application.
(24) sponsor is a natural or legal person who assumes responsibility for the initiative, organization and financing of a clinical trial in humans.
(25) auditor is normally a doctor responsible for the conduct of the trial in humans in a laboratory or in exceptional cases, another person, whose profession on the basis of its scientific requirements and the qualified his experience which advance exercise in patient care for carrying out research on the people. Conducted a clinical trial in a test by a group of persons, the auditor is this party leader responsible for carrying out. Conducted a test in several test centres, an investigator as head of the clinical trial is named by the sponsor.
(26) homeopathic medicinal product is a medicinal product which has been created according to a in the European Pharmacopoeia or, in absence thereof, by the homeopathic preparation procedure described pharmacopoeias used officially in the Member States of the European Union. A homeopathic medicinal product may contain several active ingredients.
(27) a with the use of the medicinal product related risk is a) any risk relating to the quality, safety or efficacy of the medicinal product for the patient's health or public health, medicines intended for use in animals to the health of humans or animals, b) any risk of undesirable effects on the environment.
(28) the risk-benefit balance includes an evaluation of the positive therapeutic effects of the medicinal product in relation to the risk according to paragraph 27, medicines intended for use in animals after paragraph 27 medicines containing as active ingredient only one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations are letter b. (29) herbal medicinal products.
(30) tissue preparations are medicines that are tissue within the meaning of § 1a No. 4 of the transplantation act, or have been produced from such tissues. Human sperm and egg cells (gametes) and impregnated egg cells and embryos are not medicines or tissue preparations.
(31) the reconstitution of a finished product for use in humans is in his application-enabled form immediately before his application according to the package insert or as part of the clinical trial in accordance with the inspection plan.
(32) spending is any transportation to, through or from the scope of the Act. Import is of falling under the law on pharmacy products from third countries which are not Contracting States of the agreement on the European economic area, the release for free circulation. Products in accordance with sentence 2 is considered to be introduced, if they have been transferred contrary to the customs legislation in the economic cycle. Exports are each spending in third countries which are not Contracting States of the agreement on the European economic area.
(33) anthroposophisches drug is a drug that was developed, after one in the European Pharmacopoeia or, in absence thereof, according to a homeopathic preparation procedure described in the pharmacopoeias used officially in the Member States of the European Union or using a special anthroposophic preparation process has been established according to the anthroposophical people and nature knowledge and that is intended to be used in accordance with the principles of anthroposophical people and nature knowledge.
(34) a safety assessment for a drug that is intended for use in humans, is each check to an approved drug that is carried out to determine a security risk, to describe or quantify, to confirm the safety profile of a drug or to measure the effectiveness of risk management measures.
(35) a safety assessment for a drug that is intended for use in animals, is a pharmacoepidemiological study or a clinical trial according to the conditions of the approval with the aim to establish a health risk in connection with an approved veterinary medicinal and describe.
(36) the risk management system shall include activities in the area of pharmacovigilance and measures, the risks associated with a drug should be identified, described, avoided or minimised; This includes also the assessment of the effectiveness of such activities and measures.
(37) the risk management plan is a detailed description of the risk management system.
(38) the pharmacovigilance system is a system which use the holder of the authorisation and the competent federal authority to meet in particular the tasks listed in the tenth section and duties, and is used to monitor the safety of approved medicines and the discovery of any changes of the risk-benefit balance.
(39) the pharmacovigilance system master file is a detailed description of the pharmacovigilance system, that the holder of the authorisation applies to one or more approved drugs.
(40) a falsified medicinal product is a medicine containing false information about 1 the identity, including its packaging, its marking, its label or its composition in relation to one or more of its elements, including the AIDS and the content of these components, 2. the origin, including the manufacturer, the country of manufacture, country of origin and the holder of the authorisation for the placing on the market or the holder of the authorisation or 3. the channel described in records and documents.
(41) a counterfeit is an active ingredient, the labelling on the container specifies the actual content or its accompanying documentation not all involved reflects manufacturer or not the actual distribution channel.

§ 4a this law takes exceptions from the scope are not apply to medicinal products 1, using pathogens or uses means are manufactured and intended for the prevention, detection or treatment of animal diseases, 2. the production and the placing on the market of gametes for artificial fertilization in animals, 3. tissue, that removal from within a treatment process of a person, on this without changing their material nature re to be transferred.
Sentence 1 No. 1 does not apply article 55.

§ 4 b special provisions for medicines for advanced therapies (1) for medicinal products for advanced therapies, which are medically prescribed, not routinely produced 2 according to specific quality standards and applied 3 in a specialised institution of health care under the professional responsibility of a doctor, in the territorial scope of this Act 1 as a individual preparation for single patient the fourth section, with the exception of section 33, and the seventh section of this law will find no application. The remaining provisions of the act as well as article 14, paragraph 1 and article 15 paragraph 1 to 6 of Regulation (EC) no 1394/2007 shall apply accordingly subject to the proviso that the mentioned official duties and powers according to the tasks entrusted to them under this Act by the competent authority or the competent federal authority are perceived and the place of the holder of the approval in terms of this Act or of the holder of the authorisation for the placing on the market within the meaning of Regulation (EC) No. 1394 /. 2007 of the holder who performs approval pursuant to paragraph 3 sentence 1.
(2) do not routinely made in the sense of paragraph 1 set in particular medicines are 1 number 2, 1 which are manufactured on a small scale, and where on the basis of a routine manufacturing deviations in the process are made, which are medically justified for a single patient, or 2 that still not are made in sufficient quantity, so that the necessary findings not yet available for its comprehensive assessment.
(3) medicinal products set 1 may be placed under paragraph 1 only to others, if they have been approved by the competent federal authority. Article 21 paragraph 2 to 8 shall apply mutatis mutandis. The approval may be limited. Can the required particulars and documents not provided pursuant to section 21a, paragraph 2, number 6, the applicant may include the particulars and documents concerning the mode of action, the expected impact and possible risks. The holder of the permit has the competent federal authority in certain time intervals, which sets the competent federal authority by order, to report about the extent of production and on the findings of the comprehensive assessment of the medicinal product. The authorisation is to take back, if it is later known that one of the requirements of paragraph 1 sentence 1 not existed; She shall be revoked if one of the conditions is no longer given. Article 22, paragraph 4 shall apply mutatis mutandis.
(4) the competent authority in consultation decide requests for the authorisation of a medicinal product for advanced therapies with the competent federal authority. Article 21, paragraph 4 shall apply mutatis mutandis.
Second section requirements to the medicines section 5 ban of raised concern medicinal products (1), it is prohibited to bring questionable medicines on the market or to apply for another person.
(2) medicinal products, which according to the current state of scientific knowledge there is reasonable suspicion, that they have adverse effects when used properly, that go beyond a reasonable degree according to the findings of medical science are concern.

§ 6 authorization for the protection of health (1) the Federal Ministry of health (Ministry) is authorised to impose the use of certain substances, preparations of substances or objects in the production of medicines by decree with the consent of the Federal Council, to restrict or prohibit and to prohibit the placing on the market and the use of medicinal products which are manufactured, not under those provisions, as far as risk prevention or to ward off a direct or indirect threat to the health of humans or animals with medicinal products is offered. The decree issued agriculture and consumer protection in agreement with the Ministry pursuant to sentence 1 by the Federal Ministry of food, as far as it is medicinal products intended for use in animals.
(2) the regulation referred to in paragraph 1 was made in agreement with the Federal Ministry for environment, nature conservation and nuclear safety, insofar as radiopharmaceuticals and medicinal products, ionising radiation are used in their manufacture.

§ 6a it is forbidden to bring medicines to prescribe or to apply other, unless a doping people is or should be referred to in paragraph 2 sentence 1 for purposes of doping in sport in the traffic prohibitions of medicines for purposes of doping in sport, note obligations (1).
(2) paragraph 1 shall only apply to drugs, the substances in the currently valid version of the annex of the Convention against doping (law of 2 March 1994 to the Convention of 16 November 1989 against doping, BGBl. 1994 II p. 334) contain listed groups of prohibited substances or substances which are intended for use in the listed prohibited methods. In the package insert and in the prescribing information for these drugs is to specify the following warning: "the use of the medicinal product [insert the name of the medicinal product] can lead to positive results on doping tests." A health hazard may follow from the misuse of the drug for doping purposes, this is in addition to specify. Sentence 2 shall not apply to medicinal products which have been produced according to a homeopathic procedure technique.
(2a) it is forbidden to medicinal products or active substances, the substances referred to in the annex to this Act are, or contain, to acquire in the sport in no small amount for doping purposes or to have provided doping in humans should be. The Ministry determined the not inconsiderable amount of substances referred to in sentence 1 in agreement with the Federal Ministry of the Interior after consultation of experts by decree with the consent of the Federal Council. The Ministry is authorized, in consultation with the Federal Ministry of the Interior after consultation of experts by decree with the consent of the Bundesrat more substances in the annex to this Act to record 1, which are suitable for purposes of doping in sport and their application when no therapeutic provision is dangerous, and 2. determining the not inconsiderable amount of these substances.
By Regulation pursuant to sentence 3 substances of annexed to this Act can be deleted, if the conditions of the sentence 3 No. 1 no longer exist.
(3) the Federal Ministry is authorised to determine other substances or preparations of substances on which paragraph 1 shall apply, as far as this is necessary to prevent the direct or indirect risks to health of the people through doping in sport in consultation with the Federal Ministry of the Interior by decree with the consent of the Federal Council.

§ 7 treated with ionising radiation and radioactive medicinal (1) it is forbidden to rays ionising radioactive medicinal products or medicinal products that are produced have been used in the transport to bring, unless this is permitted by law regulation referred to in paragraph 2.
(2) the Federal Ministry is empowered to allow the placing on the market of radioactive drugs or radiation ionizing the use in the manufacture of pharmaceutical products in consultation with the Federal Ministry for environment, nature conservation and nuclear safety by decree with the consent of the Federal Council, insofar as this is necessary and safe for the health of humans or animals according to the current state of scientific knowledge for medical purposes. Under the Ordinance, the distribution channel can are determined and prescribed information about the radioactivity on the container, the outer packaging and the package leaflet for the medicines. The decree is issued by the Federal Ministry of food, agriculture and consumer protection in agreement with the Ministry and the Federal Ministry for the environment, nature conservation and reactor safety insofar as it is medicinal products intended for use in animals.

Section 8 prohibitions to protect against deception (1) it is forbidden to medicinal products or active substances to manufacture or to bring in the traffic, are significantly reduced the 1 by deviation from the pharmaceutical standards in their quality or 1a.
(lapsed)
2. with a misleading name, indication or presentation are. In particular is misleading, if a) medicines a therapeutic effect or effects or ingredients an activity be enclosed, which they didn't, b) wrongly, the impression is given that a success with security can be expected or that enter after intended or prolonged use no harmful effects, c) appropriate names, indications or put up are used to deceive about the quality , are determined with the assessment of the medicinal product or active substance.
(2) it is prohibited to produce fake drugs or fake ingredients, to place on the market or otherwise to trade with them.
(3) it is prohibited to place medicinal products whose expiration date has expired, on the market.

§ 9 the person responsible for the placing on the market shall (1) medicinal products which are placed on the territorial scope of this Act on the market, the name or business name and address of the marketing authorisation. This shall not apply in the case of medicinal products intended for clinical trials in humans.
(2) medicines are allowed within the territorial scope of this Act only by a pharmaceutical company in the traffic, which has its seat in the territorial scope of this Act, in another Member State of the European Union or in another Contracting State to the agreement on the European economic area. The pharmaceutical entrepreneur appointed a local representative, this does not relieve him of his legal responsibility.

§ 10 labelling (1) drugs, the medicines in the sense of § 2 para 1 or par. 2 No. 1 and not to the clinical trial in humans determined or according to § 21 para 2 No. 1a 1b or 6 from the authorisation requirement are released, may be placed in the territorial scope of this Act only if on the containers and, if used on the outer packages in legible font , the name or business name and address of the marketing authorisation are generally understandable in German and in a sustainable way and in accordance with the information according to § 11a 1 and, if applicable, the name of the local representative nominated by him, 2 the name of the medicinal product, followed by indicating the strength and the pharmaceutical form, and if applicable, indicating that it applied for infants , Children or adults is determined, except that these details are already included in the designation; the medicinal 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 does not apply if the active ingredient name is contained in the label referred to in point 8, 3. the approval number with the abbreviation ".-Nr.', 4. the batch number, as far as the medicinal in batches on the market will be placed, with the abbreviation" ch.-B. ", as far as it not must be taken in batches on the market, the date of manufacture, the pharmaceutical form, 6 5 the contents after weight, volume or number of pieces , 7 the type of application, 8 the active substances according to type and quantity and other components according to the type, as far as this through arranged Edition of the competent federal authority according to § 28 para 2 No. 1 or prescribed by Regulation pursuant to § 12 para 1 No. 4, also in connection with paragraph 2, or according to § 36 para 1; medicines to the parenteral or topical application, including the application of the eye, all the components according to the type 8a.
for genetically derived medicinal products the active ingredient and the description of the one used in the manufacture genetically modified micro-organism or the cell line, 9 expiration date with the note "use by", 10 for medicinal products which are supplied only on medical, dental or veterinary prescription may, the note "Prescription", for other medicinal products which are supplied only in pharmacies to consumers the note may, "Apothekenpflichtig", 11 samples of note "Unsaleable pattern" , 12 Note that medicines inaccessible to retain for children, unless it's 14 intended use of non-prescription medicinal mineral water, 13 where necessary special precautions for the disposal of unused medicinal products or other special precautions, to avoid dangers to the environment,.
If the information pursuant to sentence 1 also are reflected in another language, the same information shall be given in that language. Space for providing the prescribed dosage should also be provided; This does not apply to that in paragraph 8 set of 3 these containers and vials and for medicinal products which are intended to be used only by professionals. Medicinal products which are manufactured according to homeopathic process technology and are approved according to § 25, are in addition to be marked with a note on the homeopathic nature. Other details which are not prescribed or permitted already under such a regulation by a regulation of the European Community or the European Union are permitted insofar as they are with the use of the medicinal product in the context, are important for the health education of patients and do not contradict the information according to § 11a.
(1a) (lapsed) (1 b) for medicinal products intended for use in humans, the name of the medicinal product on the outer packages also in Braille must be indicated. The in paragraph 1 sentence 1 No. 2 referred to other information to the pharmaceutical form and the Group of persons for which the medicinal product is intended, must; not listed in Braille This also applies if you include this information in the label. Sentence 1 does not apply to medicines, 1 probably are, be applied exclusively by professionals to be or 2 which brought capacity or the amount of a content of not more than 20 grams in traffic in containers of not more than 20 milliliters.
(2) there are warning labels to indicate consumers specific storage advice and storage information for professionals in certain extent required or requirements § 28 para. 2 No. 1 ordered or prescribed by a regulation according to the current state of scientific knowledge of the competent federal authority after.
(3) in the case of Sera is also the kind of beings they are won, to give the host system, which has served as the virus propagation, virus vaccines.
(4) in the case of medicinal products which are registered in the register for homeopathic medicines, rates are in place of the information referred to in paragraph 1 to provide the following information 1 No. 1 to 14, and except for the clearly visible note "Homeopathic medicines": 1 stocks according to type and quantity and the degree of dilution; Here are the symbols from the pharmacopoeias officially used to use; the scientific name of the stock can be complemented by a fancy name, 2. name and address of the marketing authorisation and, where available, its local representative, 3. type of application 4 expiry date; Paragraph 1 sentence 1 No. 9 and paragraph 7 will find application, 5. pharmaceutical form, 6 the contents by weight, volume or number of pieces, 7 Note that to keep medicines out of the reach of children, further Special precautions for storage and warnings, including another, insofar as these for a secure application are required or prescribed pursuant to paragraph 2, 8 batch number, 9 registration number with the abbreviation "Reg.-No." and the indication 'registered homeopathic medicinal ", therefore without a therapeutic indication", 10 of note to the user, if continuing during the use of the medicinal symptoms medical to get advice, 11 for medicinal products which may be placed only in pharmacies to consumers, the note "Obtainable", 12 when patterns of note "Unsaleable pattern".
Sentence 1 shall apply accordingly for medicinal products which are exempt according to § 38 paragraph 1 sentence 3 of the registry; Paragraph 1 b shall not apply.
(4a) in traditional herbal medicines according to § 39a following information must be included in addition to the information in paragraph 1: 1. the medicinal product is a traditional medicine, that is registered only on the basis of long-standing application for the application area and 2 the user should consult a doctor or another qualified person working in a health care practitioner when ongoing symptoms or occurrence other than the side effects mentioned in the package leaflet.
The indication referred to in paragraph 1 sentence 1 No. 3 shall be replaced the registration number with the abbreviation "Reg. Nr.".
(5) in the case of medicinal products intended for use in animals, the paragraphs 1 and 1a with the proviso that instead of the information referred to in paragraph 1 set to provide the following information 1 number 1 to 14 and paragraph 1a are apply: 1. name of the medicinal product followed by the strength, the pharmaceutical form and the species of animal, unless that these details are already included in the designation; contains the medicinal only an active substance, must be submitted to international short term of the World Health Organization or, as far as this is not exist, the common name, except that the specification of the active substance is already included in the designation, 2. the active substances according to type and quantity and other components according to the type, as far as this through arranged Edition of the competent federal authority according to § 28 paragraph 2 No. 1 or by Regulation pursuant to section 12 paragraph 1 number 4 in connection with paragraph 2 or is prescribed pursuant to section 36, paragraph 1, 3. the batch number, 4. the approval number with the abbreviation ". No.", 5. the name or business name and address of the marketing authorisation and, to the extent available, the name of the local representative nominated by him, 6 the animal species, the medicinal product to apply where, 7 the type of application, 8 the wait, unless it's medicinal , intended for use in animals, the aim of gaining food, 9 the expiry date in accordance with paragraph 7, 10 if necessary, special precautions for the disposal of unused medicinal, 11 indicating that medicines inaccessible to retain for children, more special precautions for storage and warnings, including further information insofar as these are necessary and prescribed pursuant to paragraph 2 for a secure application , 12 the note "for animals", 13 the pharmaceutical form, 14 the contents by weight, volume or number of pieces, 15 of medicinal products which may be placed with the note "Prescription", only on veterinary prescription for other medicinal products which are supplied only in pharmacies to consumers may, the note "Obtainable", 16 patterns of note "Unsaleable pattern".
Medicinal products for use in animals which are registered in the register for homeopathic medicines are to be provided with the clearly visible note "Homeopathic medicinal product"; instead of the information pursuant to sentence, information is 1 number 2 and 4 after paragraph 4 to make sentence 1 Nos. 1, 9 and 10. Sentences 1 and 2 shall apply mutatis mutandis for medicinal products which are exempt according to article 38, paragraph 1, sentence 3 or article 60, paragraph 1 of the registration. At traditional herbal medicinal products for use in animals, 1 number 4 is the registration number with the abbreviation "Reg.-No." instead of stating to set to make; the notes shall be: 1 number 1 after paragraph 4a set and to specify according to the application in animals referred to in point 2. The data pursuant to sentence 1 number 13 and 14 is required, if an outer packaging is available only on the outer packaging.
(6) for the label of the components, the following applies: the World Health Organization's international short names are 1 to designate the kind or, where such do not exist to use common scientific names; the Federal Institute for drugs and medical devices to determine the names to be used in consultation with the Paul-Ehrlich-Institut and the Federal Office of consumer protection and food safety and published these in a database according to § 67a;
2. the designation of the quantity units must use; biological units or other data of the value are scientifically in use, they should be using.
(7) the expiry date is to specify month and year.
(8) blister packs are with the name or the company of the marketing authorisation, the name of the medicinal product, provided the batch number and expiry date. The indication of the name and company of a parallel importer may be waived. In containers of not more than 10 millilitres of nominal and in ampoules, containing only a single unit of use, the particulars need for paragraphs 1 to be made only on the outer packages from 2 to 5; but at least the information must relate to the containers and vials referred to in paragraph 1 sentence 1 number 2 first half-sentence, 4, 6, 7, 9, as well as paragraphs 3 and 5 set are 1, 3, 7, 9, 12, 14 1 number; appropriate abbreviations can be used. Set 3 is small to other containers as the stated application, unless in proceedings according to § 25 small containers requirements for different b are based on.
(8a) fresh plasma preparations and preparations of blood cells at least the particulars must referred to in paragraph 1 sentence 1 number 1, 2, without providing the strength, dosage form and group, numbers 3, 4, 6, 7 and 9 as well as the name and the volume of the Antikoagulans-and, if applicable, the additive solution, the storage temperature, the blood group and allogeneic red blood cell preparations in addition the Rhesus formula , are specified in platelet concentrates and autologous red blood cell preparations in addition the rhesus factor. Autologous blood preparations must be also the claim made ' only to the autologous transfusion ' and autologous and directed blood preparations additionally given a note to the recipient.
(8B) in tissue preparations at least the information must referred to in paragraph 1 sentence 1 Nos. 1 and 2 without providing the strength, the pharmaceutical form and the person group, number 3 or the approval number with the abbreviation "gene.-No.", made number 4, 6, and 9, as well as specifying "Biological danger" in case of established infectivity. Autologous tissue preparations must be also the claim made "only for autologous use" and autologous and directed tissue preparations in addition given a note to the recipient.
(9) pursuant to paragraphs 1 to 5, common abbreviations may be used in the case of the information in the marketing of medicinal products. The company no. 1 may be abbreviated pursuant to paragraph 1 unless the company from the abbreviation is widely recognizable.
(10) for medicinal products intended for use in animals and to clinical trials or for residue testing, 1 number 1, 3, 5, 7, 8, 13, and 14, paragraphs 8 and 9, so far as they relate this application find paragraph 5 sentence. These drugs are as applicable with the indication "Intended for the clinical trial" or "Intended for residue testing" to provide. Blister packs are named pursuant to sentence 2 to provide the batch number and the note.
(11) subsets taken for the finished product, intended for use in humans, may be placed only with a flag, that set 1 meets at least the requirements referred to in paragraph 8. Paragraph 1 b shall not apply.
Footnote (+++ § 10 para 1: application cf. Article 109, paragraph 1 +++) § 11 leaflet (1) medicinal No. 1 are medicines in the sense of § 2 paragraph 1 or paragraph 2, which determines or no. 1a are exempt under § 21 para 2 1 b or 6 from the authorisation requirement, not to the clinical examination, or residue may be placed on the territorial scope of this Act only with a leaflet in the traffic , which is headed "Instructions" and must contain the following information in the following order in laymans terms in German, in legible writing and in accordance with the information according to § 11a: 1 identification of the medicinal product: a) the name of the medicinal product, section 10, paragraph 1, sentence 1 No. 2 can find appropriate application, b) the fabric or group or the action;
2. the application areas;
3. a list of information that must be known before taking the medicinal product: a) contra-indications, b) appropriate precautions for use, c) interactions with other medicines or other means, as far as they can influence the effect of the medicinal product, d) warnings, especially as far as this by laying the competent federal authority according to § 28 para 2 No. 2 ordered or prescribed by Regulation pursuant to § 12 para 1 No. 3;
4. the required for the proper application instructions about a) metering, b) type of application, c) frequency of administration, if necessary with indication of the exact time to which the medicinal product may or must be administered, and, where appropriate and depending on the nature of the medicinal product, d) duration of treatment if this is to be established, e) notes in case of overdose, taking action, inaction or notes on the risk of undesirable consequences of the weaning , f) the explicit recommendation, regarding the clarification of the application to check with the doctor or pharmacist;
5. a description of the side effects that can occur in normal conditions of use of the medicinal product; side effects to take countermeasures, insofar as this is necessary according to the current state of scientific knowledge; all medicinal products which are intended for use in humans, a default text to include, by the patients explicitly prompts you every suspected case of a side effect in addition is their doctors, pharmacists, healthcare professionals directly or to report members of the competent federal authority, with the message in any form, in particular also electronically, can be;
6. a note on the expiration date printed on the packaging, as well as a) warning before applying the drug after this date, b) where necessary special precautions for storage and specify of the shelf-life after opening the container or after production of the ready-made preparation by the user, c) if necessary warning against certain visible signs that the drug is no longer to use , d) the full qualitative composition according to active substances and other components, as well as quantitative composition after active substances, using common labels for each pharmaceutical form of the medicinal product, § 10 paragraph 6 applies, e) pharmaceutical form and the contents by weight, volume or number of pieces for each pharmaceutical form of the medicinal product, f) name and address of the marketing authorisation and, where available, its local representative, g) the name and address of the manufacturer or the importer , has been released to the finished product for the placing on the market
7. where a drug approved 2001/83/EC the directive under other names in other Member States of the European Union pursuant to articles 28 to 39 for the placing on the market is, a list of the names authorised in each Member State;
8. the date of the last revision of the leaflet.
For medicinal products which are intended for use in humans and are 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 authorisation and supervision of human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1), most recently by Regulation (EU) No. 1027/2012 (OJ L 316 of the 14.11.2012, p. 38) has been changed, are, also following statement must be included: "This drug is subject to an additional monitoring." This statement must precede a black symbol and an appropriate standard explanatory text paragraph 4 of Regulation (EC) No 726 / 2004 followed by article 23. Explanatory information on the terms referred to in sentence 1 are allowed. If the information pursuant to sentence 1 in the leaflet also are reflected in another language, the same information shall be given in that language. Sentence 1 does not apply to medicinal products requiring authorisation no. 1 not according to § 21 para 2. Other details which are not prescribed or permitted already under such a regulation by a regulation of the European Community or the European Union are permitted insofar as they are with the use of the medicinal product in the context, are important for the health education of patients and do not contradict the information according to § 11a. The information pursuant to sentence 1 No. 3 letter is a to d, as far as this according to the current state of scientific knowledge is necessary to address the special situation of certain groups of people, such as children, pregnant or nursing women, elderly people or people with specific diseases; also are, if necessary, to indicate possible effects of application on driving ability or the ability to operate certain machinery. The holder of the authorisation is obliged to keep scientific knowledge, which includes also the conclusions of reviews and the recommendations will be published according to article 26 of Regulation (EC) No. 726 / 2004-oriented European Internet portal for medicines on the leaflet on current.
(1a) a pattern of the leaflet and modified versions is immediately be sent to the competent federal authority, if not the medicines of the authorisation or registration is free.
(1B) the pursuant to paragraph 1 sentence 1 number 5 and set 3 required standard texts are by the competent federal authority in the Federal Gazette made known.
(2) there are references to components, knowledge of which for an effective and safe use of the medicinal product is required, and for the consumer to specify storage advice, where necessary, through Edition § 28 para. 2 ordered or prescribed by a Regulation No. 2 according to the current state of scientific knowledge of the competent federal authority after certain also in the package insert.
(2a) for radiopharmaceuticals shall apply paragraph 1 accordingly subject to the proviso that the precautions list are that the user and the patient during the preparation and have to take administration of the medicinal product and special precautions for disposal of unused medicinal products and container.
(3) in the case of medicinal products which are registered in the register for homeopathic medicines, paragraph 1 accordingly with the proviso that you are prescribed information, other than specifying the batch number, expiry date and of the notice prescribed in patterns, to make in § 10 section 4 as well as the name and address of the manufacturer are to be, which has released the finished medicinal products for the placing on the market shall apply , as far as it not to the pharmaceutical entrepreneur is. Sentence 1 applies to medicinal products which are exempt according to § 38 paragraph 1 sentence 3 of the registry.
(3a) in Sera apply paragraph 1 in accordance with with the proviso that the kind of beings, from which they are won virus vaccines the host system, which has served as the virus propagation, and of medicinal products from human blood plasma for fractionation is to specify the country of origin of the blood plasma.
(3B) in traditional herbal medicines according to § 39a applies paragraph 1 in accordance with with the proviso that sentence to specify 1 No. 2 is the information referred to in paragraph 1, that the medicinal product is a traditional medicine that is registered only on the basis of long-standing application for the field of application. In addition paragraph 4a is set 1 in the package leaflet of the reference according to § 10 record No. 2.
(3c) the holder who has approval to ensure that the leaflet at the request of patient organisations for medicinal products intended for use in humans, is available in formats designed for blind and visually impaired people.
(3d) with medicinal waters information may sentence 1 without prejudice to the obligations referred to in paragraph 2 pursuant to paragraph 1 No. 3 letter b, no. 4 as far as the note indicated on is prescribed letter e and f, no.5, and letter c is no. 6. In addition, may be waived for healing water of the order prescribed in paragraph 1.
(4) in the case of medicinal products intended for use in animals, paragraph 1 with the proviso that instead of the information referred to in paragraph 1 sentence 1 the following information set 2 and 3 in the following order must be made understood in German language, in legible writing and in accordance with the information provided in accordance with paragraph 1 according to § 11a shall apply : 1. the name and address of the marketing authorisation, if his local representative, and the manufacturer has released the finished product for the placing on the market
2. name of the medicinal product followed by the strength and the pharmaceutical form; the common name of the active ingredient will be listed if the medicinal product contains only one active ingredient and if its name is an invented name; When a drug, under other names in other Member States of the European Union pursuant to articles 31 and 43 of Directive 2001/82/EC of the European Parliament and of the Council establishing a Community code relating to veterinary medicinal of 6 November 2001 (OJ EC No. L 311, p. 1), as amended by Directive 2004/28/EC (OJ EU no. L 136, p. 58), a list of the names authorised in each Member State; is approved for placing on the market,
3. fields of application;
4. contraindications and side effects, as far as these details for the application are necessary; can do this, no details provided are, so is the note "not known" to use. Note that the users or owners, are prompted to tell each side effect the veterinarian or pharmacist, which is not mentioned in the package leaflet;
5. species for which the medicinal product intended dosage for each species, ways and means of application is, as far as necessary instructions for the intended application;
6 waiting time, as far as it is medicinal products intended for use in animals which serve the production of food; a waiting period is not required, this shall be indicated;
7. Special precautions for storage;
8. Special warnings, especially if ordered or prescribed by a regulation by Edition of the competent federal authority;
9. to the extent that this is required according to the current state of scientific knowledge, special precautions for the disposal of unused medicinal products or other special precautions, to dangers for the environment to avoid.
The date of the last revision of the leaflet is to specify. When drug premixes instructions for the proper manufacture of medicated feedingstuffs and information concerning the duration of the shelf life of the medicated feedingstuffs are to record. Further information is permitted, insofar as they are with the use of the medicinal product in the context, are important for the users or owners and do not contradict the information according to § 11a. For medicinal products for use in animals, that are registered in the register for homeopathic medicinal products, or which are exempt according to article 38, paragraph 1, sentence 3 or article 60, paragraph 1 of the registration, sentences 1, 2 and 4 accordingly with the proviso that you are to provide prescribed information except for indicating the batch number, expiry date and of the notice prescribed in patterns in section 10, paragraph 4 shall apply. For traditional herbal medicinal products for use in animals 1 b set is paragraph 4a in addition to remarks pursuant to paragraph 3 a note corresponding to the application in animals pursuant to § 10 specify set 1 number 2.
(5) to that referred to in paragraph 1 sentence 1 No. not be held 3 information required by letter a and c, as well as no. 5, so the note "not known" to use. Further details are made on the leaflet, they must be to clearly separated and delineated the paragraphs 1 to 4 of the information.
(6) the package leaflet can be omitted, if you post the paragraphs 1 to 4 statutory markings on the container or on the outer packaging. Paragraph 5 is appropriate.
(7) subsets taken of a finished product, intended for use in humans, may be placed only with a copy of the leaflet prescribed for the finished product. Paragraph 6 sentence 1 shall apply accordingly. Notwithstanding sentence 1 copies the package inserts that prescribed for the respective finished product must be added in when in the context of a long-term medication regular subsets taken from finished product in new, patient individual blister packs until again, if these have changed over the last enclosed.
Footnote section 11, subsection 1, sentence 1 input set italics: "No. 1a, 1B" would be correct.

section 11a trade information (1) the pharmaceutical entrepreneur is obliged doctors, dentists, veterinarians, pharmacists, and, as far as it is not a prescription is, other people who professionally practise medicine or dentistry, for finished medicinal products which are subject to authorisation or approval free medicines in the sense of § 2 paragraph 1 or paragraph 2 are, no. 1, and are not released for transport outside of pharmacies , to request a leaflet for professionals (SMPC) to make. These must carry the heading "Technical information" and contain the following information in legible writing in accordance with the summary of product characteristics approved in the framework of the authorisation, and in the following order: 1. the name of the medicinal product followed by the strength and the pharmaceutical form;
2. qualitative and quantitative composition to drugs and the other components, knowledge of which is required, indicating the common or chemical name; for a proper administration of the agent § 10 paragraph 6 shall apply;
3. pharmaceutical form;
4. clinical particulars: a) applications, b) dosage and administration for adults and, unless the medicinal product for use in children, children, c) contraindications, d) Special warnings and precautions for use and for immunological medicinal any special precautions to be taken by persons who come with immunological medicinal products into contact and who administer these drugs, patients , as well as to be taken by the patient precautions, where no. 1 letter a ordered or prescribed by a regulation by conditions of the competent federal authority according to § 28 para 2, e) interactions with other medicines or other means, as far as they can influence the effect of the medicinal product, f) use in pregnancy and lactation, g) effects on the ability to operate machines and to drive motor vehicles , h) side effects when used properly, i) overdose: symptoms, emergency procedures, antidotes.
5. pharmacological properties: a) pharmacodynamic properties, b) pharmacokinetic properties, c) pre-clinical safety data;
6. pharmaceutical information: a) list of excipients, b) Hauptinkompatibilitäten, c) shelf life and, if necessary, the durability making a ready-made preparation of the medicinal product or when first opening of the container, d) special precautions for storage, e) nature and contents of container, f) special precautions for the disposal of used medicinal or originating from waste materials, to avoid dangers to the environment;
7 holder of the authorisation;
8. approval number;
9. date of the registration or the renewal of the authorisation;
10th date on which revised the prescribing information.
All medicinal products which are intended for use in humans, a standard text is to record, the members expressly asks healthcare professionals to report any suspected case of an adverse reaction to the competent federal authority, where the message in any form, in particular also electronically, can be. For medicinal products which are intended for use in humans and are on the list referred to in article 23 of Regulation (EC) No 726 / 2004, also following statement must be included: "This drug is subject to an additional monitoring." This statement must precede a black symbol and an appropriate standard explanatory text paragraph 4 of Regulation (EC) No 726 / 2004 followed by article 23. Other details which are not prescribed or permitted already under this regulation by a regulation of the European Community or the European Union are allowed if they are with the use of the medicinal product in the context and do not contradict the information provided pursuant to sentence 2; they must be clearly separated from the specifications pursuant to sentence 2 and delineated. Sentence 1 does not apply to medicinal products, which according to § 21 para 2 does not require an authorisation or are manufactured according to a homeopathic process engineering. The holder of the authorisation is obliged to keep the technical information on the current state of scientific knowledge, which includes also the conclusions of reviews and the recommendations will be published according to article 26 of Regulation (EC) No. 726 / 2004-oriented European Internet portal for medicines on the. The standard texts required according to the rates of 3 and 5 are disclosed by the competent federal authority in the Federal Gazette.
(1a) in Sera also the nature of the organism from which they are obtained, virus vaccines is the country of origin of the blood plasma the host system, which has served to virus propagation, and of medicinal products from human blood plasma for fractionation to specify.
(1B) radiopharmaceuticals are also the details of internal radiation dosimetry, additional detailed instructions for the extemporane preparation and quality control of this preparation, as well as, where necessary, the maximum storage time to specify during the intermediate preparation such as an eluate or the ready to use medicinal conforms to its specifications.
(1C) for medicinal products intended for use in animals, the prescribing information under the number 4 "clinical data" must contain the following information: a) specify of each target species in which the medicinal products should be applied, b) information for use with special reference on the target species, c) contra-indications, d) Special warnings of for each target species, e) Special warnings for use, including the special precautions to be taken by the forms person , f) adverse reactions (frequency and seriousness), g) use in pregnancy, eggs, or milk production, h) interactions with other medicinal products and other forms of interaction, i) dosage and type of application, j) overdose: symptoms, emergency measures, antidotes, if necessary, k) waiting time for all foods, including those for which no waiting time is.
The information referred to in paragraph 1 sentence 2 No. 5 letter c accounts for.
(1 d) for medicinal products supplied only on medical, dental or veterinary prescription, the note may also of note "Prescription" for narcotics is the note of "Narcotic drugs", at other pharmaceutical products supplied only in pharmacies to consumers, "Apothekenpflichtig" to specify; for medicinal number 3 containing a substance or preparation, according to article 48, paragraph 1, sentence 1, shall make a corresponding indication.
(1e) for approvals of medicines according to § 24 b can information referred to in paragraph 1 be omitted which relate to applications, dosages, or other objects of the patent, which fall under the patent law at the time of the placing.
(2) the pharmaceutical entrepreneur is obliged to publicise the changes of trade information, which are relevant for therapy, professionals in an appropriate manner. The competent federal authority may, where necessary, determine by Edition form in which the changes are to make available all or certain professional circles.
(3) a pattern of trade information and amended versions is immediately to send the competent federal authority, if not the medicines from the admission is free.
(4) the obligation can be set 1 medicinal products which is administered exclusively by professionals, referred to in paragraph 1 meets set 2 package insert also by recording the information referred to in paragraph 1. The package leaflet must be equipped with the heading "Instructions and information for professionals".

§ 12 authorized authorization for the labelling, package leaflet and the pack sizes (1) is the Federal Ministry, in agreement with the Federal Ministry of Economics and technology by decree with the consent of the Federal Council the provisions of sections 10 and 11a other medicines and the scope of expert information on more information to extend to 1., 2. to prescribe that the information referred to in paragraphs 10 and 11 delivered the consumer otherwise , 3. certain medicines or pharmaceutical groups to impose, that warning signs, warning signs, or badge on a) the containers, the outer packages, the package insert or b) to attach the prescribing information are 4 to require that certain components depending on the container and the outer casings to be or to indicate them in the package insert is as far as it is necessary to a proper handling of medicines and their proper application in the area of application of this Act to ensure and to a direct or indirect danger to health to prevent that could occur as a result of lack of information by humans or animals.
(1a) that is Federal Ministry also is authorized to admit by designations of summary legal regulation with the consent of the Federal Council for substances or preparations from materials given on containers and outer packages or package leaflet in the prescribing information, insofar as it is not effective components and not to fear a direct or indirect threat to the health of humans or animals as a result of lack of information.
(1B) that is Federal Ministry also is empowered to regulate the labelling of raw materials intended for the manufacture of medicinal products, and 2. as far as it in agreement with the Federal Ministry of Economics and technology by decree with the consent of the Federal Council 1 labelling of drugs intended for clinical trials, to prevent the direct or indirect risks to human or animal health , which could occur as a result of lack of identification.
(2) as far as it is medicinal products intended for use in animals, the Federal Ministry for food, agriculture and consumer protection, that each adopts the legal regulation in agreement with the Federal Ministry occurs in the cases of paragraph 1, 1a, 1B, or 3 at the Office of the Federal Ministry. The Decree according to paragraph 1, 1a or 1B was made in agreement with the Federal Ministry for environment, nature conservation and nuclear safety, insofar as radiopharmaceuticals and medicinal products, ionising radiation are used in their production, or in the cases of paragraph 1 No. 3 warnings, warning signs, or distinctive signs in regard to information according to § 10 para 1 sentence 1 No. 13 or paragraph 5 sentence 1 number 10 , Section 11, paragraph 4, sentence 1 No. 9 or § 11a paragraph 1 sentence 2 No. 6 letter f are prescribed.
(3) the Federal Ministry is also empowered to determine that medicines only in certain sizes in the traffic may be placed by means of an Ordinance without the consent of the Federal Council and by the pharmaceutical companies on the containers or, if used, on the outer packages are to be marked. The determination of this packaging is made for certain active substances and considered the applications, the period of use and the pharmaceutical form. In determining the sizes is basically to be a three-way split: 1 packs for short duration of use or compatibility tests, 2 packs for medium duration, 3 packs for longer duration.
Third section pharmaceutical manufacturing section 13 of manufacturing authorization (1) who 1 drug in the sense of article 2, paragraph 1 or paragraph 2 No. 1, 2. Testsera or test antigens, 3. active ingredients, which are human, animal or microbial origin or manufactured on the resulting paths or 4 others to drug manufacturing certain substances of human origin
commercial - or professionally manufactures, requires a permit from the competent authority. The same applies to legal persons, not unincorporated associations and civil law companies that produce medicines for the purpose of sale to their members. Sentence 1 is appropriate application on a test, on the basis of which the share of the placing on the market medicinal explains. § 14 paragraph 4 shall remain unaffected.
(1a) paragraph 1 does not apply to 1 tissue within the meaning of § 1a No. 4 of the transplantation act, for which a permit requires 20 (b) or section 20c according to §, 2. the collection and laboratory examination of autologous blood to produce biotechnologically processed tissue products, for which a permit is needed b according to § 20, 3. tissue preparations, for which a permit is needed according to § 20 c, 4. the reconstitution of , unless it is medicinal, are intended to the clinical trial.
(2) a permit referred to in paragraph 1 need not 1 the owner of a pharmacy for the manufacture of medicinal products within the framework of the usual pharmacy operation, or for the reconstitution or packaging including the labelling of medicinal products intended for clinical trials, unless this corresponds to the test plan, 2. the institution of a hospital, where he drug may leave after the pharmacy Act , or for the reconstitution or packaging including the labelling of medicinal products intended for clinical trials, unless this corresponds to the test plan, 3. the veterinarian within the framework of the operation of a veterinary medicine cabinet for a) the decanting, packaging or marking of medicines in an unchanged form, b) the manufacture of medicinal products which contain exclusively for transport outside of pharmacies released substances or preparations from such substances , c) the production of homeopathic medicines that contain for use in animals are determined, the aim of gaining food exclusively active substances, listed in the annex of Regulation (EU) No. 37/2010 as substances are listed, a setting of maximum residue levels is not required for the d) the preparation of medicines from a finished product and not pharmacologically active constituents, e) the mixing of finished medicinal products for the immobilization of Zoo , Wild and Park animals, when these activities for animals treated by him are made, 4. the wholesaler for the decanting, packing or marking of medicines in an unchanged form, insofar as not to packages intended for sale to the consumer, 5. the retailer of that has the expertise to § 50, for the decanting, packaging or marking of medicines to the levy in an unchanged form direct to consumer , 6 manufacturers of active substances, intended for the manufacture of medicinal products, manufactured according to a process engineering in the homeopathic part of the pharmacopoeia.
(2a) the exceptions referred to in paragraph 2 do not apply to the production of blood preparations, tissue preparations, sera, vaccines, allergens, Testsera, test antigens, medicinal products for advanced therapies, xenogenic and radioactive drugs. Sentence 1 shall not apply to that in paragraph 2 number 1 or number 2 above institutions, as far as it is about 1 patient-individual filling in unaltered form, the packaging or marking in the territorial scope of this Act of approved sera of non-human or animal origin, or 2. the reconstitution or the decanting, packaging or marking of medicinal products intended for clinical trials , unless this corresponds to the test plan, or 3 is the production of test allergens. Activities are number 1 and 3 pursuant to sentence 2 to indicate the competent authority.
(2B) a permit referred to in paragraph 1 is not a person who is a doctor or else is entitled to the practice of medicine in people, as far as the drugs under their direct professional responsibility for the purpose of personal use in a particular patient are made needed also. Sentence 1 finds no application 1. medicinal products for advanced therapies and xenogeneic medicinal and 2. medicinal products intended for clinical trials, insofar as it is not only a reconstitution.
(2c) paragraph 2 sentence 1 applies to veterinarians in the context of the operation of a veterinary medicine cabinet for use in treated by them animals according to.
(3) an according to paragraph 1 for the transfer of permission granted liquefied medical gases in the shipping container, a tank vehicle includes also the transfer of liquefied medical gases in an unchanged form from the shipping container, a tank vehicle in containers which are placed in a hospital or other consumers.
(4) the decision on the grant of the permit meets the competent authority of the country in which the establishment is or should be. Blood preparations, tissue preparations, sera, vaccines, allergens, medicinal products for advanced therapies, xenogenic medicines genetically specific manufactured pharmaceuticals, active ingredients and other for the manufacture of medicinal substances, are the human, animal or microbial origin or on resulting paths are made, was made the decision on the permit in consultation with the competent federal authority.

§ 14 decision of the manufacturing authorization (1) permission may be refused only if 1 not at least one person with the required according to § 15 expertise (qualified person according to § 14), which is responsible for the activities referred to in article 19 2 (dropped out) 3 the reliability to the exercise of their activity does not have the qualified person referred to in point 1 or the applicant, 4. the obligations incumbent upon it not constantly to meet the qualified person referred to in point 1 , 5 (lapsed) 5a.
in establishments which manufacture medicated foodstuffs from drug premixes, the person to whom the technical supervision of the production is transferred, has sufficient knowledge and experience in the area of the mixing technique, the doctor whose responsibility conducted a pretreatment of the giving person for the separation of blood stem cells or other blood components, has not the required expertise 5b., 5 c.
contrary to § 4, sentence 1 No. 2 of the transfusion Act No senior medical person has been appointed or this person has not the required competence according to the State of medical science or there is no medical person contrary to § 4, sentence 1 No. 3 of the transfusion Act in carrying out the donation collection by a human, 6 intent appropriate rooms and facilities for the manufacture, testing and storage of medicines are not available or 6a.
not the manufacturer is able to ensure that the manufacture or testing of medicinal products in addition is made according to the State of science and technology and on the collection of blood and blood components under the provisions of the second section of the Act of transfusion.
(2) (dropped out) (2a) the senior medical person according to § 4, sentence 1 No. 2 of the transfusion Act can also be the qualified person referred to in paragraph 1 No. 1.
(2B) (dropped out) (3) (dropped out) (4) by way of derogation from paragraph 1 No. 6 can the production of medicines for clinical trials on humans in a contracted Pharmacy partially outside the establishment of the drug manufacturer 1., 2. commissioned the change of the expiration date of pharmaceuticals for clinical testing on humans in a laboratory by a person of the manufacturer, provided these medicines only to be used in this test are , 3. the testing of medicinal products in authorized establishments, 4. the production or testing, including the laboratory testing of donor samples of drug manufacturing is certain substances of human origin, with the exception of tissue, in other companies or bodies that require any own permission, be carried out if there are suitable rooms and facilities in them for this and ensures that production and testing according to the State of science and technology and the qualified person referred to in paragraph 1, their responsibility to carry number 1.
(5) in the event of the submitted documents is to give the applicant an opportunity, to remedy defects within a reasonable period of time. Will not remedy the deficiencies, is the granting of permission to fail.

Section 15 provided expertise (1) which is proof of the required expertise as qualified person according to § 14 by 1 the licensure as a pharmacist or 2. one dropped test and a minimum two-year practical activity in the field of qualitative and quantitative analysis, as well as other quality tests of medicines the testimony about to completed university studies of pharmacy, chemistry, biology, human or veterinary medicine.
(2) in the cases of paragraph 1 No. 2 must be demonstrated the competent authority, that the University has includes theoretical and practical instruction in at least the following basic subjects and this knowledge are available: experimental physics General and inorganic chemistry organic chemistry analytical chemistry
Pharmaceutical Chemistry Biochemistry Physiology microbiology pharmaceutical Pharmacology toxicology pharmaceutical biology.
The theoretical and practical education and sufficient knowledge can no. 2 are acquired at a University after completing University studies within the meaning of paragraph 1 and demonstrated through testing.
(3) for the manufacture and testing of blood preparations, sera of human or animal origin, vaccines, allergens, Testsera and test antigens, paragraph 2 does not apply. In place of practical activities referred to in paragraph 1, at least three years work in the field of medical serology or medical microbiology must be demonstrated. By way of derogation from sentence 2 an at least three-year activity in the manufacture or testing in plasma processing plants with manufacturing authorisation and in addition a minimum six months experience in the transfusion medicine or medical microbiology, virology, hygiene and analysis, 2. for blood preparations from blood cells must in place of practical activities referred to in paragraph 1 1 for blood preparations from blood plasma for fractionation, preparations from fresh plasma, as well as for active substances and blood components to the production of blood preparations a minimum two-year transfusion medical experience , which extends to all areas of manufacturing and testing, 3. for autologous blood preparations a minimum six-month transfusion medical experience or a one-year activity in the manufacture of autologous blood preparations, 4 for Blutstammzellzubereitungen in addition to sufficient knowledge at least two years be proven experience in this activity, particularly in the underlying technology. To prepare people for the separation of blood stem cells or other blood components, the responsible medical person must demonstrate sufficient knowledge and at least two years experience in this activity. For the packing and marking it remains with the conditions of paragraph 1 (3a) for the manufacture and testing of medicinal products for advanced therapies, xenogenic medicines, paragraph 2 does not apply tissue preparations, medicinal products for in-vivo Diagnostics by means of marker genes, radiopharmaceuticals and drugs. Instead of practical activities referred to in paragraph 1 1 for gene therapy medicinal products and medicinal products for in-vivo Diagnostics by means of marker genes have an at least two-year activity on a medically relevant area, in particular genetic engineering, microbiology, cell biology, virology, or molecular biology, 2nd for somatic cell therapy medicinal products and biotechnology, an at least two-year activity on a medically relevant area, in particular genetic engineering, microbiology, cell biology edited tissue products , an at least three-year activity on a medically relevant area, includes a minimum two-year activity in particular area of the areas referred to in paragraph 1 Virology or molecular biology, 3rd for xenogeneic medicinal, 4. tissue preparations have an at least two-year activity in the field of the manufacture and testing of such medicines in plants and facilities requiring a manufacturing authorization under this Act or a permit under the law of the European Union , 5. for radiopharmaceuticals an at least three-year activity in the field of nuclear medicine and radio-pharmaceutical chemistry and 6 for other than those in paragraph 3 sentence 3 number 2 listed substances detected at least two years work in the manufacture or testing of active substances.
(4) the practice must be completed commissioned a referred to in paragraph 1 for a permit for the manufacture of pharmaceutical products has been granted by a Member State of the European Union, another Contracting State of the agreement on the European economic area, or by a State, with the mutual recognition of certificates according to section 72a, sentence 1, no. 1 is agreed.
(5) the practical activity is not required for the manufacture of medicated feedingstuffs from drug premixes; Paragraph 2 shall not apply.

