63. Federal Act, with which the Medicines Act, the tissue safety law, the Drug Goods Import Act 2002 and the Health and Nutrition Security Act are amended

The National Council has decided:

Article 1

Amendment of the Medicines Act

The Federal Act of 2 March 1983 on the production and the placing on the market of medicinal products (pharmaceutical law), BGBl. No. 185, as last amended by the Federal Law BGBl. I n ° 115/2008 and the Federal Ministries of the Federal Ministries of Law 2009, BGBl. I No 3, shall be amended as follows:

1. In the title, in the parenthesis after the word "Medicinal Products Act" the following expression inserted "-AMG"

Section 1 (3b) reads as follows:

" (3b) The Federal Office for Health Security has, at the request of a person who wishes to place a product on the market, to determine whether a product is covered by the definition of the medicinal product. The Federal Office for Health Security can also determine whether a product is covered by the definition of the medicinal product. Within the framework of these procedures, it may obtain an opinion from the Advisory Board in accordance with § 49a. "

3. § 1 (5) reads:

"(5)" proprietary medicinal products " means medicinal products which are always manufactured in the same composition in advance and placed on the market under the same name in a form intended for delivery to the consumer or user, and medicinal products; for the supply to the consumer or user who is otherwise subject to an industrial process or which is manufactured commercially. "

4. According to Article 1 (6), the following paragraph 6a is inserted:

(6a) "Advanced therapy medicinal products" means gene therapeutics and somatic cell therapeutics referred to in Annex I, Part IV, of Directive 2001 /83/EC of the European Parliament and of the Council of 6 November 2001 establishing a Community code relating to: Medicinal products for human use, as last amended by Directive 2004 /27/EC, as well as biotechnologically processed tissue products referred to in Article 2 (1) (lit). (b) Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001 /83/EC and Regulation (EC) No 726/2004. '

5. In accordance with Article 2 (5), the following paragraph 5a is inserted:

"(5a)" Compassionate Use Programme "shall be the placing on the market of a medicinal product within the meaning of Article 83 of Regulation (EC) No 726/2004."

6. According to Article 2 (11b), the following paragraph 11c is inserted:

"(11c)" Neuremaining "is the machine-based patient-specific compilation of the once-, daily-, weekly-or monthly-ration of medicinal products in blisters."

Section 2 (13) reads as follows:

'(13)' Pharmareferenten 'shall mean persons who seek medical doctors, dentists, veterinarians, didsters, midwives, pharmacists or those referred to in Article 59 (3), (4) and (8) in order to provide them with professional information on medicinal products.'

8. § 2 para. 17 reads:

" (17) Waiting period shall be the period between the last administration of a medicinal product to animals in compliance with medicinal product legislation and the date on which such animals are not used for the production of foodstuffs or medicinal products , and which ensures that residues of the substances administered in these foods shall be subject to the maximum residue limits of pharmacologically active substances laid down in Regulation (EEC) No 2377/90 do not exceed. "

9. Section 2a, paragraph 1, last sentence reads:

"No clinical trial is a non-interventional study within the meaning of Section 3."

Section 2a (3) reads as follows:

"(3)" non-interventional study " shall be a systematic examination of authorised proprietary medicinal products to patients, provided that:

1.		the proprietary medicinal product is used exclusively under the conditions laid down in the authorisation;
2.		the non-interventional study does not require any additional diagnostic or therapeutic measures and does not bring additional strain on the patient; and
3.		the application of a particular treatment strategy is not pre-determined in a test plan, it corresponds to the medical practice and the decision on the regulation of the proprietary medicinal product is clearly separated from the decision, a Patients should be included in the study.
Epidemiological methods are used for the analysis of the data collected. Non-interventional studies should be planned and carried out according to the state of the sciences. "

The following paragraph 22 is added to § 2a:

'(22)' Paediatric investigation plan ' means a research and development programme designed to ensure that the data necessary to determine the conditions under which a medicinal product is used for treatment are developed; may be authorised in the paediatric population. The paediatric population comprises persons from birth to the completion of the 18. Years of life. "

(12) In § 5 (1), after the word "Marketing" a dash and the phrase "the import and use" inserted.

13. § 7 (1) Z 1 reads:

" 1.		Proprietary medicinal products authorised in accordance with Regulation (EC) No 726/2004, Regulation (EC) No 726/2004 in conjunction with Regulation (EC) No 1901/2006, or Regulation (EC) No 1394/2007, "

14. According to Article 7 (6), the following paragraphs 6a to 6d are inserted:

" (6a) Non-proprietary medicinal products subject to the conditions laid down in paragraph 1 of this Regulation shall apply to advanced therapy medicinal products which are not routinely manufactured for a specific patient in Austria on a specific medical prescription. in order to be used in an Austrian hospital under the exclusive professional responsibility of a doctor in this patient.

(6b) Those who apply medicinal products in accordance with paragraph 6a shall be obliged to take measures to ensure follow-up of the efficacy and of adverse reactions.

(6c) proprietary medicinal products consisting of or produced from human cells or tissues, but which are not always prepared in advance in the same composition and under the same name in a product to be delivered to the consumer or users may be placed on the market as a result of the approval of the processing procedure in accordance with Section 23 of the Tissue Safety Act, BGBl. N ° 49/2008, on the market.

(6d) Living animals shall not be considered to be proprietary medicinal products subject to the conditions laid down in the first paragraph of this Article.

(6e) Blood and blood components for direct transfusion shall not be considered as proprietary medicinal products subject to the conditions laid down in paragraph 1 of this Regulation. "

Section 7a (1) reads as follows:

" (1) Medicinal products containing antigens or halbantigens and the detection of specific defence and protective agents, desensitization or hyposensitisation may be used, unless they are always in the same composition in advance. , and placed on the market under the same name in a form intended for delivery to the consumer or user, unless the Federal Office for Safety and Security is responsible for the provision of such goods or services for domestic supply. in the health sector, the medicinal product to be used in this medicinal product Manufacturing process, including the chemical pharmaceutical documentation, has been approved by the decision. "

16. According to § 8, the following § 8a is inserted:

" § 8a. (1) proprietary medicinal products which satisfy the conditions laid down in Article 3 (1) or (2) of Regulation (EC) No 726/2004 shall not be subject to authorisation if the Federal Office for Safety in Health is subject to the conditions laid down in Article 83 of Regulation (EC) No 726/2004. 726/2004, granted a marketing authorisation under a "Compassionate use programme". The programme shall be defined for a defined group of patients who suffer from a chronic or serious illness leading to invalidity or whose disease is life-threatening and who are suffering from an approved and available It is not possible to treat medicinal products satisfactorily.