§ 16 is limitation of the manufacturing authorization permission the applicants for a specific facility and for certain medicinal products and pharmaceutical forms issued in the cases of § 14 para 4 also for a specific establishment of the commissioned or other operation. As far as permission includes the testing of medicinal products or active substances, is the type of check list.

Article 17 deadlines for issuing (1) the competent authority has to make a decision on the application for the licence within a period of three months.
(2) a permit holder requested the change of permission in relation to the medicinal products to be manufactured, or in the rooms and facilities in the sense of § 14 para 1 No. 6, the authority has to make the decision within a period of one month. In exceptional cases, the period is extended by another two months. The applicant is to put this before deadline under communication of the reasons in knowledge.
(3) the authority shall give the applicant according to § 14 para 5 opportunity to remedy deficiencies, the deadlines will be constrained until the deficiencies or the expiration of the time limit according to § 14 para 5. The inhibition begins with the day the call to remedy the shortcomings will be sent to the applicant.

Article 18 withdrawal, cancellation, rest (1) is the permission to take back, if it is later known that one of the grounds of refusal has been according to § 14 para 1 of issuance. One of the grounds of refusal has subsequently occurred she should be revoked; in place of the revocation, even the rest of the permit can be arranged. § 13 para 4 finds appropriate application.
(2) for the time being, the competent authority may order that the manufacture of a medicament is set, if the manufacturer does not submit the evidence leading to the production and testing. The provisional arrangement can be limited to a batch.

§ 19 areas of responsibility of the qualified person according to § 14 is responsible for ensuring that each batch of medicinal product in accordance with the regulations on the marketing of medicinal products has been manufactured and tested. She has to certify compliance for each production batch in a continuous register or similar document before their placing on the market.

§ 20 obligations of the holder of the authorization has previously to show any change in one of the information referred to in article 14, paragraph 1 upon presentation of evidence of the competent authority. Unforeseen change of qualified person according to § 14, the display has to be carried out immediately.

Article 20a scope for active ingredients and other substances apply § 13 para 2 and 4, and sections 14 to 20 accordingly for active substances and other substances of human origin, unless their manufacturing or testing according to section 13, paragraph 1 requires a permit for drug manufacturing.

§ 20B permit for the extraction of tissue, and laboratory investigations (1) a wants to perform facility who win certain tissues within the meaning of § 1a No. 4 of the transplantation act (sampling device) for use in humans or the necessary lab tests for obtaining, requires a permit from the competent authority. Production within the meaning of sentence 1 is the direct or extracorporeal removal of tissue including all measures that are intended to identify the tissue in a loading or processing enabled state to receive, unique and transport. Permission may be refused only if 1 a properly trained person with the required professional experience does not exist, which, as far as it is a sampling device, can at the same time be the medical person within the meaning of section 8 d para 1 sentence 1 of the transplantation act, 2. Another contributor staff is not sufficiently qualified, 3 adequate rooms for the respective tissue extraction or for the laboratory tests are not available or not guaranteed 4. , that the tissue extraction or laboratory tests are made of sections 2, 3 and 3a of the transplantation law according to the State of medical science and technology, and according to the regulations.
The competent authority prior to issuance of the permit can refrain from a visit in the meaning of § 64 paragraph 3 sentence 2 under that provision. Permission is granted by the competent authority for a specific facility and for specific tissues and the lab for a specific facility and for certain activities of the sampling device. Thereby, the competent authority can participate in the competent federal authority.
(1a) section 20c paragraph 4 sentence 1 and 2 and paragraph 5 shall apply mutatis mutandis.
(2) an own permit referred to in paragraph 1 not required, who this under contractual binding carries out activities with a manufacturer or a loading or processors of a permission in accordance with section 13 or section 20 c of the working or processing of tissues or tissue preparations has. In this case the manufacturer or the loading or processor has the sampling device or the laboratory and the display to display the local competent authority for this the particulars and documents referred to in paragraph 1 sentence 3 to attach. After the expiration of one month after the notification pursuant to sentence 2 the manufacturer or the loading or processor has to display the sampling device or the laboratory of the competent authority, unless that has objected to the authority competent for the sampling device or the laboratory. In exceptional cases, extended the time limit pursuant to sentence 3 for a further two months. The manufacturer or the loading or processors is to put this before deadline under communication of the reasons in knowledge. Has objected to the competent authority, you are time limits in set 3 and 4 blocked, until the reason for the contradiction is resolved. Paragraph 1 sentence 3 to 6 shall apply accordingly subject to the proviso that permission set 5 is granted the manufacturer or the working or processing referred to in paragraph 1.
(3) the permit is to take back, if it is later known that one of the grounds for refusal has submitted pursuant to paragraph 1 sentence 3 of the issuance. One of these grounds for refusal has subsequently occurred is the permission to revoke; in place of the revocation, even the rest of the permit can be arranged. The competent authority may prohibit provisionally the extraction of tissue or the laboratory tests if the sampling device, the laboratory or the manufacturer or the loading or processors do not submit the evidence leading to the tissue extraction or laboratory tests.
(4) paragraphs 1 to 3 shall apply mutatis mutandis for the extraction and laboratory study of autologous blood for the manufacturing of biotechnologically processed tissue products.
(5) the holder of the permit has the competent authority of any change in paragraph 1 sentence 3 requirements for permission by presenting the evidence to show before and he may the only make change, if the competent authority has given written permission. Unforeseen change of appropriately trained person according to § 20, b has to be the display immediately.

§ 20c permit for the loading or processing, preservation, testing, storage or putting into circulation of tissues or tissue preparations (1) a facility, the tissues or tissue preparations, that not with industrial processes, or be processed and their substantial working or processing procedures are well known in the European Union, certain or process, preserve, check, store, or want to bring in the traffic, requires by way of derogation from article 13, paragraph 1 of a permission of the competent authority according to the following rules. This is true also with regard to tissues or tissue preparations, their working or processing methods are new, but similar to a known procedure. The competent authority of the country in which the establishment is or should be in consultation with the competent federal authority decides on the grant of permission.
(2) the permit may be refused only when 1 a person with the necessary expertise and experience does not exist according to paragraph 3 (person responsible according to § 20 c), which is responsible, that the tissue preparations and tissues in accordance with the law applicable will be - or processed, preserved, tested, stored or marketed, 2. Another contributor staff is not sufficiently qualified , 3. suitable rooms and facilities for the proposed activities are not available, 4 is not guaranteed that the working or processing, including the identification, preservation, and storage, as well as the test be made according to the State of science and technology, or 5 a quality management system not has been established according to the principles of good practice or is not kept up to date.
By way of derogation from sentence 1 number 3 can outside the permanent establishment of the examination of tissues and tissue preparations in authorized establishments which require any own permission, be performed if there are suitable rooms and facilities in them for this and ensure that checked the State of science and technology and the person responsible according to § 20 c their responsibility to carry.
(3) proof of the required expertise of the responsible person according to § 20c is dropped test as well as an at least two years practical experience in the field of the working or processing of tissues or tissue preparations provided by the testimony about a completed University of medicine, biochemistry, biology or a degree recognized as equivalent.
(4) in the event of the submitted documents is to give the applicant an opportunity, to remedy defects within a reasonable period of time. Will not remedy the deficiencies, is the granting of permission to fail. Permission is granted for a specific facility and for certain tissues or tissue preparations.
(5) the competent authority has to make a decision on the application for the licence within a period of three months. A permit holder requested the change of permission, the authority has to make the decision within a period of one month. In exceptional cases, the period is extended by another two months. The applicant is to put this before deadline under communication of the reasons in knowledge. Is the applicant the authority pursuant to paragraph 4 set the periods until the deficiencies are so 1 opportunity to remedy deficiencies or until expiry pursuant to paragraph 4 1 deadline inhibited set the. The inhibition begins with the tag where the call to remedy the shortcomings will be sent to the applicant.
(6) the holder of the authorization has previously to show any change in one of the information referred to in paragraph 2, upon presentation of evidence of the competent authority and can only make the change if the competent authority has given written permission. When an unforeseen change of person responsible according to § 20c, the display has to be carried out immediately.
(7) the permit is to take back, if it is later known that one of the grounds of refusal has been specified in paragraph 2 at the time. One of these grounds for refusal has subsequently occurred is the permission to revoke; in place of the revocation, even the rest of the permit can be arranged. Paragraph shall apply accordingly 1 sentence 3. Provisionally, the competent authority may order that the working or processing of tissues or tissue preparations is set when loading or processors not presents the evidence for leading the working or processing. Adjusts the working or processing of tissues or tissue preparations of working or processing has to make sure that still bearing tissue preparations and tissue are stored further quality assured and transferred to other manufacturers, loading or processors or distributors with a permit pursuant to paragraph 1 or article 13, paragraph 1. This also applies to the data and information concerning the working or processing required for this tissue preparations and tissue traceability.

§ 20 d exception from the permit requirement for tissue and tissue preparations of a permit according to § 20 paragraph 1 b and section 20 c paragraph 1 requires not a person who is a doctor or is entitled to the practice of medicine in people and exercise the activities referred to therein, with the exception of the placing on the market, to apply the tissue or tissue preparation personally in their patients. This shall not apply in the case of medicinal products intended for clinical trials.
Fourth section of medicinal products article 21 authorisation (1) finished medicinal medicines in the sense of § 2 paragraph 1 or paragraph 2 are no. 1, may be placed on the territorial scope of this Act only in the traffic, if they are approved by the competent federal authority or if for the European Community or the European Union an authorisation for the placing on the market referred to in article 3 paragraph 1 or 2 of Regulation (EC) No. 726/2004 also in connection with Regulation (EC) No. 1901 /. 2006 of the European Parliament and of the Council of 12 December 2006 on medicinal and amending Regulation (EEC) No 1768/92, directives 2001/20/EC and 2001/83/EC and Regulation (EC) No 726 / 2004 (OJ OJ L 378 of 27.12.2006, p. 1) or no. 1394/2007 Regulation (EC) has granted. This also applies to medicines, no finished product and are intended for use in animals if they not to be traded to pharmaceutical entrepreneur, have a permit for the manufacture of medicinal products.
(2) a registration need not for medicines, the 1st for use in people are designed and manufactured due to demonstrably more common medical or dental prescription in the main production steps at a pharmacy in an amount up to one hundred levy finished packs a day in the usual pharmacy operation and intended to submit in the context of the existing pharmacy operating permit, 1a.
Drugs are substances of human origin are used in their manufacture and that are intended for autologous or directed, intended for a particular person only, or manufactured on the basis of a formula for individuals, unless it's medicinal products within the meaning of § 4 paragraph 4, others are 1B. as the medicinal products referred to in paragraph 1a and for pharmacies , where a patient is a prescription of medicinal products authorised in the territorial scope of this Act a) as Zytostatikazubereitung or for the parenteral nutrition as well as others, unless it is necessary for the adequate supply of the patient and is no approved drug available, manufactured in medically justified special needs cases or b) when blisters are made of unchanged drug or c) are filled in an unchanged form , 1c.
intended for use in humans are and have antiviral or antibacterial efficacy to treat of a dangerous communicable disease, whose spreading requires providing immediate and significantly exceeding the usual level of specific medicinal products, active substances made are, which have been stored for as long as their production in a pharmacy to submit in the context of the existing pharmacy operating permit or for sale to other pharmacies by the health authorities of the Confederation or of countries or of these notified bodies for these purposes , 1 d.
Tissue preparations that are subject to the approval under the provisions of section 21a, para 1, 1e.
Mineral water, bathroom Moore or other peloids are, which is manufactured in advance and not placed in a package destined for delivery to the consumer in the traffic, or are intended exclusively for external use or for inhalation on the ground, 1f. medical gases are and for single persons from medicines approved in the territorial scope of this Act by filling and marking in Enterprise , who are outside authorised according to § 50 to the retail sale of medicinal products by pharmacies, are made, 1 g.
as therapy allergens for individual patients on the basis of a formula are made, 2. to clinical trials in humans are determined, medicated feedingstuffs 3. that are intended use of medicinal premixes are produced, is granted for approved according to § 25, produced 4. for individual animals or animals of a particular stock in pharmacies or veterinary house pharmacies under the conditions of paragraph 2a, 5 for clinical testing in animals or for residue testing determines are or 6 under in article 83 of Regulation (EC) No. 726 / 2004 conditions laid down for free are provided for a use in patients, who suffer from a disease, leading to severe disability or whose Krankheit is life threatening, and; not satisfactorily treated with an approved drug This applies also to the not the categories referred to in article 3 paragraph 1 or 2 of Regulation (EC) No. 726 / 2004 related medicines; Procedural rules are determined in a Decree according to § 80.
(2a) medicinal products that contain non-shared substances and preparations of substances, for transport outside of pharmacies can be used no. 4 only referred to in paragraph 2, if the treatment is an approved drug for the relevant species or the relevant application area not available to, the necessary medical care of animals would otherwise seriously at risk and is not to be feared of a direct or indirect danger to human and animal health. The manufacturing of medicinal products in accordance with sentence 1 is allowed only in pharmacies. Sentence 2 shall not apply for the preparation of pharmaceutical products in a finished product and non-pharmacologically active constituents, as well as for the mixing of finished medicinal product for the purposes of the immobilization of Zoo, wildlife and Park animals. Not the decanting, packaging or marking of medicines in unmodified form is considered manufacture within the meaning of sentence 1, as far as 1 no finished product in sizes appropriate for each individual case in the trade are available or 2. in other cases the container or any other form of drug packaging that is directly with the drug in contact, is not damaged.
Sentences 1 to 4 do not apply to registered or exempted from registration homeopathic remedies, which, for use in animals are determined, the aim of gaining food exclusively active substances containing in the annex of Regulation (EU) No. 37 / 2010 when substances are listed, for a determination of maximum residue limits is not required.
(3) the authorisation shall be requested by the pharmaceutical entrepreneur. For a finished product that is manufactured and delivered to consumers under a single name in pharmacies or other retail establishments on the basis of uniform regulations is the approval by the Publisher of the production rule to apply. Produced a finished product for multiple pharmacies or other retail establishments and should it appear under their name and under a single name on consumer, the manufacturer has admission to apply for.
(4) the competent federal authority decides also, independently of an application for authorisation pursuant to paragraph 3 or by a permit request under article 21, paragraph 1, or article 42 paragraph 2, at the request of a competent authority of the country through the authorisation of a medicinal product, the authorisation of a tissue preparation or the authorisation of a clinical trial. The competent authority of the country has the request to add a reasoned opinion on the classification of the medicinal product or the clinical trial.

§ 21a approval of tissue preparations (1) tissue preparations that not with industrial processes, or be processed and their substantial working or processing procedures are shown in the European Union sufficiently known and their effects and side effects of the scientific knowledge material, may be placed in the territorial scope of this Act only if they have been approved by way of derogation from the authorisation requirement pursuant to section 21 para 1 of the competent federal authority. This is true also with regard to tissue preparations, their working or processing methods are new, but similar to a known procedure. Sentence 1 applies accordingly to Blutstammzellzubereitungen intended for the application of autologous or directed, earmarked for a specific person. The approval covers the procedures for obtaining, processing and testing, donor selection and the documentation for each step in the process, as well as the quantitative and qualitative criteria for tissue preparations. In particular, the critical processing procedures to evaluate are that the procedures do not clinically ineffective or harmful for the patient the tissue.
(1a) a permit referred to in paragraph 1 there is no need for tissue preparations intended for clinical trials in humans.
(2) the request for approval are to include the following information and documents by the applicant: 1. the name or business name and the address of the processor, 2. the label tissue preparation, 3. application areas, as well as the type of application and tissue preparations, only limited time to be applied, the duration of application, 4. information about the collection and laboratory analysis of the tissue as well as the working or processing , Preservation, testing and storage of the tissue preparation, 5. the method of preservation, shelf life and the nature of storage, 6 is a description of the functionality and the risks of tissue preparation, 7 documents about the results of the microbiological, chemical and physical tests and the methods applied to determine, so far as those documents are required, as well as 8 data relevant for the assessment of the medicinal product and documents.
Article 22, paragraph 4 shall apply mutatis mutandis.
(3) for the information referred to in paragraph 2 No. 3 may be submitted scientific knowledge material, which can be also in medical experience material recycled according to scientific methods. For this purpose come studies of the manufacturer of the tissue preparation, data from publications or subsequent reviews of the clinical results of the manufactured tissue preparations into account.
(4) the competent federal authority has to make a decision on the request for approval within a period of five months. Opportunity is given the applicant to remedy defects, the deadlines are inhibited until the deficiencies or the expiration of the time limit for rectification. The inhibition begins with the tag where the call to remedy the shortcomings will be sent to the applicant.
(5) the responsible federal authority granted the approval in writing under an approval number. It can combine the approval with conditions. section 28 and section 34 shall apply appropriate.
(6) the competent federal authority must approval fail only if 1 the submitted documents are incomplete, 2. that tissue preparation is not the State of scientific knowledge or 3.
the tissue preparation not which fulfils the intended function or the benefit risk ratio is unfavorable.
(7) the applicant or after approval, the holder of the authorisation has immediately to report the competent federal authority, enclosing relevant documents when changes in the particulars and documents arising under paragraph 2 and 3. In the event of a change in the documents pursuant to paragraph 3 the change may be performed only if the competent federal authority has agreed to.
(8) the approval is to take back, if it is later known that one of the grounds of refusal has been no. 2 and 3 pursuant to paragraph 6. She shall be revoked if one of the grounds for refusal is subsequently entered. In both cases also the rest of the permit can be arranged temporarily. Before a decision is taken pursuant to sentences 1 to 3, the holder of the authorisation to hear is, unless that is danger in arrears. The authorisation is withdrawn or revoked, or the approval rests so the fabric preparation in the transport may be brought and spent not within the territorial scope of this Act.
(9) by way of derogation from paragraph 1 tissue preparations that are allowed in a Member State of the European Union or in another Contracting State to the agreement on the European economic area on the market require at their initial spending for the purpose of its application in the area of application of this Act of a certificate of the competent federal authority. Prior to the issuance of the certificate, the competent federal authority has to examine whether the working or processing of the tissue preparations meet the requirements of the collection and processing procedures, including donor selection procedures and laboratory tests, as well as the quantitative and qualitative criteria for the tissue preparations the requirements of this Act and its regulations. The competent federal authority has to issue the certificate if the equivalence of the requirements arising pursuant to sentence 2 of the approval certificate or other certificate of the competent authority of the country of origin and evidence of the authorisation in the Member State of the European Union or the other Contracting State of the agreement on the European economic area will be presented. A change in the requirements is under sentence 2 to display the competent federal authority in good time before a further entry into the territorial scope of this Act. The certificate is to take back if one of the requirements has not been pursuant to sentence 2; It shall be revoked if one of the conditions has subsequently been removed pursuant to sentence 2.

Section 22 registration documents (1) the application for authorisation must be accompanied by the applicant the following information: 1. the name or business name and the address of the applicant and of the manufacturer, 2. the name of the medicinal product, 3. the constituents of the medicinal product to type and quantity; § 10 paragraph 6 shall apply 4. the pharmaceutical form, 5. the effects, 6 applications, 7 the contraindications, 8 the side effects, 9 the interactions with other means, 10 the dosage, 11 to the manufacturing process of the medicinal product, 12 the kind of application and medicines only limited time to be applied, the duration of use, 13 the pack sizes, 14 the nature of preservation , the shelf life, the type of storage, the results of durability tests, 15 the methods to control of the quality (control methods).
(1a) the information referred to in paragraph 1 must in German; added other information in German or English language number 1 to 10 other information or documents may be be in the approval procedure instead of German in English made or presented, as far as it is not information, used for the labelling, the leaflet or the prescribing information.
(2) it shall also be provided: 1. the results of physical, chemical, biological or microbiological tests and their determination methods (screening), 2 the results of pharmacological and toxicological tests, 3. the results of clinical trials or other medical, dental or veterinary testing, 4. a statement that clinical tests conducted under ethical conditions with the ethical conditions of Directive 2001/20/EC of the Parliament and of the Council of 4 April 2001 have been conducted outside the European Union to the Approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials of medicinal products for human use (OJ EC No. L 121 of the 1.5.2001, p. 34) 5th in medicinal products which are intended for use in humans, a summary description of the pharmacovigilance system of the applicant, which must include the following are equivalent: a) proof that the applicant is a qualified person according to article 63a, and the indication of the Member States in which that person is domiciled and operating, as well as the contact information for this person , b) the indication of the place where the pharmacovigilance system master file for the medicinal product concerned is run, and c) a declaration signed by the applicant, that he has the necessary resources to the tasks listed in the tenth section and duties to fulfil, 5a.
for medicinal products intended for use in humans, the risk management plan with a description of the risk management system which the applicant for the medicinal products concerned will introduce, connected with a summary, 6 for medicinal products which are intended for use in animals, a detailed description of the pharmacovigilance system of the applicant, proof that the applicant is a qualified person according to article 63a and, if necessary , of the risk management system which the applicant will introduce, as well as a proof of the necessary infrastructure to report all suspected cases of side effects in accordance with section 63 h, 7 copy of any designation of the medicinal product as medicinal medicinal products pursuant to Regulation (EC) No 141 / 2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products for orphan (OJ EC No. L 18, p. 1), 8 for medicinal products which are intended for use in humans, the drug manufacturer, confirmation that he or a person authorized by him contractually; convinced itself of the observance of good manufacturing practice in the production of active ingredient by a review site the confirmation must include the date of the audit.
The results are so to prove through documentation that nature, scope and time of tests emerge from these pursuant to sentence 1 No. 1-3. Are all the request to add relevant information and documents, whether favourable or unfavourable, for the assessment of the medicinal product. This also applies to incomplete or broken toxicological or pharmacological tests or clinical trials for the drug.
(3) in place of the results referred to in paragraph 2 No. 2 and 3 can be presented different scientific knowledge material, and while 1 in a drug, its Wirkstoffe general medical or veterinary uses for at least ten years in the European Union whose effects and side effects were, known and visible from the scientific knowledge material 2 for a drug that is similar in its composition a drug already referred to in point 1 are , 3. in the case of a drug that is a new combination of known elements, for these components; It can be presented but also for the combination as such other scientific knowledge material if the efficacy and safety of the medicinal product are determined according to composition, dosage, dosage forms and applications on the basis of these documents.
The medical experience of the respective treatment directions are also taken into account.
(3a) the drug more than an active ingredient contains, is to establish that each active ingredient contributes to the positive assessment of the medicinal product.
(3B) for radiopharmaceuticals that are generators, also a general description of the system with a detailed description of the components of the system which may affect the composition or quality of the daughter radio nuclide preparation, and qualitative and quantitative characteristics of the eluate or sublimate to be specified.
(3c) in addition, documentation shall be provided, with which a possible environmental risk assessment is made, and in the event that the storage of the medicinal product or its application or its waste requires special precautions or safeguards, to threats to the environment or people's health to avoid animals or plants, this is also specified. To reduce these hazards are be accompanied and justified. For medicinal products which are intended for use in animals are also the results of the tests for the assessment of possible environmental risks to present; Paragraph 2 shall set 2 to 4 apply accordingly.
(4) if the authorisation for a medicinal product manufactured within the territorial scope of this Act is requested, so must be verified that the manufacturer is authorized to produce the drug. This does not apply to an application according to § 21 para 3 sentence 2 (5) is applied for authorisation for a medicinal product manufactured outside the scope of this law, proof must be provided that the manufacturer is authorized under the legal provisions of the country of manufacture is, to produce medicines, and in the case of introduction from a country which is not member of the European Union or another Contracting State of the agreement on the European economic area , that the importer has a permit that authorizes the spending of the medicinal product in the territorial scope of this Act.
(6) where a registration abroad has been granted, a copy of this approval is and, insofar as it is medicinal products intended for use in people shall be accompanied by a copy of the summary of safety data, including data from the periodic updated safety reports, where available, and the reports of suspected cases of adverse reactions. Is an approval completely or partially failed been, are the details of this decision, setting out its reasons to communicate. Is an application for authorisation in a Member State or in several Member States of the European Union examined, this must be stated. Copies of the approved summary of product characteristics and the package inserts by the competent authorities of the Member States or, as far as these documents are still not available, the versions of these documents proposed by the applicant in a proceeding pursuant to sentence 3 shall also be attached. In addition, are, unless requested the recognition of authorisation from another Member State is, in article 28 of Directive 2001/83/EC or in article 32 of Directive 2001/82/EC to make the prescribed statements, as well as to make the disclosures prescribed. Sentence 5 shall not apply to medicinal products which have been produced according to a homeopathic procedure technique.
(7) the text is the application for the container, provided information, as well as the draft of summary of product characteristics to attach the outer wrapping and the package leaflet, where at the same time is the specialist information according to § 11a paragraph 1 sentence 2, where such is required. The results of assessments of the leaflet are the competent federal authority for medicinal products intended for use in humans, also to present, which were carried out in cooperation with target patient groups. The competent federal authority may request that their one or more specimens or models of sales of the medicinal product including package inserts as well as raw materials, intermediates and substances used for the manufacture or testing of the medicinal are presented in sufficient for the examination and in a condition suitable for the investigation.

Section 23 is special documentation to medicines for animals (1) for medicinal products intended for use in animals, the aim of gaining food, section 22, 1 to specify the wait and with records of the results of residue testing, in particular about the fate of the pharmacologically active components and their transformation products in the animal body, and about the influence of food of animal origin, as far as these are required for the evaluation of waiting times, taking into account maximum residue limits measures to set , to justify and 2nd in a medicinal products pharmacologically part of which in table 1 of the annex of to Regulation (EU) No. 37/2010 is not listed, a certificate to submit, is confirmed by the that at the European Medicines Agency at least six months before the filing a request under 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 residue limits of pharmacologically active substances in Foodstuffs of animal 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 152 of the 16.6.2009, p. 11) been in the currently valid version.
Sentence shall not apply 1 No. 2, § 25 para 2 sentence 5 shall apply.
(2) medicinal premixes is the feed specific as a carrier under the name of the feed type to specify. It is also establishing and documents to prove that the drug premixes for the proper manufacture of medicated feedingstuffs are suitable, in particular that they allow a homogeneous and stable distribution of the active ingredients in the medicated feed, taking into account the process coming at the compound feed production to the application; to establish and to demonstrate for what length of time the medicated feedingstuffs are stable through documents is also. In addition, there is a routinely viable control method which is suitable for qualitative and quantitative detection of the active ingredients in the medicated feedingstuffs, to describe and prove through documentation of test results.
(3) nature, scope and time of tests must emerge from the documents on the results of the residue testing and about the backlog of compliance referred to in paragraph 1 as well as the evidence regarding the suitability of medicinal premixes for the proper manufacture of medicated feedingstuffs and the examination results of the control methods referred to in paragraph 2. Other scientific knowledge material can be presented in place of the documents, evidence and examination results pursuant to sentence 1.

§ 24 control methods, testing results, and residue detection methods combined expert opinion (1) according to section 22 para 1 No. 15, par. 2 and 3 and article 23 are required documents attach the opinion of experts, in which and evaluated. In particular to the opinion in particular emerge from: 1. analytical advice, whether the medicinal product that has adequate quality, whether proposed control methods correspond to the current state of scientific knowledge and are suitable for the assessment of quality according to the recognised pharmaceutical rules, 2nd from the pharmacological toxicological opinion, what are the toxic effects and which pharmacological properties has the medicinal, 3rd clinical advice , whether the medicinal product in the specified areas of application is reasonably effective, whether it is tolerated if the proposed dosage is appropriate and which contra-indications and side-effects are, residues in food obtained from the treated animals occur 4. advice on the gap assessment, whether and for how long after the use of the medicinal product, how to assess residues and whether the proposed withdrawal period is inadequate.
Must be drawn from the opinion also that the existing after the specified waiting period residues below that no. 37 / 2010 established maximum residue limits according to type and quantity in the annex of to Regulation (EU).
(2) as far as scientific knowledge material is presented according to article 22, paragraph 3, and article 23, paragraph 3, sentence 2, must emerge from the opinion, that the scientific knowledge material in by analogy with application of the drug testing policy was developed.
(3) the opinion must be accompanied by information on the name, the training and employment of experts and his professional relationship with the applicant. The experts have to confirm that the opinion of them has been created with signature of the date.

§ 24a use of documents of Vorantragen controller of the applicant can refer to documents according to section 22 paragraph 2, 3, 3 c and § 23 paragraph 1 including the expert advice according to § 24 para 1 sentence 2 of a previous applicant (Vorantragen controller), unless the prior written consent of the Vorantragen controller submit including its confirmation, that the documents to which reference is made, meet the requirements of drug testing guidelines pursuant to section 26. The Vorantragen controller has to comment on a request for approval within a period of three months. A partial reference is not allowed.

section 24 (b) approval of a generic medicinal product, data protection
(1) in the case of a generic medicinal product within the meaning of paragraph 2 can no. 2 and 3 and § 23 paragraph 1 including the expert advice according to § 24 para 1 sentence 2 be referred without the consent of the Vorantragen bridge on the documents according to article 22, paragraph 2, sentence 1 No. 2 to 4 of the medicinal product the Vorantragen controller (reference medicinal products), provided that the reference medicinal product is approved for at least eight years or has been approved at least eight years ago. This also applies an authorisation in another Member State of the European Union. A generic drug that has been approved in accordance with this provision, must be taken at the earliest after ten years after the first approval for the reference medicinal products on the market. The period referred to in sentence 2 is extended to no more than eleven years, if the holder of the authorisation period of eight years since the approval obtained the extension of the approval to one or more new areas of application in the scientific assessment prior to their approval by the competent federal authority be judged significant clinical benefit in comparison with existing therapies.
(2) the approval as a generic requires pursuant to paragraph 1, that the medicinal product concerned has the same composition of the active substances according to type and quantity and the same pharmaceutical form as the reference medicinal product, and the bio-equivalence has been demonstrated through bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance are considered is whether it is the same active ingredient, because their properties are different significantly regarding the safety or effectiveness. In this case additional documents must be submitted by the applicant prove the safety or efficacy of various salts, ester, ethers, isomers, mixtures of isomers, complexes or derivatives of the active ingredient. The various immediate-release oral pharmaceutical forms are considered one and the same pharmaceutical form. The applicant is not obliged to submit bioavailability studies when he can prove otherwise, the generic medicinal product meets the relevant criteria according to the State of the science for the bio-equivalence. In those cases where the medicinal product does not a generic requirements, or where bio-equivalence not proven by bioequivalence studies or change of the active ingredient, the application area, strength, pharmaceutical form or the route of administration compared to the reference medicinal product are the results of appropriate pre-clinical or clinical trials to present. Medicinal products which are intended for use in animals are the appropriate safety studies of medicinal products intended for use in animals which serve food, to present the results of the corresponding residue tests.
(3) if the reference medicinal product was not approved by the competent federal authority and the competent authority of another Member State, has the applicant in the application form to indicate the Member State in which the reference medicinal product has been approved or is. The competent federal authority invites the competent authority of the other Member State, to convey that the reference medicinal product is approved or has been, a confirmation within a month, as well as the full composition of the reference medicinal product, and other documents in this case, unless they are required for the approval of generic medicinal products. In the case of the authorisation of the reference medicinal product by the European Medicines Agency, the competent federal authority asked them to the particulars referred to in sentence 2 and documents.
(4) if the competent authority of another State of of Member in which an application is submitted, the competent federal authority to transfer 2 information referred to or documents requested set of in paragraph 3, the competent federal authority to comply with this request within a month, if at least eight years after the first approval for the reference medicinal product have passed.
(5) meets a biological medicinal product which is similar to a reference biological medicinal product, because especially the raw materials or the manufacturing processes of the biological medicinal product are different from the reference biological medicinal product, are not so for applicable generic requirements referred to in paragraph 2 the results to present appropriate vorklinischer or clinical tests with regard to these variations. The type and number of additional documents to be submitted must comply with the criteria relevant to the State of the science. The results of other tests from the registration documents of the reference medicinal product shall not be provided.
(6) in addition to the provisions of paragraph 1 a cannot be cumulated exclusivity period, granted if it is a request for a new field of application of a known substance General medically used for at least ten years in the European Union, one year for the data, obtained on the basis of significant pre-clinical tests or clinical trials relating to the new field of application.
(7) paragraph 1 sentence 3 and paragraph 6 shall not apply to generics, which are intended for use in animals. In paragraph 1 sentence 2 called period extended 1. for medicinal products which are intended for use in fish or bees to years thirteen, 2. for medicinal products which are intended for use in one or more species which serve the production of food, and containing a new active substance which was approved on 30 April 2004 not yet in the community , at each extension of the approval on a more species, which serves the production of food, has been granted five years since the admission by one year. This period may not exceed a total of thirteen years for authorisation for four or more species, the aim of gaining food.
The extension of the ten-year period for a medicinal product of a species, which serves food on premise eleven, twelve or thirteen years is under the that the holder of the authorisation requested originally also the fixing of MRLs for the animals affected by the admission.
(8) if it is the extension of an authorisation for a medicinal products approved according to § 22 para 3 on a target species, which serves food that's been obtained by presenting new residue trials and new clinical trials, an exclusivity period is granted the approval for the data three years after the grant, for the above tests were carried.

§ 24c supplementations must by several market authorisation holders substantially the same documents are demanded, it will inform the competent federal authority any holder of the authorisation which documents for the further assessment are required, as well as name and address of other concerned marketing authorisation holder. The competent federal authority participating holders of admission gives opportunity to some who shall submit the documents within a period to be determined by you. An agreement not be reached, decides the competent federal authority and inform immediately all those involved. These are, as long as they do not waive the marketing authorisation of medicinal, committed to each with a fraction corresponding to the number of participating holders of authorisation the expenses for the preparation of documents to participate in; they are liable as joint and several debtors. Sentences 1 to 4 shall apply mutatis mutandis for the users of standard approvals and, if substantially the same documents are required by several applicants in approval proceedings.

section 24 d General utilization authority the competent federal authority can in performance of their duties under this Act you present documents with the exception of documents according to section 22 para 1 No. 11, 14 and 15, as well as exploit para 2 No. 1 and the report according to section 24, subsection 1, sentence 2 No. 1, provided the initial authorisation of the medicinal product in a Member State of the European Union for more than eight years is back or a procedure according to § 24 c not yet is completed or unless the articles 24a and 24B contain more specific provisions for referring to documents of a Vorantragen controller.

Section 25 decision on the approval of (1) the responsible federal authority granted approval in writing under a registration number. The approval applies only for the medicines listed in the letter of admission and for medicinal products which are manufactured according to a homeopathic process engineering, also for a according to § 25 paragraph 7 sentence 1 result made known 1994 amended prior to 17 August, mentioned and listed in the notice of admission dilution levels.
(2) the competent federal authority may admission only fail when 1 the presented documents, including such documents are to be submitted on the basis of a regulation of the European Community or the European Union, are incomplete, 2.
the drug not after each backed-up state of scientific knowledge is has been tested sufficiently or the other scientific knowledge material according to § 22 para 3 is not each backed-up state of scientific knowledge, 3. the medicinal product not according to the recognised pharmaceutical rules is made or has not the proper quality, 4 the therapeutic efficacy of specified by the applicant is missing the drug or is insufficiently justified each backed-up state of the scientific evidence by the applicant , 5. the risk-benefit balance is unfavourable, 5a.
When a drug that contains more than an active ingredient that lacks a sufficient explanation that each active ingredient contributes to the positive assessment of the medicinal product, taking into account the particularities of each drug in a tiered risk assessment, 6 the specified amount of time is not sufficient, 6a.
When drug premixes for the qualitative and quantitative detection of the active ingredients in the medicated feedingstuff of control methods are not routinely achievable, the medicinal product for use in animals is intended 6B., producing food, and contains a pharmacologically active ingredient, not in table 1 of the annex of to Regulation (EU) No. 37 / 2010 contained 7 the placing on the market of the medicinal product or its application in animals against legislation or a regulation or a directive or a decision, or a Decision of the European Community or the European Union would violate.
Admission 1 No. 4 must not be refused pursuant to sentence because therapeutic results only in a limited number of cases have been achieved. The therapeutic effectiveness is missing, if the applicant does not change with each backed-up state of the scientific results that are therapeutic results can be achieved with the medicinal. The medical experience of the respective direction of therapy must be considered. May the authorisation pursuant to sentence 1 No. 6b not be failed if the medicinal product for the treatment of equidae destined, where that article 6 para 3 of Directive 2001/82/EC are conditions laid down, and it meets the other requirements of article 6 para 3 of Directive 2001/82/EC.
(3) the admission is to fail, which differs from an approved or already in circulation medicinal of same designation in the kind or amount of the active ingredients of a medicinal. By way of derogation from sentence 1, a difference in the quantity of the active substances is harmless, if the drug in the dosage form are different.
(4) is the competent federal authority of considers that an authorisation on the basis of the presented documents can not be granted, it informs the applicant, stating the reasons. The applicant is to give the opportunity to remedy defects within a reasonable period of time, however a maximum of six months. Is not within this period of remedy the defects is the authorisation to fail. After a decision on the refusal of the registration, the submission of documents relating to remedy the defect is excluded.
(5) the approval shall be granted on the basis of the examination of the documents submitted and on the basis of expert opinion. To the assessment of the dossier, the competent federal authority can exploit their own scientific results, consult experts or requesting advice. The competent federal authority can check in companies and institutions that develop drugs, manufacture, check or clinically check accreditation-related information and documents, also relating to authorisation for the placing on the market referred to in article 3 paragraph 1 or 2 of Regulation (EC) No 726 / 2004. For this purpose, representatives of the competent federal authority in consultation with the competent authority of operating and business premises during normal business hours can enter, examine documents and demand information. The competent federal authority can run also the assessment of the documentation by independent experts of the counter and puts their assessment of the authorisation decision and, insofar as medicinal, which according to § 48 para 2, no. 1 are subject to prescription, the Accreditation Commission pursuant to paragraph 6 sentence 1 referring to draft of the approval decision. An opposing expert pursuant to sentence 5 may be authorized by the competent federal authority, who has the required expertise and to engage in activity as a counter expert required reliability. Insight in the opinion is at the request of the applicant. The applicant requires to consult asked experts from him, also this should be heard. As expert, counter expert and appraiser, paragraph 6 applies to appeal sentences 5 and 6 according to.
(5a) the competent federal authority creates also an assessment report on the documents submitted to the quality, safety and efficacy and emits is also to risk management and to the pharmacovigilance system an opinion regarding the results of the pharmaceutical and pre-clinical tests and clinical trials, as well as for medicinal products intended for use in humans,. for medicinal products intended for use in animals which serve the production of food, the assessment report also refers to the backlog results. The assessment report is to update, if this new information becomes available.
(5B) Article 5a shall not apply to medicinal products which are manufactured according to homeopathic process technology, provided that these medicines article 16 para 2 of Directive 2001/83/EC or article 19 para 2 of Directive 2001/82/EC are subject to.
(6) before the decision on the authorisation of a medicinal product, phytotherapy, homeopathy and anthroposophy attributable to the therapy directions and that prescription no. 1 subject to § 48 para 2, is an Accreditation Commission. The consultation covers the contents of the documents submitted, the expert evidence, the requested opinion, the opinions of any experts, the test result and the reasons that are essential for the decision on the approval, or judging by other experts. The federal authority when deciding on the request differs from the result of the hearing, she has the reasons for the differing decision to present. As far as it is in agreement with the Federal Ministry of food, agriculture and consumer protection to drug use in animals, the Ministry appoints the members of the Accreditation Commission, taking into account proposals of the Chambers of the health professionals, the professional associations of doctors, dentists, veterinarians, pharmacists, naturopaths, as well as the relevant umbrella organisations formed for the defence of their interests of pharmaceutical contractors, patients and consumers. In the appeal, the respective characteristics of medicinal products must be considered. The approval commissions appointed experts are on the respective areas of application and in the respective direction of therapy (phytotherapy, homeopathy, anthroposophy) have scientific knowledge and practical experience.
(7) for medicines that no. 1 not subject to prescription according to § 48 para 2, commissions for certain areas of application or treatment directions are formed at the competent federal authority. Paragraph 6 is set 4 to 6 shall apply. The competent federal authority can contribute to the preparation of the decision on the renewal of authorisations according to article 105, paragraph 3, sentence 1 the competent Commission. The decision concerns pursuant to sentence 3 medicinal products a certain direction of therapy (phytotherapy, homeopathy, anthroposophy), is the responsible Committee to participate, unless a complete refusal of the extension plans according to section 105, paragraph 3, sentence 1 or the decision of fundamental importance; She shall within two months opportunity to comment. As far as the federal authority not taken into account the opinion of the Commission the decision pursuant to sentence 4, setting out the reasons.
(7a) to improve drug safety for children and young people formed a Commission for medicines for children and young people at the Federal Institute for drugs and medicine products. Paragraph 6 is set 4 to 6 shall apply. For the preparation of the decision on the application for authorisation of a medicinal product, which is intended also for use in children or adolescents, the competent federal authority involved in the Commission. The competent federal authority can also to the preparation of the decision on the application for approval of another as to set 3 of referred to medicinal, with an application in children or adolescents into account, participate in the Commission. The Commission has the opportunity to comment. As far as the federal authority disregarded the opinion of the Commission in the decision, setting out the reasons. The Commission may also to medicines, which determine the State of the science for it, not for use in children or adolescents are admitted under what conditions these drugs can be used in children or adolescents. For the medicines of phytotherapy, homeopathy and anthroposophical medicine the tasks and powers are perceived after the sentences 3 to 7 of the commissions under paragraph 7 sentence 4.
(8) in the case of Sera, vaccines, blood preparations, tissue preparations, allergens, xenogenic medicinal products that are not medicines according to § 4, paragraph 9, the competent federal authority granted the approval on the basis of the examination of the documents submitted or on the basis of its own investigations, or on the basis of observing the tests of the manufacturer. Representatives of the competent federal authority in consultation with the competent authority of operating and business premises during normal business hours can enter and make visits in these, as well as in the means of transport serving the operation. At the request of the competent federal authority, the applicant must notify the manufacturing process. These medicines, the paragraphs 6, 7 and 7a shall not apply.
(8a) article 8 set 1 to 3 finds appropriate application on control methods according to § 23 para 2 sentence 3 (9) different strengths, dosage forms, routes of administration, or Ausbietungen of a medicinal product are requested, this approval comprehensive subject to a uniform at the request of the applicant can be so; This also applies to subsequent amendments and extensions. While a uniform registration number is to use more flags to distinguish the dosage or concentrations must be added to. For approvals under section 24 para 1 b shall apply individual approvals of a reference medicinal as a single comprehensive authorisation.
(10) the authorisation shall be without prejudice to the civil and criminal responsibility of the marketing authorisation.
Footnote (+++ § 25 paragraph 9: to the application see section 141 paragraph 9 +++) § 25a preliminary examination (1) the responsible federal authority can the approval by independent experts on completeness and then check allow, whether the medicinal product has been sufficiently tested each backed-up state of scientific knowledge. § 25, subsection 6, sentence 5 applies the appropriate.
(2) in the case of complaints within the meaning of paragraph 1, the expert has to give the applicant an opportunity, to remedy the defects within three months.
(3) the application for authorisation is after the deadline on the basis of the final opinion of the experts still incomplete or deficient in accordance with § 25 paragraph 2 No. 2, is the authorisation to fail. § 25 para 4 and 6 shall not apply to the preliminary examination.
(4) the competent federal authority ascertains that a same instructions are received approval in another Member State of the European Union will be examined, they rejected the request, and sets the applicant informed that a procedure shall 25 b apply pursuant to §.
(5) is informed the competent federal authority pursuant to § 22, that an application relates to a drug already approved in another Member State of the European Union, rejects the request, unless it was filed b according to § 25.

§ 25B of the mutual recognition procedure and decentralised procedure (1) for the issuance of a permit or authorisation in more than one Member State of the European Union has the applicant to submit a request based on identical documents in these Member States; This can be done in English.
(2) is the drug at the time of the application in another Member State of the European Union already approved or approved, is to recognise this authorisation on the basis of the evaluation report submitted by that State, except that there is reason to believe that the authorisation of the medicinal product represents a serious risk for public health, for the medicinal product for use in animals a serious danger to the health of humans or animals or for the environment. In this case, the competent federal authority has to process of Directive 2001/83/EC or article 33 of Directive 2001/82/EC in accordance with article 29.
(3) the responsible federal authority they reference Member State the medicinal product at the time of the application is not approved, has, as far as within the meaning of article 28 which the directive is Directive 2001/83/EC or article 32 2001/82/EC, to prepare draft of the assessment report, the summary of product characteristics of the medicinal product and the labelling and package leaflet and transmit the relevant Member States and the applicant. Article 25, paragraph 5, sentence 5 shall apply mutatis mutandis.
(4) for the recognition of the authorisation of another Member State, Chapter 4 of Directive 2001/83/EC and Chapter 4 of Directive 2001/82/EC are applicable.
(5) in the case of a different decision regarding the admission, its suspension or withdrawal, articles 30, 32, 33 and 34 of Directive 2001/83/EC and articles 34, 36, 37 and 38 of Directive 2001/82/EC shall apply. In the case of a decision pursuant to article 34 of Directive 2001/83/EC or article 38 of Directive 2001/82/EC is to decide on the authorisation in accordance with the decision taken pursuant to these articles or decision taken pursuant to these articles of the European Community or the European Union. A pre-litigation procedure does not take place according to § 68 of the administrative court procedure against decisions of the competent authorities of the federal upper pursuant to sentence 2. In addition, § 25 paragraph 6 shall not apply.
(6) paragraphs 1 to 5 shall not apply to medicinal products which have been manufactured according to homeopathic process technology, provided that these medicines subject to article 16 para 2 of Directive 2001/83/EC or article 19 para 2 of Directive 2001/82/EC.

section 25c measures the competent federal authority to decisions or resolutions of the European Community or the European Union the competent federal authority applies to the implementation of decisions or decisions of the European Community or the European Union pursuant to article 127a of Directive 2001/83/EC or under article 95 (b) of Directive 2001/82/EC measures.

§ Authorized 26 drug testing policies (1) that is Ministry to regulate requirements in articles 22 to 24, also in connection with article 38, paragraph 2 and article 39, paragraph 1 b designated information and opinions, and their examination by the competent federal authority by decree with the consent of the Federal Council. The regulations must comply with the each backed-up state of scientific knowledge and are continuously to adapt to these, in particular animal testing by other test procedures to replace, if this is acceptable to the State of scientific knowledge in terms of the purpose of the examination. The decree is issued, insofar as radiopharmaceuticals and medicinal products, in the manufacture ionising radiation are used and as far as is to the eco-toxicity tests, in agreement with the Federal Ministry for environment, nature conservation and nuclear safety and, as far as medicines is, that determines the use in animals are in agreement with the Federal Ministry of food, agriculture and consumer protection. On the appeal of the experts is article 25, paragraph 6, sentence 4 and 5 shall apply.
(2) the competent federal authority and the commissions have according to § 25 paragraph 7 by analogy the scientific knowledge of material according to article 22, paragraph 3, and article 23, paragraph 3, sentence 2 to apply the drug testing policy, taking into account the specificities of the respective medicines. Also the medical experience material reprocessed according to scientific methods considered scientific knowledge material.

§ 27 time limit for the issuance of (1) the responsible federal authority has to make a decision on the application for authorisation within a period of seven months. The decision on the recognition of a marketing authorisation is to meet within a period of three months from receipt of the assessment report. An assessment report is to create within a period of three months.
(2) the competent federal authority gives the applicant pursuant to § 25 para 4 opportunity to remedy deficiencies, the deadlines will be constrained until the deficiencies or the end of the period pursuant to § 25 para 4. The inhibition begins with the day the call to remedy the shortcomings will be sent to the applicant. The same applies to the time limit given to the applicant at his request, to take a position even under the assistance of experts.
(3) in the case of proceedings pursuant to § 25B par. 3 extends the time limit for the completion of the procedure according to the provisions in article 28 of Directive 2001/83/EC and article 32 of Directive 2001/82/EC for three months.

§ 28 of Edition power (1) can combine with conditions the approval the competent federal authority. Aid referred to in paragraph 2 to 3d for the protection of the environment, the competent federal authority in consultation with the Federal Environmental Agency decides, as far as effects on the environment are. The competent federal authority submitted the information required for the assessment of effects on the environment and documents the Federal Environmental Agency. Requirements can be arranged subsequently.
(2) regulations referred to in paragraph 1 can be arranged to ensure that 1 the labelling of the containers and outer packages complies with the requirements of section 10; (this can be arranged, that must be specified a) instructions or warnings, insofar as they are necessary to prevent the direct or indirect risks to human or animal health in the use of the medicinal product, b) storage information for the consumer and storage information for professionals, in so far as they are necessary to obtain the required quality of the medicinal product, 2. the package leaflet complies with the requirements of § 11; (this can be arranged, that must be specified a) in the point 1(a) above instructions or warnings, b) the storage instructions for consumers, so far as they are necessary to get the required quality of the medicinal product, 2 a.
the prescribing information complies with the requirements of section 11a; This can be arranged, that must be specified a) in point 1(a) above instructions or warnings, b) special warehousing and storage advice, insofar as they are necessary to get the required quality of the medicinal product, c) notes on requirements under paragraph 3, 3. the values correspond the documents submitted for approval after the articles 10, 11 and 11A and consistent and understandable terms and a uniform wording , also according to the recommendations and opinions of the committees of the European Medicines Agency, be used, and providing other contra-indications, side effects and interactions is allowed; the competent federal authority can generally make use for reasons of drug safety, transparency, or the efficient functioning of this power; It can be arranged that for prescription medicines certain applications are eliminated, when fear is that the therapeutic purpose is vulnerable to their specification, 4. the medicinal products in pack sizes on the market is brought, which are appropriate to the areas of application and the intended duration of application, 5 brought the drug in a container with a certain form, certain lock or any other security measure in the transport , as far as it is necessary to ensure compliance with the dosage instructions, or to prevent the danger of misuse by children.
(2a) the warnings referred to in paragraph 2 can be arranged also to ensure that the drug by physicians in certain areas of expertise may be prescribed and applied under their control or in hospitals and special clinics or in cooperation with such institutions if this is necessary to prevent a direct or indirect danger to human health in the application, in particular, if the use of the medicinal product only in the presence of special expertise or special therapeutic facilities appears safe.
(3) the competent federal authority may also specify requirements that more analytical, pharmacological-toxicological or clinical tests are performed and reported is, if sufficient evidence, that the drug can have great therapeutic value and is therefore a public interest in his immediate placing on the market, but for the comprehensive assessment of the medicinal product, other important information are required. The competent Federal Authority reviewed the results of these tests annually. Sentence 1 shall apply accordingly for documents about the backlog of compliance pursuant to § 23 para 1 No. 2 (3a) can the competent federal authority for medicinal products which are intended for granting the authorisation requirements for use in people also associate certain in the risk management system included measures to ensure of the safe use of the medicinal product to take 1, if this is in the interest of drug safety is required, perform safety evaluations 2. , if this is in the interest of drug safety is required to comply 3. obligations with regard to the collection or reporting of suspected cases of side effects that go beyond those of the tenth section, if this is in the interest of drug safety is required to take 4, if this is in the interest of drug safety is required, an adequate pharmacovigilance system to introduce 5 other necessary measures with regard to the safe and effective use of the medicinal product , if this is in the interest of drug safety is required, 6 as far as concerns with regard to individual aspects of the efficacy of the medicinal product exist, which can be eliminated perform efficacy testing after approval, only after its placing on the market the specifications in article 21a set 1 letter f of Directive 2001/83/EC meet.
(3B) which can competent federal authority for medicinal products which are determined after approval by requirements for use in people arrange 1 to introduce a risk management system and a risk management plan, if this is in the interest of drug safety is required, perform 2 safety tests, if this is in the interest of drug safety is required, an effectiveness check perform 3. If findings about the disease or the clinical methodology to suggest , previous evaluations of the effectiveness significantly, to correct the commitment, this effectiveness check after approval carried out must comply with Article 22a paragraph 1 letter comply with sentence 2 of Directive 2001/83/EC.
The prerequisites for an Edition exist pursuant to sentence 1 number 2 for more than a drug are this medicinal products which are approved in several Member States, the competent federal authority recommends and after referral to the Committee for risk assessment in the area of pharmacovigilance under article 56 paragraph 1 double letter aa of Regulation (EC) No. 726 / 2004 the affected holders of authorisation, a carry out joint evaluation of safety after approval.
(3c) can support the competent federal authority also arranged that during the production and control of such drugs and their precursors, which origin are organic or manufactured uses means, 1 met certain requirements and certain measures and procedures are applied, 2. documents shall be submitted, which justify the appropriateness of certain measures and procedures, including documents about the validation, 3. the introduction or change certain requirements , Measures and procedures requires the prior consent of the competent federal authority as far as it is necessary to ensure of adequate quality or risk management. The subpoenas are immediately executable. Opposition and appeal proceedings have no suspensive effect.
(3d) for medicinal products which are intended for use in animals, the competent federal authority in justified individual cases can arrange also that more documents, with which a possible environmental risk assessment is made, and further results from tests for the assessment of possible environmental risks be presented unless it is necessary for the comprehensive assessment of the effects of the medicinal product on the environment. The competent federal authority verifies compliance with a circulation pursuant to sentence 1 immediately after expiry of the period of the template. Paragraph 1 sentences 2 and 3 shall mutatis mutandis.
(3e) the competent federal authority can, if this is in the interest of drug safety is required for medicinal products which are intended for use in the animal also arranged by conditions that a risk management system, introduced after the admission that describes the set of activities and measures in the area of pharmacovigilance, including the assessment of the effectiveness of such measures, and that systematically collected post-authorisation insights in the use of the medicinal , documented and evaluated and you will be reported on the results of this investigation within a certain period.
(3f) for runs after the paragraphs 3, 3a, 3B and 3e the competent federal authority can determine nature, scope and time-frame of studies or tests and activities, measures and evaluations as part of the risk management system. The results are so to prove through documentation that nature, scope and time of studies or tests emerge from these.
(3 g) the holder of the authorisation of a medicinal product, which is intended for use in people, has all requirements referred to in paragraph 3, 3a and 3B to record its risk management system. The competent federal authority shall inform the European Medicines Agency on the approvals granted under the regulations according to the paragraphs 3, 3a and 3B.
(3 h) which can competent federal authority for biological medicinal products intended for use in people, appropriate measures for the better identification of adverse reaction reports arrange.
(4) the approval with a pad is to be connected, so that inhibited period provided up to the expiry of a period granted to the applicant to comment in article 27, paragraph 1. Appropriate applies to section 27, paragraph 2.

§ 29 duty of disclosure, re-registration (1) the applicant shall immediately report the competent federal authority, enclosing relevant documents if changes in the particulars and documents according to §§ 22 to 24a and 25 b. The obligation pursuant to sentence 1 has according to the authorisation of the holder of the authorisation to meet.
(1a) the holder of the authorisation has the competent federal authority without delay any prohibition or restriction imposed by the competent authorities of each country in which the medicinal product concerned on the market is brought, as well as all other new information to be communicated, which might affect the assessment of the benefits and risks of the medicinal product concerned. This information includes both positive and negative results of clinical trials or other studies which relate not only to those referred to in the approval, but all indications and populations, as well as information on an application of the medicinal product, which goes beyond the provisions of the registration of medicinal products which are intended for use in people. He has to submit all information and documents at the request of the competent federal authority demonstrating that the risk-benefit balance is still cheap. The competent federal authority can demand at any time submit of a copy of the pharmacovigilance system master file for medicinal products which are intended for use in humans. It is the holder of the authorisation to submit no later than seven days after receipt of the request. Sentences 1 to 3 shall not apply to the parallel importer.
(1B) the holder who has approval to inform the time for the placing on the market of the medicinal product, taking into account the different approved dosage forms and strengths of the competent federal authority.
(1c) the holder who has approval to display the competent federal authority in accordance with the set of 2 If the placing on the market of the medicinal product will be temporarily or permanently. The display has no later than two months prior to the adjustment of the placing on the market must be. This does not apply if circumstances exist, for reasons which the holder of the authorisation.
(1 d) the holder of the authorisation has all data relating to the sales volume of the medicinal product, as well as all the data relating to the volume of prescriptions to tell him, if the competent federal authority calls this drug for safety reasons.
(1e) the holder of the authorisation has the competent federal authority in the proceedings under article 107 c paragraph 4, to indicate changed dates or intervals for the submission of periodic updated safety reports 5 or 6 of Directive 2001/83/EC. Any changes to the date specified in the approval or the interval on the basis of clause 1 to take effect six months after its publication on the European Internet portal.
(1f) the holder of the authorisation of medicinal products which are intended for use in humans, obliged to inform the competent federal authority and the European Medicines Agency, if there are new or changed risks or the risk-benefit balance of medicinal products has changed.
(1 g) of the holder of the authorisation of a medicinal product, which is intended for use in humans, the reasons to tell the waiver of registration or failure to request of the renewal of the authorisation for temporary or permanent setting of the placing, the callback, has immediately the competent federal authority. He has in particular to explain whether the measure under sentence 1 on one of the reasons of § 25 paragraph 2 sentence 1 number 3, 4, or section 5, article 30, paragraph 2, sentence 1 number 1 or section 69, paragraph 1, sentence 2 number 4 or number 5 is based. The communication pursuant to sentence 1 has to be made when the measure in a third country will be made and based on any of the grounds referred to in sentence 2. A measure is based set of 1 or 3 on any of the grounds referred to in sentence 2, the holder of the authorisation has the European Medicines Agency in addition to communicate.
(2) when a change in the name of the medicinal product is the admission letter to change accordingly. Drug may be linked to another year, another two years, starting following January 1 or July 1, in the traffic under the old name pharmaceutical entrepreneur by the wholesalers and retailers on the announcement of the change in the Federal Gazette.
to associate a change 1 the information according to the sections 10, 11 and 11a of the dosage, the type or the duration of the application, the fields of application, if not to the infliction or it is a change in an indication, the another therapy area (2a) a limitation of contra-indications, side effects, or interactions with other drugs is, 2 of the active ingredients, except the pharmacologically active constituents , 3rd in an approved comparable dosage form, 3a.
in the treatment with ionising radiation, 4. relating to significant changes of the manufacturing process, of the pharmaceutical form, the specification or the impurity profile of the active substance or of the medicinal product, which may impact significantly on the quality, safety or efficacy of the medicinal product, and any changes in biotech manufacturing process; Sera, vaccines, blood preparations, allergens, Testsera and test antigens each change in manufacturing, investigation or providing a longer shelf life, 5. the package size and 6 the waiting time of a medicinal product intended for use in animals will happen only when the competent federal authority has approved. Sentence 1 No. 1 also applies to an extension of the target species for medicinal products which are not intended for use in animals producing food. The agreement is considered to have been given, if not within a period of three months is contradicted the change.
(2B) by way of derogation from paragraph 1 the abolition of a site for the manufacture of the medicinal product or its active substance or for the packaging or the batch release, 2. can a minor modification of a licensed physico chemical test procedure if appropriate validation studies it can be demonstrated that the updated test procedure is at least equivalent, 3. a change in the specification of an active substance or other substance to drug manufacturing for the purpose of adjustment 1 a monograph of the pharmacopoeia , if the change solely for compliance with the pharmacopoeia is made and remain the specifications for product specific properties unchanged, 4. a change of packing material, if this the drug not in touch and demonstrably not affected the tax, administration, safety or stability of the medicinal, or 5 a change in connection with the tightening of specification limits, if the change is not a consequence of a commitment due to previous assessments to review specification limits and not on unexpected events in the course of the production goes back, be displayed within twelve months after its introduction the competent federal authority.
(3) an is new approval to apply in the following cases: 1. when a change in the composition of the active substances according to type or volume, 2. a change of dosage form unless there is a change after paragraph 2a No. 3, 3.
in an extension of the areas of the application, as far as this is not a change to paragraph 2a No. 1 and 3a.
with the introduction of biotech manufacturing process.
The competent federal authority decides whether the authorisation pursuant to sentence 1.
(4) paragraphs 1, 1a set of 4 and 5, paragraphs 1e to 1 g, 2, 2a and 3 shall not apply to medicinal products for which an authorisation for the placing on the market has been granted by the European Community or the European Union. The obligations of the marketing authorisation shall apply for these medicines according to Regulation (EC) No 726 / 2004 with the proviso that there is commitment to the communication to the Member States or to inform the Member States and the competent federal authority in the scope of the Act.
(5) paragraphs 2a-3 does not apply for medicines, Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of changes of the approvals of human and veterinary medicinal products (OJ L 334 of December 12, 2008, p. 7) are subject to in the currently valid version. The paragraphs 2a through 3 are 1 for regulated homeopathic medicinal products which are intended to be applied to the people and which have been approved before 1 January 1998 or 2 for the article were considered approved, blood preparations referred to in 3, paragraph 6 of Directive 2001/83/EC and 3 for tissue preparations approved according to section 21, unless it comes in their production of an industrial process for the application.

Article 30 withdrawal, cancellation, rest (1) that is approved to take back, if subsequently becomes known, that one of the grounds for refusal of article 25 paragraph 2 No. 2, 3, 5, 5a, 6 or 7 at the time has been It shall be revoked if one of the grounds for refusal of article 25 paragraph 2 No. 3, 5, 5a, 6 or 7 has subsequently occurred. The approval is also to withdraw or revoke if 1 it turns out that the medicinal product lacks therapeutic efficacy, 2. in the cases of § 28 ABS. 3 therapeutic efficacy is insufficiently justified according to the current state of scientific knowledge.
The therapeutic effectiveness is missing, if it is established that no therapeutic results can be with the drug. In the cases of sentence 1 also the rest of the admission can be arranged temporarily.
(1a) which is admission also wholly or partly to withdraw or revoke, as far as is required this to a decision or a decision of the European Community or the European Union pursuant to article 34 of Directive 2001/83/EC or article 38 of Directive 2001/82/EC. A pre-litigation procedure does not take place according to § 68 of the administrative court procedure against decisions of the competent federal authority pursuant to sentence 1. In the cases of sentence 1 also the rest of the admission can be arranged temporarily.
(2) the competent federal authority may withdraw the authorisation 1. If in the documents pursuant to §§ 22, 23 or 24 false or incomplete declarations have been made or if one of the grounds for refusal of article 25 paragraph 2 has been no. 6a or 6B of issuance, 2. withdrawn, if one of the grounds for refusal of article 25 paragraph 2 No. 2, 6a or 6B has subsequently occurred or if not complied with one of the conditions arranged under section 28 and this deficiency within one of the competent federal authority to set reasonable time; been remedied these pads are para 3 and 3a according to § 28 annually to check withdraw 3. in consultation with the competent authority, if not or not sufficiently carried out prescribed checks of the quality for the medicines that revoke 4. in consultation with the competent authority, if it turns out that the drug is not produced after the pharmaceutical standards.
In these cases also the rest of the admission can be arranged temporarily.
(2a) in the cases of paragraphs 1 and 1a is admission to change this the relevant refusal reason referred to in paragraph 1 is omitted or is complied with the decision referred to in paragraph 1a. The registration can be changed in cases of paragraph 2 by Edition if this is sufficient to meet the needs of drug safety.
(3) before a decision is taken pursuant to paragraphs 1 to 2a. the holder of the authorisation must be heard, unless that risk in arrears is. The same applies if a decision of the competent federal authority over the change of registration, requirements for admission, revocation, withdrawal or the rest of the approval based on an agreement of the coordination group referred to in article 107 g, 107 k or article 107q of Directive 2001/83/EC. A preliminary proceedings does not occur according to § 68 of the administrative court order in cases of set 2. In the cases of § 25 paragraph 2 No. 5, the decision is immediately executable. Opposition and appeal proceedings have no suspensive effect.
(4) the authorisation for a medicinal product is withdrawn or revoked, or the approval rests so may be it brought 1 not in the traffic and spent 2. not in the scope of this Act.
The return of the drug to the pharmaceutical entrepreneur is permitted under appropriate identification. The return can be arranged by the competent authority.

Article 31 termination, extension (1) when the approved drug is brought within three years after authorisation not in traffic, or if the approved drug that was brought to the approval on the market, is no longer in three consecutive years in the traffic, 2. by written waiver, 3. after a period of five years since they were granted the license expires 1 , except that a) for medicinal products which are intended for use in people, at least nine months, b) medicinal products intended for use in animals, no later than six months before the expiry of the period provided a renewal application, 3a.
When a medicinal products which are the production of food and which contains a pharmacologically active component that in table 2 of the annex of to Regulation (EU) No. 37/2010 was recorded after expiry of a period of 60 days following publication in the official journal of the European Union, is intended for use in animals if not within this period on the fields of application in animals , the aim of gaining food, been dispensed according to article 29, paragraph 1 in the case of a change notification according to § 29 para 2a, which aims to the exclusion of the pharmacologically active ingredient, is the 60-day period until the decision of the competent federal authority or until expiry of the period under section 29, sentence 2 inhibited para 2a and it rests the approval after expiration of the 60-day period during this period; the half rates 1 and 2 Accordingly, so far as for the change of the medicinal product regulation (EC) No 1234/2008 application applies.
4. when the renewal of the authorisation is denied.
In the cases of the sentence 1 No. 1 may permit the competent federal authority exceptions, unless this is necessary for reasons of health protection for human or animal.
(1a) a registration is renewed, applies without time limit, except that the competent federal authority for the extension is a sentence 1 No. 3 referred to in paragraph 1, further extension to five years in accordance with the provisions in paragraph 1 sentence 1 No. 3 in connection with paragraph 2, taking into account an insufficient number of patients, which the medicinal product concerned , which is intended for use in humans, has been applied, has deemed necessary, and arranged, to further ensure the safe placing on the market of the medicinal product.
(2) the request for renewal shall be supplemented by a report containing the information on whether and to what extent the assessment characteristics for the medicines within the last five years have changed. The holder of the authorisation has to submit a revised version of the documentation relating to the quality, safety and efficacy to the competent federal authority to do so, all changes made since the granting of the authorisation are taken into account in the. If medicinal products which are intended for use in animals, a consolidated list of changes to be submitted instead of the revised version. For medicinal products intended for use in animals which serve the production of food, the competent federal authority may require also that the report contains information on experiences with the residue detection methods.
(3) the approval is in the cases of paragraph 1 sentence 1 No. 3 or of paragraph 1a on request referred to in paragraph 2 sentence 1 six months before its expiry for five years to extend, if no refusal reason § 25 para 2 No. 3, 5, 5a, 6, 6a or 6B, 7 or is not rescind the approval according to article 30, paragraph 1, sentence 2 or to withdraw or if the possibility of the withdrawal according to § 30 para 2 No. 1 or of withdrawal according to § 30 para 2 No. 2 no use should be made. § 25 paragraph 5 sentence 5 and paragraph 5a shall apply mutatis mutandis. When deciding on the extension is also used to check whether findings are, affect the placing under the prescription.
(4) the license expires pursuant to paragraph 1 No. 2 or 3, so the medicinal product may be placed another two years, starting following January 1 or July 1, in the transport named on the notice of lapse according to § 34. This does not apply if the competent federal authority determines that a prerequisite for the withdrawal or revocation has been according to § 30 Section 30 paragraph 4 shall apply.
Footnote (+++ § 31 para 1: to the application see section 141 paragraph 6 +++) § 32 state batch examination (1) the batch of a serum, a vaccine or an allergen may be placed without prejudice to the approval only in the transport, if it is released by the competent federal authority. The charge is to release if an examination (State charge) has revealed that the batch has been manufactured and tested after manufacturing and control methods that correspond to the current state of scientific knowledge, and that it has the required quality, efficacy and safety. The charge is to release even as far as the competent authority of another Member State of the European Union has determined after an experimental investigation that there are the conditions referred to in sentence 2.
(1a) that has federal authority competent to take a decision pursuant to paragraph 1 within a period of two months after receipt of the batch sample to be tested. Appropriate applies to section 27, paragraph 2.
(2) the Ministry shall adopt general administrative provisions relating to the requirements to be by the federal authority on the manufacturing and control methods referred to in paragraph 1 after consultation of experts from the medical and pharmaceutical science and practice and is known as a drug testing policy in the Federal Gazette. The rules must comply with the current state of scientific knowledge and are continuously to adapt to them.
(3) on the State charge verification see article 25, paragraph 8 and article 22, paragraph 7, sentence 3 mutatis mutandis.
(4) the approval referred to in paragraph 1 sentence 1 need not, as far as there referred to medicines by regulation according to § 35 par. 1 No. 4 or are exempted from the competent federal authority; the competent federal authority to indemnify if the manufacturing and control methods of the manufacturer have reached a level of development where the required quality, efficacy and safety are guaranteed.
(5) the approval referred to in paragraph 1 or the exemption by the competent federal authority pursuant to paragraph 4 is to take back if one of their conditions has not been; She shall be revoked if one of the conditions has subsequently been removed.

§ 33 fees and expenses (1) the responsible federal authority collects for the decisions on the admission, on the approval of tissue preparations, on the authorization of medicinal products for advanced therapies, about the release of batches, for the processing of applications, for the activity in the context of the collection and evaluation of drug risks, to the opposition proceedings against an administrative act issued on the basis of this Act or that on the basis of a regulation referred to in paragraph 2 sentence 1 or § 39, paragraph 3, sentence 1 number 2 or section 39B, paragraph 9 was fixing of fees and costs, as well as for other individually attributable public services including independent consultations and independent information, as far as it is not number 1 of the Federal fees law oral and simple written information within the meaning of § 7, according to this law and the Regulation (EC) No 1234 / 2008 fees and expenses.
(2) the Federal Ministry is authorized, in consultation with the Federal Ministry of Economics and technology and, insofar as medicinal use in animals, also with the Federal Ministry of food, agriculture and consumer protection by means of an Ordinance which require the consent of the Bundesrat not to determine the chargeable offences and thereby fixed rates or frame rates, as well as the reimbursement of expenses also deviated from the provisions of the administrative expenses Act be provided. The amount of the fees for the decisions on the admission, on the approval of tissue preparations, on the authorization of medicinal products for advanced therapies, about the release of batches, as well as for other individually attributable public services determined after personnel and material expenses, among which in particular the cost of the authorisation procedure, sera, vaccines, and allergens also includes the expenses for testing and for the development of appropriate examination procedures. The fee for the decision on the release of a batch is determined according to the average staff and administrative expenses; In addition, the importance, economic value or other benefit of release for the fees borrowers is adequately taken into account.
(3) by way of derogation from § 18 paragraph 1 sentence 1 of the German fees Act, entitlement to payment of fees and expenses, which are to rise according to § 33 para 1 in conjunction with the therapy allergens regulation barred three years after the announcement of the final decision on admission.
(4) insofar as a contradiction referred to in paragraph 1 successful, be set 1 or § 39, paragraph 3, sentence 1 necessary expenses within the meaning of section 80, paragraph 1, of the administrative procedures Act up to the amount in a regulation referred to in paragraph 2 or article 39B paragraph 9 for the refusal of an appropriate objection envisaged, frame charges up to their mean, refund.
(5) for the use of monographs to medicinal products exempted under article 36 from the requirement for approval, the Federal Institute for drugs and medical devices requires fees. This flat-rate remuneration agreements with associations, users belong to can be made. For the calculation of fees, paragraph 2 is set 3 application.
(6) the competent authority of the country has to reimburse these costs within the framework of the cooperative acts according to this law the competent federal authority, as far as this is paid by the polluter.

§ 34 public information (1) the responsible federal authority in the Federal Gazette announced to make: 1 the granting and renewal of authorisation, 2. the withdrawal of an authorisation, 3. the withdrawal of an authorisation, 4. the suspension of an authorisation, 5. the lapse of an authorisation, 6 the statement according to § 31 para 4 sentence 2, 7th after the change of the name § 29 par. 2, 8 the withdrawal or revocation release of a batch according to § 32 para 5 , 9. a decision on the extension of a protection period according to § 24 para 1 sentence 3 or paragraph 7 or to grant a protection period according to § 24 b § 6 or 8 set 1 No. 1 to 5 and no. 7 applies accordingly for decisions or decisions of the European Community or the European Union.
(1a) for medicinal products intended for use in humans, the competent federal authority provides the public through an Internet portal and, if necessary, other wise the following information immediately: 1. information about the granting of authorisation together with the package leaflet and the information for professionals in the current approved version, 2. the public assessment report, the information according to § 25 paragraph 5a for each proposed field of application as well as an easy formulated summary with a section on the conditions of use of the medicinal product contains , 3. summaries of risk management plans, 4. details of requirements together with deadlines and dates for compliance, 5. concerns in the field of pharmacovigilance.
The information to record operating and business secrets and personal data are 1 number 2 and 5 to delete, unless its disclosure is necessary for the protection of public health. Concerning the pharmacovigilance concerns pursuant to sentence 1 number 5 medicinal products which have been approved in several Member States, as is published in cooperation with the European Medicines Agency. For medicinal products intended for use in animals, the competent federal authority of the public provides information about the granting of authorisation together with the prescribing information, the evaluation report pursuant to sentence 1 number 2 and, if the field of application of the medicinal product refers to animals, the production of food used, also by residue studies see deletion of operating and business secrets, immediately available. Sentences 1 and 4 concern also changes to the above information.
(1B) for medicinal products intended for use in people, the withdrawal of a request for approval, as well as the refusal of the approval and the reasons to make this publicly available are. Decisions about the cancellation, make publicly available the withdrawal or the suspension of a licence are also. The federal authority is authorised for medicinal products intended for use in people, at the request of information about the receipt of a proper request for approval to give a proper request for a confirmatory clinical trial approval as well as the consent or the refusal of a confirmatory clinical trial.
(1c) the paragraphs 1a and 1B sentences 1 and 2 shall not apply to medicinal products which have been approved under Regulation (EC) No 726 / 2004.
(1 d) the responsible federal authority provides the information according to paragraphs 1a and 1B electronically. The competent federal authority provides the information according to paragraphs 1 and 1B with the decision having regard to the missing stock power available.
(1e) the competent federal authority has via the Internet portal for medicines according to § 67a, paragraph 2 in addition to the information in paragraph 1a sentence 1 number 1 to 4 and paragraph 1a to publish set 2 more at least the following information: 1 the list of medicinal products referred to in article 23 of Regulation (EC) No 726 / 2004, 2. information about the messaging paths for suspected cases of side effects of medicinal products to the competent federal authority by health professionals and patients , including the Internet forms provided by the competent federal authority.
(2) the competent federal authority can make an administrative act which is issued on the basis of this Act, publicly known in the Federal Gazette, if more than 50 users are affected by the administrative act. This administrative act is two weeks after the release of the Federal Gazette known as given. Other releases of the competent federal authority including the letter with which the parties opportunity to submit its observations is given according to section 28, paragraph 1, of the administrative procedures Act, can be published also in the Federal Gazette, if more than 50 recipients of which are affected. Sentence 2 shall apply accordingly.
Footnote (+++ § 34 paragraph 1a: to the application see section 141 paragraph 9 +++) § 35 appropriations concerning the authorisation and indemnity (1) that is Ministry authorized by decree with the consent of the Federal Council 1 (dropped out) 2. the rules on the authorisation of medicinal products which are not subject to approval pursuant to section 21 paragraph 1, as well as medicines, according to § 21 paragraph 2 number 1 g of the approval released that are , to extend, as far as it is necessary to direct or indirect risks to human health and prevent animal 3. regulations to extend the release of a batch and State batch testing on other medicinal products which are subject to fluctuations, in their composition or their active ingredient, if it is offered, to prevent direct or indirect risks to human or animal health , 4. certain medicines by the State charge examination to indemnify if the manufacturing process and the manufacturer's test procedures have reached a level of development where the quality, efficacy and safety are guaranteed.
(2) regulations referred to in paragraph 1 be no. 2 to 4 in consultation with the Federal Ministry of Economics and technology and, insofar as radiopharmaceuticals and medicinal products, in the manufacture ionising radiation used, in agreement with the Federal Ministry for environment, nature conservation and nuclear safety and, as far as it comes to pharmaceuticals, to use in animals intended , in agreement with the Federal Ministry of food, agriculture and consumer protection.

Section 36 authorized authorization for standard approvals (1) that is Ministry, after consultation of experts by decree with the consent of the Federal Council to exempt drug groups, certain medicines or medicines in certain tax forms from the requirement for approval, as far as direct or indirect risks to human or animal health is not to fear, because the requirements of the required quality, efficacy and safety are proved. The exemption can be made dependent on the protection of health of humans or animals of a specific production, composition, labelling, leaflet, information for professionals or dosage form and limited to certain types of applications, areas of application or application areas. Specifying other contra-indications, side effects and interactions by the pharmaceutical company is allowed.
(2) on the selection of medicinal products which are exempted from the requirement for approval, the legitimate interests of drug consumers, professionals and the pharmaceutical industry must be taken into account. The pharmaceutical entrepreneur is free in the choice of the name of the medicinal product.
(3) that legislative decree referred to in paragraph 1 was made in agreement with the Federal Ministry of Economics and technology and, insofar as radiopharmaceuticals and medicinal products, in the manufacture ionising radiation used, in agreement with the Federal Ministry for environment, nature conservation and nuclear safety and, as far as it is medicinal products intended for use in animals are in agreement with the Federal Ministry of food , Agriculture and consumer protection.
(4) prior to the adoption of the regulation referred to in paragraph 1 needed not the hearing of experts and the consent of the Federal Council, insofar as this is necessary to information on contra-indications, side effects, interactions, dosages, immediately to change pack sizes and precautionary measures for the application and the validity of the regulation at the latest one year is limited. The period may be extended by a further year once if the procedure cannot be completed pursuant to paragraph 1 within a period of one year.
(5) the monographs underlying the regulation referred to in paragraph 1 must be checked regularly by the competent federal authority and where necessary, to adjust the each secured state of science and technology. The monographs are affiliated to check whether the requirements of the required quality, efficacy and safety including a positive risk-benefit, for the medicinal products exempted from the requirement for approval can still considered to be proven.

§ 37 approval of the European Community or the European Union for the placing on the market, approvals of medicines from other countries (1) by the European Community or the European Union under Regulation (EC) No 726 / 2004 in connection with Regulation (EC) no 1901/2006 or regulation (EC) no of 1394/2007 granted approval for placing on the market is, as far as the sections 11a , 13 para 2a, § 21 para 2 and 2a, §§ 40, 56, 56a, 58, 59, 67, 69, 73, 84 or 94 for an authorisation is turned off, a licence granted under section 25. Also the authorisation granted by another State for a drug is considered approval within the meaning of section 21, insofar as this is determined by Decree of the Federal Ministry.
(2) the Federal Ministry is authorized, a regulation referred to in paragraph 1, which will not require the consent of the Federal Council, to enact a policy making Council or in international treaties approval of medicines equivalent will be recognized each other as. The Decree was made in agreement with the Federal Ministry of food, agriculture and consumer protection, insofar as it is medicinal products intended for use in animals.
Fifth section registration of medicinal products article 38 registration of homeopathic medicines (1) finished product no. 1 are medicines in the sense of § 2 paragraph 1 or paragraph 2, may when homeopathic remedies in the territorial scope of this Act only in the traffic be brought if it in a register to the competent federal authority for homeopathic medicines are registered (registration). An authorisation need not; Appropriate apply article 21, paragraph 1, sentence 2 and paragraph 3. A registry for medicines that a pharmaceutical entrepreneur in quantities to be brought to 1 000 packages a year on the market, unless it's to medicinal products 1 include the preparations of substances according to § 3 No. 3 or 4, which contain more than the hundredth part of the smallest dose used in medicinal products not homeopathic, subject to prescription pursuant to § 48 2 or 3 where there are facts of § 39 para 2 No. 3 , there are 4, 5, 6, 7, or 9.
(2) you are the request for registration in the articles 22 to 24 information, documents and reports referred to attach. This does not apply number 5 and 5a and paragraph 7 for details on the effects and applications, the documentation and reports about the trial, as well as for information pursuant to article 22, paragraph 2 sentence 2. The documentation of the pharmacological-toxicological testing shall be provided unless the harmlessness of the medicinal product otherwise, resulting in particular from a reasonably high degree of dilution. § Applies 22 paragraph 1a.

Section 39 the homeopathic medicines to register decision on the registration of homeopathic medicinal products (1) procedural rules that has competent federal authority and to allocate the registration number to the applicant in writing. § 25 para 4 and 5 set 5 finds appropriate application. The registration applies only to the homeopathic medicines listed in the notification and its dilution levels. The competent federal authority can connect the decision about the registration requirements. Requirements can be arranged subsequently. § 28 para 2 and 4 shall apply.
(2) the competent federal authority has to withhold the registration unless 1 the submitted documents are incomplete, 2. the medicinal product does not sufficiently analytical has been tested each backed-up state of scientific knowledge, 3. not quality adequate according to pharmaceutical has the medicinal, 4th at the medicinal reasonable suspicion is that it has adverse effects when used properly , which move beyond a reasonable degree according to the findings of medical science, 4a.
the medicinal product for use in animals is intended to serve the production of food, and it contains a pharmacologically active component, which is not listed in the annex of Regulation (EU) No. 37/2010 is listed as a substance, a setting of maximum residue levels is not required for the, 5. the recommended withdrawal period is not sufficient, 5a.
the drug unless it for use in people, not taking and not for external use is intended, 5B. the medicines as part per ten thousand of the stock, or for medicinal products which are intended for use in people more than the hundredth part of the smallest dose used in allopathic medicines subject to prescription pursuant to § 48 contains, 6 subject to the prescription medicines; except that it contains only substances that in the annex of to Regulation (EU) No. 37/2010 are listed as substances for which a determination of maximum residue limits is not necessary, 7 the drugs not to process technology described in the homeopathic part of the pharmacopoeia is manufactured, 7a.
If the application of individual active ingredients as homeopathic medicine or anthroposophisches medicines is not generally known, 8 for drug approval is granted, 9 the placing on the market of the medicinal product or its application in animals would violate legal regulations.
(2a) the medicinal product in another Member State of the European Union or in another Contracting State to the agreement on the European economic area has been registered, the registration on the basis of the decision to grant is, unless that is a reason of refusal referred to in paragraph 2. For the recognition of the registration of another Member State is Chapter 4 of Directive 2001/83/EC and for medicinal products intended for use in animals, Chapter 4 of Directive 2001/82/EC mutatis mutandis; Article 29 paragraph 4, 5 and 6 and articles 30 to 34 of Directive 2001/83/EC and article 33 paragraph 4, 5 and 6, and articles 34 and 38 of Directive 2001/82/EC shall not apply.
(2B) the applicant has documents corresponding to the competent federal authority, enclosing immediately to file a complaint, if changes in the particulars and documents according to article 38, paragraph 2, sentence 1. Section 29 applies paragraph 1a, 1e, 1f, 2-2 b. The obligation pursuant to sentence 1 has to meet following the granting of the registration of the holder of the registration. A new registration is to apply in the following cases: 1. when a change in the composition of the active ingredients type or amount, including a change in the power level, 2. a change of dosage form, as far as it is not about a change according to § 29 paragraph 2a sentence 1 number 3 is.
(2c) that registration expires after a period of five years after its issuance, unless that at the latest nine months before the expiry of the period provided a renewal application. Article 31 applies with the proviso that the grounds for refusal referred to in paragraph 2 are no. 3 to 9 applied for the termination and the extension of the registration.
(2d) withdrawal, revocation and suspension of registration applies to § 30 paragraph 1 sentence 1, paragraph 2, 2a, 3 and 4 provided that the grounds for refusal apply 2 to 9 referred to in paragraph 2.
(2e) article 34, paragraph 1, sentence 1 number 1 through 7, paragraph 1a sentence 1 number 1, 4, and 5, paragraph 1a sentence 4, paragraph 1B and 1 d shall apply mutatis mutandis.
(3) the Federal Ministry is authorized to legislate about the fees and expenses and the exemption from registration for homeopathic medicinal products according to the regulations on the admission by Decree without the consent of the Federal Council. The Decree was made in agreement with the Federal Ministry of food, agriculture and consumer protection, insofar as it is medicinal products intended for use in animals. Article 36, paragraph 4 shall apply accordingly for the change of a decree on the exemption from registration.
Footnote (+++ § 39 para 2: to apply see § 109 paragraph 10 +++) article 39a registering traditional herbal medicinal finished medicinal, herbal medicinal products and medicinal products in the sense of § 2 para 1 are allowed as traditional herbal medicinal products only be brought if they are registered by the competent federal authority. The same applies to herbal medicines, vitamins or mineral substances, unless the effects of traditional herbal medicines with regard to the application or the application areas complement the vitamins or minerals.

§ 39b registration documents for traditional herbal medicinal products (1) must the application for registration of the applicant the following information and be accompanied by documentation: 1. in article 22, paragraph 1, 3 c, 4, 5 and 7, and article 24, paragraph 1 referred to in no. 1 particulars and documents, 2. in article 22, paragraph 2, sentence 1 No. 1 results of analytical testing, 3. the summary of product characteristics of the medicinal product with the information referred to in Article 11a, paragraph 1, taking into account , that it is a traditional herbal medicines, 4. bibliographic details of the traditional application or reports of experts indicating that the concerned or a corresponding medicinal product at the time of the application for at least 30 years, of which at least 15 years in the European Union, medical or veterinary uses, the medicinal product under the specified conditions of use is harmless and that the pharmacological effects or efficacy of the medicinal product on the basis of long-standing use and experience are plausible , 5. bibliographic overview concerning the information on the safety along with an expert opinion in accordance with section 24 and, as far as assessing the harmlessness of the medicinal product required, this necessary additional information and documents, 6 registrations or approvals issued to the applicant in another Member State or in a third country for the placing on the market of the medicinal product, and details of any negative decisions on registration or approval and the reasons for these decisions.
The proof of use over a period of 30 years according to the set can be provided even 1 No. 4 If no special authorisation for a medicinal product has been granted for the placing on the market. He is also provided if the number or amount of the active ingredients of the medicinal product has been reduced during this period. A medicinal product is a corresponding medicinal product within the meaning of the sentence 1 No. 4, if it has same or similar active ingredients, the same or a similar purpose, an equivalent strength and Posology and the same or a similar route of administration as the medicinal product irrespective of the excipients used for the request for registration is made.
(1a) the information according to section 22 paragraph 1 sentence 1 number 1 to 10 have in German; added other information in German or English language other information or documents can be be made in the registration process, rather than in German but also in English or presented, as far as it is not information, used for the labelling, the leaflet or the prescribing information.
(2) instead of the template of the particulars and documents referred to in paragraph 1 sentence 1 No. 4 and 5 can be referred for medicinal products to be applied to the people also on a community or Union legal plants monograph referred to in article 16 h, paragraph 3 of Directive 2001/83/EC or a list position referred to in article 16f of Directive 2001/83/EC.
(3) the medicinal product contains more than a plant active ingredient or substance pursuant to section 39a set 2. sentence 1 in paragraph 1 to submit information referred to in no. 4 for the combination The individual active ingredients are not sufficiently known, also regarding the individual active ingredients are.

§ to register 39 c decision of registering traditional herbal medicinal products (1), the competent federal authority has the traditional herbal medicinal products and in writing with the registration number the applicant. § 25 para 4 and 5 set 5 finds appropriate application. The registration applies only to the traditional herbal medicines listed in the decision. The competent federal authority can connect the decision about the registration requirements. Requirements can be arranged subsequently. § 28 para 2 and 4 is appropriate application.
(2) the competent federal authority has to fail the registration if the application contains in section 39 (b) prescribed information and documents or 1 the qualitative or quantitative composition b paragraph 1 does not meet the specifications according to section 39 or else the pharmaceutical quality is not adequate, 2. application areas correspond to not only traditional herbal medicinal products, which determines according to their composition and the purpose of their application are , applied to the people to be without the need of medical supervision in regard to a diagnosis, prescription or monitoring of treatment, 3. the medicinal product intended harmful can, 4. the safety of vitamins or minerals that are included in the medicinal product has not been established, 5. the information on the traditional use are insufficient, especially the pharmacological effects or efficacy on the basis of long-standing use and experience are not plausible , to administer 6 medicines not only in a certain strength and dosage, 7 the medicines not only for oral or external application or inhalation is determined, 8 the according to § 39 para 1 sentence required time standard is not met 1 No. 4, 9 for the traditional herbal medicinal products or the same medicinal an authorisation pursuant to § 25 or a registration issued according to § 39 , 10. the placing on the market of the medicinal product or its application in animals would be contrary to legal regulations.
For medicinal products which are intended for use in animals, set is 1 in accordance with.
(3) the registration expires after a period of five years since they were granted, except that at the latest nine months before the expiry of the period provided a renewal application. Section 31 applies with the proviso that the grounds for refusal referred to in paragraph 2 shall apply for the termination and the extension of the registration.

section 39B other procedural rules for traditional herbal medicinal products (1) the competent federal authority informs the applicant, as well as for medicinal products which are intended to be applied to humans, the European Commission and the competent authority of a Member State of the European Union on request with the registration as traditional medicinal products and the reasons for this decision opposed taken from her.
(2) b for medicines, representing paragraph 1 of Directive 2001/83/EC article 16 d, section 25 shall apply mutatis mutandis. For the medicinal products referred to in article 16 d para 2 of Directive 2001/83/EC, a registry of another Member State is duly taken into account.
(3) the competent federal authority can the article 16 h of Directive 2001/83/EC Committee on herbal medicinal products on request for an opinion on the evidence of the traditional application request, doubts about the existence of the conditions pass § 39 para 1 sentence 1 No. 4.
(4) If a medicine used for the application has been applied in people less than 15 years of experience within the European Union, but otherwise a registration conditions are met according to the § 39a to 39 c, the competent federal authority has that article 16 c para 4 of the directive initiate 2001/83/EC provided for procedures with the participation of the Committee for herbal medicinal products.
(5) is deleted after article 16f of Directive 2001/83/EC a vegetable substance, a herbal preparation or a combination thereof, in the list, are registrations relating to containing this substance traditional herbal medicinal products intended for use in humans and carried out para 2 with reference to section 39, be revoked unless within a period of three months, you be presented particulars referred to in paragraph 1 b and documents in section 39.
(6) article 34, paragraph 1, sentence 1 number 1 through 7, paragraph 1a sentence 1 number 1, 4, and 5, paragraph 1a sentence 4, paragraph 1B and 1 d shall apply mutatis mutandis.
(7) the applicant shall immediately report the competent federal authority, enclosing relevant documents if resulting changes in the particulars and documents according to section 39 b paragraph 1 sentence 1 in conjunction with paragraph 2. Section 29 applies paragraph 1a, 1e, 1f, 2-2 b. The obligation pursuant to sentence 1 has to meet following the granting of the registration of the holder of the registration. A new registration is to apply in the following cases: 1. when a change in the application areas, as far as it is not about a change according to § 29 paragraph 2a sentence 1 number 1 is, 2. when a change in the composition of the active ingredients type or quantity, 3. a change of dosage form, as far as it is not about a change according to § 29 paragraph 2a sentence 1 number 3 is.
(8) § 30 paragraph 1 sentence 1, paragraph 2, applies to withdrawal, revocation and suspension of registration 2a, 3 and 4 provided that the grounds for refusal apply paragraph 2 pursuant to § 39 c.
(9) the Federal Ministry is authorised to lay down rules on the charges and expenses of the registry by Decree without the consent of the Federal Council for traditional herbal medicinal products according to the rules of admission. The Decree was made in agreement with the Federal Ministry of food, agriculture and consumer protection, insofar as it is medicinal products intended for use in animals.
Sixth section of protection of individuals with the clinical trial section 40 General conditions of clinical examination (1) the sponsor, the investigator and all other persons involved in the trial have to comply to 1 para 3 of Directive 2001/20/EC the requirements of good clinical practice in the conduct of the clinical trial of a drug in humans in accordance with of article. The clinical trial of a drug in humans may only be started by the sponsor, if the competent federal authority approved it pursuant to § 42 para 2 and the competent Ethics Committee approvingly assesses these in accordance with section 42, paragraph 1. The clinical trial of a medicinal product must perform only in humans, if and as long as 1 a sponsor or a representative of the sponsor, which has its headquarters in a Member State of the European Union or in another Contracting State to the agreement on the European economic area, 2. the foreseeable risks and disadvantages compared to the benefit of the person in which they are performed to (person) , and the likely importance of the medicinal product for which, dentistry are medically justifiable, 2a.
According to the State of the science in relation to the purpose of the clinical trial of a medicinal product, which consists of a genetically modified organism or a combination of genetically modified organisms or those containing unacceptable adverse effects on a) health third parties and b) the environment are not to be expected, 3. the affected person a) is age and able to recognize essence, significance and scope of the trial and to align their will after this , b) pursuant to paragraph 2 sentence 1 is been informed and has consented in writing, unless stipulated in paragraph 4 or in section 41 otherwise and c) according to paragraph 2a sentence 1 and 2 has been informed and has consented in writing the consent must be explicitly also on the collection and processing of information about the health related, 4. the person concerned not to judicial or administrative arrangement in an institution is housed, 5. it responsible is carried in an appropriate facility by a suitably qualified auditors and examination conducted by an inspector with at least two years experience in clinical trials of medicinal products , 6. a corresponding to the current state of scientific knowledge pharmacological-toxicological testing of the medicinal product has been completed, 7 each reviewer has been informed by a scientist responsible for the pharmacological-toxicological testing on their results and the risks associated with clinical trials expected to be 8.
for the case that a man killed in the conduct of the trial or the body or the health of people injured, insurance in accordance with paragraph 3, granted services, if no one else for the damage shall be liable, and 9 for the medical care of the person concerned a doctor or a dentist is responsible for dental treatment.
The person cannot write, number 3 may in exceptional cases instead of the set of 3 letters b and c required written consent be granted an oral consent in the presence of at least one witness who was included in the information of the data subject. The witness may be any person employed at the testing centre and a member of the review group. Oral consent is to be documented in writing, to date and be signed by the witness.
(1a) the examiner determines suitably qualified members of the review group. He has to guide them and to monitor, to provide them with the information necessary for their activities in the framework of implementation of the clinical trial, in particular the audit plan and the investigator's brochure. The examiner has to appoint at least an alternate with comparable qualifications.
(1B) an insurance company referred to in paragraph 1 sentence 3 number 8 is no need's in clinical trials with medicinal products approved, when applied according to the specifications laid down in the authorisation and risks and burdens through additional studies or therapy comparison are small and as far as there is an other insurance for Auditors and sponsor.
(2) the person concerned is by an auditor, the doctor or dental examination, dental is the doctor, or by one member of the review group, or dental examination, dental is to enlighten the essence, significance, risks and implications of the clinical trial, as well as their right, at any time to terminate participation in the clinical trial; a generally understandable educational document is handed over. The affected person is also opportunity for a consultation with an accountant or a member of the review group, the doctor or dental examination, dental is to give on the other conditions of the conduct of the trial. A pursuant to paragraph 1 sentence 3 number 3 letter b stated in participating in a clinical trial may revoke your consent in writing or orally at any time to the auditor or a member of the review group, without that the affected person may not be disadvantage.
(2a) the person concerned is on the purpose and scope of the collection and use of personal data, in particular of health data to inform. She is to inform you, in particular that 1 the collected data if necessary) for inspection by the inspection authority or representative of the sponsor to check the proper conduct of the trial maintained ready, b) pseudonymisiert to sponsor or commissioned by this body for the purpose of evaluating scientific output, c) pseudonymisiert passed in the case of an application for authorisation to the applicant and the authority responsible for the authorisation , d) in the case of adverse events of the medicinal product to be tested pseudonymisiert on the sponsor and the competent federal authority, 2. and be transmitted to the European database of this consent pursuant to paragraph 1 sentence 3 No. 3 letter c irrevocable is 3rd in the event of a cancellation pursuant to paragraph 1 sentence 3 No. 3 letter of b declared consent the stored data also may be used , as far as this is necessary to a) to determine the effects of the medicinal product to be tested, b) to ensure that sensitive interests of the person concerned are not affected, c) the obligation to submit of complete admission documents to meet 4 store the data referred to offices for which on the basis of § 42 para 3 specific deadlines are.
In the case of a revocation the pursuant to paragraph 1 sentence 3 No. 3 letter b told the authorities have immediately to examine the stored data for the in set 2 purposes referred to in no. 3 may be still required consent. Unneeded data is to delete immediately. In addition, the personal data collected at the end are to delete certain periods where not legal, statutory or contractual retention periods conflict on the basis of article 42, paragraph 3.
(3) the insurance sentence 3 No. 8 must referred to in paragraph 1 for the benefit of the persons affected by the clinical trial at a in a Member State of the European Union or another Contracting State to the agreement on the European economic area be taken to operate approved insurers. Its scope must in proportion to the risks associated with clinical trials and on the basis of the risk assessment to be set, that there are at least 500,000 euros available for every case of death or permanent incapacity of a person affected by the trial. As far as paid from the insurance, a claim for damages will be void.
(4) a clinical trial on minors that apply to paragraphs 1 to 3, with the following conditions: 1 the medicinal to detect or to prevent diseases when minors determined and the use of the medicinal product after the findings of medical science appears be to detect diseases in the minors or to protect him from diseases. The drug is indicated if his application for the minors is medically indicated.
2. clinical trial in adults or other research methods not sufficient test results may suggest according to the findings of medical science.
3. the consent is submitted by the legal representative after he is settled according to paragraph 2. She must correspond to the presumed will of the minor as far as one is fixable. The minors before beginning of the clinical testing of one in dealing with minor experienced examiners, the doctor or dental examination, dental is, or a suitably experienced member of the review group, the doctor or dental examination, dental is the assessment to clarify the risks and the benefits as far as this is possible in regard to his age and his mental maturity; of minors, declared the trial will not participate, or he expresses this in any other way, this is to be observed. The minors able to detect essence, significance and scope of the trial and to align his will after this is also its consent is required. Sentence 2 is an opportunity for a consultation referred to in paragraph 2 to open also the minors in addition to the legal representative.
4. the clinical examination must be carried only if it is connected to the person with the least amount of stress and other foreseeable risks; the load factor as well as the risk threshold must be specifically defined in the inspection plan and constantly reviewed by the examiner.
5. benefits except a reasonable compensation may not be granted.
A competent point of contact to provide information about all circumstances, which is a meaning for the conduct of a clinical trial can be obtained at the stands (5) of the person concerned, its legal representatives or one of their authorised representative. The contact point is to set up at the competent federal authority.