(2) In order to apply for the grant of an authorisation pursuant to paragraph 1, the

1.		the manufacturer, if he/she is a sponsor of an approved clinical trial for the medicinal product concerned, or
2.		the applicant for a marketing authorisation referred to in Article 6 of Regulation No 726/2004 for the medicinal product concerned.

(3) The Federal Minister of Health may, by means of a Regulation, adopt detailed rules on the procedure for the marketing authorisation for a proprietary medicinal product under a "Compassionate use programme", where this is intended to protect the health of required by patients.

(4) The holder of an authorisation for the implementation of a "Compassionate use programme" shall ensure that the proprietary medicinal product also includes the patients included in the programme, even after the marketing authorisation has been granted, until on the actual placing on the market. "

17. In accordance with § 9a (2), first sentence, the following sentences are inserted:

" This has to contain all information relevant for the evaluation, whether favourable or unfavorable. This shall also apply to incomplete or aborted pharmacological or toxicological tests or clinical trials, or clinical trials on the medicinal product. "

18. § 9d deleted, § 9e is given the name "§ 9d" and Section 9f shall be given the name "§ 9e" .

19. § 10c para. 2 reads:

"(2) With regard to the application for authorisation for the distribution in parallel import, § 9 (1) and § 9a (1) (1) (1) shall apply mutatily."

Article 11 (1) Z 4 reads as follows:

" 4.		shall only be delivered in dilutions which guarantee the safety of the proprietary medicinal product. In particular, the proprietary medicinal product may not contain more than one part per ten thousand of the original tincture, or not more than one hundredth of the smallest dose of the active substances, if any, used in allopathia, in the presence of which the medicinal product is present in the an allopathic medicine, the latter will be subject to prescription. "

21. In accordance with § 11, the following § 11a including the heading is inserted:

" Registration of pharmacists ' own pharmacies

§ 11a. (1) A registration for the registration of a pharmacist's own proprietary medicinal product must not be accompanied by documents in accordance with Section 9a (1) Z 8, 12, 18 to 20, and 23 and Section 9a (2). The application must also be accompanied by:

1.		information on the specification of the finished proprietary medicinal product; and
2.		A commentating and evaluating scientific summary of the
a)			pharmaceutical data contained in the registration documents,
b)			the non-clinical pharmacological and toxicological data taken from the specialist literature and required for the evaluation of the pharmacovigilance speciality; and
c)			The results of the clinical trials taken from the specialist literature and required for the evaluation of the pharmacotherapeutic speciality of the pharmacist.

(2) Documents in accordance with § 9a (1) Z 16 do not have to be submitted if the proprietary medicinal product is intended for external application or if the pack elements are not fully in contact with the proprietary medicinal product in permanent contact. Documents in accordance with Section 9a (1) Z 17 do not have to be submitted if a term is applied for, which does not exceed one year.

(3) The Federal Office for Health Security shall reject the registration by decision if one of the reasons for consideration is available in accordance with § 19 (1). "

22. § 16 (1) reads:

" (1) proprietary medicinal products which are subject to registration pursuant to § 7 of the authorization or pursuant to § 11a of the registration may only be placed on the market if the trade package has produced a product in accordance with the summary of the product properties. This information is available in German language. "

23. § 16b and the title shall be deleted.

The first sentence of Article 17 (1) reads as follows:

" Proprietary medicinal products which are subject to registration in accordance with § 7 of the authorisation or in accordance with § 11a of the registration may only be placed on the market if they are not radioactive proprietary medicinal products, if on the outer packaging and on the The following particulars shall be included in the German language: "

25. In § 18 (3), after the word "Approval" the phrase "or registration" inserted.

26. The previous § 18b receives the sales designation "(1)" , the following paragraphs 2 and 3 are added:

" (2) Competent national authority within the meaning of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001 /20/EC and 2001 /83/EC as well as Regulation (EC) No 726/2004 is the Federal Office for Health Security.

(3) The Federal Office for Health Security in the procedure for the authorisation or the amendment of the authorisation of a proprietary medicinal product shall conclude that the documents submitted do not come with the approval of the Paediatric Committee of the Agency The paediatric investigation plan shall be established in accordance with the relevant information. Where appropriate, an opinion of the Paediatric Committee shall be taken into account in accordance with Article 23 of Regulation (EC) No 1901/2006. "

27. § 20 (1) reads:

"(1) An authorisation of a proprietary medicinal product and a registration of a traditional herbal or apothectic proprietary medicinal product are in principle valid for five years."

The first sentence of Article 20 (2) reads as follows:

" The marketing authorisation holder of a medicinal product for human use or the registrant of a traditional herbal or apothectic proprietary medicinal product can at the Federal Office for Safety in the Public Health at the earliest four years after the legal force of the admissions and/or Registration certificate no later than six months before the end of five years after the legal force of the admissions or registration period. the application for an extension of the authorisation, or Register if the approval or Conditions of registration according to the last state of the sciences are given. "

29. § 20 (3), first sentence reads:

" The marketing authorisation holder of a veterinary medicinal product can, at the earliest, four years after the legal force of the marketing authorisation and/or the health care system, at the Federal Office for Safety in Health Care. Registration certificate no later than six months before the end of five years after the legal force of the admissions or registration period. the application for an extension of the authorisation, or Register if the approval or Conditions of registration according to the last state of the sciences are given. "

30. According to Article 20 (3), the following paragraph 3a is inserted:

" (3a) The Marketing Authorisation Holder Registration holders may request the amendment of the period provided for in paragraphs 2 and 3 in accordance with section 24 (4). "

31. § 21 (1) and (2) reads as follows:

" (1) The marketing authorisation holder or the holder of a registration of a traditional herbal or apothectic proprietary medicinal product has the Federal Office for Health Security on the date for the actual placing on the market of the Information on the medicine in Germany.