Article 41 special requirements of clinical examination (1) on a clinical trial for an adult person who suffers from a disease, the medicinal product to be tested should be applied to their treatment, finds section 40 para 1 to 3 with the following proviso application: 1 the use of the medicinal product to be tested must appear according to the findings of medical science be, to save the life of this person , their health to restore or to ease their suffering, or 2 they must for the Group of patients who suffer from the same disease as this person, a direct benefit be connected.
Can the consent due to an emergency situation not be obtained, a treatment that is required without delay in order to save the life of the person concerned, restore their health, or to facilitate their suffering must be promptly. Consent to any further participation is to obtain, as soon as this is possible and reasonable.
(2) on a clinical trial for a minors suffering from a disease, the medicinal product to be tested should be applied to their treatment, section 40 para 1 to 4 with the following provisions shall apply: 1 the use of the medicinal product to be tested must appear according to the findings of medical science be to save the life of the person concerned, restore their health, or to ease their suffering , or 2. a) the clinical examination must be connected to a direct benefit for the Group of patients who suffer from the same disease as the affected person, b)
(research must be for the confirmation of data obtained in clinical trials on other persons or by other research methods, essential, c) research must be a clinical condition relate to suffering of affected minors) and (d) the research must be connected for the person concerned only with minimal risk and minimal exposure. the research has only a minimal risk, type and size of the intervention is likely, that it will lead only to a very slight and temporary deterioration of health of the person concerned; It has a minimal impact, if it is to be expected that the inconvenience at best temporarily for the affected person will occur and be very slightly.
Sentence 1 No. 2 does not apply for minors, for which application would find upon reaching the age of majority (3).
(3) on a clinical trial for an adult person who is unable, suffers an illness essence, significance and scope of clinical trials to identify and to align their will after this, and that the medicinal product to be tested should be applied to their treatment, section 40 para 1 to 3 with the following provisions shall apply: 1. the use of the medicinal product to be tested must be displayed according to the findings of medical science , to save the life of the person concerned, restore their health, or facilitating their suffering; also such research must relate directly to a life-threatening or very weak clinical State, in which the person concerned resides, and the clinical trial must be connected to minimize burdens and other foreseeable risks for the person concerned; the load factor as well as the risk threshold must be specifically defined in the inspection plan and constantly reviewed by the examiner. The trial operation is only to be carried out only if the expectation is that the benefit of using of the investigational product for the person concerned outweighs the risks or take no risks.
2. the consent is taken by the legal representative or agent after he is settled according to § 40 paragraph 2. Section 40 para 4 No. 3 sentence 2, 3 and 5 shall apply mutatis mutandis.
3. the research must be essential for the confirmation of data obtained in clinical trials on persons capable of informed consent or by other research methods. § 40 paragraph 4 applies to be no. 2.
4. benefits except a reasonable compensation may not be granted.

Section 42 procedures at the Ethics Commission, approval at the Federal Authority (1) is the required under article 40, paragraph 1, sentence 2 to review of the Ethics Commission to request of the sponsor of the independent interdisciplinary Ethics Committee relevant national law for the Inspector. Is the clinical examination is performed by several reviewers, is so to provide the application to the independent Ethics Commission responsible for the head of the clinical trial. The further education, composition and funding of the IRB is determined by State law. The sponsor has to submit all information and documents the Ethics Commission, which requires them to assess. To the assessment of the dossier, the Ethics Commission can exploit its own scientific knowledge, consult experts, or request advice. It has to involve experts or requesting advice, if there is a clinical trial on minors and it does not have its own expertise in the field of Pediatrics, including ethical and psychosocial issues of Pediatrics, or if it is a clinical trial of xenogenic drugs or gene therapy medicinal products. The favourable opinion may be refused only if 1 the submitted documents are incomplete even after the expiry of a reasonable period set by the sponsor to supplement, 2. the presented documents, including the Protocol, the IB and the modalities for the recruitment of subjects are not the State of scientific knowledge, in particular the clinical trial is unsuitable, to prove the safety or efficacy of a medicinal product including a different mode of action for women and men , or 3 No. 2 to 9, paragraph 4, and article 41 are not met regulated requirements in section 40 para 1 sentence 3.
The more is determined in the Ordinance pursuant to paragraph 3. The Ethics Commission has to submit a decision on the request, which may be extended in accordance with the Ordinance pursuant to paragraph 3 or shortened pursuant to sentence 1 within a period of no more than 60 days after receipt of the necessary documents; for inspecting xenogeneic medicinal products there is no time limit for the approval period.
(2) that is required approval of the competent federal authority according to article 40, paragraph 1, sentence 2 of the sponsor at the competent federal authority to apply for. The sponsor has this to submit all information and documents, which it used to assess in particular the results of the analytical and pharmacological toxicological testing and the test plan and the clinical details of the medicinal product including the investigator's brochure. The approval may be refused only if 1 the submitted documents are incomplete even after the expiry of a reasonable period set by the sponsor to supplement, 2. the presented documents, in particular the information on the drug and the inspection plan including the investigator's brochure are not the State of scientific knowledge, in particular the clinical trial is unsuitable, to prove the safety or efficacy of a medicinal product including a different mode of action for women and men , 3 which in section 40 para 1 sentence 3 No. 1, 2, 2a and 6, case of xenogenic medicinal also the requirements particularly with regard to a third party risks insurance regulated in paragraph 8 are not met, 4 the competent federal authority, evidence, that the testing facility for the conduct of the clinical trial is not suitable or that the requests of the clinical examination referred to in paragraph 2 not can to comply or 5. in article 40, paragraph 4, or article 41 regulated requirements are not met.
The approval is considered to have been granted, if the competent federal authority submitted no reasoned objection the sponsor not more than 30 days after receipt of the application documents. If the sponsor to reasoned objections within has changed the application a period not to exceed 90 days, the application is deemed to be rejected. The more is determined in the Ordinance pursuant to paragraph 3. By way of derogation from sentence 4 should the clinical investigation of medicinal products 1 under the number 1 of the annex of to Regulation (EC) No. 726 / 2004 fall, 2. the medicinal products for advanced therapies, xenogeneic medicinal products are, 3 which contain genetically modified organisms or requires 4. whose Wirkstoff is a biological product of human or animal origin, or contains biological components of human or animal origin or for its manufacture such components , only be started, if the competent federal authority has given a written consent the sponsor. The competent federal authority has to make a decision on the application for authorisation of medicinal pursuant to sentence 7 No. 2 to 4 documents required within a period of no more than 60 days after receipt of the referred to in sentence 2, which extended or may be reduced in accordance with a regulation pursuant to paragraph 3; for inspecting xenogeneic medicinal products there is no time limit for the approval period.
(2a) the federal authority responsible for the approval of a clinical examination referred to in paragraph 2 shall inform the competent under paragraph 1 Commission of ethics provided their information to other clinical trials are for assessing significance testing peer-reviewed by the Ethics Commission; This applies in particular for info on broken or otherwise prematurely terminated tests. This is not the transmission of personal data, also operating and business secrets are true.
(3) the Federal Ministry is authorized to make arrangements to ensure of the proper conduct of the trial and obtain documents corresponding to the State of scientific knowledge by decree with the consent of the Federal Council. Under the Ordinance, regulations may be taken over: 1 the duties and responsibilities of the sponsor, the reviewer, or other persons who perform clinical testing or control including display, documentation and reporting requirements especially about side effects and other unwanted events that could occur during the study, and compromise the security of the participants or the conduct of the study, 2.
the tasks of and the procedures for ethics committees including the documents required for submission, also relating to the adequate participation of women and men as test participants and subjects, the interruption or extension or shortening of the processing time and the special requirements of the ethics committees for clinical trials according to § 40 paragraph 4 and section 41, paragraph 2 and 3, 3. the tasks of the competent authorities and the regulatory approval process, including the documents to be submitted , with information on the adequate participation of women and men as test participants and examinees and of interruption or extension or shortening the processing time, the procedure for the review of documents in enterprises and institutions as well as the conditions and the procedures for withdrawal, revocation and suspension of the approval or prohibition of a clinical trial, 4. the requirements on the testing device and the carrying out and storing evidence , 5. the delivery of name and seat of the sponsor and responsible auditor and non-personal information on clinical trials and results of the clinical trial by the competent authority to a European database, 6 the powers to the collection and use of personal data, as far as these for the implementation and monitoring of the trial required are; This also applies to the processing of data which is processed or used in files, 7 as far as medicines are concerned, which consists of a genetically modified organism or a combination of genetically modified organisms or containing, a) the collection and use of personal data, as far as this for threats to health third parties or are required for the environment in their causal network , b) the duties and powers of the authorities to fend off threats to the health third parties and the environment in their causal network, c) the transmission of data in a publicly accessible European database and d) the exchange of information with the European Commission;
In addition, can the forwarding of documents and copies of the decisions of the competent authorities and the competent examiner ethics committees are determined and prescribed, that documents on electronic storage media are submitted. Exceptions according to the Directive 2001/20/EC must be provided in the Ordinance for approved medicines.

section 42a withdrawal, revocation and suspension of the approval or the favourable opinion (1) is the approval to take back, if it is known that a refusal reason according to § 42 para 2 sentence 3; been no. 1, no. 2 or no. 3 in the granting She shall be revoked, if subsequently enter facts that would justify the refusal according to § 42 para 2 sentence 3 No. 2, no. 3, no. 4 or no. 5. In the cases of sentence 1 also the rest of the permit can be arranged temporarily.
(2) the competent federal authority may revoke the authorization if the conditions do not match the clinical trial with the information given in the application for a permit, or if the facts give rise to doubts as to the safety or the scientific basis of the clinical trial. In this case also the rest of the permit can be arranged temporarily. The competent federal authority shall inform the other authorities responsible for the supervision and ethics committees, as well as the European Commission and the European Medicines Agency, stating the reasons immediately.
(3) before a decision is taken pursuant to paragraphs 1 and 2, opportunity to comment is the sponsor within a period of one week to give. § 28 ABS. 2 Nr. 1 of the administrative procedure act shall apply mutatis mutandis. The competent federal authority arranges the immediate interruption of the test, so she sent this arrangement the sponsor immediately. Opposition and legal challenge against the withdrawal, the withdrawal or the arrangement of the suspension of the approval and arrangements under paragraph 5 have no suspensive effect.
(4) the authorisation of a clinical trial is withdrawn or revoked, or rests, so the clinical trial must not be continued.
(4a) which is favourable opinion by the competent Ethics Commission to take back if the Ethics Commission subsequently it becomes aware that a refusal reason has been according to § 42 paragraph 1 set 7 It is to undo, if the Ethics Commission of gained knowledge that subsequently 1 the requirements on the suitability of the Auditor, his Deputy, or the inspection body are no longer given, 2. There is no proper clinical trials insurance or the criteria for exemption from compulsory insurance no longer exist, 3. the arrangements for the recruitment of subjects no longer correspond to the current state of medical knowledge , in particular the clinical trial is unsuitable, to prove the safety or the efficacy of a medicinal product including a different mode of action for women and men, or 4. the conditions for the inclusion of persons are no longer given according to § 40 paragraph 4 or section 41.
Paragraphs 3 and 4 shall apply mutatis mutandis. The competent Ethics Commission informed immediately, stating the reasons the competent federal authority and the other authorities responsible for the supervision.
(5) If facts become known of the competent federal authority in the course of their activities, which justify the assumption that the sponsor, a reviewer, or a the other party no longer fulfils its obligations within the framework of the proper conduct of the trial, immediately informed the person concerned to the competent federal authority and ordered the corrective measures undertaken by that person; the measure concerns not the sponsor, this is the arrangement to teach. Measures of the competent surveillance authority according to § 69 remain unaffected.

section 42 b publishing the results of clinical trials (1) pharmaceutical entrepreneurs who bring a drug on the market, within the territorial scope of this Act that the requirement for the permit or authorisation for the placing on the market is subject to and is intended for use in humans, have confirmatory clinical trials establishing the efficacy and safety of the competent federal authority to enter into the database according to § 67a paragraph 2 to to provide reports on all results. These reports are within six months after issuance or amendment, as far as is due to make the change on confirmatory clinical trials of the approval or the authorisation for the placing on the market.
(2) if carried out a clinical trial of a medicinal product already authorised or approved for the placing on the market and this not as a comparison drug, the sponsor has the results of a clinical trial within one year after their completion according to paragraph 1 to provide.
(3) reports must contain all results of the clinical trials regardless of whether they are favourable or unfavourable, under paragraphs 1 and 2. There are also statements to subsequent changes for the test plan as well as interruptions and crashes of the clinical examination in the report to record. The rest is the final report in accordance with the requirements of good clinical practice to be worded. With the exception of the name and address of the marketing authorisation or of the sponsor, as well as the indication of the name and address of after Section 4a of the Federal Data Protection Act of einwilligender investigators, the reports may contain no personal, especially patient-related data pursuant to sentence 1. The report can be written in German or English language. § 63 b paragraph 3 sentence 1 is not applicable. The rules for the protection of intellectual property rights and protection of operating and business secrets shall remain unaffected as well as the sections 24a and 24B.
Seventh section drug section 43 pharmacy duty, placing on the market by veterinarians (1) drugs in the sense of § 2 paragraph 1 or paragraph 2 No. 1, are shared by the provisions of section 44 or the regulation adopted pursuant to article 45, paragraph 1 for the traffic outside the pharmacies; allowed except in the cases of § 47 work - or professional for end-use only in pharmacies and without official permission not in the way of shipment in the traffic the further regulates the Pharmacy Law. Outside the pharmacies no may be traded except in the cases of paragraph 4 and § 47 para 1 with the pursuant to sentence 1 medicines reserved for the pharmacy. The information about the exhibition or amendment of a permit for the shipment of medicinal pursuant to sentence 1 are to enter in the database according to § 67a.
(2) which set 1 pharmacies may reserved drugs from legal persons, not legal associations and societies of civil law and commercial law are not delivered to its members, unless that is the persons referred members to pharmacies or to that in article 47, paragraph 1 and facilities and the levy under the designated thereon conditions referred to in paragraph 1.
(3) on prescription drugs in the sense of § 2 para 1 or 2 may be placed no. 1 only by pharmacies. Article 56, paragraph 1 shall remain unaffected.
(4) medicinal products within the meaning of § 2 paragraph 1 or paragraph 2 No. 1 may in the context of the operation of a veterinary medicine cabinet by veterinarians on holder which of them are given animals treated and kept in stock for this purpose. This also applies to the delivery of medicines to the measures provided veterinary and veterinary-controlled vorbeugender disease in animals, where the amount of the levy may not exceed the requirements established on the basis of veterinary indications. Still, drugs in the sense of § 2 paragraph 1 or paragraph 2 may no. 1, which determines the implementation of veterinary measures and does not have a prescription are supplied in the required amount by veterinary pet owners. With the delivery of a written statement about art, hand over time and duration of application is the keeper.
(5) for use in animals, certain medicinal products which are not released for transport outside of pharmacies, must not persons only in the pharmacy or veterinary pharmacy, or by the veterinarian are handed out to the pet owners or others in article 47, paragraph 1. This applies not for medicated feedingstuffs and for medicinal products within the meaning of paragraph 4 sentence 3. by way of derogation sentence 1 medicines that are approved only for use in animals which are not extracting food, by pharmacies, which have a licence referred to in paragraph 1, must be delivered in the way of shipment. In addition, may 3 designated medicines in the context of the operation of a veterinary remedies in a particular case in a necessary for a short-term continuing treatment for animals treated by the vet in the way of shipment be placed in set. Other regulations about the dispensing of medicines by veterinarians to this law and the Ordinance on veterinary house pharmacies remain unaffected.
(6) medicinal products may be placed in the context of the transfer of a veterinary practice to the successor in the operation of the veterinary medicine cabinet.

Section 44 exemption from the obligation to pharmacy (1) medicinal products the pharmaceutical entrepreneur exclusively for purposes other than for the elimination or alleviation of disease, suffering, to serve physical injury or abnormal discomfort certainly are, are released for transport outside of pharmacies.
(2) also have been approved for the traffic outside the pharmacies: 1 a) natural healing waters and their salts as tablets or lozenges, b) artificial medicinal waters and their salts, also known as tablets or lozenges, however only, if they correspond to natural healing waters in their composition, 2. clay, bath Moore and other peloids, preparations for making of baths, soaps for external use, 3 with their normal German names described a) plants and parts of plants , also crushed, b) mixtures from whole or cut plants or parts of plants as medicinal, c) distillates from plants and parts of plants, d) certain juices from fresh plants and plant parts, provided that they are made without solvents, with the exception of water, 4 patch, 5. exclusively or mainly for external use disinfectants as well as mouth and disinfectant.
(3) paragraphs 1 and 2 do not apply to medicines, the 1st only on medical, dental or veterinary prescription may be placed or excluded 2. by regulation according to § 46 of the traffic outside the pharmacies are.

§ 45 authorization for further exceptions to the pharmacy duty (1) that is Ministry authorized, in agreement with the Federal Ministry of Economics and technology after hearing of experts by decree with consent Federal Council materials, preparations of substances or objects which are intended partially or exclusively to the elimination or alleviation of disease, suffering, physical injury or abnormal discomfort, for transport outside of pharmacies used to provide free , 1. to the extent that they not only on medical, dental or veterinary prescription may be placed, 2. as far as them not because of their composition or effect require the testing, storage and dispensing through a pharmacy, 3. insofar as not by their release is a direct or indirect danger to health of humans or animals, especially through improper treatment, fear or 4 if not through their release proper drug supply is compromised.
The decree is issued by the Federal Ministry of food, agriculture and consumer protection in agreement with the Ministry and the Federal Ministry of Economics and technology, insofar as it is medicinal products intended for use in animals.
(2) the approval may be limited, on finished product to certain dosages, indications or dosage forms.
(3) the Decree was made in agreement with the Federal Ministry for environment, nature conservation and nuclear safety, insofar as radiopharmaceuticals and medicinal products, ionising radiation are used in their manufacture.

Section 46 authorizes authorization to extend the pharmacy duty (1) that is Ministry in agreement with the Federal Ministry of Economics and technology after hearing of experts by decree with the consent of the Federal Council to exclude medicinal products within the meaning of section 44 of the traffic outside of pharmacies, as far as normal or habitual use direct or indirect risks to human or animal health is to be feared. The decree is issued by the Federal Ministry of food, agriculture and consumer protection in agreement with the Ministry and the Federal Ministry of Economics and technology, insofar as it is medicinal products intended for use in animals.
(2) the regulation referred to in paragraph 1 may be limited to certain dosages, indications or dosage forms.
(3) the Decree was made in agreement with the Federal Ministry for environment, nature conservation and nuclear safety, insofar as radiopharmaceuticals and medicinal products, ionising radiation are used in their manufacture.

§ 47 distribution channel (1) pharmaceutical entrepreneur and wholesalers may medicines, which dispensing is restricted to pharmacies, except pharmacies only dispose to 1 other pharmaceutical contractors and wholesalers, 2 hospitals and doctors, as far as it's a) blood preparations derived from human blood or genetically manufactured blood components, which, in the case of coagulation factor preparations, may be placed by the hämostaseologisch qualified doctor in the medically controlled self treatment of haemophiliacs to his patients , b) preparations of tissue or animal tissue, c) infusion solutions in containers with at least 500 ml, which are intended to replace or to the correction of body fluid, as well as solutions for hemodialysis and peritoneal dialysis, which, insofar as it is to the peritoneal dialysis solutions, may be placed on prescription of nephrologic qualified doctor within the framework of the medically controlled self treatment of his patients to these, d) preparations, intended exclusively for , the texture, the State or the function of the body or mental States recognize to leave, e) medical gases, where also the transfer to alternative practitioners is allowed, f) radiopharmaceuticals, g) medicines, which are marked with the indication "Intended for the clinical trial", if they are provided free of charge, h) leech and fly larvae, where also the transfer to alternative practitioners is allowed , or i) medicines, which in the case of article 21 paragraph 2 number 6 available, 3 hospitals, health departments and doctors, as far as it comes to vaccines, which are intended for a non-remunerated on the basis of article 20, paragraph 5, 6 or 7 of the infection Protection Act of 20 July 2000 (Federal Law Gazette I p. 1045) to be applied carried out vaccination or if delivery of vaccines to prevent a disease - or danger to life is necessary , 3a.
Special yellow fever vaccination centres pursuant to section 7 of the Act on the implementation of the international health regulations (2005), insofar as it is to yellow fever vaccine, 3B. hospitals and dispensaries, as far as it comes to medicinal products with antibacterial or antiviral effect, intended to, to be applied on the basis of article 20, paragraph 5, 6 or 7 of the infection Protection Act for specific prophylaxis against communicable diseases, 3 c.
Health authorities of the Federation or of the countries or places named by them in the individual case, as far as medicines is, that in the event of a threatening communicable disease, whose spreading requires providing immediate and significantly exceeding the usual level of specific medicines, stock, 4. veterinary authorities, insofar as to medicines, determined to carry out public measures are, 5.
on a statutory basis furnished or approved in consultation with the Ministry by the competent central purchasing bodies for medicines, 6 veterinarians in the context of the operation of a veterinary medicine cabinet, as far as to finished product is, for use on the animals handled by them and to submit to their holders, 7 to the practising of dentistry as far as to finished product is authorised persons, , exclusively in dentistry are used and applied in treating the patient, 8 institutions of research and science, which has been granted a permit under section 3 of the Narcotic Drugs Act, entitles to the purchase of the medicinal product concerned, 9 universities, insofar as medicinal, for the training of students of Pharmacy and veterinary medicine are needed.
The recognition of the central procurement office according to 1 No. 5 set, unless it is drug use in animals, in consultation with the Federal Ministry of food, agriculture and consumer protection.
(1a) pharmaceutical entrepreneur and wholesalers are allowed medicinal products intended for use in animals, which in paragraph 1 no only when you have 1 or 6 designated recipients, if this them a certificate of the competent authority have submitted that they section 67 have complied with their obligation to.
(1B) pharmaceutical entrepreneur and wholesalers have medicinal products which are not exclusively for use in other animals than those that serve the production of food, to lead evidence, which separately for each of these drugs temporally ordered the amount of reference, specifying the suppliers and the amount of the levy, stating can be demonstrated the recipients about the reference and the output for use in animals certain verschreibungspflichtiger , and this proof to the competent authority upon request to submit.
(1c) pharmaceutical contractors and wholesalers up to 31 March each year after in accordance with a Decree pursuant to sentence 2 electronic communication have to make medicines according to § 67a para 1 type and quantity of medicinal products issued by them in the preceding calendar year to veterinarians, the central information system on the 1 substances with antimicrobial effect, 2. in table 2 of the annex of to Regulation (EU) No. 37 / 2010 listed substances or 3 in one of the facilities of the regulation on substances with pharmacological effect listed substances. The Federal Ministry of food, agriculture and consumer protection is authorised in agreement with the Ministry, by decree with the consent of the Federal Council for more information about content and form of messages pursuant to sentence 1 to regulate and 2nd to require 1 that a) the registration number of each given medicinal product to specify is the communications, b) the communication of the amount of the drug to break down is after the first two digits of the postal code of the address of veterinarians.
In regulations pursuant to sentence 2, also arrangements through corresponding application of section 67a, paragraph 3 and 3a can be made.
(2) that are allowed in paragraph 1 No. 5-9 designated recipient take the drug only for own needs in order to carry out their tasks. The No. 5 designated central procurement agencies have been recognised only in paragraph 1, if it is shown that they under professional direction of a pharmacist or, in the case of medicinal products intended for use in animals, a veterinarian are available and there are suitable rooms and facilities for the inspection, control and storage of pharmaceutical products.
(3) pharmaceutical entrepreneur must submit samples of finished medicinal make 2 other persons who professionally practise medicine or dentistry, insofar as it is not prescription drugs, 3. education for the healthcare professions, or leave at 1 doctors, dentists, or veterinarians.
Pharmaceutical entrepreneur must allow patterns of finished medicinal training sites for the healthcare professions in a surrender to adequate the purpose of training or leave. Pattern may no substances or preparations 1 within the meaning of section 2 of the Narcotic Drugs Act as such are listed in Appendix II or III of the Narcotic Drugs Act, or 2 you may be prescribed according to section 48 paragraph 2 sentence 3 only on special recipe, containing.
(4) pharmaceutical entrepreneur must allow persons pursuant to paragraph 3 not more than two samples submit to sentence 1 only upon their written request, in the smallest package size in a year of a finished product pattern of finished medicinal or emit. The prescribing information is with the patterns, insofar as this is required according to § 11a to send. The pattern is used in particular the information of the doctor on the subject matter of the medicinal product. About the recipients of patterns as well as nature, scope and time patterns are separately for each recipient to lead evidence and to submit at the request of the competent authority.

§ 47a special distribution channel, proof obligations (1) pharmaceutical entrepreneur must a medication that is approved to carry out of an abortion, only to institutions within the meaning of § 13 of the pregnancy conflict Act of 27 July 1992 (BGBl. I S. 1398), amended by article 1 of the law of August 21, 1995 (Federal Law Gazette I p. 1050), and leave only on the prescription of a physician there. Other people may bring the drug referred to in sentence 1 not in traffic.
(2) pharmaceutical entrepreneur have the packs destined for the levy in paragraph 1 to the number set 1 these medicines all the time; without this marking the medicinal product should not be placed. The output pharmaceutical entrepreneur, of the receipt and the setting up and the doctor have the application to lead evidence and to present this evidence at the request of the competent authority for inspection.
(2a) pharmaceutical entrepreneur, as well as the establishment of have separately set 1 above pharmaceutical products that are in their possession, which in paragraph 1 to be kept and must be secured against unauthorized removal.
(3) §§ 43 and 47, see the paragraph 1 set 1 medicines listed no application.

§ 47b special distribution channel diamorphine (1) pharmaceutical entrepreneur may a slide morph content-finished product, the substitution-based treatment is approved, only to recognized institutions in the sense of § 13 paragraph 3 sentence 2 point 2a of the Narcotic Drugs Act and submit only on the prescription of a physician there. Other persons may bring the drug referred to in sentence 1 not in traffic.
(2) §§ 43 and 47, see the paragraph 1 set 1 medicines listed no application.

Section 48 (1) medicines, which are 1 by a regulation specified in paragraph 2, in conjunction with paragraphs 4 and 5, certain substances, preparations of substances or objects or where such substances or preparations from fabrics are used to, 2. under number 1 fall and intended for use in animals which serve the production of food, prescription or 3. medicinal products in the sense of article 2, paragraph 1 or paragraph 2 are number 1 , the substances with effects not commonly known in medical science or preparations of substances contain, may be given only if there is a medical, dental or veterinary prescription to consumers. Sentence shall not apply 1 number 1 for the delivery by pharmacies to the facilities of the merchant in terms of the medicines that are required on the basis of maritime labour legislation for the protection of health of persons on board and their immediate appropriate medical care on board. Set 1 number 3 also applies to medicinal products which are preparations of substances commonly known in their effects, if the effects of these preparations in medical science are not well known, except that the effects are determined according to composition, dosage, dosage form or application field – the preparation. Sentence does not apply 1 number 3 for medicines, which are preparations of substances of known effects, as far as these may be placed outside of pharmacies. Prescription pursuant to sentence 1 number 3 is replaced number 1 with the inclusion of the substance concerned or the preparation under the Ordinance referred to in paragraph 2 the prescription according to the Decree.
(2) the Federal Ministry is authorised to determine 1. substances or preparations of substances, in agreement with the Federal Ministry of Economics and technology by decree with the consent of the Bundesrat where the requirements referred to in paragraph 1 sentence 1 number 3 in connection with paragraph 1 sentence 3 are, 2 substances, preparations to determine substances or objects, a) the human health or , provided that they are intended for use in animals the health of the animal, of the user or the environment also intended directly or indirectly can endanger, if they are applied without medical, dental or veterinary monitoring, b)
often improper be used significantly, if this health directly or indirectly can be endangered by humans or animals, or c) provided that they are intended for use in animals, applying them requires a previous veterinary diagnosis or impact can have, which complicate the subsequent diagnostic or therapeutic measures or overlay, prescriptions for medicines to pick up 3rd, if on the basis of the experience gained in the use of the medicinal the conditions laid down in paragraph 2 does not There are, for medicinal products referred to in point 1 may not earlier than three years after entry into force of the underlying order prescriptions be lifted, 4. for substances or preparations from materials to prescribe, that they just may be placed, if in prescribing certain maximum residue limits for the single and day use are not exceeded or when exceeding expressly indicated has been made by the prescribing, to determine 5. , that a drug on a prescription not repeatedly may be emitted, 6 to require that a medicinal product only on a prescription must be given by doctors of a specific department or for use in facilities approved for treatment with the drug or the prescribing, dispensing and application documents must be carried, 7 relating to the form and content of the prescription , including the prescription electronically, to be issued.
The regulations be adopted pursuant to sentence 1 number 2 to 7 after consultations with experts, unless it's drugs, which no 726 / 2004 are eligible according to article 3 paragraph 1 or 2 of Regulation (EC) or that correspond to such medicines in terms of active ingredient, indication, strength and dosage form. In the Ordinance pursuant to sentence 1 number 7 may for medicines, whose prescribing requires compliance with specific safety requirements, are prescribed, that 1 the prescription must only be on an official form (special recipe), issued by the competent federal authority to request a physician, 2. information to the application, as well as confirmations must contain the form, in particular to disclosure on application and risks of the medicinal product , and 3. a copy of the prescription by the pharmacy to the competent federal authority to return.
(3) the Decree according to paragraph 2, in conjunction with paragraphs 4 and 5, may be limited to certain dosages, exponentiation, dosage forms, finished product or application areas. As an exception can be provided by prescription for sale to midwives and maternity nurses, insofar as this is necessary for a proper exercise of the profession. The restriction is on certain finished product to be applied to the people pursuant to sentence 1, if article 74a of the Directive 2001/83/EC, it is the prescription waiver on the basis of significant pre-clinical tests or clinical trials; This is the period of one year provided for in article 74a.
(4) the decree is issued by the Federal Ministry of food, agriculture and consumer protection in agreement with the Ministry and the Federal Ministry of Economics and technology, insofar as it is medicinal products intended for use in animals.
(5) the Decree was made in agreement with the Federal Ministry for environment, nature conservation and nuclear safety, insofar as radiopharmaceuticals and medicinal products, ionising radiation are used in their manufacture.
(6) the Federal Ministry of food, agriculture and consumer protection is hereby authorised, in agreement with the Ministry Ordinance with the consent of the Federal Council in the case of paragraph 1 sentence 1 No. taking 2 drugs by prescription, as far as on reason of article 67 double letter aa of Directive 2001/82/EC specified requirements are met.
Footnote (+++ § 48 para 1: to the application see § 109 paragraph 11 +++) paragraph 49 (dropped out) § 50 retail over-the-counter medicines (1) retail trade outside of pharmacies with drugs in the sense of § 2 para 1 or par. 2 No. 1, that have been released for circulation outside of pharmacies may only be operated if the entrepreneur, a legally appointed to the representation of the company, or a person authorized by the contractor with the management of the company, or the sale has the required expertise. For companies with several operating places a person must exist for each place of business which has the necessary expertise.
(2) the necessary expertise has, who can prove knowledge and skills about the proper filling, packing, marking, storing and placing on the market of medicinal products which have been approved for circulation outside of pharmacies, as well as knowledge of the rules applicable to these medicines. The Federal Ministry is empowered to legislate as to provide is proof of the necessary expertise to ensure a proper transport of medicines by decree with the consent of the Federal Council in agreement with the Federal Ministry of Economics and technology and the Federal Ministry of education and research. It may recognise certificates vocational education paid from or training in as proof. It can also determine that the expertise is evidenced by an examination before the competent authority or a body designated by you and settle the details about the testing requirements and test procedure. The legal regulation is as far as it is medicinal products which are intended for use in animals, issued by the Federal Ministry of food, agriculture and consumer protection in agreement with the Ministry, the Federal Ministry of Economics and technology and the Federal Ministry of education and research.
(3) an expertise referred to in paragraph 1 who retailed in the traffic brings, the 1st in the travel industry may be placed, 2. to prevent pregnancy or sexually transmitted diseases in humans to determine are medicinal, (dropped out) 4 for external use only certain 3. disinfectant or 5 are oxygen not needed.

§ 51 banned levy in the travel industry (1) which are peddling of medicines and the search of orders on medicines in the travel industry; are exempt from the ban on shared drugs for transport outside of pharmacies, called the 1st with their normal German names, in their effects commonly known plants or parts of plants or juices from fresh plants or parts of plants are, if these were manufactured with any other solvent as water, or mineral water and its salts in their natural ratio or their replicas are 2..
(2) the prohibition of in paragraph 1 first half-sentence does not apply, as far as the trader seeks out other people in the course of its business, except that it is for the application in animals in agriculture or forestry, commercial farms and farms of the vegetable, fruit, garden and wine, medicines, beekeeping and fishing offered for sale or that these businesses orders on medicinal products , whose tax is reserved for pharmacies, are visited. The same applies to traveling salesman and other persons who act on behalf and on behalf of a trader.

§ 52 ban of self-service (1) drugs in the sense of § 2 para 1 or par. 2 No. 1 1 not vending machines and 2 not through other forms of self-service in the traffic may be placed.
(2) paragraph 1 does not apply to finished product that 1 in the travel industry may be delivered, 2. to prevent pregnancy or sexually transmitted diseases in humans to determine and are released to the traffic outside of pharmacies, (dropped out) 4 for external use only certain 3. disinfectant or 5 oxygen are.
(3) paragraph not apply 1 No. 2 to medicinal products which have been approved for transport outside of pharmacies, if a person who has the expertise to § 50, is available.

§ 52a wholesale trade in medicines (1) who operates no.1, Testsera or test antigens wholesale trade in medicinal products in the sense of § 2 paragraph 1 or paragraph 2, requires a permit. Are excluded from this license requirements you number in article 51, paragraph 1 2 referred to and approved for transport outside of pharmacies finished product.
(2) with the application the applicant 1 has to designate the specific facility for which permission is to be granted 2. evidence to present, suitable and sufficient premises, installations and facilities has a proper storage and a proper distribution, and provided a proper transfer, packaging, and to ensure marking of medicines, a responsible person to name 3. , which has the required expertise to engage in the activity, and 4.
an explanation to attach, in which he in writing undertakes to comply with the rules and regulations for the proper operation of a wholesale business.
(3) the decision on the grant of the permit meets the competent authority of the country in which the establishment is or should be. The competent authority has to make a decision on the application for the licence within a period of three months. Requires further information on the conditions referred to in paragraph 2, the competent authority by the applicant as the period referred to in sentence 2 is suspended so long until the necessary supplementary information the competent authority.
(4) the permit may be refused only if 1 the conditions not apply pursuant to paragraph 2, 2. facts adopting justify that the applicant or the person in charge is no. 3 that does not have the required reliability for carrying out their activities, or 3. the wholesaler unable referred to in paragraph 2, to ensure compliance with the rules and regulations for proper operation.
(5) the permit is to take back, if it is later known that one of the grounds for refusal existed pursuant to paragraph 4 of the issuance. The permit shall be revoked if the conditions for the granting of the permit no longer exist; also the rest of the permit can be arranged instead of withdrawal.
(6) a permit under section 13 or section 72 includes permission for the wholesale of medicines, which are permission covered by section 13 or section 72.
(7) paragraphs 1 to 5 shall not apply to the activity of pharmacies within the framework of the usual operation of the pharmacy.
(8) the holder of the permit has previously to show any change in the information referred to in paragraph 2, as well as any substantial change of wholesale activity upon presentation of evidence of the competent authority. Unforeseen change of the responsible person referred to in paragraph 2, no. 3 has to be the display immediately.

§ 52b provision of medicines (1) pharmaceutical entrepreneur and operator of drug wholesalers, within the territorial scope of this Act a actually installed in traffic and the application in the or specific human medicines market, which has been approved by the competent federal authority or for it by the European Community or the European Union an authorisation for the placing on the market referred to in article 3 No 726 / 2004 has been granted paragraph 1 or 2 of Regulation (EC) , ensure an adequate and continuous deployment of the medicinal product so that the needs of patients in the territorial scope of this Act are satisfied.
(2) pharmaceutical entrepreneur must guarantee within the framework of their responsibilities of a needs-based and continuous delivery of full-circuit drug wholesalers. Full serving drug wholesalers are wholesalers, which maintain a vendor-neutral, complete range of nonprescription medicines, which is designed according to width and depth, that thus the weekdays; demand by patients with the wholesale business relationship pharmacies within reasonable time to keep medicines must meet at least the average needs for two weeks. Sentence 1 shall not apply to medicinal products which are subject to the distribution channel of article 47 paragraph 1 sentence 1 number 2 to 9 or of Section 47a, or delivered for other legal or factual reasons do not have wholesale.
(3) providing full end drug wholesalers to ensure a needs-based and continuous supply of pharmacies standing with them in business relationship within the framework of their responsibilities. Sentence 1 shall apply accordingly for other pharmaceutical wholesalers in the scope of medicines respectively held by them.
(4) the provisions of the Act against restraints on competition shall remain unaffected.

§ 52c Medicines Agency (1) a medicinal agent only worked within the territorial scope of this Act must, if he is established in the area of application of this Act in another Member State of the European Union or in another Contracting State to the agreement on the European economic area.
(2) the medicinal agents may accept only his work after notification in accordance with article 67 paragraph 1 sentence 1 competent authority and registration by the authority in a public database according to § 67a or a database of another Member State of the European Union or another Contracting State to the agreement on the European economic area. In the display the type of activity, the name and address are by the medicinal agents to specify. Competent authority is the authority in whose jurisdiction the pharmaceutical intermediaries domiciled pursuant to sentence 1.
(3) the medicinal agent meets not under this Act or according to requirements specified in a regulation adopted on the basis of this Act, the competent authority can refuse the registration in the database or delete.

§ 53 consultation of experts (1) the extent that according to article 36, paragraph 1, article 45, paragraph 1, and article 46, paragraph 1 prior to the adoption of legal regulations expert to listen to are built, the Ministry by Decree without the consent of the Federal Council a Committee of experts. Experts from the medical and pharmaceutical science, hospitals, the practitioners, industry stakeholders and the social security institutions should belong to the Committee. To determine details about the composition, the appointment of the members and the Committee procedure under the Ordinance. The decree is issued by the Federal Ministry of food, agriculture and consumer protection in agreement with the Federal Ministry of, insofar as it is medicinal products intended for use in animals.
(2) as far as experts to listen to are according to § 48 para 2 prior to the adoption of the regulation, paragraph 1 shall apply mutatis mutandis with the proviso that experts from the medical and pharmaceutical science, as well as experts of the drug committees of physicians, veterinarians and pharmacists should belong to the Committee. Medical and pharmaceutical practice and the pharmaceutical industry representatives participate in meetings without voting rights.
Eighth section operating regulations (1) that is Ministry authorized assurance and control of the quality of article 54, in agreement with the Federal Ministry of Economics and technology by decree with the consent of the Federal Council operating regulations for companies or institutions to adopt, spend the medicines in the area of application of this Act or where medicinal products developed, manufactured, tested, stored, packaged or be placed on the market or where otherwise with medicinal trade is driven , as far as it is necessary to ensure proper operation and the required quality of medicinal products and pharmacovigilance; This applies accordingly for active ingredients and other substances specific to drug manufacturing and fabric. The decree is issued by the Federal Ministry of food, agriculture and consumer protection in agreement with the Ministry and the Federal Ministry of Economics and technology, insofar as it is medicinal products intended for use in animals. The decree is issued each in agreement with the Federal Ministry for environment, nature conservation and nuclear safety, insofar as radiopharmaceuticals or drugs, ionising radiation are used in their manufacture.
(2) in the regulation referred to in paragraph 1, in particular rules can be taken about 1 development, production, testing, storage, packaging, quality assurance, acquiring, providing, storage and placing on the market, 2. Management and storage using the operations referred to in paragraph 1, 3. posture and control animals and the evidence used in the manufacture and testing of medicinal products , 4. requirements for the staff, 5. texture, size and furnishings, 6 requirements for hygiene, 7 nature of containers, 8 marking of containers where drugs and their precursors are kept in stock, 9 service for pharmaceutical wholesale companies, 10 deferral of batch samples as well as the extent and duration of storage, 11 identification, isolation or destruction not capable to transport medicines, 12 requirements for and the requirements of the activities referred to in paragraph 1 by the veterinarian (operating a veterinary medicine cabinet), as well as the requirements to the Application of medicines by the veterinarian in the animals treated by him.
(2a) (dropped out) (3) the provisions of paragraphs 1 and 2 shall also apply to persons who professionally carry out the activities referred to in paragraph 1.
(4) paragraphs 1 and 2 apply to pharmacies within the meaning of the Pharmacy Law, as far as this a permit according to § 13, § 52a or section 72 shall require.

Article 55 Pharmacopoeia
(1) the pharmacopoeia is one of the Federal Institute for drugs and medicine products in consultation with the Paul-Ehrlich-Institut and made known the Federal Office of consumer protection and food security collection of recognized pharmaceutical rules about the quality, testing, storage, delivery and designation of medicines and the substances used in their manufacture. The pharmacopoeia contains also rules for the quality of containers and wrappings.
(2) the rules of the pharmacopoeia are decided by the German Pharmacopoeia Commission or of the European Pharmacopoeia Commission. The announcement of the rules can be rejected for legal or technical reasons or undone.
(3) the German Pharmacopoeia Commission has the task to decide on the rules of the pharmacopoeia and to assist the competent federal authority in the work within the framework of the Convention on the elaboration of a European Pharmacopoeia.
(4) the German Pharmacopoeia Commission is formed at the Federal Institute for drugs and medical devices. The Federal Institute for drugs and medicine products appoints the members of the German Pharmacopoeia Commission of experts of the medical in agreement with the Paul-Ehrlich-Institut and the Federal Office of consumer protection and food safety and pharmaceutical science, professionals, industry stakeholders and the pharmacovigilance compared numerically same, is the Chair and shall adopt its rules of procedure. The rules of procedure requires the consent of the Ministry in consultation with the Federal Ministry of food, agriculture and consumer protection. The members are sworn to secrecy.
(5) the German Pharmacopoeia Commission to basically unanimously decide on the rules of the pharmacopoeia. Decisions which not more than three-fourths of the members of the Commission have approved are ineffective. The further regulates the rules of procedure.
(6) the provisions of paragraphs 2 to 5 find appropriate application on the activity of the German Homeopathic Pharmacopoeia Commission.
(7) the notice is made in the Federal Gazette. She can do is to indicate the source of the version of the pharmacopoeia and the beginning of the validity of the revised version.
(8) during the manufacture of medicines may only substances and the containers and packages, if applicable, with the drugs in touch, be used and customized dosage forms only that match the pharmaceutical standards. Sentence 1 applies to medicinal products which are manufactured exclusively for export, with the proviso, that the rules applicable in the receiving country may be taken into account.
(9) by way of derogation from paragraph 1 sentence 1 is by the Federal Office of consumer protection and food safety, in agreement with the German Federal Institute for drugs and medical devices and the Paul-Institut Ehrlich-notice insofar as it is medicinal products intended for use in animals.

section 55a of the official collection of investigation the competent Federal Authority published an official collection of methods for sampling and testing of drugs and their precursors. The procedures be set composed by experts in the fields of monitoring, science and the pharmaceutical entrepreneur. The collection is to keep up to date.
Ninth section special rules for medicines used in animals article 56 medicated feedingstuffs (1) medicated feedingstuffs may; be placed by way of derogation direct § 47 para 1, but only on prescription of a veterinarian, from the manufacturer to pet owners This applies also, if the medicated feedingstuffs in another Member State of the European Union or in another Contracting State to the agreement on the European economic area by using in the territorial scope of this Act of approved medicinal premixes or such drug pre-mixes which have the same quality and a comparable quantitative composition such as medicinal premixes approved within the territorial scope of this Act, be made, other pharmaceutical regulatory rules applicable to the territorial scope of this Act are observed and the medicated feed is a companion certificate, referred to by the Federal Ministry of food , Known made agriculture and consumer patterns is annexed. In the case of sentence 1, second half-sentence, the prescribing veterinarian of authority according to § 64 paragraph 1 for monitoring the pharmaceutical regulatory compliance by the keepers shall immediately transmit a copy of the prescription. The repeated delivery on a prescription is not permitted. The Federal Ministry of food, agriculture and consumer protection is authorized to adopt rules on form and content of the prescription by regulation in agreement with the Ministry and the Federal Ministry of Economics and technology.
(2) only an approved pursuant to § 25 para 1 or exempted on the basis of § 36 para 1 from the requirement for approval drug premix may be used for the manufacture of medicated feedingstuffs. On prescribing a medicated feedingstuffs from a maximum of three medicinal premixes that to be treated are species approved, respectively, for use in the should be done by way of derogation from sentence 1, 1 for the relevant application area is an approved drug premix unavailable, 2. in individual cases in the medicated feed no more than two drug premixes with each an anti-microbial active substance contained or at most a drug premix with several such substances is included and 3 is a homogeneous and stable distribution of the active ingredients in the medicated feedingstuffs is assured.
(3) medicated feedingstuffs manufactured, so the used feed must comply with the animal feed regulations before and after mixing and it may contain no antibiotic or coccidiostat as feed additives.
(4) the manufacturer of the medicated feed has to ensure that the drug daily dose in a lot in the feed is included, which the daily feed ration of the animals treated in ruminants covers the daily requirement of supplementary feed, except mineral feed, at least to the half. The manufacturer of the medicated feedingstuffs has to mark, that are clearly visible on the label which is word "medicated feedingstuffs" and specify what percentage she determined to meet the feed requirements pursuant to sentence 1, the feed mixture before dispensing.
(5) the veterinarian may only prescribe medicated feedingstuffs, 1st if they are intended to be applied to the animals treated by him, 2nd if they are intended for the species referred to in the package inserts of medicinal premixes and application areas, 3. if their application is justified according to application area and quantity according to the position of veterinary science to achieve the treatment goal, and 4. when to use in animals , that the extraction of food serve prescribed quantity of medicated feedingstuffs, the a) subject to the letters b, prescription drug premixes containing the application within which the levy following 31 days is determined, or b) antimicrobial active substances included, is intended to be applied within the seven days following the delivery, provided the conditions of the drug premix not a longer application period.
section 56a subsection 2 applies to the prescription of medicated feedingstuffs accordingly. In the case of the prescription of medicated feedingstuffs pursuant to sentence 1 No. 4 applies section 56a subsection 1 sentence 2 in addition.

section 56a prescribing, dispensing and use of medicines by veterinarians (1) the veterinarian may for transport outside the pharmacies only prescribe medicinal products not shared the pet owners subject to special provisions on the basis of paragraph 3 or only submit these, if 1 they for animals treated by him are intended, 2. they are approved or it on the basis of § 21 para 2 are allowed no. 4 in conjunction with paragraph 1 in traffic or in the scope of a legal regulation According to section 36 or § 39, paragraph 3, sentence 1, no. 2 fall or according to § 38 paragraph 1 into circulation may be placed, 3. According to the approval for the application area in the treated animal species are intended, 4. their application to application area and quantity according to the position of veterinary science is justified, to achieve the treatment goal in this case , and 5 to the application on animals producing food, a) is subject to the letters b, prescribed or given quantity of prescription drugs to the application within which the levy determines following 31 days, or b prescribed or given quantity of medicinal products containing antimicrobial active substances and are provided according to the conditions not only for the local application is the application within which the levy determines following seven days , provided the conditions for admission not a longer application period.
The veterinarian may again only give prescription drugs for use in animals which serve the production of food, for the particular case or prescribe, unless he has examined the animals treated or the treated animal stock over a period of 31 days prior to the date of the last application of disposal or to verschreibenden pharmaceutical products provided for according to the instructions of his treatment. Sentence 1 No. 2 to 4 applies to the application by the veterinarian. By way of derogation from sentence 1 the veterinarian may the keepers of medicinal premixes neither prescribe nor submit to them.
(1a) paragraph 1 sentence 3 shall not apply where a veterinarian applies medicines an animal treated by him, and the drug solely for that purpose by him have been manufactured.
(2) as far as the necessary medical care of animals otherwise seriously at risk would be and direct or indirect risks to human and animal health is not to be feared, may the veterinarian in individual animals or animals of a certain stock by way of derogation from paragraph 1 described sentence 1 No. 3, also in connection with paragraph 1 sentence 3, hereinafter referred to approved or prescribe medicinal products exempted from the approval , apply or submit: 1 as far as for the treatment is an approved drug for the relevant species and the relevant application not available, a drug approved for the relevant species and another application area;
2. unless a drug suitable for number 1 for the relevant species not available stands, a drug approved for a different species;
3. If a drug suitable for number 2 not available is, a drug that is approved for use in humans or, also by way of derogation from paragraph 1 set a record 3, 1 No. 2, also in connection with paragraph 1 drug, which is approved in one Member State of the European Union or another Contracting State to the agreement on the European economic area for use in animals; in the case of animals which serve only such medicines from other Member States of the European Union or other States party to the agreement on the European economic area for use in animals, the production of food, food-producing are admitted;
4. If a suitable for number 3 medicines not available, one in a pharmacy or by the veterinarian according to § 13 para 2 sentence 1 No. 3 letter d manufactured medicines.
In animals, the aim of gaining food, you may the medicines are used only by the veterinarian or administered under his supervision, and only pharmacologically active substances that no. 37/2010 are listed in table 1 of the annex of to Regulation (EU). The vet has to specify the wait time; the further regulates the veterinary pharmacies of the House Ordinance. Sentences 1 to 3 shall apply by analogy to medicinal products manufactured according to § 21 para 2 in conjunction with § 2a n ° 4. Registered or exempted from registration homeopathic medicines may be different prescribed by paragraph 1 sentence 1 No. 3, issued and applied. This applies to medicinal products which are intended for use in animals which serve the production of foods, only if they contain only ingredients that no. 37/2010 are as substances listed in the annex of to Regulation (EU), a setting of maximum residue levels is not required for the.
(2a) by way of derogation from paragraph 2 sentence 2 must medicines for equidae, producing food and nothing in section IX of part II of the equine in the sense of Regulation (EC) no 504 / 2008 of 6 June 2008 on the implementation of Directive 90/426/EEC of the Council as regards methods for the identification of equidae (OJ L 149 of the 7.6.2008, p. 3) is set in the currently valid version, also prescribed, given or applied, if they substances, in Council Regulation (EC) no 1950/2006 of the Commission of 13 December 2006 establishing a list of for the treatment of equidae essential substances under Directive 2001/82/EC of the European Parliament and of the Council establishing a Community code relating to veterinary medicinal products (OJ L 367 of the 22.12.2006, p. 33) are listed.
(3) the Federal Ministry of food, agriculture and consumer protection is authorized in agreement with the Ministry Ordinance with the consent of the Bundesrat 1 requirements of the levy and the prescription of drugs for use in animals, also with regard to the treatment to set to ban 2 subject to a legislative decree referred to, when prescribing, dispensing, or the application of medicinal products intended for use in animals 5 , which contain antimicrobial active substances in article 11, paragraph 4, sentence 1 to depart from number 3 and 5 listed of the instructions, as far as this to prevent a direct or indirect threat to the health of humans or animals through the use of these drugs is required, 3. to prescribe that the veterinarian in the treatment of certain animals in certain cases is to create a determination of the sensitivity of the pathogen causing a disease to specific antimicrobial active substances or to create , 4. to prescribe that a) veterinarians release, prescription, and application, also with regard to treating for transport outside the pharmacies must through evidence not shared drugs, b) medications may be applied only by the veterinarian himself, if these medicines aa) human or animal even when intended directly or indirectly can endanger health, if they are not correctly applied , bb) repeatedly in substantial non-intended use be used and thus health directly or indirectly can be endangered by humans or animals, 5. to prescribe that the vet certain by way of derogation from paragraph 2 medicinal products which contain certain antimicrobial active substances, only a) for the registration species provided for or areas of application submit or prescribe or b) may apply in the species provided for in the authorisation or in the specified areas of application , as far as this is necessary to obtain the effectiveness of antimicrobial active substances for the treatment of humans and animals.
In regulations pursuant to sentence 1 can also set 1 in the case of Theorem 1 number 3 requirements on the sampling, the samples to be taken, the procedure of investigation and verification are, 2. in the case of Theorem 1 number 4 letter a a) type, form and content of evidence as well as the duration of storage are regulated, b) be prescribed that summarized the evidence on the orders of the competent authority according to their specifications by the veterinarian and made available to you , as far as this is necessary to ensure a sufficient monitoring of the application of medicines for animals that serve the production of food,.
Regulations pursuant to sentence 1 number 2, 3 and 5 is provision for it to meet that the animals receive the necessary medical care at any time. The accountability can be limited to certain medicinal products, applications or forms.
(4) the veterinarian may by Regulation pursuant to paragraph 3 sentence 1 No. 2 certain medicinal keepers neither prescribe nor submit to this.
(5) the Federal Ministry of food, agriculture and consumer protection is authorized to establish an animal drug application Commission by decree with the consent of the Federal Council in agreement with the Ministry. The animal drug application Commission describes the State of veterinary science, in particular for the use of medicinal products containing antimicrobial active substances in guidelines. Under the Ordinance, details about the composition is to determine the appointment of the members and the procedure of the animal drug application Commission. In addition, can be transmitted through legal regulation more tasks the animal drug application Commission.
(6) it is believed that a justification set is no. 3 1 No. 4 or of § 56 paragraph 5, sentence 1 State of veterinary science in the sense of paragraph 1, provided that the animal drug application Commission guidelines set 2 to comply under paragraph 5.
Footnote (+++ section 56a para 2a: apply see § 109 paragraph 12 +++) § 56b exceptions the Federal Ministry of food, agriculture and consumer protection shall be authorised in agreement with the Federal Ministry by decree with the consent of the Federal Council to allow exceptions to article 56a, insofar as the necessary medical care of animals would otherwise seriously at risk.

§ 57 acquisition and ownership by pet owners, evidence
(1) the pet owners may acquire medicinal products which are not released for circulation outside the pharmacies for use in animals only in pharmacies, the veterinarian who treated the animal population or in the cases of § 56 para 1 manufacturers. Others who are not mentioned in article 47, paragraph 1, may acquire such medicines in pharmacies. Sentence 1 shall not apply to medicinal products within the meaning of § 43 para 4 sentence 3. Sentences 1 and 2 shall not apply as far as medicines that are approved only for use in animals which are not extracting food, a) of the keepers in the way of shipment according to section 43, paragraph 5, sentence 3 or 4, or b) by other persons that are not mentioned in article 47, paragraph 1, in the way of shipment according to section 43, paragraph 5, sentence 3 or article 73, paragraph 1 number 1a be purchased. By way of derogation from sentence 1, the keepers of medicinal premixes may not acquire.
(1a) pet owners may not have medicines, where by a regulation is mandatory, that they may be applied only by the veterinarian himself, owned. This does not apply if the drug for a purpose other than the application in animals intended or possession under Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use of certain substances with a hormonal or thyrostatic action and of beta-agonists in the beta-agonists, and repealing directives 81/602/EEC, 88/146/EEC and 88/299/EEC (OJ EC No. L 125, p. 3) is allowed.
(2) the Federal Ministry of food, agriculture and consumer protection will be empowered to impose in agreement with the Ministry Ordinance with the consent of the Federal Council that 1 companies or people, keep the animals producing food, and bring this or derived from those products in question, and 2 other persons, which in article 47 paragraph 1 not shown are records relating to the purchase , to lead the storage and the whereabouts of the medicines and register or evidence of the use of medicines have, as far as it is required in order to ensure a correct application of medicines and when it comes to companies or persons referred to in point 1, to the implementation of legal acts of the European Community or the European Union in this area is required. Under the Ordinance, nature, form and content of the register and certificates and the duration of their storage can be controlled. Under the Ordinance may be that evidence on the orders of the competent authority are according to their specifications by the pet owner and you are made available, as far as this is necessary to ensure a sufficient monitoring in connection with the use of drugs in animals, the aim of gaining food, prescribed also.
(3) the Federal Ministry of food, agriculture and consumer protection shall be authorised to impose by decree with the consent of the Federal Council in agreement with the Ministry, that companies or persons, the 1st keep animals at an animal shelter or similar device or professional vertebrate animals, excluding animals which serve the production of foods, breed 2. keep or temporarily care for other companies or persons , To have evidence relating to the purchase of prescription drugs that have been acquired for the treatment of the animals referred to in paragraphs 1 and 2. Under the Ordinance, type, form and content of the evidence and the duration of their storage can be controlled.

§ 57a application by pet owners, pet owners and other persons who are not veterinarians, a prescription may apply only in animals, as far as the medicines from the veterinarian have been prescribed or given, in which the animals are in treatment.

Section 58 application in animals producing food (1) in addition to pet owners and other persons who are not veterinarians, prescription drugs or other prescribed by the veterinarian or acquired drug in animals, the aim of gaining food, may apply subject to a measure of authority according to § 58 d paragraph 3 sentence 2 number 2 only after a veterinary treatment statement for the case concerned the requirement of § 57a. Non prescription medicines, which are not released for transport outside of pharmacies and applying them not on the basis of a veterinary treatment statement is made, may only be applied, 1 if they are approved or in the scope of a legal regulation according to § 36 or § 39, paragraph 3, sentence 1, no. 2 fall or they may be placed after article 38 par. 1 in traffic , 2. the species referred to in the labelling or package leaflet of the medicinal products and applications for 3rd in an amount which corresponds to the dosage and duration of use of the labelling of the medicinal product.
By way of derogation from sentence 2 medicinal products within the meaning of § 43 para 4 sentence 3 only after the veterinary official statement according to section 43, paragraph 4, sentence 4 may apply.
(2) the Federal Ministry of food, agriculture and consumer protection will be authorised to prohibit that medicinal products which are intended for use in animals which the extraction of food serve in agreement with the Ministry Ordinance with the consent of the Federal Council, for specific application areas or sections in the traffic, or applied for these purposes insofar as it is necessary to prevent indirect risks to human health.
(3) the Federal Ministry of food, agriculture and consumer protection will be entitled, in consultation with the Ministry Ordinance with the consent of the Federal Council to determine details to technical systems for oral application of medicines in animals, the maintenance and cleaning of this equipment and due diligence of the keeper, to reduce a spread of antimicrobial active substances.

section 58a releases about farming (1) who cattle (Bos taurus), pigs (SUS scrofa domestica) and chickens (Gallus gallus), turkeys (Meleagris gallopavo) stops working - or professional, keeping these animals acquired the competent authority in accordance with paragraph 2 on the respective species and operation, in which the animals are kept (animal farm), no later than 14 days after the start of the position to communicate. The communication shall contain also the following information: 1 the name of the keeper, 2. address of animal husbandry operation, and which in accordance with veterinary legislation on the marketing of cattle for animal husbandry operation registration number, 3. the attitude of a granted) cattle supplemented by specifying whether's to fattening calves up to the age of eight months or beef cattle from the age of eight months , b) of pigs supplemented by indicating whether pig 30 kg or fattening pigs over 30 kg (type of use) is.
(2) that obligation according to paragraph 1 sentence 1 applies 1 for chickens destined for the purpose of meat production (MAST) or Turkey, and from the date of the respective hatching of these animals and 2 for cattle certain for the purpose of fattening or pigs, and from the time at which the respective animals from the dam are deposed.
(3) an individual who keeps animals within the meaning of paragraph 1 sentence 1 on 1 April 2014, has to make the communication referred to in paragraph 1 sentences 1 and 2 no later than 1 July 2014.
(4) a person who is required under paragraphs 1 or 3 of the communication, has to communicate any changes related to the information subject to release within 14 working days. The notification under paragraphs 1 or 3, each also in combination with sentence 1, electronically or in writing must be made. The prescribed notices can be made by a third party, as far as the pet owner has shown this stating the third party of the competent authority. Paragraphs 1 and 3, as well as sentence 1 not apply if the information required for veterinary regulations on the marketing of livestock have been provided. In these cases, the authority responsible for the implementation of the animal health provisions on the marketing of cattle transmitted information required for the authority responsible for the implementation of paragraphs 1 and 3, as well as of sentence 1. The transmission can be done pursuant to sentence 5 in accordance with section 10 of the data protection act in the automated retrieval procedures.

section 58 b messages about drug use (1) who keeps animals for which section 58a messages about their attitude are to make, has the competent authority with regard to medicinal products that contain antibacterial disrupters and animals held by him have been applied, for every animal farm, for which a registration number has been assigned to him according to the animal health conditions on the marketing of livestock , taking into account the type of use twice a year for each treatment to communicate 1 the name of the applied medicinal, 2. the number and type of animals treated, 3. subject to paragraph 3 the number of treatment days, 4. the total applied amount of medicines that contain antibacterial active substances, 5 for each half of the number of animals of each species, the a) in each half at the beginning of the operation (b).
recorded in the course of each half in operation, c) have been submitted during any half-year from the operation.
The messages 1 number 5 are letters b and c pursuant to sentence stating the date of the respective action to make. The message is to make following the last month of the half, in which the treatment is done at the latest on the 14th day of that month. section 58a, paragraph 4, sentence 2 and 3 shall apply mutatis mutandis.
(2) by way of derogation from paragraph 1 sentence 1 may which set 1 number of 1 through 4 listed in paragraph 1 be replaced with the following information: 1. the name of the acquired for the treatment by the veterinarian or prescribed medicinal, 2. the number and species of animals for which a veterinary treatment statement has been issued, 3. the identity of the animals for the treatment instructions of the veterinarian has been issued , provided that specify the type of use arising from, 4. subject to paragraph 3 the duration of treatment prescribed in 5 days the total applied by the veterinarian or given quantity of the medicinal product.
Sentence 1 shall apply only if one keeps the animals 1 compared to the veterinarian at the time of purchase or the prescription of medicines in writing, assured differ from the treatment statement without consultation with the veterinarian, and 2. If the communication referred to in paragraph 1 sentence 1 to the competent authority in writing assures that has been deviated in the treatment of the handling instructions of the veterinarian.
section 58a, paragraph 4, sentence 2 and 3 applies with regard to the set 1 in accordance with.
(3) in the case of medicinal products which contain antibacterial substances and have a therapeutic levels of the active ingredient of more than 24 hours, the vet tells the pet owner the number of treatment days in the sense of paragraph 1 set 1 number 3, added to the number of days in which the medicinal products concerned retains its therapeutic levels of the active ingredient, with. In addition to paragraph 1 sentence 1 number 3 of pet owners these days as days of treatment tells.

§ 58c determination of the frequency of therapy (1) the competent authority determined for each half of the average number of treatments using antibacterial active substances, based on the respective operation, for which according to the animal health conditions on the marketing of cattle, a registration number has been allocated, and the species of animals kept, taking into account the type of use, by them in accordance with the calculation method for determining the frequency of therapy from 21 February 2013 (BAnz AT 22.02.2013 B2) 1 for each applied active substance the number of treated Are been multiply animals with the number of treatment days and adds the resulting number each for all administered substances of the half and 2 the number determined according to the number 1, then by the number of animals of the species concerned, kept the average in the half-year, divided (occupational therapy semiannual, frequency).
(2) no later than the end of the second month of the half of the year, following the releases of the preceding six months after section 58, b paragraph 1 sentence 1, the competent authority shall the Federal Office of consumer protection and food safety for the purposes of paragraph 4, and of article 77 paragraph 3 sentence 2 in anonymised form the semiannual occupational therapy frequency each determined according to paragraph 1. Furthermore, the competent authority shall each on request, the Federal Institute for risk assessment in anonymised form the semiannual frequency of therapy each determined according to paragraph 1, as well as in section 58 b paragraph 1 sentence 1 number 4 listed with, insofar as this is necessary for carrying out a risk assessment of the Federal Institute for risk assessment in the field of antibiotic resistance. The messages can be made pursuant to sentences 1 and 2 in accordance with § 10 of the of the Federal data protection act in the automated retrieval procedures.
(3) as far as the countries set up a joint body for the purposes of paragraph 1, you are in the sections 58a and 58 b referred information of this site to submit; This determines the semiannual occupational therapy frequency in accordance with the calculation method for determining the frequency of treatment referred to in paragraph 1 and inform in paragraph 2 set the 1 and 2 authorities referred to. Paragraph 2 sentence 3 shall apply accordingly.
(4) the Federal Office of consumer protection and food safety obtained from notified to him details of the respective semi-annual occupational therapy frequency 1 as a key figure 1 median (value lower than 50 per cent of all recorded half-yearly therapy frequencies), and 2. as Figure 2 the third quartile (value, lower than 75 percent of all collected half-yearly operational therapy frequency) frequency of nationwide six-month therapy for each section 58a, paragraph 1 referred to species. The Federal Office of consumer protection and food safety discloses these figures until the end of the third month of the half of the year, following the releases of the preceding six months after section 58 b paragraph 1, for the respective expired six months in the Federal Gazette and breaking down, taking into account the type of use.
(5) the competent authority or the joint agency pursuant to paragraph 3 informs the operational half-yearly therapy frequency determined according to paragraph 1 for the respective species of animals held by him within the meaning of section 58a paragraph 1, taking into account the type of use the keeper. The pet owners may require further information about the sections 58a and 58 (b) collected, stored or otherwise processed data insofar as they relate to its operating.
(6) that are collected or communicated under paragraph 5 and stored at the competent authority or the joint agency pursuant to paragraph 3 to the sections 58a and 58 b to be kept for a period of six years. The period begins at the end of June 30 or December 31 of half of the year in which the nationwide half-yearly frequency of therapy is been posted pursuant to paragraph 4. After this period, the data is to delete.

section 58 d reduction treatment with antibacterial active substances (1) to the effective reduction of the application of medicines that contain antibacterial active substances, to contribute who work - or professional keeps animals within the meaning of section 58a paragraph 1 sentence 1, has 1 each two months after a notice of the key figures of the nationwide six-month therapy frequency according to § 58 c paragraph 4 sentence 2 to determine whether in the past period of time his operational half-yearly frequency of therapy in the respective species of animals held by him under consideration of the type of use based on animal operation of husbandry, for him a registration number has been allocated according to the animal health conditions on the marketing of cattle, above the key figure 1 or Figure 2 of the nationwide six-month therapy frequency is located, 2. the finding referred to in point 1 immediately after its determination in its operational documents to record.
(2) is the operational half-yearly therapy frequency of a keeper based on the farm of animal, for which according to the animal health conditions on the marketing of cattle a registration number has been assigned to him, 1 above code 1 has the nationwide six-month therapy frequency, the pet owners with the help of a veterinarian to check, what reasons may have led to this excess and how the treatment of animals held by him in the sense of section 58a paragraph 1 with medicines , the antibacterial active substances contain, can be reduced, or 2. above the key figure 2 of the nationwide six-month therapy frequency has a reducing of treatment with medicinal products containing antibacterial active substances of pet owners on the basis of a veterinary consultation period of two months after the pursuant to paragraph 1 number of measures contains 1 resulting date to create a written plan, , aim.
Examination of the keeper reveals pursuant to sentence 1 number 1 that the treatment of the affected medicines can be reduced, the pet owner has to take steps that can lead to a reduction. The pet owner has to ensure that the measure pursuant to sentence 1 number 1 and the plan to sentence 1 number 2 steps, ensuring the necessary drug care of the animals perform. The plan is under sentence 1 number 2 to add a schedule, if the measures to be taken according to the plan can be met within a period of six months.
(3) the plan set is 1 paragraph 2 referred to in paragraph 2 the competent authority without being asked at the latest two months after the resulting from paragraph 1 to provide number 1 resulting date. Extent to the effective reduction of treatment with medicinal products containing antibacterial active substances, necessary, the competent authority to the pet owners may order 1, that the plan is to change or supplement, orders take 2. taking into account the level of veterinary science to reduce the treatment with medicinal products containing antibacterial active substances, in particular as regards a) the observance of generally accepted guidelines on the application of medicines , contain the effective antibacterial agent, or parts thereof, as well as b) vaccination of animals
3. with regard to the prevention of diseases in the light of the State of good professional practice in agriculture or the good hygienic practices in animal husbandry requirements for the keeping of animals arranged in particular with regard to the feeding, hygiene, the ways and means the mast including the mast duration, the facilities of the stables as well as their establishment and stocking density, 4. rearrange the , that medicinal products containing antibacterial active substances, may be applied for a certain period of time in an animal holding only by the veterinarian, if the species thought to be the specific of a pet owner, taking into account the type of use, observed semiannual therapy frequency twice significantly in order above the number 2 of nationwide therapy frequency.
The aim of the modification or addition to the plan to specify in the arrangement pursuant to sentence 2 is no. 1. In arrangements pursuant to sentence 2, number 2, 3 and 4 is to meet that animals at any time receive the necessary medical care provision for it. The competent authority may decide to even number 3 the keepers over measures pursuant to sentence 2, if these rights of the keeper from administrative acts revoked or restrict from other legislation, if the necessary reduction of treatment with medicinal products containing antibacterial active substances, cannot be reached by other effective measures, and actual evidence on the effectiveness of further measures of the competent authority. Sentence 5 shall not apply where conflict directly applicable legislation of the European Community or the European Union.
(4) has the keeper arrangements pursuant to paragraph 3 sentence 2 number 1 to 4, in the case of the number 3 in connection with sentence 5, are not followed and lies which therefore reviewed observed semiannual therapy frequency above the key figure 2 of the nationwide incidence of therapy for the respective species held by a keeper, taking into account the type of use, the competent authority may the rest of livestock in the operation of the keeper for a certain period of time , arranged for three years, at the latest. The arrangement of the rest of animal husbandry should be repealed as soon as it is ensured that the orders referred to in sentence 1 shall be followed.

section 58e regulation appropriations (1) that is Federal Ministry of food, agriculture and consumer protection authorised to regulate details of style, form and content of the messages of the keeper b in agreement with the Ministry by decree with the consent of the Federal Council Article 58a, paragraph 1 or § 58. In the Ordinance pursuant to sentence 1 can be provided that 1 the releases according to section 58 can be replaced b paragraph 1 or 3 by the transmission of information or records that are going to be, on the basis of other medicinal products legislation, in particular on the basis of a regulation pursuant to section 57 paragraph 2, 2 farms up to section 58a and section 58 b be excluded a particular stock size requirements after.
A decree may pursuant to sentence 1 number 2 only be adopted as far as 1 with the exception of companies achieving the objective of reducing the treatment with medicinal products containing antibacterial active substances, is not jeopardised and the representativeness of the determination of the key figures of the nationwide six-month therapy frequency receive 2 remains.
(2) the Federal Ministry of food, agriculture and consumer protection is hereby authorised, in agreement with the Ministry Ordinance with the consent of the Federal Council, 1 for the purpose of the determination of the median and quartiles of the nationwide six-month therapy frequency to set requirements and details of the calculation of key figures, 2. the modalities, including the procedure for the a) disclosure according to § 58 c paragraph 5, b) deletion of the data according to § 58 c paragraph 6 to fix.
(3) the Federal Ministry of food, agriculture and consumer protection shall be authorised in agreement with the Ministry Ordinance with the consent of the Federal Council the further details about 1 the record pursuant to section 58 d paragraph 1 number 2, to regulate the requirement for delivery including the procedure 2. content and scope of the plan to reduce the treatment with medicinal products containing antibacterial active substances, referred to in section 58 d paragraph 2 sentence 2 number 2 and 3 according to § 58 d, paragraph 3, sentence 1.
(4) the Federal Ministry of food, agriculture and consumer protection is hereby authorised in agreement with the Ministry Ordinance with the consent of the Bundesrat fish that serve the production of foods to include within the scope of sec. 58a-58f and the regulations adopted for the implementation of these provisions, as far as this for achieving the objective of reducing the treatment with medicinal products containing antibacterial active substances , is required. A decree must be adopted first pursuant to sentence 1, if the results of a nationwide carried out by official or carried out on behalf of a public authority nationwide research project about the treatment with medicinal products containing antibacterial active substances in fish, the aim of gaining food, have been published in the Federal Gazette.

section 58f data using the data according to the sections 58a to 58 d may solely for the purpose of determining and calculating the frequency of therapy, monitoring of compliance with the sections 58a be processed, altered, and used up to 58 d, and to prosecute and punish violations of drug laws. Notwithstanding sentence 1 the competent authority may, if it has reason to believe, that a violation of the food and feed law, animal welfare legislation, or the animal health legislation, -58 d to the authorities responsible for follow-up of infringements transmit data after the sections 58a, as far as this data for the prosecution of the offence is required.

§ 58 g evaluation the Federal Ministry of food, agriculture and consumer protection reported the German Parliament five years after entry into force of this law on the effectiveness of the measures taken pursuant to the sections 58a to 58 d.

Section 59 clinical trial and residue examination with animals that serve food (1) No. 1 by way of derogation from article 56a par. 1 of the manufacturer may be a medicinal product in the meaning of § 2 paragraph 1 or paragraph 2 or to be applied on its behalf for the purposes of the clinical trial and residue testing, confined the application on a test that is required according to type and size according to the current state of scientific knowledge.
(2) by the animals, which perform these checks, food must be won. Sentence 1 shall not apply if the competent federal authority has set a reasonable waiting time. The wait must according to the Ordinance on veterinary pharmacies of the House are waiting at least 1 and, where appropriate, include a safety factor, the nature of the medicinal product is taken into account with the, or, 2., if maximum residue limits for residues No. 37/2010 laid down in the annex of to Regulation (EU), make sure that these maximum residue limits in foods derived from animals, are not exceeded.
The manufacturer has test results on residues of medicinal products applied and their transformation products in food, indicating the detection procedures to submit the competent federal authority.
(3) a clinical examination, or residue occurs in animals which serve the production of food, the display must contain the following additional information according to section 67, paragraph 1, sentence 1: 1 name and address of the manufacturer and the persons who carry out inspections on its behalf, 2. nature and purpose of examination, 3. type and number of animals provided for inspecting, 4th place , Commencement and expected duration of the test, 5. details of the intended use of the products of animal origin obtained during or after completion of the test.
(4) the tests are records to which are the competent authority upon request to submit.

§ 59a traffic in substances and preparations of substances (1) persons, companies and institutions, which are listed in article 47, paragraph 1 may substances or preparations of substances for the production of such medicines or for use in animals not acquire on the basis of a legal regulation according to § 6 in the manufacture of pharmaceutical products for animals cannot be used, and not provide production or application for such a , store, Pack, to lead or bring in the traffic. Pet owners and other individuals, businesses and institutions that are not listed in article 47, paragraph 1, may not acquire such substances or products, store, Pack, or carry with them, except that they are intended not prohibited manufacture or application for a legal regulation according to § 6.
(2) veterinarians must obtain only substances or preparations made of materials that are not released for transport outside of pharmacies, for use in animals and such substances or preparations may be placed only on veterinary surgeons, if they are approved as medicines or on the basis of § 21 para 2 No. 3 or 5 or may be brought on the basis of a legal regulation according to § 36 no admission in traffic. Pet owners may purchase them only for an application in animals or store by a veterinarian as medicines have been prescribed or issued by a veterinarian. Other people, enterprises and institutions which are not listed in article 47, paragraph 1, may by Regulation pursuant to § 48 not acquire certain substances or preparations of substances, store, Pack, to lead or bring in the traffic, except that the substances or preparations for a purpose other than the application in animals are determined.
(3) the feed legislation remain unaffected.

section 59 (b) substances for performing residue monitoring of pharmaceutical entrepreneurs has for medicinal products intended for use in animals, the aim of gaining food, necessary for the implementation of residue controls substances upon request in sufficient quantity against a reasonable compensation to the competent authority. For medicinal products, which no longer will be marketed by the pharmaceutical company, the obligations pursuant to sentence 1 until the expiry of three years after the date of the last placing by the pharmaceutical companies, but not more than up to the expiry date specified pursuant to § 10 para 7 the batch most recently marketed.

section 59 c proof obligations for substances, providing as veterinary medicinal products can be used in enterprises and institutions, the substances or preparations made of materials that can be used as veterinary medicinal products or to the manufacture of veterinary medicinal products and anabolic, infection, parasite-repellent, anti-inflammatory, hormonal or psychotropic properties, manufacture, store, introduce or bring in the traffic, have to lead evidence of the reference or disposal of these substances or preparations of substances , which before supplier or recipient and the amount each received or emitted arising, to keep these records at least three years and to submit at the request of the competent authority. Sentence 1 shall apply also to persons who professionally carry out these activities. Insofar as substances or preparations of substances with thyreostatic, estrogenic, androgenic or gestagenic action or beta-agonists with anabolic effect, are to lead this evidence in the form of a register, covering the quantities produced or acquired and the sold for the manufacture of medicinal products or used quantities in chronological order specifying the supplier and receiver.

§ 59d administration of pharmacologically active substances to animals, the food serve pharmacologically active substances, the 1st as prohibited substances in table 2 of the annex of to Regulation (EU) No. 37/2010 of the Commission of 22 December 2009 on pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin (OJ OJ L 15 of the 20.1.2010, S. 1), most recently by the implementing Regulation (EU) No. 489 / 2013 (OJ L 141 of the 28.5.2013, p. 4) has been modified, or 2 not listed in the annex of Regulation (EU) No. 37/2010 are listed, should not be given to a serving of the food-producing animal. Sentence 1 shall not apply in the cases of section 56a paragraph 2a and article 16 paragraph 2 of Regulation (EC) no 470 / 2009 as well as for the administration of animal feed containing authorised feed additives.

Section 60 (1) pets on medicinal products which is exclusively for use in ornamental fish, ornamental or songbirds, homing pigeons, terrarium animals, small rodents, serving ferret or not obtaining food rabbit and for transport outside of pharmacies are approved, find the provisions of §§ 21-39B and 50 have application.
(2) the rules on the manufacture of medicinal products shall apply with the proviso that evidence is a two-year practical activities pursuant to § 15 para 1.
(3) the Federal Ministry of food, agriculture and consumer protection is authorized to extend the rules on the approval on medicines for the animals referred to in paragraph 1 in agreement with the Federal Ministry of Economics and technology and the Federal Ministry by decree with the consent of the Federal Council, insofar as it is necessary to prevent the direct or indirect risks to human or animal health.
(4) the competent authority may allow exceptions to section 43, paragraph 5, sentence 1, as far as dealing with the supply of medicines in the animals referred to in paragraph 1.

§ 61 powers of veterinary educational institutions of veterinary education in the higher education sector, the serve of the animals there treated drug supply and led by a veterinary surgeon or pharmacist, have the rights and obligations that a veterinarian is according to the provisions of this Act.
Tenth section pharmacovigilance section 62 organization of the pharmacovigilance system of the competent federal authority (1) the responsible federal authority has to prevent a direct or indirect threat to the health of humans or animals the risks arising in the application of medicines, especially side effects, interactions with other drugs, corruption, as well as potential risks to the environment due to the use of a veterinary medicinal product, centrally collect, evaluate and coordinate the measures to be taken under this Act. You then acts with the services of the World Health Organization, the European Medicines Agency, the regulatory authorities of other countries, health and veterinary authorities of the Länder, the drug commissions of the Chambers of the health professionals, national Pharmakovigilanzzentren as well as with other agencies that collect in carrying out their tasks of drug risks. The competent federal authority may inform the public about drug risks and intended measures. The Federal Authority operates a pharmacovigilance system. As far as she is responsible for medicinal products which are intended for use in people, regularly performs audits of its pharmacovigilance system and all two years report, for the first time on 21 September the European Commission shall 2013혼다 (2) that all suspected cases of adverse reactions of which she become aware captured competent federal authority. Messages from patients and health professionals can be made particularly electronically, in any form. Reporting by owners of approval under section 63c take place electronically.
(3) the competent federal authority has for medicinal products which are intended for use in humans, each reported her and occurred in the domestic suspicion of a serious side effect 15 days and each occurred in Germany and reported her suspicion of a non-fatal side effect 90 days electronically to the database referred to in article 24 of Regulation (EC) No 726 / 2004 (EudraVigilance database) and, if necessary, to convey to the holder of the authorisation. The competent federal authority has each reported her and occurred in the domestic suspicion of a serious side effect of medicinal products intended for use in animals, immediately, at the latest however within 15 days after the announcement, the European Medicines Agency and the holder of the authorisation, if it has still no knowledge, to submit. The competent federal authority cooperates with the European Medicines Agency and the holder of the authorisation, to determine in particular duplications of suspect messages. The competent federal authority involved patients, health professionals, or the holder of the authorisation to the tracking of the received messages, if necessary.
(4) the competent Federal Authority controlled the management of funds for the activities connected with pharmacovigilance, the operation of communication networks and market surveillance, maintain their independence in carrying out these pharmacovigilance activities.
(5) in the case of medicinal products intended for use in humans, the competent federal authority in cooperation with the European Medicines Agency in particular the following measures: 1. monitors the results of measures to reduce risks, which are part of the risk management plans, and requirements according to article 28, paragraph 3, she judged 3a and 3B, 2. updating of the risk management system, 3. evaluates them data in the EudraVigilance database , to determine whether there are new or changed risks and whether the risk-benefit balance is affected by drugs.
(6) the competent federal authority can in enterprises and institutions, which medicines produce or bring into circulation or clinically examine the collection and analysis of drug risks and check the necessary coordination. For this purpose, representatives of the competent federal authority in consultation with the competent authority of operating and business premises during normal business hours can enter, inspect documents including the pharmacovigilance system master file and demand information. Sentence 1 applies also to companies commissioned by companies and institutions pursuant to sentence 1. There is a report on the inspection. The report is to give the companies and institutions pursuant to sentence 1 to the opinion. An inspection leads to the result that the holder of the authorisation fails of the pharmacovigilance system, as described in the pharmacovigilance system master file, and in particular the requirements of the tenth section, the competent federal authority indicates the deficiencies the marketing authorisation holder and give him opportunity to comment. The competent federal authority informed in such cases, unless it is to businesses and institutions, the drug for use in humans produce, bring in traffic or check, the competent authorities of other Member States, the European Medicines Agency and the European Commission.
Footnote (+++ tenth section (sections 62 to 63j): application cf. Article 63j par. 1 +++) § 63 phased plan the Federal Government created by General administrative regulations with the consent of the Federal Council to carry out the tasks according to § 62 a phased plan. In this, the cooperation of involved authorities and on the different security levels, the intervention of the pharmaceutical entrepreneur and participation closer regulated the or of the Federal Government Commissioner for the interests of patients and patients and she each determined according to the provisions of this Act, measures to be taken. In the phases, also information tools and paths can be determined.

section 63a of stufenplanbeauftragter (1) who as pharmaceutical company finished product, the medicinal products in the sense of § 2 para 1 or par. 2 No. 1, brings in the traffic, has one in a Member State of the European Union to instruct a pharmacovigilance system to set up, maintain qualified person with the required expertise and reliability necessary for the performance of their duties (stufenplanbeauftragter) established and known to collect messages about drug risks , to evaluate and to coordinate the necessary actions. Sentence 1 does not apply to persons, insofar as they require b of any manufacturing authorization number 1, 2, 3, 5 or paragraph 2 according to article 13, paragraph 2, sentence 1. The phased plan representative is responsible for the fulfilment of reporting obligations, insofar as they relate to drug risks. He has also to make sure that at the request of the competent federal authority more information for the assessment of the risk-benefit of a medicinal product, including its own reviews, immediately and completely transmitted. The further regulates the drug and active ingredient production regulation. Persons other than referred to in sentence 1 shall not engage in any activity as stufenplanbeauftragter.
(2) the Commissioner of the phased plan can be simultaneously competent person according to § 14, or person responsible according to § 20 c.
(3) the pharmaceutical entrepreneur has previously notify the phased plan Commissioner and any change of the competent authority and the competent federal authority. Unforeseen change of the phased plan representative is the communication to take place immediately.