(2) The marketing authorisation holder or the holder of a registration of a traditional herbal or apothectic proprietary medicinal product has the Federal Office for Health Security any temporary or permanent cessation of the To report on the marketing of the proprietary medicinal product at home. This notification shall be made, unless there are special circumstances, no later than two months before the date on which the placing on the market is placed. "

32. § 22 (1) first sentence reads:

" Where an approved or registered traditional herbal or apothectic proprietary medicinal product is to be established within three years of the legal force of the marketing authorisation and/or the marketing authorisation. The registration certificate is not actually placed on the market or is placed on the market in the country previously placed on the market. traditional herbal or apothectic proprietary medicinal products are no longer available on the market for three consecutive years, the authorisation shall be terminated, respectively. Registration. "

33. In accordance with Article 23 (4), the following paragraphs 5 to 8 are added:

" (5) The registration of a homeopathic proprietary medicinal product shall be repealed if:

1.		is aware that, in the decision on the registration, a reason for refusal pursuant to Section 11 (4) has been or has been retrospected, and that the protection of human or animal health by means of a subsequent pre-registration of conditions in the the meaning of Section 11 (2) does not appear to be guaranteed; or
2.		the proprietary medicinal product is placed on the market by the holder of a registration without complying with the conditions laid down in accordance with Article 11 (2) and that the registration for the protection of human or animal health appears to be lifted, or
3.		the holder of the registration has waived the registration.

(6) The registration of a pharmacist's own proprietary medicinal product shall be repealed if:

1.		, it is known that the decision to register has had a reason for failure pursuant to Article 11a (3) or has subsequently occurred, and that the protection of human or animal health by means of a subsequent pre-registration of conditions in the the sense of Section 18 (3) does not appear to be guaranteed; or
2.		the proprietary medicinal product is placed on the market by the holder of the registration without complying with the conditions laid down in accordance with Article 18 (3) or § 24a (2), and the registration for the protection of human or animal health appears to be lifted, or
3.		the registration holder waived the registration.

(7) The registration of a traditional herbal medicinal product shall be repealed if:

1.		is aware that, in the decision on the registration, a reason for refusal pursuant to Section 13 (2) has occurred or has subsequently occurred, and the protection of the health of humans or animals by subsequent amortiation of conditions in the the meaning of Section 13 (1) does not appear to be guaranteed; or
2.		the proprietary medicinal product is placed on the market by the holder of a registration without complying with the conditions laid down in accordance with Article 13 (1) and the registration for the protection of public or animal health appears to be lifted, or
3.		the holder of the registration has waived the registration.

(8) If there is a reason for cancellation pursuant to Section 5 (1) (1) or (2), (6) (1) or (2) or (7) (1) or (2) or (2) or (2) (2) or (2) (2) or (2) or (2) (2) or (2), Health care the rest of the registration. "

34. § 24 (1) first sentence reads:

"Any change in the data that was decisive for the approval or registration as a traditional herbal or apothecary proprietary medicinal product is to be immediately communicated to the Federal Office for Health in the Health Care."

35. § 24 (4) Z 1 reads:

" 1.		the period laid down in Article 20 (2) and (3) for the application for the renewal of the authorisation, or registration as well as the PSURs for the PSURs provided for in § 75b (4) or in accordance with § 18 (3), "

The following sentence shall be added to Article 24b (2):

" The Marketing Authorisation Holder the holder of a registration has, furthermore, for the purposes of pharmacovigilance, to provide the Federal Office for Safety in the Health Care with all data relating to the sales volume of the proprietary medicinal product. "

Article 26a (3) reads as follows:

In the case of investigational medicinal products imported from outside the European Economic Area, each batch, whether or not manufactured in the European Economic Area, shall be subject to all the necessary analyses by the pharmaceutical industry; and to carry out tests to ensure the quality of the investigational medicinal products in accordance with the information provided for in accordance with § 40. This shall also apply to investigational medicinal products intended to be used as comparative preparations in a clinical trial and which have been produced in a country not party to the Agreement on the European Economic Area, where it is to be used in the , and imported from outside the European Economic Area, provided that no documents are available which confirm that each batch has been manufactured in accordance with the standards laid down by the European Community standards shall be at least equivalent. "

38. § 27 (1) first sentence reads:

" In a register (pharmacopoitic register) which is to be held by the Federal Office for Health in the Health

1.		authorised proprietary medicinal products,
2.		Homeopathic proprietary medicinal products within the meaning of Section 11 (1), provided that their registration is not to be rejected in accordance with Section 11 (4),
3.		Proprietary medicinal products within the meaning of Section 11a (1), provided that their registration is not to be rejected in accordance with Section 11a (3) of this Regulation,
4.		traditional herbal medicinal products within the meaning of Section 12, provided that their registration is not to be rejected in accordance with Section 13 (2),
under an ongoing number (registration number or register number). "

39. In § 27 (2) and (3), the word order shall be "pursuant to paragraph 1 (2) and (3)" or . 'within the meaning of paragraph 1 (2) and (3)' through the phrase "in accordance with paragraph 1 Z 2 to 4" or . 'within the meaning of paragraph 1 (2) to (4)' replaced.

40. § 28 receives the sales designation "(1)" , the following paragraph 2 is added:

" (2) The planning and conduct of clinical trials shall be carried out in accordance with the provisions of this Federal Law in accordance with the state of the sciences and in accordance with the principles of good clinical practice. In order to interpret the principles of good clinical practice, the generally accepted principles and requirements published in Volume 10 of the rules governing medicinal products in the European Community are to be used. "

41. Article 37a (1) is added to the following sentence:

"If the significant changes are the inclusion of new test centres, Section 41b (5) shall apply, with the proviso that any objections by the Commission shall be communicated no later than within 30 days."

Section 39 (3) reads as follows:

" (3) The examiners shall be informed of the purpose and extent of the collection and use of personal data. In this context, the participants in the examination shall in particular be informed that data

1.		can be checked by the monitor, during an audit, and during an inspection by the authority; and
2.		encrypted to the sponsor.
With the consent of paragraph 2, the explicit consent to data protection is also to be obtained. "

43. § 40 reads:

§ 40. (1) The conduct of a clinical trial is only permissible provided that the Federal Office for Safety in Health Care does not prohibit the conduct of the clinical trial pursuant to para. 3 or 4, respectively. has been approved in accordance with paragraph 6. Prior to the clinical trial, the sponsor has to submit a request for approval to the Federal Office for Safety in the Health Care (Bundesamt für Sicherheit im Healthcare), to submit all the necessary documents for the assessment of the clinical trial and to submit the To seek the opinion of an Ethics Committee. The Ethics Committee can be referred to the Federal Office or, at the same time, at the same time as the sponsor before submitting the application.