§ 63 b General pharmacovigilance obligations of the holder of the registration (1) the holder of the authorisation is obliged to establish a pharmacovigilance system and to operate.
(2) the holder of the authorisation is required for medicinal products which are intended for use in humans to check 1 on the basis of his pharmacovigilance system to evaluate all information scientifically, possibilities of mitigation and prevention and, if necessary, to take measures to minimize risk and prevention, to undergo 2. its pharmacovigilance system regularly at reasonable intervals of audits; While he has noted the key results in its pharmacovigilance system master file and make sure that it take measures to remedy the defect. If the measures taken to remedy the defect are completely performed, the note can be deleted 3 maintain a pharmacovigilance system master file and to provide them on request, a risk management system for each individual medicines or to operate 4., which has been approved after October 26, 2012 for a circulation according to § 28 paragraph 3 1 number 1 is granted b set, the results of risk-reduction measures to monitor 5. , which are part of the risk management plan or as requirements according to § 28 paragraph 3, 3a to 3 c have been named, and to determine whether there are new risks, existing risks have changed 6 to update the risk management system and monitor pharmacovigilance data, or the benefit risk ratio of drugs has changed.
(3) the holder of the authorisation may no information concerning pharmacovigilance without prior or simultaneous notification to the competent federal authority in relation to the approved medicinal as well as for medicinal products which are intended for use in humans, including the European Medicines Agency and the European Commission known publicly. It ensures that such information in an objective and not misleading manner are presented.
Footnote (+++ tenth section (sections 62 to 63j): application cf. Article 63j par. 1 +++) (+++ § 63 b para 2: application cf. Article 63j par. 2 +++) section 63 c documentation and reporting obligations of the holder of the authorisation for medicinal products intended for use in humans, for suspected cases of adverse reactions (1) the holder of the authorisation has to do documents concerning all suspected cases of adverse reactions, as well as information about emitted quantities.
(2) the holder of the authorisation has also 1 known each him which became suspicion of a serious side effect occurred domestically, to capture and the competent federal authority without delay, at the latest but within 15 days after the announcement, 2. each him which became suspicion of a serious adverse reaction occurred in a third country, to capture and the competent federal authority and the European Medicines Agency immediately , at the latest within 15 days after the announcement electronically to display. The competent federal authority may request from the holder of the authorisation, also suspected cases of non-fatal side effects that have occurred in Germany, to capture and you immediately, at the latest however within 90 days after the announcement, electronically to display.
(3) the holder of the approval must ensure that all suspicious messages from side effects of medicinal products intended for use in humans, are available at a central location within the company in the European Union.
(4 b apply) paragraphs 1 to 3, article 62, paragraph 6, and article 63 according to 1 for the holder of the registration is not the holder of the authorisation or holder of the registration according to § 39a, 2nd for a pharmaceutical company, according to § 39a and bringing a zulassungspflichtiges or an employee freely from the requirement for approval or a traditional herbal medicines on the market.
Paragraphs 1 to 3 shall apply according to 1 for the holder of the registration according to § 38, 2nd for a pharmaceutical entrepreneur who is not the holder of the registration according to § 38 and a subject to registration or provided free from the obligation to register homeopathic medicinal product on the market brings, 3 for the applicant before granting the authorisation.
Paragraphs 1 to 3 apply regardless of whether the drug is still in the traffic or the authorisation or the registration still exists. The fulfilment of the obligations under paragraphs 1 to 3 can be transferred by written agreement between the holder of the authorisation and the pharmaceutical entrepreneur who is not the holder of the authorisation, wholly or in part on the holder of the authorisation.
(5) paragraphs 1 to 4 shall not apply to medicinal products for which an authorisation for the placing on the market has been granted by the European Community or the European Union. The obligations of the marketing authorisation shall apply for these medicines according to Regulation (EC) No 726 / 2004 as applicable with the proviso that there is commitment to the communication to the Member States or to inform the Member States and the competent federal authority in the scope of the Act. Medicines, where approval of the competent federal authority is based on the mutual recognition or where a federal authority is rapporteur in an arbitration referred to in article 32 of Directive 2001/83/EC, the competent federal authority takes over the responsibility for the analysis and monitoring of all suspected cases of adverse reactions, which occur in the European Union; This also applies to medicinal products which have been authorized in the decentralised procedure.
Footnote (+++ tenth section (sections 62 to 63j): application cf. Article 63j par. 1 +++) § 63d periodic updated safety reports (1) the holder of the authorisation submits periodic updated safety reports that include the following: summaries of data, which are for the assessment of the benefits and risks of a drug of interest, including the results of all checks, the impact on the approval can have 1, 2. a scientific assessment of the risk-benefit balance of the medicinal , which on all available data, is also based on data from clinical trials for indications and populations, representing not the admission, 3. all data relating to the sales volume of the medicinal product, as well as all his present data relating to the volume of prescriptions, including an estimate of the number of people who use the drug.
(2) the reports are to submit electronically to the competent federal authority.
(3) the template interval for periodic updated safety reports referred to in paragraph 1 is specified in the approval. The deadline for the submission is calculated from the date of issue of the approval. Interval template and dates can be set (4) of Directive 2001/83/EC in the European Union according to the procedure under article 107 c. The holder of the authorisation may request the Committee for medicinal products for human or the coordination group referred to in article 27 of Directive 2001/83/EC, that a uniform date paragraph 6 of Directive 2001/83/EC laid down pursuant to article 107 c in the European Union or changed the template interval of periodic updated safety reports. Are permitted for medicines prior to October 26, 2012, or only domestically and for the interval of the template and dates in the approval or under article 107 c paragraph 4, 5 or 6 of Directive 2001/83/EC are laid down, transmitted the holder of the authorisation updated periodic safety update reports under paragraph 1 immediately after prompt or in the following cases: 1. If a medicinal product not yet on the market has been : at least every six months after admission and up to the on the market of placing, 2. If a medicinal product on the market has been installed: at least every six months during the first two years after the first placing on the market, once a year in the next two years, and thereafter at intervals of three years.
(4) 1 if a pad after article 28 paragraph 3 or 3a has been granted, 2. If by the competent federal authority for a drug for approval because of concerns in connection with pharmacovigilance data or due to concerns on the basis of not sufficiently balanced regularly updated reports are requested, or 3. for medicinal products, which according to article 22, paragraph 3 or article 24 b paragraph 2 are approved, submits periodic updated safety reports only in the following cases, be by way of derogation from paragraph 1 If interval and dates for the submission of periodic updated safety reports in accordance with article 107 c, paragraph 4 of Directive 2001/83/EC in the approval have been diagnosed.
The competent federal authority submitted the requested regular assessment reports updated safety reports pursuant to sentence 1, paragraph 2 the Committee for risk assessment in the area of pharmacovigilance, which checks whether the initiation of the proceeding (4) of Directive 2001/83/EC is necessary under article 107 c. Sentence 1 number 2 and 3 shall apply accordingly for the holders of registrations according to section 38 or section 39a, as well as for the pharmaceutical entrepreneur, not the holder of the authorisation or holder of the registration in accordance with section 38 or section 39a is and of a zulassungs-or subject to registration or an employee free of the obligation concerning the authorisation or the registration or a traditional herbal medicines on the market brings.
(5) the responsible federal authority then assessed the periodic updated safety reports whether there are new or changed risks or the risk-benefit balance of medicinal products has changed, and shall take the necessary measures. For medicines, for which a single date or a uniform template interval (4) of Directive 2001/83/EC has been established pursuant to article 107 c, as well as for medicinal products which are authorised in several Member States and for the periodic updated safety reports in the authorisation are set, the procedure applies 107e and 107 g for the assessment referred to in articles.
(6) compliance with the obligations under paragraphs 1 to 4 can be transferred by written agreement between the holder of the authorisation and the pharmaceutical entrepreneur who is not the holder of the authorisation, wholly or in part to the holder of the authorisation. Paragraphs 1 to 5 shall not apply to a parallel importer.
Footnote (+++ tenth section (sections 62 to 63j): application cf. Article 63j par. 1 +++) (+++ article 63d: application cf. Article 63j par. 2 +++) section 63e European procedure in the cases of articles 107i of to Directive 2001/83/EC the competent federal authority takes measures there. Articles 107i shall apply to the procedure, to 107 k of Directive 2001/83/EC.
Footnote (+++ tenth section (sections 62 to 63j): application cf. Article 63j par. 1 +++) (+++ section 63e: application cf. Article 63j par. 2 +++) § 63f General requirements for non-Interventional safety tests are (1) non-Interventional safety tests which are carried out by the holder of the authorisation on its own motion, to indicate the competent federal authority. The competent federal authority may request the log and the progress reports by the holder of the authorisation. Within a year after completion of the data collection, the holder of the authorisation of the competent federal authority has to submit the final report.
(2) for non-Interventional safety testing performed paragraph 3, 3a or 3B of the holder of the authorisation on the basis of a circulation according to § 28, the procedure applies pursuant to § 63 g.
(3) conducting safety tests according to paragraphs 1 and 2 is not allowed if 1 through the use of a medicinal product should be promoted, allowances for the involvement of health professionals in such tests not be confined 2. According to their nature and amount of time spent and costs incurred or 3 creates an incentive for a preferred prescription or recommendation of certain medicines.
(4) the holder of the authorisation has safety tests according to paragraphs 1 and 2 of the physicians Federal Association, the Association of top federal of health insurance fund and the Association of private health insurance e. V. immediately to display. There are place, time, target and Protocol of testing as well as name and lifelong doctor number participating physicians to provide. If participating doctors provide services at the expense of the statutory health insurance, are to specify the type and the amount of compensation actually paid to them pursuant to sentence 1 ads, as well as to send each a copy of the contracts concluded with them and each a representation of the effort for the participating doctors and a justification for the appropriateness of the compensation. Changes mentioned in sentence 3 are within four weeks after the end of each quarter to send; the compensation actually paid shall be mapped to participating physicians specifically stating the lifelong doctor number. Within one year of completion of data collection, the number are stating the total participating doctors to transmit each and a total involved patients and type and amount of each and a total paid compensation. Under this paragraph, the information is electronically.
Footnote (+++ tenth section (sections 62 to 63j): application cf. Article 63j par. 1 +++) (+++ § 63f: application cf. Article 63j par. 2 +++) § 63 g special conditions for ordered non-Interventional safety testing
(1) the holder of the authorisation has not Interventional safety tests, that paragraph 3, 3a or 3B have been arranged according to § 28, the draft of the verification protocol before 1 the competent federal authority, if it is a test that is performed only in the domestic, 2. the Committee for risk assessment in the area of pharmacovigilance, if it is a check, which is carried out in several Member States of the European Union , to present.
(2) a non-Interventional safety assessment may only be started pursuant to paragraph 1, if the draft of the Protocol for testing number 1 by the competent federal authority was approved pursuant to paragraph 1 or approved tests referred to in paragraph 1 number 2 through the Committee for risk assessment in the area of pharmacovigilance and the draft minutes of the competent federal authority. The competent federal authority has of the protocol draft within 60 days of the approval of the examination to decide. A permit shall be refused if promoting the use of the medicinal product, the goals cannot be reached with the test design or is a clinical trial according to § 4, paragraph 23, sentence 1.
(3) after the beginning of an examination referred to in paragraph 1 are significant amendments to the Protocol prior to their implementation, 1 if it is a test performed only domestically by the competent authority of federal, 2. If it is a test that is conducted in several Member States of the European Union, approved by the Committee for risk assessment in the field of pharmacovigilance. Performs examination in the cases of sentence to 1 number 2 in Germany the holder of the authorisation shall inform the competent federal authority over the approved changes.
(4) after an examination referred to in paragraph 1, the final audit report 1 in the cases referred to in paragraph 1 is number 1 of the competent federal authority, 2. in the cases referred to in paragraph 1 to submit number 2 to the Committee for risk assessment in the area of pharmacovigilance within twelve months of completion of data collection, if not through the pursuant to sentence 1 number 1 or 2 competent authority is been waived on the template. The final report is to communicate electronically together with a summary of the audit results.
Footnote (+++ tenth section (sections 62 to 63j): application cf. Article 63j par. 1 +++) (+++ § 63 g: application cf. Article 63j par. 2 +++) section 63 h documentation and reporting requirements for medicinal products which are intended for use in animals (1) the holder of the authorisation has records of all suspected cases of adverse reactions that occur in the European Union or a third country for medicinal products intended for use in animals, , as well as information about the delivered quantities.
(2) the holder of the authorisation has 2 a known for medicinal products intended for use in animals, also 1 each which became suspicion of a serious side effect occurred within the territorial scope of this Act, to capture and the competent federal authority him) any suspicion of a serious unexpected adverse reaction known to him by a health care professional who was not caused in a Member State of the European Union , b) in the case of medicinal products which contain material from raw material of human or animal, each it known which became suspicion of infection, which is a serious side effect and was caused by a contamination of these medicines with pathogens and not in a Member State of the European Union has occurred, immediately, at the latest within 14 days after becoming known, the competent federal authority and the European Medicines Agency, of and 3. frequent or observed in some cases substantial abuse , if his health can be endangered immediately the competent federal authority without delay to display. The obligation pursuant to sentence 1 number 1 and 2 letter a shall apply accordingly for adverse reactions in people on the basis of the application of a medicinal product intended for use in animals.
(3) the holder of the authorisation, which has received approval in the way of mutual recognition or decentralised procedure ensures also for medicinal products which are intended for use in animals, that every suspected case 1 a serious adverse reaction or 2 a side effect which occurred while people on the basis of the application of a medicinal product intended for use in animals, within the territorial scope of this Act , also of the competent authority of the Member State is accessible, its marketing authorisation was based on the recognition or who was rapporteur in the context of Arbitration referred to in article 36 of Directive 2001/82/EC.
(4) the competent federal authority are for medicinal products intended for use in animals, to submit all to the evaluation of suspected or observed abuse present documents as well as a scientific assessment.
(5) the holder of the authorisation has for medicinal products which are used in animals intended, if not by obligation or set 5 or 6 other is determined, on the basis of in paragraph 1 and in article 63a paragraph 1 one mentioned obligations of the competent federal authority regular updated report on the safety of the medicinal product immediately upon request or at least every six months after approval to submit the placing on the market. In addition, he has two years after the first placing on the market and once a year in the next two years to submit such reports immediately upon request or at least every six months during the first. Then he has the reports at intervals of three years, or immediately after a call to present. The periodic safety update report on the safety of medicines include a scientific evaluation of the benefits and risks of the medicinal product concerned. The competent federal authority can extend the reporting intervals upon request. For medicinal products which are exempt according to article 36, paragraph 1 of the authorisation, the competent federal authority determines the date of the submission of the periodic safety update report on the safety of the medicinal product in a notice published in the Federal Gazette. Sentences 1 to 6 do not apply to the parallel importer.
(6 b paragraph 3 apply) paragraphs 1 to 5, article 62, paragraph 6, and article 63 according to 1 for the holder of the registration is not the holder of the authorisation or holder of the registration according to § 39a, 2nd for a pharmaceutical company, according to § 39a and bringing a zulassungspflichtiges or an employee freely from the requirement for approval or a traditional herbal medicines on the market.
Paragraphs 1 to 4 shall apply according to 1 for the holder of the registration according to § 38, 2nd for a pharmaceutical entrepreneur who is not the holder of the registration according to § 38 and a subject to registration or provided free from the obligation to register homeopathic medicinal product on the market brings, 3 for the applicant before granting the authorisation.
Paragraphs 1 to 4 shall apply regardless of whether the drug is still in the traffic or the authorisation or the registration still exists. The fulfilment of the obligations under paragraphs 1 to 5 can be transferred by written agreement between the holder of the authorisation and the pharmaceutical entrepreneur who is not the holder of the authorisation, wholly or in part on the holder of the authorisation.
(7) paragraphs 1 to 6 shall not apply to medicinal products for which an authorisation for the placing on the market has been granted by the European Community or the European Union. The obligations of the marketing authorisation apply for these medicines according to Regulation (EC) No 726 / 2004 and its commitments according to Regulation (EC) No 540/95 respectively amended with the proviso that there is commitment to the communication to the Member States or to inform the Member States and the competent federal authority in the scope of the Act. Medicines, where approval of the competent federal authority is based on the mutual recognition or where a federal authority is rapporteur in an arbitration referred to in article 36 of Directive 2001/82/EC, the competent federal authority takes over the responsibility for the analysis and monitoring of all suspected cases of adverse reactions, which occur in the European Union; This also applies to medicinal products which have been authorized in the decentralised procedure.
Footnote (+++ tenth section (sections 62 to 63j): application cf. Article 63j par. 1 +++) § 63i documentation and reporting requirements for blood and tissue preparations and tissue
(1) the holder of a permit or authorisation for blood preparations within the meaning of article 3 has number 6 of Directive 2001/83/EC or a permit for tissue preparations within the meaning of § 21a documents about suspected cases of serious incidents or serious adverse reactions that have occurred in the Member States of the European Union or in the States party to the agreement on the European economic area or in a third country , as well as to the number of callbacks.
(2) the holder of a permit or authorisation for blood or tissue preparations within the meaning of paragraph 1 has also suspicion of a serious incident or suspicion of a serious adverse reaction to document and immediately, at the latest however within by 15 days, notify the competent federal authority. The display must contain all necessary information, in particular name or company and address of the marketing authorisation, designation and number or identification code of the blood or tissue preparation, day and documentation of occurrence of suspicion of serious incident or of serious adverse reaction, date and place of the blood components or tissue removal, supplying establishments or facilities, as well as giving personal details. The incidents displayed pursuant to sentence 1 or reactions are to investigate their cause and effect and to evaluate and the results of the competent Federal Authority forthwith, as the measures for traceability and for the protection of donors and recipients.
(3) the blood and plasma establishments or tissue establishments have any suspicion of a serious incident or suspicion of a serious adverse reaction to report to the competent authority without delay in requiring approval or not approval - blood or tissue preparations as well as blood and blood components and tissues. The message must contain all necessary information such as name or business name and address of the donation - te, name and number or identification code of the blood or tissue preparation, day and documentation of occurrence of suspicion of serious incident or of serious adverse reaction, date of manufacture of the blood or tissue preparation and giving personal details. Paragraph 2 sentence 3 shall apply accordingly. The competent authority forwards the messages pursuant to sentences 1 and 2, as well as the communications pursuant to sentence 3 of the competent federal authority.
(4) the holder of a permit or authorisation for blood or tissue preparations within the meaning of paragraph 1 has an updated report on the safety of medicines immediately when prompted on the basis of the obligations of the competent federal authority referred to in paragraph 1 or, as far as callbacks or cases or suspected cases of serious adverse events or serious adverse reactions are affected, at least once a year to present. Sentence 1 shall not apply for the parallel importer.
(5) section 62, paragraph 6 applies to blood and plasma establishments or tissue establishments accordingly; § 63 b paragraph 3 shall apply accordingly for the holder of an authorisation by blood or tissue preparations.
(6) serious incident in the preceding provisions is any untoward occurrence relating to the extraction, examination, treatment, loading or processing, preservation, storage or distribution of tissues or blood preparations that could have the transmission of an infectious disease, death or a life-threatening condition, a handicap or a capacity loss of patient require a hospital stay or extend could lead to a disease or this could extend. Any faulty identification or confusion of germ cells or impregnated egg cells in part of a medically assisted insemination is considered fatal incident.
(7) a serious adverse reaction within the meaning of the above rules is an unintended response, including a communicable disease, in the donor or in the recipient associated with the extraction of tissue or blood or the transfer of tissue or blood preparations, which is fatal or life-threatening, has a disability or a loss of ability or requires hospitalization or extended or leads to a disease or extended this.
Footnote (+++ tenth section (sections 62 to 63j): application cf. Article 63j par. 1 +++) § 63j exemptions (1) the rules of the tenth section shall not apply to medicinal products which are used in the context of a clinical trial as investigational.
(2) § 63 b, with the exception of paragraphs 1 and 3, the articles 63d and 63e, 63f 63 g shall not apply to medicinal products intended for use in animals.
Footnote (+++ tenth section (sections 62 to 63j): to the application cf. Article 63j par. 1 +++) Eleventh section monitoring section 64 implementation monitoring (1) operations and facilities, in which medicines are manufactured, tested, stored, packaged or placed on the market or trade is driven in where else with them, are subject to the supervision of the competent authority; as far as the same is true for companies and institutions that develop medicines, clinical test, undergo a residue testing or according to § 47a, paragraph 1, sentence 1 or for use in animals acquire certain medicinal drugs or apply. The development, production, testing, storage, packaging and the placing on the market of active substances and other materials destined for drug manufacturing and fabric and other trade in these substances and materials subject to monitoring as far as they are regulated by a legal regulation according to § 54, § 12 of the transfusion Act or section 16a of the transplantation law. In the case of § 14 paragraph 4 20 b para 2 are subject to number 4 and § the extraction facilities and the laboratories of the supervision of the local authority for them. Sentence 1 shall apply also to persons who professionally carry out these activities or medicines not only for their own needs with lead for the sponsor of a clinical trial or his representative according to article 40, paragraph 1, sentence 3 No. 1 as well as for persons or body of persons, the pharmaceutical products for others to collect. Sentence 1 shall not apply to the reconstitution, insofar as not to medicines, which are intended for the clinical trial.
(2) the persons responsible for monitoring this activity professionally must exert. The competent authority may consult an expert. She should involve members of the competent federal authority as an expert as far as it is blood preparations, tissue and tissue preparations, radiopharmaceuticals, genetically engineered medicines, sera, vaccines, allergens, drugs for novel therapies, xenogeneic medicinal products or active substances or other substances that are human, animal or microbial origin or manufactured on the resulting paths. At pharmacies, which are no hospitals or requiring a permit not according to section 13, the competent authority can hire expert monitoring.
(3) the competent authority has to ensure that the rules governing medicinal products, active substances and other substances specific to drug manufacturing, the advertising on the territories of the Salvation being of the second section of the transfusion law, sections 2, 3 and 3a of the transplantation law and about the nature of the pharmacy are observed. She has to make it on the basis of a monitoring system with particular reference to possible risks at reasonable time intervals and in reasonable amounts, and if necessary unannounced inspections, and establishing effective follow-up. It has to be officially examined drug samples.
(3a) operations and facilities, requiring a permit b paragraph 1 according to the sections 13, 20 c, 72, or § 72, as well as veterinary house pharmacies must be checked generally every two years pursuant to paragraph 3. The competent authority permission granted 72 b paragraph 1 § 13, 20 c, 52a, 72, or § according to the § first, if she are convinced by an inspection of that there are the conditions for the granting of permission.
(3B) the competent authority inspections for the monitoring of the rules on the marketing of medicinal products which are intended for use in humans, in accordance with the guidelines of the European Commission article 111a of Directive 2001/83/EC carries out, unless it is monitoring the implementation of clinical audit. It collaborates with the European Medicines Agency through exchange of information on planned and conducted inspections, as well as in the coordination of inspections of businesses and institutions in countries that are not Member States of the European Union or other parties to the agreement on the European economic area.
(3c) the inspections may also at the request of another Member State, which carried the European Commission or the European Medicines Agency. Without prejudice to any agreements concluded between the European Union and countries that are not Member States of the European Union or other parties to the agreement on the European economic area, the competent authority may request a manufacturer in the country which is not member of the Union or Contracting State of the agreement on the European economic area, to undergo an inspection according to the guidelines of the European Union.
(3d) is a report about the inspection. The competent authority which carried out the inspection, informs the content of the draft of report the verified companies, organisations or persons and gives them opportunity to comment before final completion.
(3e) the inspection will set 2 concluded that the companies, institutions or persons do not comply with the legal regulations after evaluation of the opinion to paragraph 3d, this information is so far as the principles and guidelines of good manufacturing practice and good distribution practice of law of the European Union for drug for use in humans or the principles and guidelines of good manufacturing practice of law of the European Union for medicinal products for use in animals are concerned , entered into the database after § 67a.
(3f) within 90 days after an inspection to the inspection of good manufacturing practice and good distribution practice from a certificate is issued the verified companies, institutions or persons, if the inspection has led to the result that the relevant principles and guidelines are respected. The period of validity of the certificate should not exceed three years. The certificate is to take back, if it is later known that the conditions have not been; It shall be revoked if the conditions are no longer met.
(3 g) which are information about the exhibition, the refusal, withdrawal or revocation of the certificate according to paragraph 3f to enter in a database according to § 67a. This also applies to the grant that according to the § § 13, 20, 20 c, 52a, 72, or § 72 introduce withdrawal, the withdrawal or the suspension of a permit b paragraph 1 as well as for the registration and deletion of medicinal agents or by companies and institutions, the active ingredients, or otherwise trade, without a permit in order to be.
(3 h) paragraphs 3b, 3c and 3e-3 g do not apply on veterinary pharmacies of the House and on plants and facilities that produce only medicated feedingstuffs. In addition, paragraph 3d set 2 on veterinary pharmacies of the House shall not apply.
(4) the persons responsible for monitoring are authorized 1 plots, to enter business premises, premises, means of transport and urgent for the prevention of danger to public safety and order also premises during normal business hours, to visit and to make recordings in business premises, premises and means of transport to the documentation, where an activity referred to in paragraph 1 is exercised; the fundamental rights of laid down in article 13 of the Basic Law on inviolability of the home is restricted in so far, 2. documents on development, manufacturing, testing, clinical trial or residue testing to see acquisition, storage, packaging, marketing and other whereabouts of medicinal products financial security required according to § 94 the promotional material in circulation and the, 2a.
Copies or photocopies of documents by number 2 or prints or copies of disks on which documents are stored after number 2 to customize or to require, so far as it is not personal information of patients, 3. natural and legal persons and associations not incorporated all the necessary information seeking in particular about the operations referred to in point 2, 4. preliminary arrangements , also on the closure of the operation or of the institution to meet, as far as it is necessary for the prevention of urgent threats to public safety and order.
(4a) as far as it is necessary for the implementation of this Act or of the regulations adopted on the basis of this Act or of Regulation (EC) No. 726 / 2004, the experts of the Member States of the European Union must, as far as they accompany the persons entrusted with the monitoring powers perceive no. 1 pursuant to paragraph 4.
(5) the debtor information the information on such questions, may refuse the answer himself or one of his No. 1-3 of the code of civil procedure referred to members of the danger of criminal prosecution or proceedings would expose in section 383, paragraph 1 according to the law of administrative offences.
(6) the Federal Ministry is empowered by decree with the consent of the Federal Council in cases to set rules on the performance of monitoring tasks, where medicines are brought by a pharmaceutical company in the scope of the Act on the market which has no seats in the scope of the law, insofar as it is necessary for the implementation of the rules on the transport of medicines, as well as about the advertising on the areas of the health system. While the lead responsibility for monitoring tasks, arising due to the removal of a drug from a particular Member State of the European Union, assignable to each a specific country or an institution supported by the countries. The decree is issued by the Federal Ministry of food, agriculture and consumer protection in agreement with the Federal Ministry of, insofar as it is medicinal products intended for use in animals.

Paragraph (1) as far as it is necessary for the implementation of the rules on the marketing of medicinal products, the advertising on the territories of the Salvation being of the second section of the transfusion law, sections 2, 3 and 3a of the transplantation law and about the nature of the pharmacy are monitoring people commissioned entitled, against acknowledgement of receipt after its selection for the purposes of the investigation to demand 65 sampling samples or to remove. This power extends in particular on the taking of samples of feedingstuffs, drinking water and in living animals, including this necessary interventions to these animals. Insofar as not expressly waived the pharmaceutical entrepreneur, a part of the sample is or, unless the sample not or is divisible without compromising the purpose of the investigation not into parts of equal quality, a second piece of the same way, taken as a sample, to leave.
(2) to reduced back samples are officially seal or seal. They are to be provided with the date of sampling and the date of the day, after which the lock or seal be considered lifted.
(3) for specimens that are not removed at the pharmaceutical entrepreneur, adequate compensation is by the pharmaceutical company to provide, as far as not expressly waived.
(4) as a private expert to the testing of samples referred to in paragraph 1, sentence 2 are left behind, can only be ordered, who owns 1 ACC. to § 15 expertise. Instead of practical activities pursuant to article 15, paragraph 1 and 4 a practical activity in the investigation and assessment of medicines in drug investigation authorities or other similar medicinal institutions, can happen 2 which has required reliability to the pursuit of activities as an expert for the examination of official samples and 3. suitable rooms and facilities for the proposed investigation and assessment of medicinal products.

Section 66 Duldungs - and duty (1) who monitor to § 64 paragraph 1 is subject to, is obliged to tolerate the measures after the sections 64 and 65 to assist persons working in the audit in carrying out their tasks, to denote spaces and means of transport in particular them upon request, open spaces, containers and containers, to provide information and to allow the taking of samples. The same obligation to § 52a and the head of the clinical trial, as well as their representatives, also with regard to requests of the competent federal authority for the qualified person according to article 14, the person responsible according to § 20 c, the phased plan officers, information officers, the person in charge.
(2) the Duldungs - and duty referred to in paragraph 1 takes appropriate application measures the federal upper authorities according to § 25 paragraph 5, sentence 4 or paragraph 8 sentences 2 and 3, or according to § 62, paragraph 6.

Section 67 general duty of disclosure
(1) companies and institutions which develop medicines, manufacture, clinical test or undergo a residue test, check, store, Pack, bring into circulation or otherwise trade, have this before recording the activities of the competent authority, in a clinical trial in humans of also the competent federal authority, to display. Sentence 1 shall apply mutatis mutandis to institutions, win the tissues that perform the laboratory analysis required for obtaining, tissue, process, preserve, check, store or bring in traffic. The development of medicinal products is to show, as far as it is governed by a legal regulation according to § 54. The same applies to persons who independently and professionally carry out these activities, as well as for persons or associations of persons, collect the medicines for others. In the display the type of activity and the establishment to be specified; collected medicines, details about the nature of the collection and the storage facility shall specify. A clinical trial in humans is pursuant to sentence 1 to display are also their sponsor, the competent authority provided that present his representative according to article 40, paragraph 1, sentence 3 number 1 as well as the auditor and his Deputy, as far as necessary with indication of position as Director of the clinical trial, namely to designate. Sentences 1 to 4 shall apply accordingly for companies and institutions, the active ingredients or others to drug manufacturing in the placing on the market produce certain substances, check, store, Pack, or else with them commercial drive, as far as these activities by a legal regulation according to § 54 are regulated. Sentence 1 shall not apply to the reconstitution, insofar as not to medicines, which are intended for the clinical trial.
(2) the manufacture of medicinal products is intended, for which a permit is not required according to § 13, the medicines with their name and composition are to display.
(3) subsequent amendments are also to show. Enterprises and facilities that produce active substances, introduce, or otherwise do business with them, an ad simply annually, provided that the changes have no effect on the quality or safety of the active ingredients.
(3a) the commencement of a clinical trial in humans is referred to in paragraph 1 to show, their history, termination, and results of the competent federal authority are to be communicated; the more is determined in the regulation according to § 42.
(4) paragraphs 1 to 3 shall apply to the pharmacy act not for those who have a permit according to § 13, § 20B, 20 c, § 52a or § 72, and for pharmacies. Paragraph 2 does not apply to veterinary pharmacies of House.
(5) a person who brings a drug that is exempt under § 36 paragraph 1 from the requirement for approval as a pharmaceutical company on the market, has to show it before the competent federal authority and the responsible authority. In the display the manufacturer, used name, the non-active components used, and the actual composition of the medicinal product are insofar as not laid down in the regulation according to article 36, paragraph 1, insofar as the regulation allows such differences according to § 36 para 1 to specify. To display any change of data and the completion of the placing.
(6) a person who carries out investigations intended to collect evidence in the application of medicinal products authorised or registered, this has the competent federal authority, the Federal Association of statutory health insurance physicians, the Association of top federal of health insurance fund and the Association of private health insurance e. V. immediately to show. This place are to designate time to specify target and post-marketing monitoring plan as well as to the Federal Association of statutory health insurance physicians and the leading organisation Federal of health insurance fund which involved doctors specifically stating the lifelong doctor number. Compensation given to doctors for their involvement in investigations pursuant to sentence 1, are to be such that creates no incentive for a preferred prescription or recommendation of certain medicines according to their nature and amount. If participating doctors provide services at the expense of the statutory health insurance, are to specify the type and the amount of compensation actually paid to them pursuant to sentence 1 ads, as well as to send each a copy of the contracts concluded with them and each a representation of the effort for the participating doctors and a justification for the appropriateness of the compensation. Changes of the information mentioned in clause 4 are within four weeks after the end of each quarter to send; the compensation actually paid shall be mapped to participating physicians specifically stating the lifelong doctor number. Within one year of completion of data collection, the number are stating the total participating doctors to transmit each and a total involved patients and type and amount of each and a total paid compensation. The competent federal authority is a final report within a year after capturing data during investigations with medicinal products which are intended for use in humans, transmit. § applies 42 b paragraph 3 sentence 1 and 4. The details are under this paragraph in investigations with medicinal products which are intended for use in humans, electronically. To do so, the federal upper authorities made known electronic format requirements; the competent federal authority has to provide you submitted ads and final reports of the public through an Internet portal. § 42 b paragraph 3 sentence 4 according to shall apply for the publication of the advertisements. The sentences 4 to 6 do not apply to ads compared to the competent federal authority. For medicinal products which are intended for use in animals, the ads are to refund pursuant to sentence 1 only in relation to the competent federal authority. The sentences 1 to 13 do not apply for safety testing according to § 63f. (7) who intends commercial - or professionally drug, the business owner pharmaceutical in another Member State of the European Union to the placing on the market by another are admitted to spend for the first time from that Member State within the scope of the Act for the purpose of placing on the market within the scope of the law, has to inform the holder of the authorisation prior to the commencement of activities. For medicinal products for which an authorisation for the placing on the market pursuant to Regulation (EC) No. 726 / 2004 has been granted, is set 1 with the proviso that the display is to provide the holder of the approval and the European Medicines Agency. The Agency is a fee for the verification of compliance with the conditions, which are set in the European Union law legislation on medicines and the authorisations for the placing on the market, to be paid; the calculation of the fee depends on the Union law legislation.

§ 67a re-purposed information system (1) the authorities responsible for the enforcement of this Act of the Federal and State Governments with the German Institute for medical documentation and information (DIMDI) work together to build a jointly usable central information system of medicines, drugs and tissue as well as their manufacturer or importer. This information system summarizes information across the authority necessary for the respective tasks. The German Institute for medical documentation and information built this information system on the basis of data provided by the competent authorities or federal upper authorities after the legal regulation under paragraph 3 available and ensure its ongoing operations. Data from the information system are transmitted to the competent authorities and federal upper authorities to fulfil their duties regulated in the law, as well as to the European Medicines Agency. The competent authorities and federal upper authorities also gain access to the current data from the information system for their duties regulated in the law. A delivery in other places is permitted, as far as this provides legal regulation pursuant to paragraph 3. The German Institute for medical documentation and information may require fees for his services. These are set in a catalogue of charges which require the consent of the Ministry.
(2) the German Institute for medical documentation and information does not provide generally available databases with information on medicines via an Internet portal. The Internet portal is connected to the European Internet portal established by the European Medicines Agency pursuant to article 26 of Regulation (EC) No. 726 / 2004 for medicines. In addition, the German Institute for medical documentation and information provides information about the mail order of medicines intended for use in people, through a generally accessible Internet portal available. This Internet portal is connected to the Internet portal, operated by the European Medicines Agency, which contains information about the shipping trade and the common mail logo. The German Institute for medical documentation and information has announced the addresses of the Internet portals in the Federal Gazette.
(3) the Federal Ministry is empowered to give powers to the processing and use of data for the purposes of paragraphs 1 and 2 and on 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 decree with the consent of the Federal Council and to make arrangements with regard to the transmission of data by the authorities of the Federal and State Governments at the German Institute for medical documentation and information , including the personal and operational data for the purposes of regulated in this law, and the nature, the scope and the data requirements. This legal regulation can be that ads must be carried out on electronic or optical storage media, or must, as far as this is necessary for a proper implementation of the rules on the marketing of medicinal products prescribed. The decree is issued by the Federal Ministry of food, agriculture and consumer protection in agreement with the Ministry, the Federal Ministry of the Interior and the Federal Ministry of Economics and technology insofar as it is medicinal products intended for use in animals.
(3a) the Federal Ministry of food, agriculture and consumer protection is hereby authorised, in agreement with the Ministry, the Ministry of the Interior and the Federal Ministry of Economics and technology by decree with the consent of the Federal Council, arrangements to meet with regard to the transmission of data by the German Institute for medical documentation and information to the authorities of the Federal and State Governments, including the personal and operational data , for the purpose of repeated observations, investigations and reviews for the detection of risks for the health of humans and animals by applying certain medicinal products which are intended for use in animals (animal drug monitoring), as well as with regard to the nature and scope of the data and the data requirements. Paragraph 3 sentence 2 shall apply accordingly.
(4) the decree is issued under paragraphs 3 and 3a in agreement with the Federal Ministry for environment, nature conservation and nuclear safety, insofar as radiopharmaceuticals or drugs, ionising radiation are used in their manufacture.
(5) the German Institute for medical documentation and information shall take the necessary measures so that data is transmitted only to authorised persons and only this access to this data.

§ 68 notification and information obligations (1) for the implementation of this law competent authorities and agencies of the Federal and State Governments have themselves 1 to inform the authorities responsible for enforcing the law, authorities and experts and each other to support 2nd in case of infringements and suspected infringements of provisions of the pharmaceutical legislation, to promptly inform Heilmittelwerberechts or pharmacy law for the respective spheres of competence, and in the discovery activities.
2. the authorities referred to in paragraph 1 1 grant the competent authority of another Member State of the European Union or for medicinal products which are intended for use in humans, the European Medicines Agency on substantiated request information and submit the required certificates and documents, as far as this is necessary for the monitoring of compliance with the pharmaceutical regulatory, heilmittelwerberechtlichen and pharmacy legislation or to the prevention or to ward off drug risks , 2. determine all facts communicated by the applicant authority of another Member State and you communicated the result of the test.
(3) the authorities of the competent authorities of another Member State and the European Medicines Agency or the European Commission communicate all information referred to in paragraph 1, which are required for the monitoring of compliance with the legal medicines, heilmittelwerberechtlichen and pharmacy regulations in that Member State or for the prevention or to ward off drug risks. In cases of infringements or suspected of infringing activity also the competent authorities of other Member States, the Ministry may, insofar as it is medicinal products intended for use in animals, also the Federal Ministry for food, agriculture and consumer protection, as well as the European Medicines Agency and the European Commission shall be informed.
(4) the authorities may referred to in paragraph 1, insofar as this is necessary to comply with the legal medicines, heilmittelwerberechtlichen and pharmacy requirements or to prevent or to ward off drug risks, inform the competent authorities of other States and the competent bodies of the Council of Europe. Paragraph 2 takes no. 1 application. At the briefing by Contracting States of the agreement on the European economic area that are not Member States of the European Union, these via the European Commission.
(5) the transport is the Ministry with the competent authorities of other States, bodies of the Council of Europe, the European Medicines Agency and the European Commission. The Ministry onto this power on the authorities of the federal upper or by decree with the consent of the Federal Council the Supreme Land authorities. In addition, can the Ministry in some cases transfer authority the Supreme authority of the country, unless they agreed to. The Supreme Land authorities can delegate the powers pursuant to sentences 2 and 3 on other authorities. As far as it is medicinal products intended for use in animals, the Federal Ministry of food, agriculture and consumer protection takes the place of the Ministry. The decree is issued pursuant to sentence 2 in this case, in agreement with the Ministry.
(5a) In the case of the monitoring of advertising for medicinal products intended for use in people, no 2006 / 2004 of the European Parliament and of the Council of 27 October 2004 on cooperation between national authorities responsible for the enforcement of consumer protection laws (OJ is the Federal Office of consumer protection and food safety of the traffic with the competent authorities of other Member States of the European Union and the European Commission for the implementation of Regulation (EC) EU no. L 364, p. 1), as amended by article 16 no. 2 of Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 (OJ EU no. L 149, p. 22) as a central connection point.
(6) in the cases of paragraph 3, sentence 2 and paragraph 4 stops the transmission of personal data, insofar as they protect interests of those affected would adversely affect, especially when the recipient no adequate standard of data protection is guaranteed. Personal data may be transmitted even if the recipient no adequate standard of data protection is guaranteed insofar as this is necessary for reasons of health protection.

Article 69 measures taken by the competent authorities (1) the competent authorities take to eliminate determined violations and the arrangements necessary for the prevention of future violations. You can prohibit in particular the placing on the market of medicinal products or active substances, their Rückruf order and ensure this if 1 the required approval or registration for the medicinal product does not exist or whose rest is arranged, 2. the medicinal product or the active substance not according to the recognised pharmaceutical rules made is or is not quality adequate according to pharmaceutical, 3. the therapeutic efficacy is lacking the medicinal , 4. reasonable suspicion exists that the medicinal product has harmful effects which go beyond a degree acceptable according to the findings of medical science, 5. the prescribed quality checks not performed, 6 which required permission for the manufacture of the medicinal product or the active substance or the introduction within the scope of the Act does not exist or is a reason to withdraw or to revoke the permission in accordance with section 18, paragraph 1 or 7.
the required permission to operate a wholesale not according to § 52a or a reason for the withdrawal or revocation of the permit is given according to § 52a para 5.
In the case of the set of 2 number 2 and 4 may order the competent federal authority the callback of a medicinal product, provided that their action in the context of measures is through drug offered article 30, article 31, paragraph 4, sentence 2 or § 32 para 5 to ward off threats to the health of humans or animals under section 28. The decision of the competent federal authority pursuant to sentence 3 is immediately enforceable. Insofar as 2 paragraph 4 such medicines after set, intended for use in animals, the application is restricted to the intended use.
(1a) in medicinal products for an authorisation for the placing on the market or approval 1 pursuant to Regulation (EC) No. 726 / 2004, or 2. the procedure of recognition pursuant to chapter has been granted 4 of Directive 2001/83/EC or Chapter 4 of Directive 2001/82/EC or 3. on the basis of the opinion of the Committee referred to in article 4 of Directive 87/22/EEC of 22 December 1986 before 1 January 1995 , the competent federal authority shall inform the Committee for medicinal products or the Committee for veterinary medicinal products of identified violations of drug laws in accordance with the procedures provided for in the above acts stating detailed reasons and of the proposed approach. These medicines the competent authorities prior to the briefing of the Committee can make the necessary arrangements pursuant to sentence 1 to eliminate established and to prevent future violations, unless these are urgently needed to protect of the health of humans or animals or the protection of the environment. In the cases of sentence 1 Nos. 2 and 3 inform the competent authorities, the European Commission and the other Member States, in the cases of sentence 1 No. 1 the European Commission and the European Medicines Agency on the competent federal authority at the latest on the following working day of the reasons for these measures. In the case of paragraph 1 sentence 2 No. 4 can arrange also the competent federal authority the suspension of approval or order the recall of a drug, unless their action is urgently needed for the protection of the rights referred to in sentence 2; in this case, set is 3 according to.
(2) the competent authorities may prohibit collecting medicines, if a proper storage of medicines is not guaranteed, or if there is reasonable suspicion that the collected drugs being misused. Collected medicinal can be ensured if due to insufficient storage or through their toll the health of humans and animals.
(2a) which competent authorities may in addition, drug use in animals as well as substances and preparations of substances within the meaning of § 59a make sure if the facts justify the adoption, that rules on the marketing of medicinal products are not been respected.
(3) the competent authorities can ensure promotional material that does not comply with the rules on the transport with medicines and about the advertising on the areas of the health system.
(4) in the case of paragraph 1, sentence 3 can be also a public warning by the competent federal authority.
(5) the competent authority may drug, which is intended for use in humans and its dispensing has been banned or that was withdrawn from the market, because 1 the conditions for the placing on the market does not exist, 2. not the specified composition has the medicinal kind and quantity, or 3. the controls of pharmaceutical products or the components and the intermediates not carried out or some other requirement or another in consultation with the competent federal authority in a Prerequisite for the grant of the manufacturing authorisation has not been fulfilled, in exceptional cases its toll on patients already being treated with this drug, allow for a transitional period, if it is medically appropriate and is displayed for the data subject.

§ 69a monitoring of substances which the paragraphs 64 to 69 can be used as veterinary medicinal products that in table 2 of the annex of to Regulation (EU) No. 37 apply accordingly for the enterprises referred to in section 59 c, institutions, and individuals, as well as for such enterprises, institutions and people, the substances / 2010 of the Commission of 22 December 2009 on pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin (OJ L 15 of the 20.1.2010, p. 1) are listed in the currently valid version, manufacture, store, introduce or bring in the traffic.

§ 69b use of certain data (1) which transmit livestock of ongoing operations competent authorities for food, feed, animal welfare and animal health legislation for the collection of data for the indicator and the registration for the monitoring according to § 64 para 1 sentence 1 second half-sentence, competent authority on request the data necessary for the performance of their task.
(2) the data may be kept for the duration of three years. The period begins at the end of that year, in which the data have been transmitted. After the deadline, the data is to delete if they no longer must be stored in accordance with other provisions.
Twelfth section special rules for Bundeswehr, German Federal Police, riot police, civil protection article 70 the provisions of this Act will application and enforcement of the law (1) facilities that serve the supply of medicines of the Bundeswehr, the federal police and the willingness to police forces of the countries, as well as on the application for civil protection corresponding to drug stocks.
(2) in respect of the Bundeswehr, the enforcement of this Act in monitoring the movement of medicinal products responsibility the authorities and experts of the Bundeswehr. With regard to the federal police he is the authorities and experts of the Federal Police. In the field of drug supply for civil protection it is the positions of the Federal Ministry of the Interior; as far as landing sites are determined, needed to do this, the consent of the Federal Council.

§ 71 do not have medicines issued to the army, the Federal Police, as well as for purposes of civil and civil protection on federal or countries exemptions (1) which can be prescribed by no. 9 specifying the expiration date in article 10, paragraph 1. The competent federal ministries or, as far as medicines are delivered to countries, the competent authorities of the countries to ensure that quality, efficacy and safety in such medicinal products are guaranteed.
(2) the Federal Ministry is authorized by regulation of the countries and of the civil and civil protection to allow exceptions from the provisions of this Act and the regulations adopted on the basis of this Act for the area of the Bundeswehr, the Federal Police, the readiness of police forces, insofar as this is justified to carry out the specific tasks in these areas, and the protection of human or animal health is maintained. The decree is issued by the Federal Ministry of food, agriculture and consumer protection in agreement with the Federal Ministry of, insofar as it is medicinal products intended for use in animals.
(3) the decree is issued, as far as she touched the area of the Bundeswehr, in agreement with the Ministry of Defense, and, as far as she touched the area of the federal police and civil protection, in consultation with the Federal Ministry of the Interior, each without the consent of the Federal Council; as far as the Decree touched the area of standby police forces of countries or of civil protection, it was made in agreement with the Federal Ministry of the Interior with the approval of the Bundesrat.
Thirteenth section imports and exports article 72 import permit (1) who 1 drug in the sense of article 2, paragraph 1 or paragraph 2 No. 1, 2. active ingredients, which are human, animal or microbial origin or manufactured on the resulting paths or 3 others to drug manufacturing certain substances of human origin commercial - or professionally from countries that are not Member States of the European Union or other parties to the agreement on the European economic area , wants to introduce in the territorial scope of this Act, requires a permit from the competent authority. Article 13, paragraph 4 and paragraphs 14 to 20a are apply mutatis mutandis.
(2) to persons and bodies that work - or professional, want to introduce human origin for direct use in human medicine, paragraph 1 with the proviso applies that permission may be refused only if the applicant can prove that for assessing the quality and safety of medicinal products and for the required transfer of pharmaceutical products in their application-enabled form according to the State of science and technology qualified personnel and suitable rooms are available.
(3) paragraphs 1 and 2 shall not apply to 1 tissue within the meaning of § 1a No. 4 of the transplantation act, for which a permit is needed b according to § 72, 2.
autologous blood to produce biotechnologically processed tissue products, for b requires a permit according to § 72, tissue preparations are 3 within the meaning of § 20 c for b requires a permit according to § 72, and 4 determines substances, medicinal products manufacturing process technology described for the production of after one in the homeopathic part of the pharmacopoeia.

§ 72a certificates (1) the importer must medicinal products within the meaning of § 2 para of 1 and 2 No. 1, 1a, 2 and 4, or active ingredients only introduce, if 1 the competent authority of nationality by means of a certificate has confirmed that medicinal products or active substances according to recognized rules for the production and the quality of the European Union or to the standards, which are equivalent to those , manufactured, the production site of regular monitoring, oversight by adequate measures, including repeated and unannounced inspections, is carried out and the competent authority is informed in the event of significant deviations from the accepted principles, and such certificates for medicinal products within the meaning of § 2 para 1 and 2 are no. 1, which are intended for use in people and drugs, the human, animal or microbial origin , or 2 the competent authority has certified active substances that are manufactured, are mutually recognized, resulting means that the mentioned principles during the production and ensure the quality of medicines and the substances used, as far as human, animal, or microbial origin they are, or substances that are manufactured, or are complied with in the manufacture of the active ingredients resulting way or 3 certified the competent authority , that imports in the public interest lies.
The competent authority may exhibit only 1 sentence 1 number 2 a certificate referred to in, if a certificate does not exist pursuant to sentence 1 number 1 and it or a competent authority of a Member State of the European Union or another Contracting State to the agreement on the European economic area is regularly satisfied in the country of manufacture, compliance with the above principles in the manufacture of medicinal products or active substances , 2nd sentence 1 number 3 only give, if a certificate does not exist pursuant to sentence 1 number 1 and a certificate is not intended or not possible pursuant to sentence 1 number 2.
(1a) paragraph 1 sentence 1 does not apply to 1. medicinal products which are intended for clinical testing in humans or for use in a hardship program, 2. medicinal of human origin for direct application or Blutstammzellzubereitungen, are designed for application-oriented, intended for a specific person 3. are substances that are human, animal or microbial origin and medicinal products to be manufactured for the production of after a process technology described in the homeopathic part of the pharmacopoeia , 4. substances which number 1 to 3 are substances according to § 3, insofar as they are not subject to the requirements of good manufacturing practice in accordance with the principles and guidelines of the European Commission, 5. fabric within the meaning of § 1a No. 4 of the transplantation act, for which a certificate or a certificate referred to in article 72 requires b, 6 autologous blood to produce biotechnologically processed tissue products, for which a certificate or a certificate referred to in article 72 requires b , 7 tissue preparations in the meaning of § 20 c, for which a certificate or a certificate referred to in article 72 requires b, and 8 active ingredients that are manufactured and imported from this which is not member of the European Union or another Contracting State of the agreement on the European economic area in a State and in the list published by the European Commission under article 111 (b) of Directive 2001/83/EC is listed.
(1B) in paragraph 1 sentence 1 No. 1 and 2 for substances that are human, animal or microbial origin, or for substances that are manufactured, are contained rules resulting way according to for others to drug manufacturing specific substances of human origin.
(1c) medicines and substances that are human, animal or microbial origin or substances which are manufactured, resulting means, as well as other substances of human origin, except the medicinal products referred to in paragraph 1a No. 1 and 2, for drug manufacturing may not on the basis of a certificate referred to in paragraph 1 sentence 1 No. 3 will be introduced.
(1 d) paragraph 1 sentence 1 shall apply to the importation of active substances and other substances of human origin intended for drug manufacturing, unless their supervision by a legal regulation according to § 54.
(2) the Federal Ministry is authorised to determine that substances and preparations of substances that can be used as a medicinal or for the manufacture of medicinal products, may not be introduced if it is needed to ward off dangers for human health or for risk management by decree with the consent of the Federal Council.
(3) the Federal Ministry is entitled, by decree with the consent of the Federal Council to determine the other conditions for the import of the medicinal products referred to in paragraph 1a No. 1 and 2, where this is necessary to ensure a proper quality of medicines. It can be found in particular rules on the tests carried out by the person in charge according to § 14 and the possibility of a monitoring in the country of manufacture by the competent authority.
(4) (dropped out) § 72 b import authorisation and certificates for tissue and certain tissue preparations (1) who tissue within the meaning of § 1a No. 4 of the transplantation law or tissue preparations within the meaning of § 20 c commercial or professional for the purposes of which wants to introduce tax to others or to the working or processing requires a permit from the competent authority. § 20c is para 1 sentence 3 and para. 2 to 7 apply mutatis mutandis. Article 72, paragraph 2 shall apply accordingly for the importation of tissue preparations for immediate use.
(2) the importer must introduce only the tissues or tissue preparations referred to in paragraph 1, if 1 has confirmed the authority of the country of origin by means of a certificate that the extraction, laboratory testing, loading or processing, preservation, storage or testing conducted according to the standards, which are at least equivalent to the standards of good practice set by the European Union, and such certificates are mutually recognised, or 2. the authority responsible for the importer has certified , that the standards of good professional practice in the mining, laboratory testing, loading or processing, preservation, storage or testing complied after they or a competent authority of another Member State of the European Union or another Contracting State to the agreement on the European economic area is in the country of manufacture has satisfied, or 3. the authority responsible for the importer has certified that the import in the public interest is , if a certificate is not referred to in point 1 and a certificate referred to in point 2 is possible.
Notwithstanding sentence 1 No. 2 can the competent authority by a visit to the refrain extraction facilities in the country of origin if you prompt submission to any complaints by the importers or their facilities or premises as well as the quality assurance system of the person who wins the tissue in the country of origin, are already known.
(3) the Ministry is authorised to determine the other requirements for the importation of tissues or tissue preparations in order to ensure proper quality of tissues or tissue preparations by decree with the consent of the Federal Council referred to in paragraph 2. It can be found in particular arrangements for the checks by the responsible person according to § performs 20 c and carry out surveillance in the country of origin by the competent authority.
(4) paragraph 2 applies set 1 on the importation of tissue and tissue preparations within the meaning of paragraph 1, as far as their supervision by a legal regulation is governed by § 54, § 12 of the transfusion Act or section 16a of the transplantation law.
(5) paragraphs 1 to 4 shall apply mutatis mutandis for autologous blood for the manufacturing of biotechnologically processed tissue products.

Article 73 shipment ban (1) medicinal products which are subject to the obligation of approval or approval according to § 21a or registration, may be moved only within the territorial scope of this Act, if she traffic in the territorial scope of this act according to § 21a approved, certified, registered or exempted from the authorisation or the registration and 1 of the recipient in the case of introduction from a Member State of the European Union or another Contracting State to the agreement on the European economic area of pharmaceutical company , Wholesaler or veterinarian is, operates a pharmacy or as a hospital under the pharmacy Act by a pharmacy of a Member State of the European Union or another Contracting State to the agreement on the European economic area with drugs supplied, 1a.
in the case of shipment to the final consumer, the drug from a pharmacy of a Member State of the European Union or another Contracting State to the agreement on the European economic area, which is authorized for the shipping trade under its national law, insofar as it complies with German law with regard to the rules on the mail order pharmacy, or according to the German pharmacy law will be sent according to German regulations to mail order or e-commerce or 2 the recipient in the case of introduction from a country , which is not the Member State of the European Union or another Contracting State of the agreement on the European economic area, according to § 72 has a permit.
The medicinal products referred to in Section 47a, paragraph 1, sentence 1 may be moved only within the scope of this Act, if the receiver is one of the facilities therein. The Ministry released an updated overview of the Member States of the European Union and the other Contracting States of the European economic area, which for mail order and e-commerce with medicines comparable security standards are the German law on a regular basis.
(1a) medicated feedingstuffs may be spent within the territorial scope of this Act only if they correspond to the pharmaceutical regulatory legislation in the area of application of this Act 1 and 2 of the receiver to the persons referred to in paragraph 1 belongs or in the case of § 56 para 1 sentence 1 is pet owners.
(1B) it is forbidden to spend fake drugs or fake ingredients in the territorial scope of this Act. The competent authority may allow exceptions in duly justified cases, in particular for the purposes of the investigation or prosecution.
(2) paragraph 1 sentence 1 shall not apply to medicinal products, the 1st in the individual case in small quantities for the supply of medicines in certain animals in animal shows, tournaments or similar events are intended 2. intended for own needs of institutions of research and science are and used for scientific purposes, with the exception of medicines determined to clinical trials in humans, 2a.
required in small amounts by a pharmaceutical entrepreneur, a plant with a permit according to § 13 or by a testing laboratory as illustrative sample or analytical purposes 2B., are transferred from a company with permission according to § 13 the purpose of the working or processing and the subsequent onward or back spending or for the purpose of making an approved for the placing on the market in the area of application or authorized medicinal product from a Member State of the European Union or another Contracting State to the agreement on the European economic area , promoted 3. under the supervision by the scope of the Act or of control type II placed under a customs warehousing or a free zone or in a free zone of control type I or free warehouse spent, 3a.
are approved in a Member State of the European Union or another Contracting State to the agreement on the European economic area and after temporary storage at a pharmaceutical company, manufacturer or wholesaler are re-exported or more spent or back spent, 4 for the head of a foreign State or his company be brought and for use during his stay in the territorial scope of this Act only 5 for personal use or consumption by the members of a diplomatic mission or consular post in the area of application of this Act or civil servants are international organizations which have their headquarters there, as well as their family members are, as far as these people not Germans in the territorial scope of this Act are permanently resident, 6 when entering within the scope of this Act in an amount corresponding to the normal personal needs or the usual requirement of serving not the production of food animals carried on entry are inserted, 6a.
may be brought in the country of origin in traffic and be sourced without number - or professional mediation in a quantity corresponding to normal personal needs from a Member State of the European Union or another Contracting State to the agreement on the European economic area, 7 in means of transport be carried and intended solely for the use or consumption of persons transported by these means of transport are, determined 8 for use or consumption on sea-going vessels are and be consumed on board the ships , 9 as samples the competent federal authority for the purpose of admission or the State charge examination will be sent, 9a.
When samples are required for analytical purposes by the competent authority in the context of pharmacovigilance, 10 by federal or State authorities in the Interstate traffic related.
(3) by way of derogation from paragraph 1 sentence 1 finished medicinal product may, for use in people certainly are, are not approved for the traffic within the territorial scope of this Act, approved according to section 21a, registered or exempted from the authorisation or registration, be spent within the territorial scope of this Act, if 1 ordered by pharmacies on this order of individuals in small amounts and be delivered by these pharmacies within the framework of the existing pharmacy operating permit , 2. they legally may be brought in the State in traffic, from which they are spent within the territorial scope of this Act, and 3 for them in terms of the active substance are identical and comparable in terms of the potency drug for the relevant application area in the scope of the Act not be available or if they are to keep in stock after the pharmacy legislation or trade association guidelines or in the Division of the Ministry of defence for emergencies or procured at short notice must be , if medicines for the relevant application area not available within the territorial scope of this Act. The order and delivery shall require the medical or dental prescription for medicinal products which have not been involved from Member States of the European Union or the other Contracting States of the agreement on the European economic area. The further regulates the pharmacy operation order.
(3a) by way of derogation from paragraph 1 sentence 1 finished medicinal products which are authorised or registered or exempted from registration or registration for the purposes of applying in animals, in the territorial scope of this Act will be spent only if 1 ordered by pharmacies for veterinarians and pet owners and are released by these pharmacies within the framework of the existing pharmacy operating permit or ordered by the veterinarian in the context of the operation of a veterinary medicine cabinet for animals treated by him not to traffic in the territorial scope of this Act may be, 2. they are admitted to the European Union or another Contracting State to the agreement on the European economic area for use in animals in a Member State, and 3rd in the territorial scope of this Act no approved medicines appropriate to achieving the treatment target, which is intended for use in animals is available.
The ordering and dispensing in pharmacies may be carried out only if there is a veterinary prescription. Paragraph 3 sentence 3 shall apply accordingly. Veterinarians who pursuant to sentence 1 order medicines from pharmacies or prescribe, have to display this without delay to the competent authority. To specify for which species is in the display, and ordered according to type and quantity which application the use of the medicinal product is intended, the State from which the medicinal product in the territorial scope of this Act is spent, the designation and the quantity of the medicinal product and its active ingredients.
(4) on medicinal products referred to in paragraph 2, the provisions of this Act do not apply number 4 and 5. Medicinal products referred to in paragraph 2 number 1 to 3 and 6 to 10 and article 3 the provisions of this Act do not apply with the exception of articles 5, 6a, 8, 13-20a, 52a, 64 to 69 and 78, as well as in the cases of paragraph 2 paragraph 2 and paragraph 3 also with the exception of sections 48, 95 paragraph 1 No. 1 and 3a , Paragraph 2 to 4, § 96 number 3, 10 and 11 and § 97 paragraph 1, 2, paragraph 1 and 9, paragraph 3. On medicinal products according to paragraph 3a the provisions of this Act do not apply with the exception of § § 5, 6a, 8, 48, 52a, 56a, 57, 58 paragraph 1 sentence 1, the §§ 59, 64 to 69, 78, 95 paragraph 1 No. 1, 2a, 2B, 3a, 6, 8, 9 and 10, paragraph 2 to 4, § 96 number of 3, 13, 14 and 15 to 17, article 97, paragraph 1 , 2 number 1, 21 to 24 and 31, and paragraph 3, as well as the regulations of on the basis of article 12, paragraph 1 number 1 and 2, paragraph 2, in article 48, paragraph 2 number 4 and paragraph 4, article 54, paragraph 1, 2 and 3 of section 56a, paragraph 3 adopted veterinary pharmacies of the House Ordinance and the regulation adopted on the basis of §§ 12, 54 and 57 on proof obligations for medicines , which are intended for use in animals.
(5) physicians and veterinarians may in the exercise of their profession in the 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 Convention of Schengen (OJ L 405 of 30.12.2006, p. 1) carrying only medicines which are authorised or registered for circulation in the area of application of this Act or are exempted from the authorisation or registration. By way of derogation from paragraph 1 doctors may set 1, the health service within the meaning of Directive 2011/24/EC of the European Parliament and of the Council of 9 March 2011 on patient rights in cross-border health care (OJ L 88 of the astronomy, p. 45) provide, at the place of their establishment, approved medicines in small quantities in one for the provision of cross-border health care lead essential extent in the original packaging with himself, if and as far as medicines of the same composition and are approved for same applications also in the territorial scope of this Act; the doctor may use these drugs only. Also 1 veterinarians may by way of derogation from paragraph 1 sentence, as nationals of a Member State of the European Union or another Contracting State to the agreement on the European economic area 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) provide, at the place of their establishment approved medicines in small quantities in one for the provision of the services result in essential extent in the original packaging with, if and as far as medicines of the same composition and are approved for same applications also in the territorial scope of this Act; the veterinarian may use these drugs only. He's the keeper on that for the corresponding to indicate within the territorial scope of this Act authorised medicinal fixed latency.
(6) for the customs clearance for free circulation in the case of paragraph 1 are no. 2 and of paragraph 1a No. 2 in conjunction with paragraph 1 No. 2 requires a certificate of authority for the recipient, where the medicinal products are referred, confirms that complies with the conditions laid down in paragraph 1 or paragraph 1a. Customs services shall send the certificate of the authority that issued this certificate at the expense of the carried.
(7) in the case of paragraph 1, a receiver has no. 1, is the wholesaler or operates a pharmacy, to prove the existence of financial security according to § 94.

section 73a export (1) by way of derogation from sections 5 and 8 paragraph 1 may which are there designated drug running or spent from the scope of the Act, if the competent authority of the country of destination has approved the import of or the introduction. Pursuant to sentence 1, must be drawn from the approval that the grounds for refusal of the competent authority of the country of destination are known, that hinder the placing on the market within the territorial scope of this Act.
(2) at the request of the marketing authorisation, the manufacturer, the exporter or the competent authority of the country of destination, the competent authority or the competent federal authority, as far as it's approved claims and the marketing authorisation holder has its seat outside the scope of the medicines Act, issues a certificate according to the World Health Organization's certificate system. If the application is made by the competent authority of the country of destination, is the consent of the manufacturer prior to issuance of the certificate to obtain.

§ 74 participation of customs authorities (1) the Federal Ministry of finance and the it certain customs services contribute to the monitoring of introduction of pharmaceutical products and substances within the scope of this Act and the export. The authorities can 1 programmes of the type referred to in sentence 1 and whose means of transport, containers, loading and packaging materials to monitor stop, 2. the suspicions of violations of prohibitions and restrictions of this Act or the regulations adopted pursuant to this law, resulting in the performance of their duties, the competent administrative authorities communicated, 3. in the cases of paragraph 2 lay, that the programmes of the type referred to in sentence 1 at the cost and risk of the designated one for pharmacovigilance competent Authority will be demonstrated.
The mail and postal secrecy according to article 10 of the basic law is restricted pursuant to sentences 1 and 2.
(2) the Federal Ministry of Finance regulates the details of the procedure referred to in paragraph 1 by legal Ordinance which shall not require the consent of the Federal Council, in agreement with the Ministry. It may impose particular obligations to advertisements, applications, information and the performance of services, as well as to the tolerance of the consultation in business papers and other documents and the toleration of tours and samples of free samples. The Decree was made in agreement with the Federal Ministry for the environment, nature conservation and nuclear safety, as far as it is radioactive medicinal products and active substances or medicinal products and active substances, ionizing radiation used in their manufacture, and in agreement with the Federal Ministry of food, agriculture and consumer protection, as far as it is medicinal products and active substances, intended for use in animals.
Fourteenth section of information officer, medical representatives section 74a information officer (1) who as entrepreneurs finished product, the medicinal products in the sense of § 2 paragraph 1 or paragraph 2 No. 1 pharmaceutical, brings into circulation, has to hire a person with the necessary expertise and reliability necessary for the performance of their duties, to perform the function of scientific information about the drug responsible (information officer). The information Commissioner is responsible, in particular, that the prohibition of § 8 para 1 is respected no. 2 and labelling, the leaflet, the prescribing information and advertising with the content of the authorisation or the registration or, if the medicinal product by the authorisation or registration is optional, with the content of the regulations on the exemption from the approval or the registration according to § 36 or § 39 para 3 match. Sentence 1 does not apply to persons, insofar as they require according to § 13 para 2 sentence 1 No. 1, 2, 3 or 5 of any manufacturing authorization. Persons other than referred to in sentence 1 shall not engage in any activity as information officer.
(2) the information Commissioner may also be stufenplanbeauftragter.
(3) the pharmaceutical entrepreneur has previously communicated the information Commissioner and any change to the competent authority. Unexpected change of the information Commissioner has the communication to take place immediately.

Section 75 (1) pharmaceutical entrepreneur may expertise only persons who possess the expertise referred to in paragraph 2, hire full-time search members by practitioners to them about drugs in the sense of § 2 para 1 or par. 2 No. 1 Professional to inform (medical representatives). Sentence 1 applies also to a telephone information. Persons other than referred to in sentence 1 shall not engage in any activity as medical representatives.
(2) the expertise have 1 pharmacists or persons with a certificate of a check deposited to completed university studies of pharmacy, chemistry, biology, human or veterinary medicine, 2. pharmacist Assistant as well as persons with a completed training as a technical assistant in pharmacy, chemistry, biology, human or veterinary medicine, 3. medical sales representatives.
(3) that competent authority may a deposited check or completed training as sufficiently acknowledge that at least equivalent to one of the training of the persons referred to in paragraph 2 is.

Section 76 is obligations (1) the medical representatives, he technically informed professionals about individual medicines, to present the specialist information according to § 11a. He has to record in writing notices of health of professional about side effects and contra-indications or other risks of medicinal products and to inform the customer in writing.
(2) as far as the medical representatives, commissioned by the pharmaceutical company to submit samples of finished medicinal product to persons entitled according to article 47, para. 3, he has about the recipients of patterns as well as nature, scope and time patterns to lead evidence and to submit at the request of the competent authority.
Fifteenth section determination of the authorities of the federal upper and other provisions of § 77 competent federal authority (1) competent federal authority is the Federal Institute for drugs and medical devices, except that the Paul-Ehrlich-Institut or the Federal Office of consumer protection and food safety is responsible.
(2) the Paul-Ehrlich-Institut is responsible for Sera, vaccines, blood preparations, preparations of bone marrow, tissue preparations, fabric, allergens, medicinal products for advanced therapies, xenogeneic medicinal products and genetically engineered blood components.
(3) the Federal Office of consumer protection and food safety is responsible for medicinal products which are intended for use in animals. For the purpose of monitoring the effectiveness of antibiotics, the Federal Office of consumer protection and food safety performs repeated observations, investigations and reviews of resistance in animal pathogens to substances with antimicrobial effect, contained as active substances in veterinary medicinal products, by (Resistenzmonitoring). The Resistenzmonitoring includes the preparation of reports.
(4) the Federal Ministry is authorised to change the jurisdiction of the Federal Institute for drugs and medical devices and the Paul-honest-Institut, if necessary, to take account of recent scientific developments, or if reasons of uniform workload require such a change by Decree without the consent of the Federal Council.

§ 77a independence and transparency (1) make the federal upper authorities and the competent authorities with regard to the guarantee of independence and transparency, that officials of the regulatory authorities or other competent authorities concerned with the authorisation and monitoring or of them experts commissioned no financial or other interests in the pharmaceutical industry--which could affect their neutrality. These individuals each year to make a statement.
(2) within the framework of their duties under this Act the federal upper authorities and the competent authorities shall make publicly available the bylaws of their committees, agendas, as well as the result minutes of their meetings; There are operating, to maintain service and trade secrets.

§ 78 rates (1) which is a Federal Ministry of Economics and technology empowered, in consultation with the Ministry and, insofar as it is medicinal products intended for use in animals, in agreement with the Federal Ministry of food, agriculture and consumer protection price ranges that given off by decree with the consent of the Federal Council 1 for medicines, wholesale, pharmacies or veterinarians in the resale are , 2. prices for medicinal products which are manufactured in pharmacies or veterinarians and submitted, as well as for dispensing tanks, setting 3 prices for special services of pharmacies in the dispensing of medicines. By way of derogation from sentence 1 the Federal Ministry of Economics and technology is authorized, in consultation with the Ministry Ordinance requiring not the consent of the Federal Council, the proportion of fixed surcharge which is not promoting the provision of emergency service to adapt according to the cost development of pharmacies of economic operations. The price rules for wholesale on the basis of set 1 number 1 also apply to pharmaceutical entrepreneur or any other natural or legal person exercising an activity pursuant to § 4 paragraph 22 for delivery to pharmacies, which relate the medicines for sale to the consumer. The medicine pricing regulation, which has been adopted on the basis of clause 1, also applies to medicinal products which are transported in accordance with section 73, paragraph 1, sentence 1 number 1a in the territorial scope of this Act.
(2) the prices and price ranges must take the legitimate interests of drug consumers, the veterinarians, pharmacies and wholesale account. A uniform pharmacy selling price for medicinal products which are excluded from the traffic outside the pharmacies must be guaranteed. Sentence 2 shall not apply for non-prescription medicines that are not at the expense of the statutory health insurance.
(3) for medicinal products referred to in paragraph 2 sentence 2, for which the regulation referred to in paragraph 1 prices and price ranges are intended, have pharmaceutical business operators to ensure a uniform price; for non-prescription medicines, provided at the expense of the statutory health insurance, the pharmaceutical entrepreneur for the purpose of calculating the pharmacies with the health insurance companies have to give their single selling price, the distribution in individual cases cannot be derogated from. Social service providers, private health insurance, as well as their respective associations can agree with pharmaceutical companies for the prescription medicines dispensed to the detriment of their discounts on the single price of the marketing authorisation.
(3a) applies for a medicinal product the amount of a refund pursuant to § 130 b of the fifth book of the social code, the pharmaceutical entrepreneur delivers the drug to the amount of the refund. Notwithstanding sentence 1, the pharmaceutical entrepreneur can deliver the drugs to an amount below the refunded amount; the obligation in paragraph 3 sentence 1 first half-sentence remains unaffected. The selling price for set 1 or set 2 also applies to persons who do not receive the medicines as insured persons of a statutory health insurance fund in the form of benefits in kind.
(4) in the case of medicinal products supplied by pharmacies in case of a threatening communicable disease, whose spreading significantly higher deployment of specific medicinal products requires an immediate and the usual amount, and that no. 3 c have been stocked for this purpose according to article 47, paragraph 1, sentence 1, the land selling price applies as a basis to be determined in accordance with paragraph 2 prices and price ranges. The same applies to medicinal products which are manufactured appropriately stocked drugs in pharmacies and in these cases for this purpose. Paragraph 2 sentence 2 at the country level shall apply in these cases.

Article 79 exception appropriations for times of crisis (1) the Federal Ministry is empowered to allow exceptions to the provisions of this Act and the regulations adopted on the basis of this Act in agreement with the Federal Ministry of Economics and technology by decree with the consent of the Bundesrat, if the necessary supply of the population with medicines would otherwise seriously compromised and not to fear a direct or indirect danger to health of people by medicinal products; in particular, arrangements can be made to counter a proliferation of hazards that can occur as a response to the suspected or confirmed spread of pathogenic agents, toxins, chemicals or an exposure to ionizing radiation.
(2) the Federal Ministry of food, agriculture and consumer protection is hereby authorised, in agreement with the Federal Ministry and to admit exceptions to the provisions of this Act and the regulations adopted on the basis of this Act by legal Ordinance which shall not require the consent of the Bundesrat, the Federal Ministry of Economics and technology when the necessary care of the herds with medicines would otherwise seriously at risk and not to worry about direct or indirect risks to human or animal health through medicines.
(3) the regulations shall be taken pursuant to paragraph 1 or 2 in agreement with the Federal Ministry for environment, nature conservation and nuclear safety, insofar as radiopharmaceuticals and medicinal products whose manufacture uses ionizing radiation, or regulations for the prevention of hazards of ionizing radiation.
(4) the period of validity of the Legislative Decree pursuant to paragraph 1 or 2 is limited to six months.
(5) in the event of a supply shortage of the population with medicines that are required, or in case of a threatening communicable disease, whose spreading requires providing immediate and significantly exceeding the usual level of specific medicines, can for the prevention or treatment of life-threatening diseases, the competent authorities in each individual case allow, that medicinal products which are authorised or registered not for circulation in the area of application of this Act , 1 temporary transport to be placed, as well as 2. by way of derogation are spent by § 73 para 1 in the territorial scope of this Act.
Sentence 1 shall apply if the medicines in the country legally are allowed in traffic, from which they are spent within the territorial scope of this Act. The permit by the competent authority is considered b paragraph 2 sentence at the same time certificate according to § 72a paragraph 1 sentence 1 No. 3 or § 72 1 number 3, that imports in the public interest lies. In the case of a supply shortage or a threatening communicable disease within the meaning of sentence 1, the competent authorities in individual cases may allow even a temporary departure of permission or approval requirements or other prohibitions under this Act. By the Ministry, it is determined that a supply shortage or a threatening communicable disease within the meaning of sentence 1 exists or no longer exists. The assessment is made by a notice published in the Federal Gazette. The announcement was made in agreement with the Federal Ministry for environment, nature conservation and nuclear safety, insofar as radiopharmaceuticals and medicinal products, ionising radiation are used in their manufacture.
(6) measures the competent authorities under paragraph 5 must be limited to the necessary and must be adequate to meet the health risks that are caused by the lack of supply or the threatening communicable disease. Contradiction and application for annulment against measures under paragraph 5 have no suspensive effect.

Section 80 authorization process and hardship arrangements the Federal Ministry is empowered by legal regulation, which requires not the consent of the Federal Council, further details on the procedure 1 the authorisation including the renewal of the authorisation, 2 the State. batch testing and release of one batch 3 ads for amending the admission documents, 3a.
the competent federal authority and the persons in the case of the placing on the market in cases of hardship involved according to § 21 para 2 sentence 1 No. 6 in conjunction with article 83 of Regulation (EC) No 726 / 2004, 4. the registry including the extension of the registration, 4a.
the publication of the results of clinical trials according to § 42b, 5. the messages from drug risks and 6 the electronic submission of documents to the numbers 1, 3, 4, 4a and 5 including the formats to be used to regulate; can choose the forwarding of copies to the competent authorities, as well as require that documents in multiple copies, as well as on electronic or optical storage media be submitted. The Ministry may transfer this authorization without the consent of the Federal Council to the competent federal authority. In the Ordinance pursuant to sentence 1 No. 3a in particular the tasks of the competent federal authority with regard to the participation of the European Medicines Agency and the Committee for medicinal products for human according to article 83 of Regulation (EC) can be controlled No 726 / 2004 as well as the areas of responsibility of the doctors and the pharmaceutical entrepreneur or sponsors, including display, documentation and reporting requirements for adverse reactions according to article 24 (1) and article 25 of Regulation (EC) No 726 / 2004. It can also arrangements for medicines are made, the conditions corresponding to the article 83 of Regulation (EC) No 726 / 2004 concerning medicines, not to the article 3 para 1 or 2 to this regulation are mentioned. The regulations shall be taken pursuant to sentences 1 and 2 in agreement with the Federal Ministry of food, agriculture and consumer protection, insofar as it is medicinal products intended for use in animals.

Article 81 relative to other laws the provisions of narcotics and nuclear law and of the animal protection Act remain unaffected.

Article 82 General regulations the Federal Government adopts the General regulations necessary for the implementation of this Act with the consent of the Federal Council. As far as it is addressed to the competent federal authority, the General regulations of the Ministry shall be adopted. The General administrative rules pursuant to sentence 2 shall be taken in agreement with the Federal Ministry of food, agriculture and consumer protection, as far as it is medicinal products intended for use in animals.

Approximation to the law of the European Union (1) section 83 regulations or general administrative provisions under this Act can also for the purpose of approximation of the laws, regulations and administrative provisions of the Member States of the European Union are adopted, so far as the matters shall of this Act relate to the implementing of regulations, directives, decisions or resolutions of the European Community or the European Union, is required.
(2) (dropped out) § 83a regulations in certain cases the Ministry is authorised to change references to legislation, insofar as it is necessary to adapt to changes in these rules by Decree without the consent of the Federal Council in legislative acts of the European Community or the European Union in this Act or in regulations adopted pursuant to this Act. It's rules on medicinal products or substances that are intended to be applied to the animal, the Federal Ministry for food, agriculture and consumer protection, which adopts the legal regulation in agreement with the Ministry takes the place of Ministry.

§ 83b promulgation of regulations regulations can be announced by way of derogation according to this law of article 2 paragraph 1 of the adorn - and notice Act in the Federal Gazette.
Sixteenth section liability § 84 for medicines is strict liability (1) as a result of the application of a medicinal product intended for use in humans, which was and is subject to the approval or is liberated by a regulation of the admission in the territorial scope of this Act on the consumer a person killed or injured the the body or the health of a people not insignificant, so is the pharmaceutical entrepreneur , who brought the drug in the territorial scope of this Act on the market, to replace the injured the damage caused. The replacement obligation only if 1 that has adverse effects of medicinal products intended, that go beyond a reasonable degree according to the findings of medical science or damage caused by a corresponding not the findings of medical science labelling, prescribing information, or use information occurred 2.
(2) the medicinal product applied is according to the facts of the case, to cause the damage, it is assumed that the damage caused by this drug is causing. The suitability in each case judged by the composition and dosage of the medicinal product applied according to the nature and duration of its intended application, after the temporal relation to the occurrence of the damage, after the loss patterns and the health condition of the victim at the time of application, as well as all other circumstances in which speak in an individual case for or against the damage caused. The presumption does not apply if other change is appropriate according to the circumstances of the individual case, to cause the damage. Other change is not in the application of other medicinal products that are suitable to the circumstances of the individual case, to cause, unless claims are not given due to the application of these drugs under that provision for reasons other than the missing causality for the damage, the damage.
(3) the obligation of the marketing authorisation pursuant to paragraph 1 sentence 2 No. 1 is excluded, if to assume under the circumstances is that the harmful effects of the medicinal product have its cause in the field of development and production.

§ 84a of right to information (1) evidence of facts, giving rise to the assumption that a drug has caused the damage, so the injured party by the pharmaceutical entrepreneur can request information, unless this is to determine whether a right to claim damages according to § 84 is not required. The claim is known suspected cases of adverse reactions and interactions and all other findings that may be for the evaluation of the acceptability of harmful effects of importance on the pharmaceutical entrepreneur known effects, side effects and interactions as well as him. The paragraphs 259 to 261 of the Civil Code shall apply accordingly. Information claim as far as not, than the information in accordance with legal provisions to keep secret are or the secrecy is equivalent to a majority interest of the marketing authorisation or a third party.
(2) a right to information exists under the conditions of paragraph 1 also to the authorities who are responsible for the authorisation and supervision of medicinal products. The authority is not obliged to supply the information, as far as information in accordance with legal provisions is to keep secret or confidentiality corresponds to a majority interest of the marketing authorisation or a third party. Under the Act of freedom of information remain unaffected.

§ 85 contributory negligence was involved in the damage a fault of the injured party, § 254 of the German Civil Code apply.

§ 86 amount of damages for killing (1) In the case of the killing is the damages by reimbursement of the costs of an attempted cure, as well as of financial disadvantage to make, has suffered by the deceased as a result that lifted during the illness his earning capacity or reduced or a reproduction of his needs had occurred. The indemnifiable has also to replace one the cost of the funeral, which is the obligation to pay these costs.
(2) the deceased was at the time of the injury to a third party in a relationship, by dint of he opposite law responsible this was or could be responsible, and the right to maintenance is deprived, the third party as a result of the killing of the indemnifiable has to pay compensation to the third party as the deceased would have been obligated during the alleged period of his life to the granting of maintenance. The obligation occurs even if the third party at the time of the injury was produced, but not yet born.

§ 87 extent of compensation for personal injury In the event of a breach of the body or the health is the damages by reimbursement of the costs of healing, as well as of financial disadvantage to afford, incurred by the injured party as a result, that as a result of the injury temporarily or permanently his earning capacity lifted or mitigated or entered a reproduction of his needs. In this case, a cheap compensation in money may be required because of the damage, which is non-pecuniary damage.

§ 88 limits the indemnifiable liable 1. in the event of the death or injury of a person up to the capital amount of 600,000 euros or up to the amount of a pension every year 36,000 euros, 2. in the event of the death or injury of several people by that same drug without prejudice to the limits given in paragraph 1 up to the amount of a capital of 120 million euros or up to a pension, the amount of 7.2 million euros per year.
Exceed the compensation to be paid to the more than one claimant in the case of the set the specified maximum 1 No. 2, so decrease the individual compensation in the ratio, which is her total to the maximum.

§ Compensation through money pensions (1) which damages to be granted a third party is for the future by payment of money pension claims for damages because of elimination or reduction of earning capacity and increase of the needs of the injured and the according to § 86 para 2 to 89.
(2) the provisions of § 843 2 to 4 of the civil code and of article 708 find no. 8 of the civil procedure code shall apply.
(3) is recognized in the sentencing of the debtor to pay a money pension did not affect safety performance, so the person entitled may require however guarantee if the financial situation of the debtor have deteriorated significantly. under the same condition, he may require an increase of security specified in the judgment.

Article 90 (dropped out) section 91 further liability remain unaffected statutory regulations, according to which an be replaced pursuant to § 84 to the further extent than according to the provisions of this section shall be liable or that another for damages is responsible.

§ 92. mandatory nature of the obligation under this section may in advance neither excluded nor limited. Contrary agreements are null and void.

§ 93 several indemnifiable several are liable, they are liable as joint and several debtors. In the relationship of the person liable to each other depends on the obligation to damages, as well as the amount of compensation to be paid by the circumstances, in particular depends on to what extent the damage is mainly caused by the one or the other part.

§ 94 the pharmaceutical entrepreneur has financial security (1) provision to meet that he can fulfil his legal obligations to the compensation of damages, one arising from the application by him in the medicinal product, intended for use in humans, which is subject to the approval or through legal regulation has been released from the admission (cover). The cover must be provided in the amounts referred to in section 88, sentence 1. She can only 1 by a liability insurance policy with an independent insurance company, authorized in the area of application of this Act to conduct business, for which in the event of a reinsurance a reinsurance contract only with a reinsurance company, headquartered in the territorial scope of this Act, in another Member State of the European Union, in another Contracting State to the agreement on the European economic area or in one of the European Commission on basis of article 172 of the directive 2009/138/EC of the European Parliament and of the Council of 25 November 2009 relating to the taking up and pursuit of insurance and reinsurance (Solvency II) (OJ OJ L 335 of December 17, 2009, p. 1) as equivalent recognized State has, is, or 2. waivers or warranty obligations of a domestic credit institution or credit institution of another Member State of the European Union or another Contracting State to the agreement on the European economic area are provided.
(2) the financial security provided by a liability insurance policy, so the article 113 paragraph 3 and paragraphs 114 to 124 of the German insurance contract law shall apply, mutatis mutandis.
(3) by a waivers or warranty obligations of a credit institution, the financial security can be provided only if it is ensured that the credit institution, as long as its use must be expected, will be able, to meet its obligations within the framework of financial security. The § 113 paragraph 3 and paragraphs 114 to 124 of the insurance contract Act shall apply mutatis mutandis for the waivers or warranty obligations.
(4) the competent authority within the meaning of § 117 paragraph 2 of the German insurance contract law is the authority responsible for conducting the monitoring according to article 64.
(5) the Federal Republic of Germany and the countries are not obliged to the financial security referred to in paragraph 1.

section 94a territorial jurisdiction (1) for proceedings instituted on the basis of section 84 or of § 84a 1 is the Court in whose district the plaintiff at the time of the proceedings his normal place of residence has his residence, in the absence of such.
(2) paragraph 1 remains no. 1 of the civil procedure code not taken into consideration in the determination of the international jurisdiction of the courts of a foreign State according to § 328 paragraph 1.
Seventeenth section of criminal law and penalty provisions § 95 penal provisions (1) with imprisonment up to three years or with fine who a medicinal product on the market brings 1. contrary to § 5 paragraph 1 or applied to other, 2. a regulation pursuant to section 6, which prohibits the placing on the market of medicinal products, is contrary to, so far as it refers to this regulation for a specific offence, punished, 2a.
contrary to Article 6a, paragraph 1 medicines for purposes of doping in sport in the traffic brings, prescribes or applies for other, 2. contrary to section 6a of the sentence 1 acquires a medicinal product or an active substance paragraph 2a or has 3. contrary to § 7 paragraph 1 radioactive medicinal or medicinal products during their manufacture ionising radiation have been used, brings into circulation, 3a.
contrary to § 8 para. 1 No. 1 or paragraph 2 in conjunction with § 73 para 4 or section 73a, medicinal products or active substances produces, brings in the traffic or otherwise trades with them, sentence 1 with medicinal products which may be placed only on prescription to consumers, trades or these drugs emits 4. contrary to article 43, paragraph 1, sentence 2, para. 2, or 3 , 5. medicinal products which may be placed, violates article paragraph 1 other than 47 referred to persons or bodies or is contrary to § 47 para 1a or contrary to section 47, paragraph 2, sentence 1 applies only on prescription to consumers, 5a.
contrary to article 47a, paragraph 1 gives a there designated medicines other than those designated thereon or brings into circulation, 6 contrary to § 48 para 1 sentence 1 in conjunction with a legal regulation according to § 48 para 2 is no. 1 or 2 medicines, which are intended for use in animals, the aim of gaining food, 7. are medicated feedingstuffs contrary to section 56 para 1 without the necessary prescription to pet owners , 8 contrary to section 56a para 1 sentence 1, also in conjunction with set of 3, or prescribes 2 medicines, emits or applies, which are intended for use in animals, which serve the production of food, and only on prescription to consumers may be placed, 9.
Medicinal products which may be placed only on prescription to consumer, acquires contrary to article 57, paragraph 1, animals was applied to 10 contrary to article 58, paragraph 1, sentence 1 medicinal products which may be placed only on prescription to consumers, food-producing or 11 contrary to section 59d sentence 1 number 1 administered a banned substance a listed animal.
(2) an attempt is punishable.
(3) in especially serious cases, the punishment is imprisonment from one year up to ten years. Usually is a particularly serious case, if the perpetrator 1 through a designated which in paragraph 1 acts a) endangers the health of a large number of people, b) exposing another to the danger of death or serious injury to body or health or c) from coarse self-interest for themselves or another large scale financial benefits gained, or 2. in the cases of paragraph 1 No. 2a a) drugs for doping purposes in sports to persons under 18 Years are off or was applied to these people or b) is professional or a member of a gang which is connected to the continued Commission of such acts, or 3 in the cases of paragraph 1 establishes no. 3a counterfeit medicinal products or active substances or brings into circulation and is it professional or a member of a gang, which is connected to the continued Commission of such acts.
(4) is negligent of the perpetrators in the cases of paragraph 1, as the penalty is imprisonment up to one year or a fine.

§ 96 penal imprisonment up to one year or with fine will be punished who emits a drug 1 violates article 4 paragraph 3 sentence 1, limited 2. a regulation pursuant to section 6, which requires the use of certain substances, preparations of materials or objects in the production of medicines, or prohibits, contravenes as far as them for a specific offence on this regulation refers, 3. contrary to article 8, paragraph 1 No. 2 , also in conjunction with section 73a, medicinal products or active substances produces or brings into circulation, 4 without permission according to § 13 paragraph 1 sentence 1 or section 72, paragraph 1, sentence 1 manufactures a medicinal product, a substance or a listed substance or introducing, 4a.
without permission according to § 20 para 1 sentence 1 or 2 7 fabric WINS set or conducting laboratory tests or without permission in accordance with section 20 c of paragraph 1 be - or processed, preserved set 1 tissues or tissue preparations, checks, store or brings into circulation 5. contrary to article 21, paragraph 1, medicinal or pharmaceutical products, for use in animals intended, or in a regulation according to § 35 par. 1 No. 2 or § 60 para. 3 designated medicines without authorisation or approval of the European Community or of the European Union on the market brings, 5a.
According to section 21a para 1 sentence 1 tissue preparations on the market brings without permission, 5B. without certificate according to § 21a, paragraph 9, sentence 1 first spends a tissue preparation, a 6 to section 22 para 1 No. 3, 5 to 9, 11, 12, 14 or 15, par. 3 set 1 or § 23 para 2 sentence 2 or 3 required information is not complete or not correct b or 3 c or according to § 22 para. 2 or 3 , § 23 para 1, para 2 sentence 2 or 3, paragraph 3, also in conjunction with section 38 paragraph 2, required documents or executable arrangement according to § 28 paragraph 3, 3a, 3B or 3c paragraph set 1 number 2 required document incompletely or with no real content, submit to 7 Despite section 30, paragraph 4, sentence 1 No. 1, also in conjunction with a legal regulation according to § 35 par. 1 No. 2 , brings a medicinal product on the market, 8 contrary to section 32 para 1 sentence 1, also in conjunction with a legal regulation according to § 35 par. 1 No. 3, a batch without releasing on the market brings, brings 9 contrary to section 38, subsection 1, sentence 1 or section 39a set 1 medicinal as homeopathic or traditional herbal medicines registration in the traffic-free, 10 contrary to section 40 para 1 sentence 3 No. 2 , 2a conducts the clinical trial of a medicinal letter a, no. 3, 4, 5, 6, or 8, also in connection with paragraph 4, or article 41, 11 contrary to article 40, paragraph 1, sentence 2 begins the trial of a pharmaceutical product, emits a there designated medicines without prescription 12 contrary to Section 47a, paragraph 1, sentence 1 if the Act not according to § 95 para. 1 No. 5a with punishment is threatened , 13 contrary to § 48 para 1 sentence 1 7 medicinal gives no. 1 in connection with a legal regulation according to § 48 para 2 No. 1, 2 or number, if the Act is not threatened with punishment in article 95, paragraph 1 No. 6, wholesale operates 14 without permission according to § 52a paragraph 1 sentence 1, 14a.
violates article 52c paragraph 2 sentence 1 absorbs as a medicinal agent, 15 contrary to section 56a (4) prescribes medicines or emits 16 contrary to § 57 sentence 1 in conjunction with a legal regulation according to section 56a subsection 3 sentence 1 No. 2 a there designated drug possession has para 1a 17 contrary to article 59, paragraph 2, sentence 1 food WINS, 18 violates article 59a par. 1 or 2 substances or preparations from materials acquires , offers, store, packed, with leads or brings into circulation, 18a.
contrary to section 59d, sentence 1, number 2 a substance a listed animal 1 b or paragraph 1 d, 18 b. contrary to section 72a, paragraph 1, sentence 1, also in conjunction with paragraph, or administered section 72a paragraph 1c contrary to introducing a drug, a drug or another substance in the said paragraphs, 18 c.
without permission according to § 72 para. 1 sentence 1 tissues or tissue preparations of introducing, 18 d.
contrary to § 72 para 2 sentence 1 tissues or tissue preparations introduces 18e.
contrary to § 73 para 1 sentence 1 spends a falsified medicinal product or a counterfeit substance within the territorial scope of this Act, 19 brings a drug for use in humans in the traffic, even though that doesn't required liability insurance waivers or is warranty obligation according to § 94 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 human and veterinary medicinal products and the Establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1), most recently by Regulation (EU) No. 1027/2012 (OJ L 316 of the 14.11.2012, p. 38) has been changed, violates, by he a) contrary to article 6 paragraph 1 sentence 1 of the regulation in conjunction with article 8 paragraph 3 subparagraph 1(c) to e, h to iaa or letter ib of Directive 2001/83/EC of the European Parliament and of the Council of the 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311 of 28.11.2001, p. 67), most recently by the directive of 2012/26/EC (OJ L 299 of the 27.10.2012, p. 1) is changed, a statement or a document incorrectly or incompletely attaches or b) contrary to article 31 paragraph 1 sentence 1 of the regulation in conjunction with article 12 paragraph 3 subparagraph 1 sentence 2 letter c to e, h and j or k of Directive 2001/82/EC of the European Parliament and of the Council of the 6 November 2001 on the Community code relating to veterinary medicinal products (OJ EC No. L 311, p. 1), as amended by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 (OJ EU no. L 136, p. 58), adds a specified incorrectly or incompletely.

Article 97 penalty provisions (1) any person is, who is a 1.
§ 96 number 1 to 5b, 7-18e or number 19 or 2. § 96 number 6 or paragraph 20 Act referred to negligently commits.
(2) any person who intentionally or negligently a medicinal product on the market brings 1. contrary to article 8, paragraph 3, in the traffic brings medicines, which bear the name or the company of the marketing authorisation, 2. contrary to article 9, paragraph 1, brings 3. contrary to § 9 para 2 sentence 1 medicinal products on the market, without having its seat within the territorial scope of this Act or in another Member State of the European Union or in another Contracting State to the agreement on the European economic area is also, , 4. contrary to article 10, also in connection with article 109, paragraph 1, sentence 1 or a legal regulation according to § 12 para. 1 No. 1, medicines without the mandatory labelling in the transport brings, 5. contrary to § 11 para 1 sentence 1, also in conjunction with subsection 2a 3B or 4, each also in combination with a Decree according to article 12, paragraph 1 involve no. 1, medicines without the prescribed leaflet in the traffic , 5a.
contrary to section 11, paragraph 7, sentence 1 is a subset of, an enforceable order 6 para 2 contravenes according to § 18, 7 against a) §§ 20, 20B paragraph 5, section 20c paragraph 6, in conjunction with § 72b paragraph 1 sentence 2, contrary to § 52a paragraph 8, section 67, paragraph 8, sentence 1 or § 73 paragraph 3a set 4, b) § 21a, paragraph 7, sentence 1, § 29, paragraph 1, sentence 1 , also in connection with sentence 2, contrary to article 29 paragraph 1 c, sentence 1, § 63 c paragraph 2, section 63 h paragraph 2, § 63i, paragraph 2, sentence 1 or c) § 67 paragraph 1 sentence 1, also in conjunction with sentence 2, also in connection with § 69a, contrary to section 67, paragraph 5, sentence 1 or paragraph 6 sentence 1 a display not, incorrectly, incompletely or not timely reimbursed , 7a.
contrary to § 29 par. 1a sentence 1, paragraph 1B or 1 d one communication does not, incorrectly, incompletely or not in time, spends 8 contrary to section 30, paragraph 4, sentence 1 No. 2 or § 73 para 1 or 1a medicines within the scope of this law, performs the clinical trial of the medicinal 9 contrary to section 40 para 1 sentence 3 No. 7 9a.
without a Deputy according to § 40 paragraph 1a sentence 3 named to have, performing a clinical examination, 9. contrary to § not, provides the reports 42 b paragraph 1 or paragraph 2 incorrectly, incompletely or not in time, 10 contrary to article 43, paragraph 1, 2 or 3 brings set 1 medicines work - or professional in the traffic or with medicinal products which are supplied without a prescription to consumers may , Commercial drives or gives off this drug, emits certain medicinal products which have not been released for transport outside of pharmacies in not proper way 11 contrary to section 43 paragraph 5 sentence 1 for use in animals, 12 contrary to § 47 para 1 to others as there designated persons or bodies or contrary to section 47 makes para 1a medicinal products which may be placed, without prescribing consumers or contrary to section 47, paragraph 2, sentence 1 applies , 12a.
contrary to section 47, paragraph 4, sentence 1 pattern without written request in a language other than the smallest package size or the allowance, emits or leave can be, not presents 13 which not or not correctly leads b or para 4 sentence 3 or certificates prescribed in Section 47a, paragraph 2, sentence 2 in article 47, paragraph 1, or the competent authority upon request, 13a.
emits a there designated medicinal product without the prescribed marking contrary to Section 47a, paragraph 2, sentence 1, 14 contrary to § 50 para 1 operates retail sale of pharmaceutical products, 15 contrary to § 51 para 1 hawks medicines in the travel industry or seeking orders that, 16 violates article 52 par. 1 medicinal means of self service on the market brings, 17 contrary to section 55 paragraph 8, sentence 1 in conjunction with sentence 2 , a fabric, a container or a wrapping used or customize a dosage form, 17a.
contrary to article 56, paragraph 1, sentence 2 send a copy of a prescription not or not timely, 18 contrary to article 56, paragraph 2, sentence 1, § 3 or 4 set 1 or 2 medicated foodstuffs establishes, 19 contrary to article 56, paragraph 4, sentence 2 a feed ready mix not, incorrectly, incompletely, features not in the prescribed manner or in a timely manner, 20th contrary to section 56 paragraph 5 sentence 1 will prescribe a medicated feedingstuff , 21 contrary to section 56a subsection 1 sentence 1 No. 1, 2, 3 or 4, each also in combination with sentence 3, medicines, a) are intended for use in animals, which are not extracting food, and only on prescription to consumers be delivered may, b) without prescription consumers may be placed, prescribes, emits or applying, 21 a.
prescribes violates article 56a par. 1 sentence 4 medicinal premixes or emits, 22 acquires medicinal products which may be placed without prescription to consumers, contrary to § 57 para 1, 22a.
contrary to § 57a applying medicines, 23 contrary to article 58, paragraph 1, sentence 2 or 3 medicinal animals was applied, the aim of gaining food, 23a.
contrary to section 58a, paragraph 1, sentence 1 or 2 or paragraph 3, paragraph 4 set 1, set 2 or set 3 or section 58 b paragraph 1 sentence 1, 2 or 3 or paragraph 2 sentence 2 number 2 or paragraph 3 a message not properly, not completely, not in the prescribed manner or not timely 23. contrary to article 58 d paragraph 1 number 2 is, a there called finding not , records not properly or in a timely manner, 23 c.
contrary to section 58 d paragraph 2 sentence 1 number 2 a stated plan not, not, not completely, created not in the prescribed manner or in a timely manner, 23d.
to section 58 d, paragraph 3 or paragraph 4 sentence 1 is an enforceable order, 24 a recording or obligation to section 59 paragraph 4 contravenes 24a.
contrary to § set do not, not properly or in a timely manner leaves 59 b 1 substances, sentence 1 in conjunction with sentence 2, a designated thereon evidence leads 24. contrary to section 59 c, incorrectly or not completely, not or not at least three years kept or not or not timely submit, 24 c.
contrary to section 63a, paragraph 1, sentence 1 a phased plan officer not charged or refunded violates article 63a par. 3 a communication, not, not fully or not in time 24 d.
contrary to section 63a, para 1, sentence 6 performs an activity as stufenplanbeauftragter, 24e.
contrary to § a pharmacovigilance system not operates 63 b paragraph 1, 24f. contrary to § 63 b paragraph 2 No. 1 not or not timely takes a there called action, 24 g.
contrary to § 63 b paragraph 2 paragraph 3 do not, not properly or not fully leads a pharmacovigilance system master file or not, not, not fully or not timely makes available, 24 hours.
contrary to § 63 b paragraph 2 No. 4, incorrectly or not completely runs a risk management system for each individual drug, 24i. contrary to § 63 paragraph 3 sentence 1 published there called information without there called previous or simultaneous communication, 24j.
contrary to article 63d paragraph 1, also in conjunction with paragraph 3 sentence 1 or paragraph 3 sentence 4, a safety report not, incorrectly, incompletely or not in time presents, 24 k.
contrary to § 63f, paragraph 1, sentence 3 final report not or not timely submitted, 24 l.
contrary to § 63 g paragraph 1 a draft of verification protocol not, not properly or in a timely manner, submit to 24 m.
contrary to § 63 g paragraph 2 sentence 1 with a safety assessment begins, 24n.
contrary to § 63 g paragraph 4 sentence 1 an examination report not, incorrectly, incompletely or not timely submits, 24o.
violates article 63h paragraph 5 sentence 1, 2 or sentence 3 a report not, incorrectly, incompletely or not timely submit, 24 p.
contrary to § 63i, paragraph 3, sentence 1 a message is, not, not properly or in a timely manner 24q.
contrary to § 63i, paragraph 4, sentence 1 a report presents not, not properly or in a timely manner, contravenes 25 an enforceable order according to § 64 para 4 No. 4, also in conjunction with § 69a, 26 § 66, also in conjunction with § 69a, is contrary to a Duldungs - or duty, 27 contrary to an enforceable order according to article 74, paragraph 1, sentence 2 not demonstrating a shipment no. 3 , 27a.
contrary to section 74a, paragraph 1, sentence 1, an information Commissioner not commissioned or violates article 74a par. 3 a message not, not fully or not timely reimbursed, performs an activity as information officer 27. contrary to section 74a, para 1, sentence 4, 28 contrary to section 75, subsection 1, sentence 1 commissioned a person as medical representatives, 29 contrary to section 75, subsection 1, sentence 3 work as medical representatives exerts, 30 a capture , Mitteilungs - or accountability after contravenes section 76, paragraph 1, sentence 2 or paragraph 2, 30a.
(lapsed) 31 a legal regulation according to § 7 paragraph 2 sentence 2, article 12, paragraph 1 No. 3 1(a), article 12, paragraph 1 b, § 42 para 3, § 54 para 1, article 56a par. 3, article 57, paragraph 2 or paragraph 3, section 58 subsection 2 or section 74, paragraph 2 or an enforceable order on the basis of such legal regulation for a specific offence on this fine provision refers, 32nd (dropped out) 33 (dropped out) 34 (dropped out) 35th (dropped out) 36 (fallen away) (2A) any person is , who intentionally or negligently infringed article 1 of Regulation (EC) No 540/95 of Commission of 10 March 1995 laying down the rules for the release of suspected unexpected, non-fatal adverse reactions, the inside or outside the community in accordance with Regulation (EEC) No. 2309 / 93 approved human or veterinary medicinal products found are (OJ L 55 of the 11.3.1995, p. 5), in conjunction with section 63 h paragraph 7 sentence 2 violates, by not ensuring that a there known side effect is submitted to the European Medicines Agency and the competent federal authority.
(2B) is any person who violates the Regulation (EC) No 726 / 2004, by he intentionally or through negligence to 1 article 16 paragraph 2 set 1 or set 2 in conjunction with article 8 paragraph 3 paragraph 1 letter c to e, h up to letter or iaa ib of Directive 2001/83/EC or contrary to article 41 paragraph 4 sentence 1 or 2 in conjunction with article 12 paragraph 3 subparagraph 1 sentence 2 letter c to e , h or j letter k of Directive 2001/82/EC, in conjunction with section 29 (4) sentence 2, which where communication is not, not, not fully or not timely European Medicines Agency or the competent federal authority, 2. contrary to article 28 paragraph 1 in connection with article 107 paragraph 1 subparagraph 2 of Directive 2001/83/EC does not ensure , that a message anywhere therein is available, 3. contrary to article 49 paragraph 1 sentence 1 or paragraph 2 sentence 1, each in connection with section 29 (4) sentence 2, does not ensure that a there known side effect will be communicated to the competent federal authority or the European Medicines Agency, paragraph 3 sentence 1 a 4. contrary to article 49 referred to there documents not , performs incorrectly or incompletely.
(2c) any person who is against the Regulation (EC) is, no 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal and amending Regulation (EEC) No 1768/92, directives 2001/20/EC and 2001/83/EC and Regulation (EC) No 726 / 2004 (OJ OJ L 378 of 27.12.2006, p. 1) violates, by he intentionally or negligently 1 contrary to article 33 clause 1 a there called a drug not, not properly or in a timely manner brings into circulation, 2. an enforceable order paragraph 2 sentence 4 is contrary to article 34, 3.
contrary to article 34 paragraph 4 sentence 1 not or not timely submit the referred report, 4. contrary to article 35 the authorisation for the placing on the market not or not timely to a specified third party transfers set 1, and this recourse to there documents referred not or not timely provided, 5. contrary to article 35 information not, not properly or in a timely manner makes set 2 , or 6 contrary to article 41 paragraph 2 sentence 2 income of assessing therein do not, not properly or in a timely manner presents.
(3) the offence can be punished with a fine up to €25 000.
(4) in cases 1 paragraph 1 managing authority within the meaning of article 36, paragraph 1, number 1 of the code of administrative offences is number 2, the paragraph 2 point 7 letter b, number 7a, 9 b-24e-24q, of paragraphs 2a to 2 c and 2 of paragraph 2 number 7 letter c, as far as the Act to the competent federal authority is committed , the federal authority competent under section 77.

Article 98 recovery items, an offence under section 95 or 96 section or an offence refers to article 97, can be withdrawn. section 74a of the Penal Code and article 23 of the code of administrative offences are to be applied.

section 98a extended decline in the cases of section 95, paragraph 1, no. 2a, as well as the production and the placing on the market of counterfeit medicines according to § 95 para. 1 No. 3a in conjunction with § 8 paragraph 2 is to apply article 73d of the Penal Code, if the offender professional or a member of a gang, which has joined the the continued Commission of such acts.
Eighteenth section of Überleitungs-and transitional provisions of first subsection above management rules on the occasion of the law on the restructuring of the pharmaceutical legislation § 99 medicines Act 1961 medicines Act 1961 in the meaning of this Act is the law on the marketing of medicinal products by May 16, 1961 (BGBl. I p. 533), last amended by the Act of July 2, 1975 (BGBl. I S. 1745).

Section 100 (1) a permit according to article 12, paragraph 1 or § 19 ABS. 1 of the German medicines Act 1961 has been granted and duly consisted on 1 January 1978, is considered in the previous extent permit within the meaning of § 13 para 1 sentence 1 continue.
(2) a permit that applies according to article 53, paragraph 1 or article 56 of the medicines Act 1961 as granted and duly consisted on 1 January 1978, is considered in the previous extent permission according to § 13 para 1 sentence 1 continue.
(3) the manufacture of drugs under the medicines Act was 1961 by a permit not subject it needs however according to section 13, paragraph 1, sentence 1 a permission, it will be valid one as issued, entitled exercising the activity of the manufacture of medicinal products on 1 January 1978 for at least three years, but only, as far as production on previously produced or the composition of similar drugs remains limited.