(2) The examination of an application by the Federal Office for Health Security has to be carried out without unnecessary delay, but at the latest within 35 days. The Federal Office for Health and Safety (Bundesamt für Sicherheit im Healthcare) has to verify the proper application, the fundamental justification and relevance of the project as well as the requirements for the preparation of the investigational products. If the Federal Office for Health and Safety does not express its opinion within 35 days, the application shall be deemed to have been approved subject to the fourth paragraph. These periods shall not apply to clinical trials within the meaning of paragraph 6.

(3) The Federal Office for Health Security has-if the conditions laid down in this Federal Act are not fulfilled-to prescribe the conditions or conditions which are appropriate for the protection of the conditions and to ensure that appropriate conditions are met. period of time. If it is not possible to ensure compliance with the requirements of this Federal Law, the Authority shall prohibit the sponsor from carrying out the clinical trial with a communication.

(4) If the Ethics Committee has not delivered a favourable opinion in the proceedings pursuant to § § 41a and 41b, the Federal Office for Safety in Health shall prohibit the conduct of the clinical trial with a decision if the sponsor has the following: Objections of the Ethics Committee are not taken into account. The communication is to be issued by the Federal Office for Health Security without any unnecessary delay, but no later than 60 days after the application has been submitted.

(5) The Federal Office for Health Security may, if there are concerns about the correct delivery of the opinion of the Ethics Committee or its correctness, the Medicines Advisory Board with the examination of the application for approval . If the patient is in favour of conducting the clinical trial, it is possible to refrain from any undersawing.

(6) The conduct of a clinical trial in connection with medicinal products for gene therapy and somatic cell therapy, including xenogenic cell therapy, requires the approval of the Federal Office for Safety in Health Care.

(7) The Federal Office for Health Security has to decide on applications in accordance with paragraph 6 without unnecessary delay, but at the latest within 90 days after the application has been submitted. In cases where an advisory body is referred to it, this period shall be extended by a further 90 days.

(8) In addition to the provisions of this Federal Act, the requirements of § § 74 to 79 of the German Genetic Engineering Act shall apply for a clinical trial in connection with medicinal products for gene therapy. "

44. § 41 (3) receives the sales designation "(4)" , the following paragraph 3 is inserted:

" (3) The members of the Ethics Committee and their representatives shall fully disclose any relations with the pharmaceutical industry in relation to the Governor of the State. They have to abstain from their activities in the Ethics Committee in all matters in which a relationship with the pharmaceutical industry is likely to cast doubt on their full unpartiality. "

45. In § 41a, paragraph 5, last sentence, the quote "§ 40 (5)" by quoting "§ 40 (6)" replaced.

46. § 41a (6) second sentence reads:

"In the case of applications within the meaning of section 40 (6) the time limits shall apply in accordance with § 40 (7)."

47. § 41c (1) reads:

" (1) In so far as the Federal Office for Health Security has objective reasons to believe that the requirements of the permit application are no longer met in accordance with § 40 (1), or has information available in respect of the If safety or the scientific basis of the clinical trial raises concerns, it may suspend or prohibit the clinical trial. In any case, this shall apply even if a clinical trial is carried out by the sponsor without the compliance with the provisions of § 40. "

48. According to § 41c (4), first sentence, the following sentence is inserted:

"This is true even if the clinical trial has already been completed."

(49) § 43a (3) the following sentence is added:

"Any use of the data collected up to that point shall require the express consent of the data protection authorities."

The following sentence shall be added to Article 47 (7):

"The aim of an inspection of an Ethics Committee may also be to determine, by means of objective, independent verification, whether the Ethics Committee fulfils its tasks in accordance with the state of the art in accordance with this federal law."

51. In accordance with § 47 (7), the following paragraph 7a is inserted:

" (7a) If an inspection finds that a clinical trial is carried out against the provisions of this Federal Act, or concerns arise regarding the safety or scientific basis of the clinical trial, the clinical trial shall not be subject to any clinical trial. The Federal Office for Health and Safety (Bundesamt für Sicherheit im healthcare) may also take measures within the meaning of Section 41c (1) without prior procedure or prior to the adoption of a decision by the Federal Office for Health and Safety in the Health Care Sector. , but shall be subject to a written notice within two weeks. , if the measure taken is deemed to have been repealed. "

52. In § 47, paragraph 8, the quote shall be: "§ 2a (15)" by quoting "§ 2a (16)" replaced.

53. According to § 47, the following § 47a is inserted:

" § 47a. Ethics committees are required to provide the Federal Office for Health Security with all information and documents necessary for the fulfilment of the tasks required under this section. "

54. In Section 48 (3), the word shall be: "Application Observations" through the phrase "Non-interventional studies" replaced.

55. § 49 (11) reads:

" (11) The members of the Medicines Advisory Board, which have been entrusted by the Federal Office for Health Security with the preparation of expert opinions in connection with procedures under the Medicines Act, are due to be given one in relation to the management of the Mühewaltung and the amount of time that the applicant has to pay appropriate compensation. "

56. § 50a (3) Z 3 reads:

" 3.		are not compatible with, or exceed, labelling, use or technical information (SPC summary). "

57. At the end of Section 57 (1) Z 7, the word "and" § 57 (1) Z 8 reads as follows:

" 8.		scientific institutes and investigative bodies of local authorities and universities and the Austrian Agency for Health and Food Safety, provided that these medicinal products are required to carry out their duties, and "

58. In accordance with § 57 (1) Z 8 the following Z 9 is added:

" 9.		organized emergency services, provided that they are addicted to their medical needs. "

59. The Word "and" at the end of section 61 (1) (3), the following shall be replaced by an indents, the item at the end of section 61 (1) (4) shall be replaced by a dash and the word "and" replaced, the following Z 5 shall be added:

" 5.		the delivery by pharmacies after new remaining due to a special arrangement by the doctor or on behalf of the patient. "

60. § 62 (2) reads:

" (2) Not applicable as establishments within the meaning of paragraph 1

1.		Public pharmacies which are medicinal products within the scope of pharmacy operations in accordance with the pharmacies operating regulations of 2005, BGBl. II No 65/2005, as last amended by BGBl. II. 114/2008, manufacture, control or place on the market unless the medicinal products are delivered in a frequency, number or quantity exceeding the pharmacies of the pharmacies operating in accordance with the pharmacies operating order of 2005
a)			public pharmacies, or
b)			"anstaltsapotheken", or
c)			Hospitals,
2.		Pharmacies which manufacture, control or place on the market medicinal products as part of pharmacy operations in accordance with the pharmacies operating order in 2005, unless the medicinal products are used in a pharmacy operation in accordance with the conditions laid down in Pharmacy Operating Regulations 2005, frequency, number or quantity delivered to
a)			"anstaltsapotheken", or
b)			Hospitals, except for those who run the Anstaltsapotheke,
3.		Establishments for the manufacture of investigational medicinal products, in so far as it relates to the refilling, including filling, packaging and marking, and the investigational medicinal products intended for use in a hospital,
4.		Public pharmacies in respect of the preparation of investigational medicinal products, in so far as it concerns the refilling, including filling, packaging and labelling, and the investigational medicinal products used in the public pharmacies In accordance with § 20 of the Federal Law on hospitals and health care institutions (KAKuG), BGBl. No 1/1957, as last amended by BGBl. I n ° 49/2008,
5.		medical and veterinary skin pharmacies,
6.		Tissue banks, in so far as their activities fall exclusively within the scope of Section 1 of the tissue safety law,
7.		establishments which are authorised to supply medicinal products in accordance with Article 59 (3), (4) and (8);
8.		nuclear-medical institutions or laboratories which produce radiolabed medicinal products exclusively for the purpose of direct application to patients or to holders of a permit for the management of radioactive substances according to the Radiation Protection Act, BGBl. No 227/1969, as last amended by BGBl. I No 13/2006, and
9.		Health facilities of the Federal Army in which medicinal products are manufactured for the medical care of members of the Federal Army. "

61. § 62a (2) Z 4 reads as follows:

" 4.		storage, testing, magistral production (formulation and supply of recipes) and preparation of pharmacies of proprietary medicinal products, re-remaining and dispensing of medicinal products, "

62. According to § 62a (2) (4), the following Z 4a is inserted:

" 4a.		ensuring the provision of pharmaceutical information and advice on the spot in the case of the supply of medicinal products to immobile residents of homes for the elderly, nursing homes or other care facilities by pharmacists of the pharmacy supplying the medicinal products; "

63. § 65 (1) reads:

" (1) The essential changes with regard to the production, placing on the market or control of medicinal products, in particular with regard to the information referred to in Article 63 (2) (1) to (3), the effects on the nature of the medicinal products or on the nature of the medicinal products, or A production or distribution program may have to be approved by the Federal Office for Safety in Health in the sense of Section 63 (1). The Federal Office for Health and Safety (Bundesamt für Sicherheit im healthcare) has to decide on a request within 30 days after the application has been submitted. This period may, in exceptional cases, be extended to 90 days. "

64. § 67 (1) first sentence reads:

" The Federal Office for Health and Safety in the health care sector shall periodically, in accordance with section 62 (1) before the granting of an authorization pursuant to Section 63 (1) or, if necessary, before the granting of an authorization pursuant to Section 65 (1) and subsequently periodically to verify that the provisions of this section and of the corresponding regulations adopted pursuant to this section are complied with and that the nature of the medicinal products necessary for the health and life of humans or animals is complied with is guaranteed. "

Section 67 (1a) reads as follows:

" (1a) The Federal Office for Health and Safety (Bundesamt für Sicherheit im Healthcare) has a risk-based inspection and rehearsals plan to the Federal Minister of Health each year by 1 July on the implementation of the operational inspections and on the checks provided for in § 76 for to submit the following calendar year for approval. The authorisation shall be deemed to have been granted unless objections are raised within three months from the date of entry into force. The Federal Office for Health and Safety has to act in compliance with the approved inspection and sampling plan and report to the Federal Ministry of Health (Federal Ministry of Health) by 31 March of the following calendar year on the implementation of the implementation. "

66. § 67 (2) first sentence reads:

" The inspections of establishments producing or controlling medicinal products shall be carried out at least once in three years, by establishments which process human blood or blood components, provided that they are intended for transfusion, or distribute, once in two years, from other establishments at least once in five years. "

67. In accordance with § 67 (3), the following paragraph 4 is added:

" (4) The Federal Office for Health Security may carry out operational audits in third countries when medicinal products are imported from third countries to establish whether they have been manufactured and controlled in accordance with standards which have been established by the standards of good manufacturing practice laid down in the European Community are at least equivalent. "

68. § 68 (1) Z 2 reads:

" 2.		Facilities and means of transport of such establishments, which have been entrusted with storage or transport by holdings within the meaning of section 62 (1), provided that they can be used for the storage or transport of medicinal products, "

69. In accordance with § 68 (1), first sentence, the following sentence shall be inserted:

"It is also possible to consult the document on the necessary commercial authorization in accordance with the trade order in 1994."

70. § 68 (5), first sentence reads:

" Within 90 days of the completion of an operation review, the Federal Office for Health Security shall issue a certificate on the subject if the operational verification has shown that the operation is subject to the provisions of this section, which shall: pursuant to this Section, shall be in accordance with the Regulations and the operating licence. "

71. In § 68 (5), the 5. Sentence the word "recall" by the word "Undo" replaced.

72 (1) (1) (1) reads:

" 1.		a university degree from the fields of human medicine, dentistry, veterinary medicine or pharmacy in Austria or in another contracting party to the Agreement on the European Economic Area or in the Swiss Have successfully completed the Swiss Confederation or have the qualifications of a knowledgeable person, "

73. § 72 (4) Z 3 reads:

" 3.		Prerequisite for the filing of the examination is at least the existence of the general university entrance qualification or a professional qualification in the upscale service for health and nursing care. "

74. § 72 (5) reads as follows:

" (5) nationals of a Contracting Party to the Agreement on the European Economic Area or the Swiss Confederation, to which a certificate of formal qualifications within the meaning of Directive 2005 /36/EC on the recognition of professional qualifications is provided , which entitles the person to pursue the profession as a Pharmareferent, is to be admitted by the Federal Minister of Health to practise the profession as a Pharmareferent. "

75. In § 75a (3), first sentence, the following is:

" If the notification relates to an approved proprietary medicinal product or a registered traditional herbal or apothecthic proprietary medicinal product, the Federal Office for Safety in Health shall have the authorisation holder or the holder of the medicinal product. Notify us immediately, but no later than 15 days after the notification has been made. "

76. In Section 75b (9), the word shall be: "Application Observations" by the word "Non-interventional studies" replaced.

77. § 75b (10) reads:

"(10) Paragraph 1 to 7 shall also apply to the holder of a registration as a traditional herbal or apothecary proprietary medicinal speciality."

78. In § 75c of the first sentence, the word order shall be "Holder of registration as a traditional herbal medicinal product" through the phrase "Owner of a registration as a traditional herbal or apothecary proprietary medicinal specialty" replaced.

79. In § 75d (1) and (3) the word order shall be "Federal Ministry of Health or a body commissioned by the Federal Ministry of Health" through the phrase "Bundesamt für Sicherheit im Healthcare" and in Section 75d (5) the phrase "the Federal Minister of Health or the body responsible for the health of the Federal Minister for Health" through the phrase "the Federal Office for Health Security" replaced.

80. In accordance with § 75e, the following § 75f is inserted:

" § 75f. (1) For medicinal products according to § 7 para. 6a, the requirements for traceability in accordance with § § 5 (4) and 16 (5) of the tissue safety act apply, even if the medicinal products contain cells or tissues of animal origin.

(2) For medicinal products in accordance with § 7 para. 6a, the reporting obligations under § § 17 and 32 of the tissue safety law shall apply, even if the medicinal products contain cells or tissues of animal origin. "

81. § 76a (1) reads:

"(1) Monitoring of transport with food suspected of being a medicinal product or containing prohibited active substances in accordance with Section 1 (2) Z 1 of the Anti-Doping Federal Act 2007 (hereinafter referred to as" goods ") shall be the responsibility of the Governor. "

82. § 76a (2) (2) (2) reads:

" 2.		Persons who comply with the training requirement in accordance with § 24 (3) LMSVG. "

83. § 76b reads:

" § 76b. (1) Supervisory bodies in accordance with § 76a (2) shall provisionally seize goods or if there are reasonable grounds for suspecting that these substances are contained within the meaning of Section 1 (2) (1) (1) of the Anti-Doping Federal Act 2007, or that they constitute a danger to the life or health of humans or animals.

(2) On the provisional seizure or seizure To date, the Board of Supervisors shall ensure that the Board of Supervisors shall issue a certificate to the person entitled to dispose of the goods, indicating the place of storage and the nature and quantity of the goods seized or seized.

(3) In the case of the provisional seizure, the Board of Supervisors shall immediately report to the District Administrative Authority, in the case of ensuring, however, to report to the Public Prosecutor's Office on the freezing, depending on whether the infringement is likely to constitute a criminal offence or an administrative transgressive action. In the event of an administrative surrender, the provisional seizure shall be issued if a notice of seizure of the seizure is not issued within four weeks.

(4) The right of disposal of goods provisionally confiscated or seized is first of all the authority to which the Board of Supervisors is a member, and if the infringement constitutes an administrative surrender, from the date of the release of the confiscated property of the goods. Authority that has issued the seizure notice. If the infringement is a criminal offence, the right of disposal shall be filed with the public prosecutor's office from the date of entry of the report, from the date on which the indictment is brought to the court.

(5) The goods provisionally seized or seized shall be left in operation. They shall be closed or marked in such a way that a change is not possible without injury to the containers, the packaging or the marking. The persons entitled to dispose of the goods so far have been seized by the Board of Supervisors in writing of the criminal-law consequences of the shipment or alteration of the seizure or alteration. to draw attention to the breach of the seal of service.

(6) The maintenance of the goods in operation before damage is the responsibility of the previous person entitled to dispose of the goods. Where special measures are required for this purpose, it shall notify the issuing body beforehand, which shall, if necessary, have arrangements at the expense of the person concerned with regard to the introduction, storage, sealing or marking of such products. meet. The measures are to be taken in the presence of a supervisory body, except in the event of a risk of default.

(7) During the period of freezing or Seizure may be taken from samples of the goods only by order of the competent authority or the competent public prosecutor's office.

(8) The provisions of § § 87 and 106 of the StPO are to be applied in a reasonable way.

(9) The district administrative authority shall declare the seized goods to be forfeited as a precautionary measure, if there is a serious and significant risk to man or animal and the person entitled to power does not ensure that the goods are Goods are not placed on the market after they have been released.

(10) With regard to the costs of an investigation, § 381 para. 1 Z 3 StPO applies in criminal proceedings. In the administrative criminal proceedings, the penal shall be required to pay the compensation of the costs of the investigation to the relevant investigative institution. "

84. In accordance with § 76b, the following § 76c is inserted:

" § 76c. (1) Before recovery of the goods declared for expired goods, the Authority shall give the accused person and the person concerned by the decay the opportunity to submit their comments.

(2) The fallen goods shall be usefully exploited. The goods to be destroyed shall be destroyed at the expense of the accused person or the person affected by the decay, if a beneficial utilization is not possible or if the recovery of the goods cannot be expected to result in the recoverable proceeds of the product being recovered. The cost of recovery will exceed The destruction of the lost goods shall be allowed by the accused person or by the person affected by the decay at their expense under the supervision of a supervisory body.

(3) The proceeds of the recovery shall be deducted from the federal government after deduction of the expenses associated with it and of the unrecoverable costs of the criminal proceedings as well as on the object of any public liabilities that may have to be borne by the public. "

The following sentence shall be added to Article 77:

"If necessary, Section 76b (9) shall apply."

86. In accordance with Section 78 (2), the following paragraphs 3 and 4 are added:

" (3) Institutions of the Federal Office for Health Security shall provisionally seize medicinal products if there are reasonable grounds for suspecting that they constitute a danger to the life or health of humans or animals. § 76b (2) to (9) and § 76c are applicable.

(4) The Federal Office for Health and Safety (Bundesamt für Sicherheit im healthcare) has to declare the medicinal product it confiscated as a precautionary measure if the medicinal product poses a serious and significant risk to humans or animals and if the medicinal product is used for the treatment of human health, the Authorised persons do not ensure that the medicinal product is not placed on the market after its release. "

87. § 80 (3) Z 3 and 4 reads:

" 3.		Health Austria GesmbH, university institutes and other research institutions, insofar as they are active in the interests of public health, for tasks in the sense of the purpose of the provisions of paragraphs 1 and 2,
4.		the Österreichische Apothekerkammer, the Austrian Medical Association, the Austrian Dentists ' Chamber, the Austrian Veterinary Chamber and the Austrian Social Insurance Institutions, as far as these data are essential to fulfil the tasks assigned to them by law, "

88. § 80 (5) reads:

" (5) The Federal Office for Health and Safety and the Federal Ministry of Health are also authorized, in so far as this is provided for in the relevant relevant medicinal products relevant to the European Community, to:

1.		to enter data in the European databases provided therein; and
2.		To communicate information to the competent authorities of the Member States of the European Union, the Agency and the European Commission. "

89. According to § 81, the following § 81a is inserted:

" § 81a. The Federal Office for Health Security is authorized, in accordance with the technical possibilities, to provide, by means of a regulation, that the provisions of this Federal Act, in accordance with the Proprietary Medicinal Products 2002 Act, the Blood Safety Act, the The German Medical Devices Act, the Medical Devices Act and the Tissue Safety Act have to be submitted in electronic form, as well as advertisements and notifications. In any case, provision should be made for exceptions to hardship cases in this Regulation. "

90. In Section 82a (1), the quote shall be "§ 8 (2) (12) and (14)" by quoting "§ 8 (2) Z 13 to 16" replaced.

91. § 82a (1) last sentence reads:

"These persons are obliged to make a statement annually to the Federal Office for Health Security (Bundesamt für Sicherheit im healthcare), which is to be transmitted at the request of the Federal Ministry of Health."

92. In Section 83 (1), the following Z 4a shall be inserted after Z 4:

" 4a.		as the marketing authorisation holder or holder of a registration does not comply with the obligations laid down in § 56, "

93. § 84 (1) Z 6 reads:

" 6.		Medicinal products subject to authorisation pursuant to Regulation (EC) No 724/2004, Regulation (EC) No 724/2004, in conjunction with Regulation (EC) No 1901/2006, or Regulation (EC) No 1394/2007, without the authorisation of such medicinal products, or does not issue or provide for the submission, in accordance with such authorisation, "

94. In accordance with § 84 (1) Z 6 the following Z 6a is inserted:

" 6a.		does not comply with its obligations under Regulation (EC) No 1901/2006 or does not comply in good time, "

95. In accordance with § 84 (1) Z 7 the following Z 7a is inserted:

" 7a.		In the sense of § 11a, the pharmacist's own proprietary medicinal products shall be delivered domesically or for the purpose of delivery without being registered in accordance with § 27, "

96. In accordance with § 84 (1) Z 25 the following Z 25a shall be inserted:

" 25a.		when the transport of medicinal products is contrary to the obligations laid down in accordance with Article 62 (1) of this Regulation,

97. In accordance with Section 84 (2), the following paragraph 3 is added:

" (3) In the case of the criminal code referred to in paragraphs 1, Z 1, 2, 3, 5, 6, 7, 7a, 8, 9, 16, 17 and 32, the decay of the medicinal products forming the subject of the offence may be recognised. The decay can also be recognized independently if no specific person can be prosecuted or punished. "

98. In accordance with § 84, the following § 84a is inserted:

" § 84a. The customs authorities shall transmit to the Federal Office for Health Security the copy of their notification of a transgressing of the Medicinal Product Act 2002. "

99. According to § 85a, the following § 85b and title is inserted:

" Participation of the institutions of the Public Security Service

§ 85b. The institutions of the public security service shall have the Federal Office for Health and Safety in the public health and the institutions according to § 76a above their requests to ensure the exercise of the powers pursuant to Sections 47 (6) and (7a), 56a, 67 to 69, 76 to 76b, 77 and 78 within the framework of its legal sphere of action. "

100. In Section 89 (5), the quote shall be: "pursuant to § 11" by quoting "in accordance with § 7" replaced.

101. In accordance with Article 94c (13), the following paragraph 13a is inserted:

" (13a) For applications for the authorisation of a reference medicinal product for which the application for authorisation has been submitted before the end of the 30. The protection periods of § 15a of the German Medicines Act (Medicines Act) in the version before the entry into force of the Novelle BGBl apply. I No 153/2005. '

102. In accordance with § 94d, the following § 94e is inserted:

" § 94e. (1) Pharmacy's own proprietary medicinal products, which are in accordance with § 9d as amended before the entry into force of this Federal Law in the version of the Federal Law BGBl. In accordance with § 11a of this Federal Act, the Federal Law Gazette of the Federal Republic of Germany (BGBl) applies as registered apothecary proprietary proprietary medicinal products. I No 63/2009.

(2) At the time of the entry into force of this Federal Act in the version of the Federal Law BGBl. I No.63/2009 pending applications for admission as a pharmacist's own proprietary medicinal product are considered to be registrations for registration as an apothecary proprietary medicinal product.

(3) The amendment of the use information and labelling of pharmacies of proprietary medicinal products, which according to § 9d in the version before the entry into force of this Federal Law in the version of the Federal Law BGBl. I No 63/2009, and which result from the changeover to registration, have to take place until 31 December 2014.

(4) proprietary medicinal products, as amended by the Federal Law of the Federal Republic of Germany (BGBl), as amended in accordance with § 16b of the German Federal Act. No 63/2009 should be placed on the market without the information on the use of the package leaflet, and must comply with the requirement for information on the use of the use of the package until 31 December 2014. On a reasoned request, the Federal Office for Health Security may extend this period. "

103. § 95 para. 8e in the version of the Federal Law BGBl. I n ° 49/2008 is given the sales designation "(f)" .

104. The word "and" at the end of Section 96 (1) (1) (1), the following shall be replaced by a paint, the item in accordance with Section 96 (1) (2) shall be replaced by an accoration, the following Z 3 and Z 4 shall be added:

" 3.		with regard to Section 84a in agreement with the Federal Minister for Finance, and
4.		as regards § 85b in agreement with the Federal Minister for Home Affairs. "

105. The point in accordance with § 97 Z 26 is replaced by a dash, the following Z 27 and Z 28 are added:

" 27.		The Directive of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications, OJ L 327, 30.12.2005, p. No. 22), as last amended by Council Directive 2006 /100/EC of 20 November 2006 adapting certain directives in the field of freedom of movement to take account of the accession of Bulgaria and Romania, OJ L 255, 30.9.2006, p. No. OJ L 363, 20 December 2006, p. 141,
28.		the Agreement between the European Community and its Member States, of the one part, and the Swiss Confederation, of the other part, on the free movement of persons, OJ No. OJ L 114/6 of 30 April 2002, BGBl. III. No 133/2002, as amended by the Protocol, with a view to the accession of the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia as a result of their accession to the European Union, 1. No. OJ L 89/30 of 28 March 2006, BGBl. III No 162/2006. "

Article 2

Amendment of the tissue safety law

The tissue safety law, BGBl. I n ° 49/2008, as last amended by the Federal Ministries of State Law 2009, BGBl. I No 3, shall be amended as follows:

1. § 1 para. 1 second sentence reads:

" Furthermore, it regulates the processing, storage and distribution of human cells and tissues for use in humans, unless they are used for the manufacture of medicinal products which are always prepared in advance in the same composition and under the conditions of shall be placed on the market in a form intended for supply to the consumer or user, used by investigational medicinal products or by medical devices. "

2. § 2 Z 22 reads:

" 22.		Advanced therapy medicinal products: gene therapy medicinal products and somatic cell therapeutics referred to in Part IV of Annex I to Directive 2001 /83/EC of the European Parliament and of the Council of 6 November 2001 establishing a Community code relating to: Medicinal products for human use, as last amended by Directive 2004 /27/EC as well as biotechnologically processed tissue products referred to in Article 2 (1) (lit). (b) Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001 /83/EC and Regulation (EC) No 726/2004. '

3. In accordance with Section 3 (1), the following paragraph 1a is inserted:

" (1a) By way of derogation from paragraph 1, the collection of cells and tissues may also be carried out by unreported removal devices if, in the context of a medical intervention, the status of medical science is unforeseen. The need for the later autologous use of these cells and tissues. "

4. § 5 (6), first sentence reads:

"Obtained cells or tissues, with the exception of germ cells obtained in the context of a partner donation, shall be marked with the identification code ISBT 128."

5. § 7 receives the sales designation "(1)" , the following paragraphs 2 and 3 are added:

" (2) Provided that this is compatible with the protection of donors and the impeccable nature of donated cells and is necessary in view of the peculiarities of medically assisted reproduction, the Federal Minister for Health Provision shall be made for derogations from the requirements of § 6.

(3) The Federal Minister of Health has to provide for derogations from § § 6, 11 and 12 (3) by means of a regulation for the collection in accordance with § 3 (1a). "

6. According to Article 11 (3), the following paragraph 3a is inserted:

" (3a) The distribution of cells or tissues may also be transferred to a holding which does not have an authorization pursuant to § 22. § 15 para. 2 shall apply mutatily for this operation. "

7. According to Article 26 (3), the following paragraph 3a is inserted:

" (3a) The powers of the institutions of the Federal Office for Health Security, as referred to in paragraph 3, shall also exist with regard to facilities or means of transport of such establishments, which are provided by tissue banks with the distribution of cells or tissues. have been commissioned. "

8. In accordance with § 35 (3), the following paragraph 3a is inserted:

" (3a) Anyone who does not comply with the requirements of Article 15 (2) as being responsible for the distribution of cells or tissues, shall, if the action does not constitute the offence of a criminal act falling within the jurisdiction of the courts, enter into a criminal act. Administrative surrender and is punishable by a fine of up to 7,270 euros. "

Article 3

Amendment of the Proprietary Medicinal Products Import Act 2002

The Medicinal Products Import Act 2002, BGBl. I n ° 28/2002, as last amended by the Federal Law BGBl. I n ° 52/2008 and the Federal Ministries Act of 2009, BGBl. I No 3, shall be amended as follows:

1. § 8 (2) shall be replaced by the sales designation "(3)" , the following paragraph 2 is inserted:

"(2) The attempt is punishable."

Article 4

Amendment of the Health and Food Safety Act

The Health and Nutrition Security Act, BGBl. I No 63/2002, as last amended by the Federal Law Gazette (BGBl). I n ° 143/2008 and the Federal Ministries of the Federal Ministries of Law 2009, BGBl. I No 3, shall be amended as follows:

1. In accordance with Article 6a (1), the following paragraph 1a is inserted:

"(1a) The Federal Office for Health and Safety provides scientific advice on the development programme of medicinal products upon request."

Section 6a (5) last sentence reads as follows:

" In any case, it should be specified that the member appointed by the staff of the Federal Ministry of Health shall be chaired by the member of the staff of the Federal Ministry of Health, and that the arrangement of the procedural provisions as well as the issue of certificates and certificates shall be determined. the certification of official documents for purposes of presentation abroad shall be assigned to the head of the department according to § 8 (2) (2) (13) to (16) of the Agency. "

3. In Section 6a (6), the following shall be taken after the 3. The following sentence is inserted:

"If the fees are not paid without further notice, they will be required to be informed."

4. In § 8 (2) (13), the word order shall be deleted ", scientific advice from potential applicants" .

5. § 8 (7) 2. sentence reads:

"In the area of paragraph 2 Z 13, services for third parties may not be provided by the area pursuant to § 8 (2) Z 13 to 16."

6. In § 12 para. 4, the quote shall be "§ 8 (2) Z 13 to 15" by quoting "§ 8 (2) Z 13 to 16" replaced.

7. § 19 (15) reads:

" (15) Revenue from activities in accordance with § § 6, 6a and 8, and in particular fee income, shall be revenue of the Agency. The Agency has the books relating to the tasks in accordance with § 8 (7), in relation to the tasks pursuant to § § 6a and 8 (2) (13) to (16) as well as with regard to the task pursuant to § 8 (2) Z 17 in a separate accounting and cost-accounting shall be carried out separately. In addition, the annual accounts of the Agency shall be subject to a separate section in each case. The management of the Agency shall ensure that revenue in accordance with § 6a is used exclusively for the financing of the tasks referred to in Articles 6a and 8 (2) (2) to (16). "

Fischer

Faymann