§ 101 (dropped out) section 102 (1) who carries out the activities of the production manager on 1 January 1978 entitled, may continue this activity in the previous extent.
(2) who according to § 14 ABS. 1 of the German medicines Act 1961 has the expertise on January 1, 1978 and not engaged in the activity as head of production, must perform the activities as production manager if he can establish a two-year activity in drug manufacturing. The practical activity is before June 10, 1965, is to prove before recording the activity of another year practical work.
(3) a person who has started a degree before June 10, 1975 pursuant to § 15 para 1, acquires the expertise as a producer, when he has finished the University and an activity for at least two years under § 15 para 1 and 3 exercised until June 10, 1985. Paragraph 2 shall remain unaffected.
(4) paragraphs 2 and 3 shall apply mutatis mutandis to a person who wants to carry on the business as head of control.

section 102a (dropped out) section 103 (1) for medicinal products, which in 1961 are approved according to section 19a or 19d section in conjunction with section 19a of the medicines Act on January 1, 1978 or on January 1, 1978 is a admission referred to in article 4 paragraph 1 of the law on the establishment of a Federal Office for Sera and vaccines from July 7, 1972 (BGBl. I p. 1163) as granted , an authorisation is valid according to § 25 as granted. On approval the corresponding sections 28 to 31 apply.
(2) (lapsed) § 104 (dropped out) section 105 (1) finished product, the medicinal products in the sense of § 2 para 1 or par. 2 No. 1 and are on 1 January 1978 in traffic, are considered as approved if they are on September 1, 1976 in traffic or on the basis of an application, which is made up to this point, be 1961 entered in the special register under the medicines Act.
(2) medicinal must appear pursuant to paragraph 1 within a period of six months since 1 January 1978 the competent federal authority under release the name of the active ingredients according to type and quantity and the areas of application. At the display of homeopathic medicines, the notification of the applications can be omitted. A copy of the ad is to send the competent authority, communication of the information required. The finished medicinal may continue to be placed only in the traffic, when time comes in the display.
(3) the authorisation of a medicinal product on time indicated pursuant to paragraph 2 goes off no. 3 on April 30, 1990 by way of derogation from article 31, paragraph 1, unless an application for renewal of authorisation or for registration prior to the date of extinguishment is made, or the drug by Decree of the approval or the registration is free. Section 31, paragraph 4, sentence 1 applies 1 approval pursuant to sentence, unless the return is filed according to § 31 para 1 sentence 1 No. 2-January 31, 2001.
(3a) when finished medicinal product referred to in paragraph 1 a change is set 1 until the first renewal of the authorisation according to § 29 para 2a No. 1, insofar as it concerns the fields of application, and no. 3 only permissible as long as she disclosed to the applicant shortcomings in the effectiveness or safety is required to remedy by the competent federal authority; Moreover para 2a finds on medicinal pursuant to paragraph 1 up to the first renewal of the authorisation section 29 sentence 1 No. 1, 2 and 5 no application. A finished product referred to in paragraph 1, which is manufactured according to a process engineering in the homeopathic part of the Pharmacopoeia, may 1 changed composition of the pharmacologically active ingredients until the first renewal of the authorisation by way of derogation from article 29, para. 3 qualitative and quantitative, if the change are limited to that one or more previously contained active ingredients contain no longer or in lesser amount after the change to , 2. with amended amount of pharmacologically active ingredient and within the current scope with modified indication, if the medicinal product as a whole made result is adjusted which, according to § 25 paragraph 7, sentence 1 in 1994 amended prior to August 17, 3. (dropped out) 4 with amended amount of pharmacologically active constituents, insofar as a medicines with multiple active ingredients , whose number has been reduced, or 5 with modified type or amount of the pharmacologically active ingredients without increasing their number within the same scope and the same direction of the therapy, if the total medicinal one according to § 25 paragraph 7, sentence 1 in front of 17 August 1994 amended known made result or a pattern for a medicinal product submitted by the Federal Institute for drugs and medicine products adapted and the drug through the customization will not have a prescription , placed on the market; a change is allowed only as long as she disclosed to the applicant shortcomings in the effectiveness or safety is required to remedy by the competent federal authority. The pharmaceutical entrepreneur has to indicate the change and in the event of a change of the composition of the former name of the medicinal product at least for a period of five years with a clearly distinctive addition, the confusion with the previous designation excludes, to provide. After a period of six months after the notification, the pharmaceutical entrepreneur can get the drug only in modified form in the traffic. Has the competent federal authority for certain medicines prescribed use a leaflet with uniform wording no. 3 by obligation according to § 28 para 2, the medicinal changes pursuant to sentence 2 No. 2 by way of derogation may be placed by § 109 paragraph 2 only with a package leaflet pursuant to section 11 in the traffic.
(4) the application for renewal of the authorisation are by way of derogation from § 31 para 2 to section 22 para 1 No. 1 to 6 to attach the documents. The date of submission of the documents according to section 22 para 1 No. 7 to 15, para. 2 No. 1 and paragraph 3a, at medicinal premixes in addition the documents according to section 23, paragraph 2, sentence 1 and 2, as well as the analytical opinion according to article 24, paragraph 1 determines the competent federal authority in detail. On request of the competent federal authority are to submit further documents proving sufficient biological availability of the pharmacologically active ingredients of the medicinal product, if that is required according to the current state of scientific knowledge. A rating expert opinions shall be attached. Appropriate apply article 22, paragraph 2, sentence 2 and paragraph 4 to 7 and § 23 paragraph 3. The documents after the sentences 2 to 5 must be submitted four months after the request of the competent federal authority.
(4a) to the application for renewal of authorisation pursuant to paragraph 3 the documentation according to § 22 para 2 are no. 2 and 3, as well as the opinion according to article 24, paragraph 1, sentence 2 range No. 2 and 3 until February 1, 2001, as far as these documents not already by the applicant, presented § 22 para 3 finds appropriate application. Sentence 1 shall not apply to medicinal products which are manufactured according to a process engineering in the homeopathic part of the pharmacopoeia. For whole blood, plasma or blood cells of human origin requires no. 2 by way of derogation from sentence 1 not the documents pursuant to section 22 par. 2 and opinion according to § 24 para 1 sentence 2 No. 2, except that therein substances are included, that do not occur in the human body. Except in the cases of section 109a the license expires if you do not timely filed documents referred in the sentences 1 to 3.
(4B) at the presentation of the documents pursuant to article 22, paragraph 2 number 2 can for veterinary medicinal products containing pharmacologically active substances in table 1 of the annex of to Regulation (EU) No. 37/2010 are listed on which under the provisions of article 13 of Regulation (EC) No. 470 / 2009-based Act filings reference be made, as far as a medicinal products with this pharmacologically active component in a Member State of the European Union is approved and the conditions of a reference pursuant to § 24A are met.
(4C) the medicinal pursuant to paragraph 3 is allowed in an other Member State of the European Union or another Contracting State of the agreement on the European economic area according to Directive 2001/83/EC or Directive 2001/82/EC, is the renewal of the authorisation granted if 1 is located the drugs in the other Member State in the transport and 2 the applicant a) all in § 22 para 6 provided information and attaches the then required copies and b) explained in writing , that the documents submitted pursuant to paragraphs 4 and 4a with the registration documents agree on which the authorisation in another Member State unless it is based, that the renewal of the authorisation of the medicinal product can represent a danger to the public health, medicinal products for use in animals a threat to the health of humans or animals or for the environment,.
by way of derogation from article 38 paragraph 2 according to section 22 para 1 No. 1 to 4 to attach the documents are (4 d) the application for registration. The documents No. 7 to 15 and paragraph 2 are no. 1, as well as the analytical opinion pursuant to section 22 paragraph 1 pursuant to § 24 para 1 to submit to the competent federal authority on request. § 22 para 4 to 7 with the exception of design of technical information is appropriate. The documents pursuant to sentences 2 and 3 shall be submitted two months after the request of the competent federal authority.
(4e) the decision on the application for renewal of the authorisation or registration in accordance with paragraph 3 sentence 1 apply for according to § 25 paragraph 5 sentence 5 and § 39, paragraph 1, sentence 2.
(4f) which is referred to in paragraph 1 authorisation to extend sentence 1 for five years, if there is no reason of refusal pursuant to article 25, para 2; on request pursuant to paragraph 3 Article 31 shall apply for further extensions. The specifics of a particular direction of therapy (phytotherapy, homeopathy, anthroposophy) are taken into account.
(4 g) for medicinal products, the blood preparations are, is application according to § 25 paragraph 8.
(5) in the event the applicant has within a reasonable period of time, to remedy the defects but a maximum period of twelve months after notification of the complaints; the defect is present in a font set. Is not within this period of remedy the defects is the authorisation to fail. After a decision on the refusal of the registration, the submission of documents relating to remedy the defect is excluded. The Federal Authority has no objection in all appropriate cases pursuant to sentence 1 first half-sentence, but the renewal of the authorisation on the basis of joining sentences 1 and 2 with a circulation of paragraph 5a, which is abandoned the applicant to remedy the deficiencies within a period to be determined by your discretion to pronounce.
(5a) which can competent federal authority pursuant to paragraph 3 sentence 1 with pads connect the renewal of the authorisation. Pads can have also the warranty requirements on the quality, safety and efficacy on the content in addition to securing the requirements referred to in article 28, paragraph 2, unless that must be due to serious defects of the pharmaceutical quality, efficacy or safety complaints communicated under paragraph 5 or fails the renewal of the authorisation. Sentence 2 shall apply accordingly for the request of documents pursuant to § 23 para 1 No. 1. In the notification of the extension is to specify, whether immediately or before a date set by the competent federal authority must be granted the rest. The compliance is to inform the competent federal authority accompanied by an affidavit of an independent counter expert to confirm that the quality of the medicinal product complies with the current state of scientific knowledge. § 25, subsection 5, set of 5, 6 and 8, and article 30, paragraph 2, sentence 1 second alternative No. 2 shall apply mutatis mutandis. The sentences 1 to 6 shall apply accordingly for the registration in accordance with paragraph 3 set 1 (5B) a pre-litigation procedure according to § 68 of the administrative court procedure against the decision on the renewal of the authorisation pursuant to paragraph 3 sentence 1 does not take place. The immediate enforcement should be arranged according to article 80 paragraph 2 No. 4 of the administrative court procedure, except that the execution for the pharmaceutical entrepreneur would have an undue, provided not by prevailing public interests hardness result.
(5c) by way of derogation from paragraph 3 sentence 1 expires admission one after paragraph 2 of time shown medicinal product, for the pharmaceutical company until December 31, 1999, sentence 1 taking back the request for renewal of the authorisation pursuant to paragraph 3 on 1 February 2001, declared unless is the procedure for the renewal of the authorisation pursuant to sentence 2 return. Had the pharmaceutical entrepreneur the documents required pursuant to paragraph 4 on time submitted sentence 2 after a request mentioned before 17 August 1994 pursuant to paragraph 4 or the filing date for the medicinal product concerned was after this date or is the request only pronounced for the medicinal product concerned after that date have been, so is the procedure for the renewal of the authorisation by the competent federal authority at its request to revisit; the application must be set 1 until January 31, 2001 under the documents according to paragraph 4a.
(5 d) the paragraph 3 sentence 2 and paragraphs 3a to 5c shall apply mutatis mutandis for orphan medicinal products, in accordance with § 4 paragraph 2 of EC law transfer regulation of 18 December 1990 (Federal Law Gazette I p. 2915) Annex 3 No. 2 Chapter II No. 1 and 2 until June 30, 1991 a renewal application has been made to § 2.
(6) (dropped out) (7) paragraphs 1 to 5 d also apply to medicinal products intended for use in animals which are no finished product as far as they are subject to the approval or registration and are in circulation on January 1, 1978.

Article 105a (1) (dropped out) (2) (dropped out) can with finished product that not subject to prescription according to § 49, refrain first from an examination of the submitted information for professionals, and indemnify the pharmaceutical entrepreneur of the duties according to § 11a and the medical representatives from the requirement in section 76, paragraph 1, sentence 1, until the unified text of trade information for appropriate medicines by obligation according to § 28 para 2 No. 3 is arranged (3) the competent federal authority.
(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-honest-Institute.

§ 105 b 
Entitlement to payment of fees and expenses, which are to raise adopted Decree for the renewal of the authorisation or the registration of a finished product in the sense of § 105 ABS. 1 according to § 33 para 1 in conjunction with one according to § 33 para 2 or one according to § 39 para 3, barred with the expiration of the fourth year after the announcement of the final decision on the renewal of the authorisation or the registration to the applicant.

Section 106 (dropped out) section 107 (dropped out) § 108 (dropped out) section 108a batch of a serum, a vaccine, a test allergen, a reagent or a test Antigen, when effect of accession after § 16 of the second implementing regulation to the medicines Act of 1 December 1986 (Coll. I no. 36 S. 483) is released, considered to be shared in the sense of § 32 para 1 sentence 1 in the area referred to in article 3 of the Unification Treaty. On the release according to § 32 paragraph 5 applies.

section 108 b (dropped out) section 109 (1) on finished medicines which are medicines in the sense of article 2, paragraph 1 or paragraph 2 No. 1 and is on 1 January 1978 in traffic have been applies Article 10 subject to the proviso that instead of in article 10, paragraph 1, sentence 1 number 3 mentioned registration number, if any, occurs the register number of the specialty register under the medicines Act in 1961 with the abbreviation "Reg. Nr.". Sentence 1 shall apply to the renewal of the authorisation or the registration.
(2) the texts for labelling and package leaflet shall be provided no later than July 31, 2001. Up to this point medicines are allowed set 1 by the pharmaceutical entrepreneur, after that date by wholesalers and retailers, with a labelling and package leaflet in the transport referred to in paragraph 1, which complies with the requirements applicable up to the date referred to in sentence 1.
(3) finished pharmaceutical products, which shared no. 1 to 3 or section 45 for the traffic outside the pharmacies are medicinal products within the meaning of section 105, paragraph 1, and article 44, paragraph 1 or paragraph 2 and covered by the letters a to e, without prejudice to the provisions of paragraphs 1 and 2 from 1 January 1992 by the pharmaceutical entrepreneur only in traffic are allowed , when they on the container and, where used, the outer packaging and a leaflet one or several of the following notes apply: "(Traditionell angewendet: a) reinforcing or strengthening, b) to the improvement of well-being, c) to the support of organ function, d) prevention, e) as mild-acting medicines."
Sentence 1 shall not apply, as far as staying the application areas within the framework of a registration after result made known according to § 25 paragraph 7, sentence 1 as amended prior to August 17, 1994 by article 25, paragraph 1, or any.

section 109a (1) for the medicinal products referred to in article 109, paragraph 3, as well as for medicines, non-prescription and not by a legal regulation on the basis of section 45 or of § 46 because of its ingredients, due to its dosage form or because they are chemical compounds with specific pharmacological effects or are used to them, are excluded from the traffic outside of pharmacies, the renewal of the authorisation according to article 105 par. 3 and then pursuant to § 31 in accordance with the provisions of paragraphs 2 and 3 may be granted.
(2) the necessary quality requirements are met, if the documents exist no. 1 as well as the analytical opinion pursuant to section 22 paragraph 2 according to article 24, paragraph 1 and pages of the marketing authorisation freehold is the medicinal product in accordance with the General administrative provision pursuant to section 26 is tested and has the necessary pharmaceutical quality assured. Form and content of the affidavit will be determined by the competent federal authority.
(3) the requirements for the effectiveness are met, if the medicinal product claimed applications that created list of areas of application for materials or material combinations are recognized in one of the competent federal authority after consultation by a Commission appointed by the Federal Ministry for the § 25 paragraph 6 set 4 to 6 applies appropriate. These applications will be set taking into account the characteristics of the medicinal and traditional and documented experience and receive the additional: "Traditionally used". Such applications are: "to strengthen or strengthening of...", "to the improvement of well-being...", "to support organ function of...", "to prevent against...", "as mild-acting medicines at...". Application areas, which have the effect that the drug traffic outside of pharmacies is excluded, may not be recognized.
(4) paragraphs 1 to 3 shall only apply if documents paragraph 4a not been submitted according to article 105 and the applicant in writing declares that he seeks a renewal of the authorisation according to article 105 par. 3 in accordance with the provisions of paragraphs 2 and 3.
(4a) the paragraphs 2 and 3 on medicinal products referred to in paragraph 1 apply by way of derogation from paragraph 4, if the renewal of the authorisation to fail, because a result made known according to § 25 paragraph 7, sentence 1 in 1994 amended prior to August 17, proving the effectiveness can no longer be recognized.

Section 110 for medicinal products which are subject to section 21 of duty for approval, or according to § 38 of the obligation to register and located in traffic on 1 January 1978, the competent federal authority may order supports warnings insofar as it is necessary to prevent direct or indirect danger to humans or animals when the use of the medicinal product.

§ 111 (dropped out) § 112 who on 1 January 1978 medicines in the sense of § 2 paragraph 1 or paragraph 2 No. 1, which are released to traffic outside of pharmacies in retail trade outside of pharmacies on the market brings, this activity may further exercise, as far as he was after the law on the exercise of the profession in the retail sector by August 5, 1957 (BGBl. I p. 1121), amended by article 150 para. 2 No. 15 of the law of May 24, 1968 (BGBl. I p. 503) , was authorized.

§ 113 medicines may be applied by way of derogation from article 58, paragraph 1 if the labelling or the accompanying documents indicating that the medicines according to article 105, paragraph 1 may further be placed on the market.

§ 114 (dropped out) section 115 a person carrying out the activity of Pharmaberaters on 1 January 1978 according to § 75, needs of the prescribed qualifications not.

Section 116 physicians who may on January 1, 1978, according to national regulations to the production and are entitled to supply medicinal products to the persons covered by them, this activity in the previous extent continue. § 78 shall apply.

§ 117 (dropped out) section 118 section 84 does not apply to damage caused by medicinal products was submitted before January 1, 1978.

§ 119 finished product, the medicinal products in the sense of § 2 paragraph 1 or paragraph 2 are no. 1 and when effect of accession in the area referred to in article 3 of the Unification Treaty in traffic, may be placed without in § 11 prescribed leaflet by wholesalers and retailers on the market, provided they meet the applicable before accession becomes effective medicines regulations of German Democratic Republic. The competent federal authority may order restrictions warnings, insofar as it is necessary to prevent direct or indirect danger to humans or animals when the use of the medicinal product.

Section 120 in a clinical examination, which is performed when effective accession in the area referred to in article 3 of the Unification Treaty, is to take out the insurance pursuant to section 40 para 1 No. 8.

§ 121 (dropped out) article 122 the duty of disclosure according to section 67 does not apply to establishments, facilities for persons in the area referred to in article 3 of the Unification Treaty, already performing an activity within the meaning of that provision to be of accession.

§ 123 has the required expertise as a medical representatives pursuant to article 75, paragraph 2 No. 2 also, who has completed training as a pharmaceutical engineer, pharmacy Assistant, or veterinary engineer in the area referred to in article 3 of the Unification Treaty.

§ 124 the §§ 84 to 94a are applicable to medicinal products which have been given in the area referred to in article 3 of the Unification Treaty before accession takes effect to the consumer.
Second subsection transitional provisions on the occasion of the first act to amend the medicines Act § 125 (1) determines the competent federal authority after consultation with the commissions according to § 25 paragraph 6 and 7 for medicines that are approved on 2 March 1983, the period within which the documentation of the control method are to be submitted according to article 23, paragraph 2, sentence 3.
(2) for medicines, which permission has been requested after 1 March 1983 and before March 4, 1998, apply the provisions of article 23, with the proviso that documents control methods before the time arising out of paragraph 1 must be presented.
(3) a time limit for the submission of documents concerning the method of control referred to in paragraph 1 has been determined and documents are not submitted or they do not meet requirements of § 23 paragraph 2 sentence 3, the approval may be revoked.

§ 126 
For medicinal products which are intended for use in animals and which are admitted to be of accession in the area referred to in article 3 of the Unification Treaty, article 125, paragraph 1 and 3 shall apply mutatis mutandis.
Third subsection must transitional provisions on the occasion of the second act to amend the drug Act section 127 (1) medicines that are on February 1, 1987 in traffic and are subject to the labelling requirements of section 10, a year after the first one on the 1 February 1987 renewal of authorisations or for the exemption from the registration, or, as far as homeopathic remedies them, five years after February 1, 1987, by the pharmaceutical company according to the provisions of § 10 para 1 No. 9 in the traffic be brought. Up to this point, drug may be marketed pursuant to sentence 1 by the pharmaceutical entrepreneur, after that date by wholesalers and retailers without specifying an expiration date in the traffic if shelf life more than three years, or for medicinal products to which the scheme of section 109 applies, amounts to more than two years. section 109 shall remain unaffected.
(2) medicines, which are in circulation on 1 February 1987 and paragraph 1a are subject to the labelling requirements of article 10, are allowed, para 1a in the traffic of the pharmaceutical entrepreneur until December 31, 1988 by wholesalers and retailers also after that date without the information according to § 10.

The pharmaceutical entrepreneur has for medicinal, located on February 1, 1987 in traffic, to submit the text of technical information with the first request for renewal of the authorisation or registration the competent federal authority on the 1 February, 1987 section 128 (1). Sentence 1 shall not apply insofar as the competent federal authority has exempted up on another drug, which is not subject to prescription according to paragraph 49, of the duties under section 11a; in this case the design of technical information shall be provided to prompt the competent federal authority.
(2) in the cases of paragraph 1 the §§ 11a apply, 47 para 3 sentence 2 and section 76 para 1 as of the time of renewal of the authorisation or registration or establishing a trade information by article 36, paragraph 1, or in the cases of paragraph 1 sentence 2 six months after the decision of the competent federal authority over the content of information for professionals. Up to this point, finished medicinal may be placed on the market where the leaflet corresponds to the regulations of § 11 para 1 as amended by the second act to amend the medicines Act.

Article 129 § 11 paragraph 1a is on medicines, which are located on February 1, 1987 in traffic, with the proviso application that your leaflet is sent after the next extension of the authorisation or registration the competent authority.

§ 130 who on 1 February 1987 as ordered private experts to the investigation of samples in accordance with section 65, subsection 2, may this activity in the previous extent further exercise.

Section 131 of the commitment to the template or sending a specialist information according to § 11a shall apply accordingly § 128 for medicinal products which are to be of accession in the area referred to in article 3 of the Unification Treaty in circulation.
Fourth subsection transitional provisions on the occasion of the fifth Act amending the medicines Act § 132 must (1) medicines that are on August 17, 1994 in the traffic and the pursuant to sections 10 and 11 are subject to the regulations, one year after the first one on the 17 August 1994 renewal of the authorisation or, as far as them from admission are free, at the time referred to in the regulation according to § 36 or , insofar as they are homeopathic medicines, five years by the pharmaceutical entrepreneurs according to the provisions of §§ 10 and 11 in the traffic be brought after August 17, 1994. Up to this point medicines are allowed 1 pharmaceutical entrepreneur, after that date by wholesalers and retailers with a labelling and package leaflet in the traffic to set, which complies with the requirements applicable up to 17 August 1994. section 109 shall remain unaffected.
(2) the pharmaceutical entrepreneur has finished medicinal are in circulation on August 17, 1994, to submit the text of technical information with the first request for renewal of the approval of the competent federal authority on the 17 August 1994, the § 11a as amended by this Act. Section 128, paragraph 1, sentence 2 shall remain unaffected.
(2a) a manufacturing licence is not the section 16, is to adapt section 16 until August 17, 1996. Sentence 1 applies accordingly to § 72.
(2B) who on August 17, 1994 as head of production for the production or control head for the examination of blood preparations exerts and the requirements of § 15 para 3 as amended by force until August 17, 1994 met, may this activity continue.
(3) (lapsed) (4) § 39 para 2 No. 4a and 5a shall not apply to medicinal products which have been registered up to December 31, 1993 or registering up to this point has been applied for or which have been displayed and according to § 38 paragraph 1 sentence 3 as amended prior to September 11, 1998 on the market have been brought pursuant to article 105 par. 2. § 39 para 2 No. 4a shall also not apply medicinal pursuant to sentence 1, for which a new registration is requested because a part is to be removed or multiple components to be removed or to increase the degree of dilution of components. § 39 para 2 No. 4a and 5a for decisions about the registration or their extension not apply on medicinal products that are the same type and quantity of the components and in terms of the formulation with the medicinal products referred to in sentence 1. § 21 para 2a sentence 5 and section 56a para 2 sentence 5 also apply to medicinal products intended for use in animals, whose degree of dilution is less than the sixth decimal potency, provided that she are registered in accordance with sentence 1 or 2 have been or are exempt from registration.
Fifth subsection transitional provision on the occasion of the seventh law amending the medicines Act § 133 the duty of disclosure according to section 67 in conjunction with § 69a applies to the enterprises referred to in section 59 c, institutions, and persons already on 4 March 1998 an activity within the meaning of section 59 c exercise with the proviso that the display at the latest up to has to be April 1, 1998.
Sixth subsection transitional provisions on the occasion of the transfusion Act § 134 who upon entry into force of the transfusion Act of 1 July 1998 (BGBl. I S. 1752) as production manager for the production or control head exercises for the testing of blood preparations or Sera from human blood, and that meets requirements of § 15 para 3 as amended by force until that date, may further exercise this activity. At the time referred to in sentence 1, who carries out the activities of the pretreatment of persons for the separation of blood stem cells or other blood components according to the State of science and technology, must continue this activity.
Seventh subsection transitional provisions on the occasion of the eighth law amending of the medicines Act § 135 must (1) medicines that are on 11 September 1998 in transport and the pursuant to sections 10 and 11 are subject to the regulations, one year after the first one on the 11th September 1998 renewal of the authorisation or, as far as them from admission are free, at the time referred to in the regulation according to § 36 or , insofar as they are homeopathic remedies, on October 1, 2003 by the pharmaceutical entrepreneur according to the regulations of §§ 10 and 11 in the traffic be brought. Up to this point medicines are allowed 1 pharmaceutical entrepreneur, after that date by wholesalers and retailers with a labelling and package leaflet in the traffic after set, which complies with the requirements applicable up to 11 September 1998. section 109 shall remain unaffected.
(2) a person who performs the activity as manufacturing or control manager for that in § 15 par. 3a empowered medicinal referred to products or active substances on 11 September 1998, may continue this activity in the previous extent. § 15 para 4 does not apply to the practical activity for the production of medicinal products and active substances according to § 15 para 3a until October 1, 2001.
(3) homeopathic remedies, located on 11 September 1998 in transport and a request for registration has been eliminated for that until October 1, 1999, may be brought by way of derogation from § 38 paragraph 1 sentence 3 until a decision on the registration in the traffic, provided that comply with the requirements in force until 11 September 1998.
(4) § 41 as amended, no. 6 shall not apply to declarations of consent, which was submitted prior to September 11, 1998.
Eighth subsection transitional provisions on the occasion of the tenth law to amend the medicines Act § 136 
(1) for medicines, where she applied for renewal already has been granted according to article 105, paragraph 3, sentence 1, you are para 4a set in § 105 at the latest with the request pursuant to § 31 para 1 to submit 1 designated documents No. 3. These medicines is the authorisation to extend, if there is no refusal reason according to § 25 paragraph 2; Article 31 shall apply for further extensions.
(1a) on medicinal products under § 105 para 3 sentence 1, that are made after a process technology described in the homeopathic part of the Pharmacopoeia, § 105 para 3 sentence 2 in force until 12 July 2000 amended until a decision of the Commission in accordance with § 55 paragraph 6 concerning the inclusion of this technology finds application, unless up to October 1, 2000 has been a request for inclusion in the homeopathic part of the pharmacopoeia.
(2) for medicines, where before 12 July 2000 shortcomings in the effectiveness or safety are notified to the applicant, section 105 applies paragraph 3a in the version applicable up to July 12, 2000.
(2a) Article 105 par. 3a sentence 2 is in force until 12 July 2000 amended up to January 31, 2001, subject to the proviso application that a notice of lack of is not required and a change is only allowed, if it limits itself, that one or more previously contained active ingredients are no longer included after the change.
(3) for medicinal products which have been manufactured according to a process engineering in the homeopathic part of the Pharmacopoeia, § 105 ABS. 5 c continues to apply as amended prior to July 12, 2000.
Ninth subsection transitional provisions on the occasion of the eleventh Act amending the medicines Act § 137 derogation from § 13 para 2, § 47 para 1 No. 6, § 56 para 2 sentence 2 and paragraph 5 sentence 1 may medicated foodstuffs until December 31, 2005 after the force until November 1, 2002 regulations produced, placed on the market, and applied. Up to the manufacture of medicated feedingstuffs here by way of derogation from § 56 para 2 sentence 1 from a maximum of three medicinal premixes that are approved, each for use in the species to be treated must be 31 December 2005 as long as 1 for the relevant application area is an approved drug premix unavailable, 2. in individual cases in the medicated feed no more than two 33060_gi_copal_g+c_1x40_int.indd drug premixes are included and 3 a homogeneous and stable distribution of the active ingredients in the medicated feed is guaranteed.
By way of derogation from sentence 2 No. 2 must contain only a 33060_gi_copal_g+c_1x40_int.indd drug premix in the medicated feed, if it contains two or more antibiotic active substances.
Tenth subsection transitional provisions on the occasion of the 12th law amending the medicines Act section 138 (1) for the manufacture and importation of active substances, which, are microbial origin, as well as other substances specific to drug manufacturing human origin, which are manufactured or transferred within the territorial scope of this Act, commercial - or professionally for the purposes of the disposal of to others see §§ 13, 72 and 72a as amended by force until August 5, 2004 to September 1, 2006 application , unless it is for blood specific to drug manufacturing and blood components of human origin. Is taken from blood to the preparation or reproduction of autologous cells in part of the tissue engineered tissue regeneration and is it still no manufacturing authorization requested been section 13 to September 1, 2006 does not apply.
(2) on August 5, 2004 a person who is authorized to carry on the business of the manufacturing or control head, may continue notwithstanding this activity by article 15, paragraph 1.
(3) for clinical trials of drugs in humans, for which prior to August 6, 2004 you have been provided necessary documents of the Ethics Committee responsible for the head of the clinical trial according to § 40 paragraph 1 sentence 2 in the version applicable up to August 6, 2004, sections 40 to 42, 96 No. 10 and § 97 paragraph 2 apply no. 9 in the version applicable up to August 6, 2004.
(4) a person who authorized performs the activity of wholesale trade in medicines on 6 August 2004 and up to December 1, 2004, according to § 52a para 1 to operate of a wholesale trade in medicines made an application for a permit, may notwithstanding § 52a paragraph 1 up to the decision, the activities of wholesale trade of medicinal products exert over the request; § 52a para 3 sentence 2 to 3 does not apply.
(5) an official recognition, para 2a for the wholesale trade with given certain medicines due to the legal regulation according to § 54 for use in animals, applies to certain medicines as a permit within the meaning of § 52a wholesale with for use in animals. The owner of recognition has to submit the appropriate documents and declarations § 52a para 2 until March 1, 2005 the competent authority.
(6) a person who authorized other substances as substances that are of human or animal origin or resulting paths are made, on 6 August 2004 without import permission to § 72 within the territorial scope of this Act has spent this activity may up to September 1, 2005 continue.
(7) medicinal products which have been authorized by the competent federal authority before 30 October 2005, may b of pharmaceutical entrepreneurs by way of derogation from article 10, paragraph 1 until the next renewal of the authorisation, but not longer than until October 30, 2007, continue to be placed on the market. Medicinal products which have been brought by pharmaceutical companies in accordance with sentence 1 in the traffic may be placed by way of derogation from article 10, paragraph 1 by wholesalers and retailers in the traffic b.
Eleventh subsection transitional provisions on the occasion of the first act amending the Act of transfusion and drug regulations § 139 who upon entry into force of article 2 No. 3 of the first act amending the Act of transfusion and drug legislation by February 10, 2005 (Federal Law Gazette I p. 234) exerts the activity as a producer or as control manager for the testing of blood stem cell preparations and fulfils the conditions of article 15 par. 3 in the version applicable up to that time , these activities must continue.
Twelfth subsection transitional provisions on the occasion of the thirteenth law amending the medicines Act § 140, by way of derogation from section 56a, paragraph 2 and article 73, paragraph 3 may medicines in animals which are not extracting food, be spent until October 29, 2005, according to the force until September 1, 2005 regulations within the scope of the Act, prescribed, issued and applied.
13th subsection transitional provisions on the occasion of the fourteenth law amending of the medicines Act, section 141 (1) medicines are located on 5 September 2005 in the traffic and the pursuant to sections 10 and 11 are subject to the regulations, must two years after first following on September 6, 2005 renewal of the authorisation or registration or as far as by the authorisation or registration are exempted, which at the time referred to in the regulation according to § 36 or § 39 or , insofar as they require any extension, on January 1, 2009 by the pharmaceutical entrepreneur according to the regulations of §§ 10 and 11 in the traffic be brought. Up to the respective dates, medicines may be placed pursuant to sentence 1 by the pharmaceutical entrepreneur, after these times further from wholesalers and retailers with a labelling and package leaflet in the transport complying with the force until September 5, 2005. section 109 shall remain unaffected.
(2) the pharmaceutical entrepreneur has for medicinal, located on 5 September 2005 in the transport sector, with the first to the wording of the technical information to submit provided by September 6, 2005 application for renewal of the authorisation of the competent federal authority, the § 11a; as far as these medicinal products require any extension, the obligation by January 1, 2009.
(3) a person who has the expertise in not according to § 15, but is authorised on 5 September 2005, to perform the activities described in section 19 a competent person is considered qualified person (4) finished product transport located on 5 September 2005 and after 6 September 2005 pursuant to § 4 para 1 first authorisation according to § 21 are subject to, may further be marketed according to § 14 , if for them an application for admission has been situated until September 1, 2008.
(5) the time periods for the data protection under section 24 b paragraphs 1, 4, 7 and 8 do not apply to reference medicinal products which permission has been applied for prior to October 30, 2005 for these medicines apply protection periods according to § 24a in force until the expiry of 5 September 2005 amended and the period is ten years b paragraph 4 in article 24.
(6) for medicines, which permission was extended from January 1, 2001, § 31 para 1 No. 3 in force until 5 September 2005 amended shall apply; § 31 para 1a applies these drugs unless they are extended after September 6, 2005. For approvals, whose five-year period of validity ends until 1 July 2006 at the latest, the period of § 31 para 1 remains no. 3 in the amended before September 6, 2005. The competent federal authority may specify the requirement of a further extension for medicines, which permission was extended to January 1, 2001 and before September 6, 2005, if necessary, to further ensure the safe placing on the market of the medicinal product. Before September 6, 2005, asked applications on renewal of authorisations, requiring any extension under this paragraph, be deemed to have been done. Sentences 1 and 4 shall apply, mutatis mutandis, to registrations. Registration renewals or registrations of pharmaceutical products that apply according to article 105, paragraph 1 were approved, considered as an extension within the meaning of this paragraph. Article 136, paragraph 1 shall remain unaffected.
(7) the holder of the authorisation has for a drug that is approved, but at this point is not in the traffic, the competent federal authority immediately to show, that the medicinal product concerned not in the traffic is brought on 5 September 2005.
(8) for contradictions that were collected before September 5, 2005, § 33 in force until 5 September 2005 amended shall apply.
(9) section 25, paragraph 9, and article 34 apply paragraph 1a not medicinal, which permission has been requested before September 6, 2005.
(10) on medicinal products which have been registered until 6 September 2005 as homeopathic remedies or registering has been requested prior to April 30, 2005, are the hitherto applicable regulations continue to apply. The same applies to medicinal products which have been shown to article 105 par. 2 and have been brought according to § 38 paragraph 1 sentence 3 as amended on the market prior to September 11, 1998. § 39 para 2 No. 5 b shall not apply to medicinal products which are the same type and quantity of the components and in terms of the formulation with the medicinal products referred to in sentence 1 also in decisions about registration or its extension.
(11) article 48, paragraph 1, sentence 1 is no. 2 only apply as of the date on which a legal regulation entered into force, according to section 48, paragraph 6, sentence 1 no later than on 1 January 2008. The Federal Ministry of food, agriculture and consumer protection announced the day after sentence 1 in the Federal Law Gazette.
(12) section 56a is paragraph 2a to apply only after the list referred to there has been created and made known by the Federal Ministry of food, agriculture and consumer protection in the Federal Gazette or, unless it is part of a directly applicable legal instrument of the European Community or the European Union in the official journal of the European Union published.
(13) for medicines, located on 5 September 2005 in the traffic, and that at this time the report is compulsory for par. 5 sentence 2 in force until 5 September 2005 amended under section 63, b paragraph 5 sentence 3 for the next report to be submitted to the September 6, 2005, section 63 shall apply.
(14) the approval of a traditional herbal medicinal product, which was extended to 105 section in conjunction with section 109a, expires on April 30, 2011, except that an application for authorisation or registration according to § 39a was made before January 1, 2009. The license expires after 105 section in conjunction with section 109a also after the decision on the application for authorisation or registration according to § 39a. The medicinal product may be placed after the decision twelve months in the present form in the traffic.
Fourteenth subsection § 142 transitional provisions on the occasion of the fabric Act (1) a person that paragraph 3a in the version applicable up to this point has the expertise according to § 15, on August 1, 2007, as a qualified person may further exert the activities as the qualified person.
(2) Whoever for tissues or tissue preparations until October 1, 2007 a permit a b paragraph 1 or paragraph 2 or § 20 c paragraph 1 or a manufacturing authorisation according to article 20 according to § 13 ABS. 1 or until February 1, 2008 approval authorization has sought pursuant to section 21 para 1 or until September 30, 2008 according to article 21, paragraph 1, it may further gain tissues or tissue preparations , in the laboratory study, be - or process, preserve, store or bring in the traffic, until it was decided on the request.
(3) a person who on August 1, 2007 for tissues or tissue preparations within the meaning of article 20 b paragraph 1 or § 20 c para 1 a manufacturing authorisation after article 13, paragraph 1 or tissue preparations within the meaning of article 21, paragraph 1 an authorisation pursuant to § 21 para 1 has, needs no new application under section 20B paragraph 1, § 20 para 1 or § 21 para 1 procure.
Fifteenth subsection § 143 transitional provisions on the occasion of the law to improve the fight against of doping in sport (1) finished medicinal products which have been authorized and subject to the provisions of section 6a (2) sentence 2 to 4, prior to November 1, 2007 by the competent federal authority may even without the instructions prescribed in Article 6a, paragraph 2, sentence 2 and 3 in the package leaflet of pharmaceutical entrepreneurs up to the next renewal of the authorisation , but not longer than until December 31, 2008, on the market.
(2) If a substance or group of substances in the annex of the Convention of 16 November 1989 against doping (BGBl. 1994 II p. 334) recorded, may until the next renewal of authorisations of medicinal products that are approved at the time of publication of the revised annex in the Federal Law Gazette and which these substances contain, without which in Article 6a, paragraph 2, sentence 2 and 3 prescribed instructions in the package leaflet of pharmaceutical entrepreneurs , but not longer than are brought up to the expiry of one year after the publication of the annex in the Federal Law Gazette, in the traffic. Sentence 1 shall apply accordingly for substances which are intended for the use of prohibited methods.
(3) medicinal products which have been brought by pharmaceutical companies in accordance with paragraph 1 on the market may be placed by wholesalers and retailers further without that section 6a paragraph 2 sentence 2 and 3 prescribed instructions in the package leaflet in the traffic.
(4) the time limits referred to in paragraphs 1 and 2 shall apply accordingly for the adaptation of the wording of the prescribing information.
Sixteenth subsection transitional provisions on the occasion of the law amending drug-legal and other provisions of section 144 (1) who produces authorized in § 4 b paragraph 1 above pharmaceutical products for advanced therapies on July 23, 2009 and until January 1, 2010 for a manufacturing licence, can manufacture this drug on until a decision on the request.
(2) a person who authorized in § 4 b paragraph 1 above pharmaceutical products for advanced therapies with the exception of biotechnologically processed tissue products on July 23, 2009 in traffic brings and until August 1, 2010 requested an authorisation pursuant to § 4 b paragraph 3 sentence 1 May this drug up to bring the decision on the request in the traffic.
(3) a person who tissue engineered product within the meaning of § brings 4 b paragraph 1 on July 23, 2009, authorized in the transport and until January 1, 2011, an authorisation pursuant to § 4 requested b paragraph 3 sentence 1, can these drugs up to bring the decision on the request in the traffic.
(4) a person that paragraph 3a in the version applicable up to this point has the expertise on July 23, 2009, as a qualified person according to § 15, may continue the activity as a qualified person.
(4a) a person who possessed expertise under article 15, paragraph 1 and 2 for medicines which are Sera and require an expertise according to article 15, paragraph 3, by the revision of article 4 paragraph 3 in the from force July 23, 2009 version prior to July 23, 2009, as a qualified person was allowed to the activity as a qualified person from July 23, 2009 to October 26, 2012 continue. This also applies to a person who had the expertise from July 23, 2009, as a qualified person under article 15, paragraph 1 and 2 for these medicines.
(5) a person who on July 23, 2009 for the production or the laboratory study of autologous blood to produce biotechnologically processed tissue products has a manufacturing authorisation according to article 13, paragraph 1, requires any new permission in accordance with section 20B paragraph 1 or 2 (6) is the duty of disclosure according to § 67 paragraph 5 from the 1 January 2010 for medicines, on July 23, 2009, already on the market.
(7) a person who manufactures medicines on July 23, 2009 according to Section 4a, sentence 1, number 3 in the version applicable up to July 23, 2009, must indicate this to the competent authority according to § 67 up to February 1, 2010. Who on July 23, 2009 carries out an activity according to Section 4a, sentence 1, number 3 in the version applicable up to July 23, 2009, for a permit pursuant to the § § 13B, 20 or section 20 c is needed, and until August 1, 2011, the permission has requested that this activity may be up to further exercise the decision on the application.
Seventeenth subsection § 145 transitional provisions on the occasion of the law on the restructuring of the pharmaceutical market
For drugs that are already approved at the time of entry into force, the pharmaceutical entrepreneur and the sponsor have according to § 42 for the first time no later than 18 months after the entry into force of the law of the competent federal authority to provide b paragraph 1 and 2 required reports. Sentence 1 shall apply for clinical trials for which the sections 40 to 42, as amended as of August 6, 2004 have found application.
Eighteenth subsection transitional provision of § 146 transitional provisions on the occasion of the second Act amending drug-legal and other regulations must (1) medicines that are on October 26, 2012 in the traffic and number 2 are subject to the provisions of article 10, paragraph 1, two years after the first following on October 26, 2012 extension of the authorisation or registration or extent of the authorisation or registration are exempted or if they require any extension , on 26 October 2014 of the pharmaceutical business according to the provisions of article 10, paragraph 1 number 2 in the transport will be brought. Up to the respective dates, medicines may be placed pursuant to sentence 1 by the pharmaceutical entrepreneur, after these times further from wholesalers and retailers with a labelling in the transport is analogous to the requirement that force until October 26, 2012.
(2) pharmaceutical products, located on 26 October 2012 in traffic and are subject to the provisions of § 11, need to regarding the inclusion of the standard text for article 11, paragraph 1, sentence 1 No. 5 two years after the first publication according to article 11, paragraph 1 (b) to the standard text for article 11, paragraph 1, sentence 1 number 5 following extension of the authorisation or registration or , from admission are free, or, if they require any extension, two years, or, as far as registered according to article 38 or article 38 or article 39 paragraph 3 of the registration are exempted medicines, five years after the notification according to § 11 paragraph 1 b to the standard text for article 11, paragraph 1, sentence 1 number 5 of the pharmaceutical business according to the provisions of section 11 in the traffic be brought. Up to the respective dates, medicines may be placed pursuant to sentence 1 by the pharmaceutical entrepreneur, after these times further from wholesalers and retailers with a leaflet in the traffic is analogous to the requirement that force until October 26, 2012.
(2a) who on October 26, 2012 medicines according to § 13 paragraph 2a sentence 2 number 1 or 3 manufactures, this the competent authority has to § 13 to display paragraph 2a sentence 3 until February 26, 2013.
(3) the pharmaceutical entrepreneur has regarding the inclusion of the standard text according to § 11a paragraph 1 sentence 3 for medicinal, located in the traffic on October 26, 2012, with the first to the wording of the prescribing information to submit application according to § 11a paragraph 1 sentence 3 made the announcement according to § 11a paragraph 1 set 9 the standard text for renewal of the authorisation of the competent federal authority , corresponds to the § 11a; These medicinal products require any extension, the commitment of two years after the publication of the notice shall apply.
(4) the period of article 31 paragraph 1 sentence 1 applies approvals or registrations, whose five-year period of validity ends until October 26, 2013, continue to number 3 and of article 39 paragraph 2 c of § 39 c paragraph 3 sentence 1 in the version applicable up to October 26, 2012.
(5) the obligation number 5a does not apply according to article 22, paragraph 2, sentence 1 for medicinal products which have been authorized prior to October 26, 2012 or for which a proper approval is already were placed before October 26, 2012.
(6) a person who authorized performs the activity of wholesale until October 26, 2012 and until February 26, 2013 to operate of a wholesale trade in medicines has made an application for a permit, may exercise by way of derogation the activities of wholesale trade of medicinal products of § 52a paragraph 1 until the decision on the application; § 52a paragraph 3 sentence 2 to 3 does not apply.
(7) the obligation under § 63 applies to medicinal products which have been approved before 26 October 2012, 21 July 2015 b paragraph 2 paragraph 3 or, if this occurs earlier, from the date on which the approval is extended. The obligation applies under section 63 for medicines for which prior to October 26, 2012 a proper application has been posted at 21 July §§ 63f and 63 g for 2015 (8) apply to assessments commenced after October 26, 2012 b paragraph 2 No. 3.
(9) a person who has engaged in an activity as a medicinal agent on 2 January 2013 and until May 2, 2013 shows his activity to the competent authority, may exercise 52 c continue this activity until the decision on the registration according to §.
(10) companies and institutions which otherwise trade with active ingredients, must show their activities until 26 April 2013 with the competent authority.
(11) a person who offers medicinal products intended for use in humans, for the purposes of the retail trade through mail order via the Internet, to its activities, specifying the information required in article 67 paragraph 8 to the... [insert: date four months after the entry into force referred to in article 15 paragraph 4] the competent authority show. *) (12) which are number 1 requirements mentioned in article 94, paragraph 1, sentence 3 for reinsurance contracts from 1 January 2014 application.
)) Note of the editorial management: approved implementing Act of the European Commission in article 15 paragraph 4 in relation is so far not yet been adopted.
Nineteenth subsection § 147 transitional provision transitional provision on the occasion of the third law to amend medicines legal and other provisions for non-Interventional safety testing according to § 63f and investigations according to article 67 paragraph 6, that were begun, before August 13, 2013 63f, paragraph 4 and article 67, paragraph 6 find up to December 31, 2013, in the version applicable up to the 12th August 2013 application.

Annex (to section 6a of the para 2a) (site of the original text: Federal Law Gazette I 2007, 2511-2512;)
bzgl. der einzelnen Änderungen vgl. Fußnote)
Stoffe gemäß § 6a Abs. 2a Satz 1 sind:
I.
Anabole Stoffe
1.
Anabol-androgene Steroide
a)
Exogene anabol-androgene Steroide
1-Androstendiol
1-Androstendion
Bolandiol
Bolasteron
Boldenon
Boldion
Calusteron
Clostebol
Danazol
Dehydrochlormethyltestosteron
Desoxymethyltestosteron
Drostanolon
Ethylestrenol
Fluoxymesteron
Formebolon
Furazabol
Gestrinon
4-Hydroxytestosteron
Mestanolon
Mesterolon
Metandienon
Metenolon
Methandriol
Methasteron
Methyldienolon
Methyl-1-testosteron
Methylnortestosteron
Methyltestosteron
Metribolon, synonym Methyltrienolon
Miboleron
Nandrolon
19-Norandrostendion
Norboleton
Norclostebol
Norethandrolon
Oxabolon
Oxandrolon
Oxymesteron
Oxymetholon
Prostanozol
Quinbolon
Stanozolol
Stenbolon
1-Testosteron
Tetrahydrogestrinon
Trenbolon
Andere mit anabol-androgenen Steroids b related substances) endogenous Anabolic Androgenic Steroids Androstenediol androstenedione Stanolone, synonymous with dihydrotestosterone dehydroepiandrosterone, synonymous with dehydroepiandrosterone (DHEA) testosterone 2.
Other anabolic agents clenbuterol selective androgen receptor modulators (SARMs) Tibolone Zeranol Zilpaterol II. peptide hormones, growth factors and related substances 1 substances erythropoietin stimulating erythropoiesis human (EPO) Epoetin alfa, alfa beta, delta, omega, theta, zeta and analog recombinant human Erythropoetine d be Poetin (dEPO) methoxy polyethylene glycol-Epoetin beta, synonymous with PEG-Epoetin beta, continuous erythropoiesis receptor Activator (CERA) Peginesatid, synonymous with Hematid 2. chorionic gonadotrophin (CG) and luteinizing hormone (LH) chorionic gonadotropin (HCG) Choriogonadotropin alfa Lutropin alfa 3. Corticotropine corticotropin Tetracosacaride 4. growth hormone , Re leasing factors, re leasing peptides and growth factors called somatropin, synonymous with growth hormone human, growth hormone (GH) Somatrem, synonymous with somatotropin (methionyl), human growth hormone re leasing factors, synonymous with growth hormone releasing hormones of hormones (GHRH) Sermorelin Somatorelin growth hormone re leasing peptides, synonymous with growth releasing peptides (GHRP) mecasermin, synonymous with insulin-like growth factor 1, insulin-like growth factor-1 (IGF-1) IGF-1 analogues III. hormones and metabolic modulators 1 aromatase aminoglutethimide anastrozole, Androsta-1,4,6-triene 3,17 Dione, synonym Androstatriendion 4-Androsten-3,6,17 trione (6-oxo) exemestane Formestane letrozole Testolactone 2. selective estrogen receptor modulators (SERMs) raloxifene tamoxifen Toremifen 3.
Other antiestrogen changing substances clomiphene Cyclofenil fulvestrant of 4 Myostatinfunktionen substances Myostatinhemmer Stamulumab 5. metabolic modulators of insulin PPARδ (peroxisome proliferator activated receptor Delta) - agonists, synonymous with PPAR - delta agonists GW051516, synonymous with GW 1516 AMPK (PPARδ-AMP-activated protein kinase) - axis agonists AICAR.
(IV) (dropped out) this list includes the different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives.