Change Of The Medicines Act, The Health And Food Safety Act, The New Psycho-Active Substances Act And The Anti-Doping Federal Act 2007

Original Language Title: Änderung des Arzneimittelgesetzes, des Gesundheits- und Ernährungssicherheitsgesetzes, des Neue-Psychoaktive-Substanzen-Gesetzes und des Anti-Doping-Bundesgesetzes 2007

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48. Federal Law, with which the Medicines Act, the Health and Nutrition Security Act, the New Psychoactive Substances Act and the Anti-Doping Federal Act 2007 will be amended

The National Council has decided:

Article I

Amendment of the Medicines Act

The Drug Law-AMG, BGBl. No. 185/1983, as last amended by the Federal Law BGBl. I No 114/2012, shall be amended as follows:

1. § 1 (1) and (2) reads as follows:

"(1)" medicinal products " means substances or preparations of substances which:

1.

are intended for use in or on the human or animal body and as a means of healing or alleviation or for the prevention of human or animal diseases or pathogenic complaints; or

2.

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

a)

to restore, correct or influence physiological functions by means of a pharmacological, immunological or metabolic action, or

b)

as a basis for a medical diagnosis.

(2) A medicinal product shall be subject to articles containing a medicinal product or to which a medicinal product is applied and which are intended for use on the or in the human or animal body. "

2. § 1 (4) (1) and (2) reads:

" 1.

chemical elements, natural chemical substances and chemical compounds obtained by processing on a synthetic route,

2.

Plants, parts of plants and plant components in any form, including substances obtained by extraction, "

3. According to Article 1 (4), the following paragraphs 4a and 4b are inserted:

"(4a)" active substances " means substances or mixtures of substances which are intended to be used in the manufacture of a medicinal product and, when used in the manufacture of medicinal products, for medicinal products which are active in the manufacture of medicinal products; to be made.

(4b) "excipient" means any component of a medicinal product, with the exception of the active substance and the packaging material. "

4. According to Article 1 (24), the following paragraphs 25 and 26 are added:

"(25)" Counterfeit medicinal product " means any medicinal product which has been falsified:

1.

its identity, including its packaging and labelling, its name or composition, with regard to any component, including the excipients and the content of these ingredients; or

2.

its origin, including the manufacturer, country of manufacture, country of origin and marketing authorisation holder or holder, or

3.

the records and documents relating to the distribution channels used.

(26) 'adulterated active substance' means an active substance in which the following has been falsified:

1.

the identification of the latter on the container with regard to the actual content, or

2.

the records and documents relating to the manufacturers involved or the distribution channels used. "

5. § 2 (3a) reads:

"(3a)" pharmaceutical agent "means a person established in a Contracting Party of the European Economic Area who has the power to carry out the activity of the mediation of medicinal products for human use."

6. In accordance with Section 2 (3a), the following paragraph 3b is inserted:

"(3b)" Bulkware "is a medicinal product which only has to be bottled or packaged in order to become the end product."

7. The following paragraphs 7a and 7b shall be inserted in accordance with Article 2 (7):

"(7a)" distance " means the conclusion of a contract with the exclusive use of one or more distance communication means.

(7b) "means of distance communication" means means of communication which may be used to conclude a contract without the simultaneous physical presence of the parties, in particular printed matter with or without address, catalogues, press releases with order form, pre-manufactured standard letters, long-distance calls with persons or vending machines as interlocutors, radio, videophone, teletopia, teleshopping as well as publicly accessible electronic media, which allow individual communication, such as the Internet or the electronic mail. "

8. § 2 para. 10 reads:

"(10)" manufacture "means the winning, the preparation, the preparation, the working or processing, the refilling, including the filling and packaging of medicinal products or active substances, as well as the identification of proprietary medicinal products and investigational medicinal products."

9. § 2 para. 11, first sentence reads:

" 'placing on the market' shall be the holding, holding or dispensing of medicinal products or active substances. '

(10) In § 2 (13a), after the word "medicinal product" the phrase "or active substances" inserted.

11. According to Article 2 (15), the following paragraph 15a is inserted:

"(15a)" conciliation of medicinal products " means all activities, with the exception of wholesale trade, in connection with the sale or purchase of medicinal products for human use which consist of, independently and in the name of another, legal or natural to negotiate without acquiring or physically dealing with these medicinal products. "

12. § 2 para. 18 reads:

"(18)" Effectiveness "shall be the suitability of a medicinal product to comply with the purposes of Article 1 (1) of this Directive."

Section 2 (21) reads as follows:

"(21)" intermediate product "means a medicinal product which has to undergo one or more stages of production in order to become a bulkware."

14. In § 4 (1) and (2) and § 6 (1), the following shall be taken into account in each case "medicinal product" the phrase "or active substances" inserted.

15. In § 4 (2) (1), the word order shall be " The Pharmacopoa Act, BGBl. No. 195/1980, " through the phrase " The Drug Book Act 2012, BGBl. I No 44/2012, " replaced.

16. In § 4 para. 2 Z 2 the expression "Drug Book Law" by the expression "Drug Book Law 2012" replaced.

17. In § 5 (1) and Article 6 (2), the following shall be taken into account in each case "medicinal products" the phrase "or active substances" inserted.

18. § 6 para. 3 Z 1 reads:

" 1.

the medicinal products shall be accompanied by an activity or a property which is not sufficiently substantiated according to the state of scientific knowledge or practical experience, or

19. In accordance with § 9a (1) Z 11 the following Z 11a is inserted:

" 11a.

in the case of medicinal products for human use, a written confirmation by the manufacturer that he has verified and established, through audits, the compliance with good manufacturing practice for active substances by the manufacturer of active substances on the spot; the confirmation must also be confirmed by the manufacturer the date of the audits, "

20. § 9c first sentence reads:

" A request for authorisation of a proprietary medicinal product which corresponds to a monograph of the pharmacopoeia within the meaning of § 1 of the Pharmacopoeia Act 2012, but which does not satisfy the requirements of § 7 para. 2, is not mentioned in § 7 para. 9, and not a Registration in accordance with § 12 shall not be accompanied by documents in accordance with § 9a (1) Z 8, 12 to 15, 18 to 21, 24 to 27 and 29 to 31. "

21. In accordance with Article 17 (5), the following paragraph 5a is inserted:

" (5a) In the external packaging of proprietary medicinal products intended for use in humans, safety features and a device for the detection of possible manipulation of the outer packaging shall be affixed, provided that this is done by Article 54a of the Directive 2001 /83/EC on the Community code relating to medicinal products for human use, OJ L 327, 30.4.2001, p. No. OJ L 311, 28.11.2001, p. 67, as last amended by Directive 2011 /62/EU, OJ L 311, 28.11.2011, p. No. OJ L 174, 01.07.2011 S 74, is required or is laid down in accordance with Article 54a of Directive 2001 /83/EC. The Federal Minister for Health shall, where necessary for reasons of safety of medicinal products or to comply with Union law obligations, lay down more detailed provisions relating to the safety features, in particular those which: Medicinal products for human use shall be subject to safety features or , as well as of the nature, nature, characteristics, specifications and other requirements related to the verification of the security features. "

22. § 17 (6), first sentence reads:

"(1) to (3), (5) and (5a) shall not apply to radioactive proprietary medicinal products subject to the provisions of Z 1 of this paragraph."

23. In § 17 (9) the expression " 1 to 5 " by the expression " 1 to 5a " replaced.

The following paragraph 4 is added to Article 18b:

" (4) Competent national authority within the meaning of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001 /83/EC is the Federal Office for Safety in the health sector. "

25. § 53 (1) Z 13 reads:

" 13.

to take a prescription drug in distance sales. "

26. In accordance with § 57 (1) Z 6 the following Z 6a is inserted:

" 6a.

the Federal Ministry of the Interior, the authorities responsible for the emergency care, the provision of care and assistance for operations, provided that they need the medicinal products to carry out their duties, "

27. In § 59 (2), the word "Authorisation Holder" by the word "Registrant" replaced.

28. In § 59 (9) the word "Mail Order" by the word "Distance" replaced.

29. § 59 the following paragraphs 10 and 11 are added:

" (10) The prohibition of distance sales in accordance with paragraph 9 shall not apply to medicinal products for human medicinal products authorised or registered in Austria which are subject to distance marketing.

1.

within Austria by public pharmacies, or

2.

to Austria by pharmacies of another EEA Contracting Party which, in accordance with the legislation in force there, have the power to do so,

shall be given.

(11) The distance ban referred to in paragraph 9 shall not apply to medicinal products for human use which comply with the national legislation of another EEA Contracting Party, provided that they are not subject to prescription therein, which are subject to distance marketing by: public pharmacies in the territory of this EEA Contracting Party. "

30. In accordance with § 59, the following § 59a and heading is inserted:

" Distance

§ 59a. (1) The distribution of medicinal products for human use by distance sales pursuant to Article 59 (10) (1) and (11) may only be made by public pharmacies complying with the requirements laid down in paragraphs 2 and 3.

(2) Public pharmacies intending to offer medicinal products for human use for sale to the public through distance selling shall have this prior to the Office of the Federal Office for Safety in the Public Health, stating the name the operator and the address, the date of the commencement of the activity and the address of the websites used for that purpose, including any information on their identification. Any changes to this information shall be reported immediately.

(3) The websites referred to in paragraph 2 shall at least

1.

have the address and other contact details of the Federal Office for Safety in Health,

2.

on each page of the website relating to the sale of medicinal products for human use by distance selling, the common logo referred to in Article 85c (3) of Directive 2001 /83/EC, which must include a link to the list referred to in paragraph 4 (3), show clearly visible, and

3.

have a connection to the Internet portal of the Federal Office for Health Security in accordance with § 27 (4).

(4) The Federal Office for Health Security has at least the following information available through the Internet portal pursuant to § 27 (4):

1.

information on the legislation to be applied to the public for the sale of medicinal products for human use by distance selling;

2.

information on the purpose of the common logo, in accordance with Article 85c (3) of Directive 2001 /83/EC,

3.

a list of the public pharmacies referred to in paragraph 1 and the addresses of their websites,

4.

information on the risks to the health and life of human beings by means of medicinal products for human use, which are made illegally by distance to the public; and

5.

a periodic update of the EEA Contracting Parties in which the provision of medicinal products by distance is subject to comparable safety standards to the Austrian legislation.

(5) Medicinal products for human use, which are delivered by distance sales, may only be dispatched in a quantity corresponding to the usual personal needs, and shall be

1.

to be packed, transported and delivered in such a way that their quality and effectiveness are not compromised, and

2.

demonstrably the person who has been informed by the client of the order of the respective public pharmacy.

(6) In the course of the ordering process, a consultation must also be carried out on any interactions, whereby according to the technical availability the e-medications according to § 16a of the Health Telematics Act 2012, BGBl. I No 111/2012. The Federal Minister of Health has to make more detailed regulations by means of a regulation in order to, from the technical availability, also include the purchase of medicinal products by distance marketing into the e-medication in accordance with § 16a health telematics law 2012 .

(7) The Federal Minister of Health, under the Regulation, shall lay down detailed provisions concerning the requirements for the delivery of medicinal products for human use by means of distance marketing and the dispatch thereof, adopt, in particular, the ordering process, packaging, transport, storage, delivery, collection, assurance of pharmaceutical advice and the requirement of a quality system.

31. § 62 (1) reads:

" (1) In so far as it is necessary to ensure the nature of the medicinal products or active substances necessary for the health and life of humans or animals and the supply of medicinal products or active substances, the Federal Minister for Health by Regulation Operating regulations for establishments which manufacture, control or place on the market medicinal products or active substances. "

32. § 62 sec. 2 Z 1 and 2 reads:

" 1.

Public pharmacies within the framework of the usual pharmacy operations according to the pharmacies operating order 2005, BGBl. II No 65/2005, in the current version, manufacture, control or placing on the market,

2.

Establishments which manufacture, control or place on the market medicinal products within the framework of the usual pharmacy operations in accordance with the pharmacies operating order of 2005, "

33. In accordance with § 62 (2), the following paragraphs 2a to 2c are inserted:

" (2a) In so far as public pharmacies make medicinal products beyond the usual pharmacy business to other public pharmacies, to institutional pharmacies or to hospitals, these require a corresponding authorization in accordance with § 63 (1). This also applies to anstaltic pharmacies, which make medicines to other institutions or hospitals, except to those who operate the respective old-age pharmacies.

(2b) In the case of the re-remaining of medicinal products, an operating licence in accordance with § 63 (1) is required for public pharmacies or hospital pharmacy, provided that the newly remaining medicinal products go beyond the usual pharmacy operation. Number of persons to be delivered.

(2c) In assessing the overrun of the usual pharmacy operations referred to in paragraphs 2a and 2b, in particular, it shall be considered, where applicable, that:

1.

the production and distribution volume of the medicinal products;

2.

the risk potential of the manufacturing process,

3.

the frequency of deliveries of medicinal products; and

4.

the number of persons who have been supplied with new medicinal products on average per year.

The Federal Office for Health and Safety (Bundesamt für Sicherheit im healthcare) has detailed rules for the examination and the technical and staffing of a public pharmacy or a hospital pharmacy by means of a regulation. Evaluation of the criteria according to Z 1 to 4 to be adopted. The regulation is to be published on the homepage of the Federal Office for Safety in Health Care. The Federal Office for Health and Safety in the Health Care Service has to determine this with a notice when the usual pharmacy operation is exceeded. "

34. § 62 (3) Z 1 reads as follows:

" 1.

Manufacture, placing on the market, import and export of medicinal products or active substances, "

35. § 62 (3) Z 2 reads:

" 2.

The nature and extent of the control of medicinal products or active substances, such as the control of a control laboratory, "

36. In accordance with § 62 (3), the following paragraph 3a is inserted:

" (3a) In the Regulation referred to in paragraph 1, the Federal Minister of Health, in agreement with the Federal Minister of Finance, may implement customs supervision measures on the import and export of active substances in order to implement the provisions of the Union's legal provisions. in order to ensure that they comply with good manufacturing and distribution practices for active substances. Provision may also be made for the active substances referred to in Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff, OJ L 139, 30.4.1987, p. No. OJ L 256 of 07. 09. 1987 S 1, as last amended by Implementing Regulation (EU) No 155/2012, OJ L 327, 31.12.2012, p. No. 1., for the purpose of monitoring by the customs authorities. '

37. In § 63 (1), after the word "medicinal products" the phrase "or of medicinal products and active substances" inserted.

38. According to § 63, the following § 63a is inserted:

" § 63a. (1) Companies pursuant to § 62 (1), which exclusively produce, place on the market or control active substances, have submitted a request to the Federal Office for Health Security at least 60 days prior to the intended start of their activities. to issue an authorization. The application shall be accompanied by documents which contain at least the following information:

1.

name or company name and permanent address,

2.

active substances which are to be produced, placed on the market or controlled; and

3.

Information on the premises and the technical equipment.

(2) The Federal Office for Health Security may carry out an operational review of the applicant on the basis of a risk assessment. If the Federal Office for Health Security announces an operational review within 60 days from the receipt of the documents referred to in paragraph 1 above, the activity may not be carried out until the Federal Office for Security has been granted an authorisation. Health care. If the Federal Office for Health Security does not express itself within 60 days, the application shall be deemed to have been approved. If the conditions for a permit are not met, the Federal Office for Safety in Health Care has to determine this with a communication.

(3) Any changes which may have an effect on the quality or safety of the active substances produced, placed on the market or on the market shall require the approval of the Federal Office for Safety in the Health Care.

(4) § § 64 to 66a, 67 (1) with regard to periodic review, 69 and 71 shall apply mutatily to establishments in accordance with paragraph 1. "

39. In § 64 (1) and (3), § 65 (1) and § 66 (§ 66) shall be made according to the word "medicinal product" the phrase "or active substances" inserted. "

40. § 64 (5) reads:

" (5) The Federal Office for Health Security has the data concerning the authorization to manufacture and place medicinal products or active substances on the market in accordance with § 63 (1), § 63a (2) or (3) or § 65 (1) in the database of the Union according to Article 111 (6) of Directive 2001 /83/EC. '

41. According to § 66a the following § 66b is inserted:

" § 66b. The authorization in accordance with § 63 (1) or § 63a (2) or (3) or § 65 (1) shall be repealed if the holder of the operating licence waived the authorization. "

Section 67 (1) reads as follows:

" (1) The Federal Office for Health and Safety (Bundesamt für Sicherheit im Healthcare) has holdings in accordance with § 62 (1) before granting an authorization pursuant to Section 63 (1) or, if necessary, before granting an authorization pursuant to Section 65 (1) and subsequently on the basis of a to check the risk assessment periodically to ensure that the provisions of this section or of the regulations adopted pursuant to this section are complied with and that they are necessary for the health and life of humans or animals The nature of the medicinal products or active substances is guaranteed. The Federal Minister of Health may, by means of a regulation, authorise the provincial authorities to review such types of holdings in the Land concerned, in respect of which this is due to the product range with regard to the safety of medicinal products warranted. "

43. In § 67 (2) and (3), the following shall be given after the word "medicinal product" the phrase "or active substances" inserted.

44. § 67 (4) reads:

" (4) The Federal Office for Health Security may carry out operational reviews of manufacturers of medicinal products in third countries in order to determine whether they have been manufactured and controlled in accordance with the standards laid down by the European Commission. Union shall be at least equivalent to established standards of good manufacturing practice. The Federal Office for Health and Safety (Bundesamt für Sicherheit in Healthcare) may, if there are grounds for failure to comply with the requirements of this section or of the regulations adopted pursuant to this section, have to comply with the requirements of this section in the case of non- Manufacturers or distributors of active substances carry out operational inspections. The Federal Office for Health Security has to cooperate with the Agency in the coordination of operational audits in third countries and to inform them about planned and carried out operational audits. "

45. In accordance with § 67 (4), the following paragraphs 5 to 7 are added:

" (5) The Federal Office for Health Security may, if there are grounds for failure to act in breach of the provisions of this Section or of the regulations adopted pursuant to this Section, in the case of establishments producing auxiliary substances. or introduce operational audits. The Federal Office for Health Security can also carry out operational audits at the premises of marketing authorisation holders, registration holders or drug investigators.

(6) Operational reviews as referred to in paragraphs 1 and 4, and operational audits in accordance with paragraph 5, of establishments producing or importing adjuvants may also be carried out at the request of another Member State, the European Commission or the Agency. are carried out. Without prejudice to any agreements between the European Union and countries which are not parties to the Agreement on the European Economic Area, the Federal Office for Health and Safety (Bundesamt für Sicherheit im Sicherheit im Healthcare) may be a manufacturer in the country that does not The State Party of the Agreement on the European Economic Area, is required to submit an operational review in accordance with the requirements of the European Union

(7) The Federal Office for Health and Safety in the Public Health Service has carried out operational inspections of companies which have

1.

medicinal products for human use, or

2.

Active substances

, manufacture, control or place on the market, in accordance with the guidelines of the European Commission referred to in Article 111a of Directive 2001 /83/EC, and in doing so with the Agency, by exchanging information on planned and implemented Operational audits. "

46. § 68 (1) (1) and (2) are:

" 1.

Establishments pursuant to section 62 (1) and

2.

Facilities and means of transport of such establishments, which have been entrusted by establishments pursuant to § 62 (1) with storage or transport, provided that they can be used for the storage or transport of medicinal products or active substances, "

47. § 68 (4) second sentence reads:

"The content of the minutes has to be based on the guidelines published by the European Commission in accordance with Article 51 of Directive 2001 /82/EC or Article 111a of Directive 2001 /83/EC."

48. § 68 (5) reads:

" (5) The Federal Office for Health Security shall issue a certificate within 90 days after the completion of an operation review, if the operational verification has shown that the operation is subject to the provisions of this Section, the regulations adopted pursuant to this section and the operating licence. The form and content of the certificate shall take account of the guidelines published by the European Commission in accordance with Article 51 of Directive 2001 /82/EC and Article 111a of Directive 2001 /83/EC. If these conditions are not met, the Federal Office for Health and Safety (Bundesamt für Sicherheit im healthcare) has to determine this within the stated period of time. The certificate shall be withdrawn if it becomes known subsequently that the conditions have not been fulfilled. It shall be revoked if the conditions are no longer fulfilled. "

49. § 68 (5), the following paragraph 6 is added:

" (6) The Federal Office for Health Security has to enter the certificates issued by it in accordance with paragraph 5 into the database of the Union according to Article 111 (6) of Directive 2001 /83/EC. In this database, the Federal Office for Health Security also has to enter information on establishments which do not comply with the provisions of this Federal Law or regulations adopted pursuant to this Federal Act. This also applies to the registration and deletion of drug intermediaries. "

50. In accordance with § 71, the following § 71a and heading is inserted:

" Drug Intermediaries

§ 71a. (1) A mediator who has a registered office in Austria shall report to the Federal Office for Safety in the Health Care its name, the company name and its permanent address. Any modification of these data shall be reported immediately by the drug mediator. The Federal Office for Health Security has a register of reports on the reports of drug intermediaries. This is to be made publicly available on the homepage of the Federal Office for Health Security.

(2) The Federal Office for Health Security has to issue a confirmation on request concerning the registration. The registration must be refused or deleted if the conditions laid down in this Federal Act or pursuant to a regulation adopted pursuant to this Federal Act have not been fulfilled or have subsequently been omitted.

(3) The Federal Minister of Health may, by means of a regulation, lay down more detailed provisions concerning the requirements for the activities of the mediation of medicinal products, in particular with regard to documentation requirements and quality assurance measures. "

51. The title of § 75q reads:

"Quality defects, falsified medicinal products"

52. In accordance with Section 75q (7), the following paragraph 8 is added:

"(8) The provisions of paragraphs 2 to 4, 6 and 7 shall apply mutatily to counterfeit medicines."

53. The title before § 77 reads:

"Monitoring and protection measures"

(54) § 78a is added to the following sentence:

§ 78b is to be applied for the enforced enforcement of a provisional seizure. "

55. According to § 78a, the following § 78b is inserted:

" § 78b. If the business or company owner or his authorised representative refuses to tolerate the surveillance or safeguard measures provided for under this Federal Act, they may be forced to do so. "

56. In the XIII. Section will be after the section heading "Sanctions" The following § § 82b to 82d shall be inserted together with the headings:

" Judicial punishable acts

§ 82b. (1) Anyone who falsifies medicinal products, active substances or excipients with the attachment (§ 1 para. 25 and 26), that they are left to another, shall be punished with imprisonment of up to three years.

(2) It is also necessary to punish those who offer, provide or leave falsified medicinal products, active substances or auxiliary substances to another, or keep them in stock with the aim of leaving them to another, to be left to another.

(3) Anyone who commits a criminal offence pursuant to para. 1 or 2 as a doctor, dentist, veterinarian, pharmacist, Dentist or midwife shall be punished with imprisonment for up to five years.

(4) It is also necessary to punish those who commit an offence pursuant to para. 1 or 2 with the intention of obtaining a continuous intake through their recurrent commission and have already been convicted of such a criminal offence.

(5) Anyone who commits the offence (para. 4) also as a doctor, dentist, veterinarian, pharmacist, Dentist or midwife is to be punished with imprisonment for up to ten years.

(6) If the offence referred to in paragraph 1 or 2 results in the death of a person or serious bodily injury (§ 84 para. 1 StGB) of a larger number of people, then the perpetrator shall be punished with imprisonment of five to fifteen years.

(7) Who falsifies or falsifies the trade package or any other document referring to a medicinal product, an active substance or an adjuvant, that the document is used for that purpose, counterfeit medicines, active substances or If the offender is not to be punished according to paragraph 1 or 2, it is punishable by imprisonment for up to one year.

(8) Those who tempt another person or otherwise contribute to the fact that this person or a family member (§ 72 StGB) procured falsified medicinal products in order to be applied to him or the family member is not to be punished according to the provisions of paragraphs 1 to 7.

Recovery

§ 82c. (1) Counterfeit medicinal products, active substances, auxiliary substances and documents (§ 82b (7)) shall also be used, unless the conditions for confiscation in accordance with § 26 of the German Civil Code (StGB) are already available, if there is no specific person for a criminal offence pursuant to § 82b may be prosecuted or convicted, unless the person entitled to the right of disposal makes a lawful use of the product in a credible way and guarantees that the medicinal product, the active substance, the excipient or the document shall not be placed on the market is brought.

(2) § § 443 to 446 of the Code of Criminal Procedure in 1975 (StPO), BGBl, apply to the procedure. No. 631/1975, corresponding. For the application of the StPO, falsified medicinal products, active substances, excipients and documents shall be treated as objects, the property of which is generally prohibited.

Customs clearance and information requirements of customs authorities

§ 82d. (1) If certain facts indicate that falsified medicinal products, active substances, auxiliary substances or documents (Section 82b (7)) are being transported to or from Austria, the customs authorities shall be entitled to make them safe. They shall report immediately to the competent public prosecutor's office. If it declares that the conditions of a guarantee (§ 110 StPO) are not available, the guarantee shall be repealed immediately.

(2) In the context of the control of falsified medicinal products, active substances, excipients or documents, the customs authorities may process personal data (§ 4 Z 9 of the Data Protection Act 2000, DSG 2000, BGBl. I n ° 165/1999) and transmit them to the competent law enforcement authorities to the extent that this is necessary for the fulfilment of their legal tasks. "

Section 83 (1) Z 3 reads as follows:

" 3.

Medicinal products shall be placed on the market in accordance with § 17 or § 17a or of a regulation pursuant to § 17 (5a) or (9), "

Section 83 (1) Z 5 reads as follows:

" 5.

Medicinal products shall be issued in breach of § § 57, 58 and 59, or against a discharge authority determined by a regulation pursuant to § 59 (3) or contrary to § 59a (5) or (6) or to the requirements of a regulation pursuant to Section 59a (5) of the Regulation, "

59. In accordance with § 83 (1) Z 5, the following Z 5a is inserted:

" 5a.

Offer a range of products in accordance with § 59a (1) to (3) in distance selling, "

60. In § 83 (1) Z 8, after the expression "§ 62 (1)" the phrase "or § 63a (1)" inserted.

61. § 83 (1) Z 14 reads as follows:

" 14.

the reporting obligation is violated in accordance with § § 75g, 75n or 75q, "

62. In accordance with Section 83 (1) Z 14, the following Z 15 and 16 are added:

" 15.

the activity of a mediator without the conditions set out in Article 71a (1) or in breach of the requirements of a regulation pursuant to Section 71a (3), or

16.

as a mediator of its obligation under Section 94i (5) does not comply. "

63. § 84 para. 1 Z 2 reads:

" 2.

Produces or places on the market medicinal products or active substances which do not comply with the quality requirements of section 4 (1) and (2) or which are contrary to the prohibitions provided for in paragraph 3, "

64. § 84 (1) Z 24, 25 and 25a reads as follows:

" 24.

operate in accordance with § § 62 (1) or 63a (1) contrary to an operating order issued in accordance with Section 62 (1), or fail to comply with a requirement imposed in accordance with § 64 (3), § 66 or § 69 (1) (2) (2) (2) of the Code;

25.

a holding pursuant to section 62 (1) or section 63a (1) without authorization within the meaning of Section 63 (1), Section 63a (2) or § 65 (1) or Article 65 (1), or exceeds an authorization within the meaning of Section 64 (4),

25a.

when the transport of medicinal products or active substances is contrary to the obligations laid down in accordance with Article 62 (1) of this Regulation,

65. In § 84 (1) Z 29 and 30, respectively, after the expression "§ 62 (1)" the phrase "or § 63a (1)" inserted.

§ 85b reads:

" § 85b. The institutions of the Public Security Service have the Federal Office for Health and Security (Bundesamt für Sicherheit im Health) and the institutions pursuant to § 76a above their requests to ensure the exercise of the powers pursuant to § § 47 (6) and (7a), 56a, 67 to 69, 75f, 76 to 76b, 77 until 78b in the context of their legal sphere of action. "

67. In accordance with § 94h, the following § 94i and heading is inserted:

" Transitional arrangements for the Novelle BGBl. I No 48/2013

§ 94i. (1) For proprietary medicinal products which prior to the entry into force of this Federal Law in the version of the Federal Law BGBl. I n ° 48/2013 as a medicinal book monograph in accordance with § 9c and fulfilling the requirements for registration as a traditional herbal medicinal product according to § 12, the documents according to § 12a must be granted in the case of other extinguishing of the marketing authorisation to the Federal Office for Health Security is to be submitted by 2 January 2016 at the latest. If a timely submission does not take place, the products may still be placed on the market until 31 December 2016. The Federal Office for Safety in the Health Care Office has issued a notice of the extinguisher. Until 2 January 2016, the authorisation holder shall submit an application for registration as a traditional herbal medicinal product speciality, thus the authorisation shall remain pending the decision of the Federal Office for Safety in the Health Care of the Registration valid. Proprietary medicinal products already placed on the market at this time may still be handed down until the relevant expiry date of the proprietary medicinal product.

(2) § 17 (5a) in the version of the Federal Law BGBl. I No 48/2013 shall enter into force in the Official Journal of the European Union three years after the publication of the delegated act of the European Commission in accordance with Article 54a of Directive 2001 /83/EC. The Federal Minister of Health has, by regulation, made known the date of publication of the delegated act and the date of entry into force of Section 17 (5a) of the Federal Law Gazette II.

(3) § § 59 (10) (1) and (59a) (1) to (4) in the version of the Federal Law BGBl (Federal Law Gazette). No 48/2013 shall enter into force one year after the publication in the Official Journal of the European Union of the implementing acts of the European Commission pursuant to Article 85c (3) of Directive 2001 /83/EC. The Federal Minister of Health has, by regulation, made known the date of publication of the implementing acts and the date of entry into force of Sections 59 (10) (1) and (59a) (1) to (4) of the Bundesgesetzblatt (Bundesgesetzblatt) Part II.

(4) Companies within the meaning of § 62 (1), which produce, control or place on the market active substances and before the entry into force of this Federal Law in the version of the Federal Law BGBl. No 48/2013 pursuant to Section 63 (1) of this Regulation shall be deemed to be granted in accordance with Section 63a (2).

(5) Pharmaceutical mediators who are engaged in their activities before the entry into force of this Federal Law, as amended by the Federal Law BGBl. I n ° 48/2013 have begun, must be within two months after the proclamation of the Federal Law BGBl. I n ° 48/2013 at the Federal Office for Health Security in accordance with § 71a of the German Federal Office for Health and Safety. "

68. § 96 (2) (2) (2) reads:

" 2.

§ 76b-if it is a guarantee or seizure in the proceedings according to the Code of Criminal Procedure 1975 (StPO), BGBl. No. 631)-and § § 82b, 82c and 85a of this Federal Law is the Federal Minister for Justice, "

(69) § 96 (2) the following Z 3 is added:

" 3.

§ 82d is the Federal Minister of Finance "

70. The point at the end of Section 97 Z 29 shall be replaced by an accoration, the following Z 30 shall be added:

" 30.

Directive 2011 /62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001 /83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into force of falsified medicinal products Medicinal products in the legal supply chain, OJ L 124, 20.4.2002 No. OJ L 174, 01.07.2011 S 74. "

Article II

Amendment of the Health and Food Safety Act

The Health and Nutrition Security Act-GESG, BGBl. I No 63/2002, as last amended by the Federal Law Gazette (BGBl). I No 112/2011, shall be amended as follows:

1. The point at the end of Section 6a (1) Z 8 shall be replaced by an accoration, the following Z 9 shall be added:

" 9.

the monitoring of the supply of medicinal products for human use by means of distance marketing by public pharmacies in accordance with § 59a of the Medicines Act. "

2. In accordance with Section 12a (1), the following paragraph 1a is inserted:

" (1a) (1) with regard to the payment of the levy by self-calculation, no application shall be made, provided that the respective legal representation of the person concerned by the surrender is due to an agreement with the Federal Office for Security in the Health care the levy for its members in the form of an annual fee. The amount of the annual fee is to be based on the revenue expected to be achieved by means of self-calculation. "

Article III

Amendment of the New-Psychoactive-Substances-Act

The New-Psychoactive-Substances-Act, NPSG, BGBl. I No 146/2011, shall be amended as follows:

1. In § 5 (1) the word order shall be "unless an confiscation pursuant to § 26 StGB (German Civil Code) takes place" through the phrase "if not already the conditions for confiscation pursuant to § 26 StGB (German Civil Code)" replaced.

2. § 5 (2) reads:

" (2) For the proceedings, § § 443 to 446 of the Code of Criminal Procedure 1975 (StPO), BGBl. No. 631/1975, corresponding. For the application of the StPO, a new psychoactive substance shall be treated as an object, the possession of which is generally prohibited. "

3. § 7 together with headline reads:

" Seizection authority and information requirements of the customs authorities

§ 7. (1) When certain facts indicate that new psychoactive substances are transported to or from Austria for the purpose of achieving a psychoactive effect in the human body, the following shall be: Customs authorities have the power to ensure that they are safe. They shall report immediately to the competent public prosecutor's office. If it declares that the conditions of a guarantee (§ 110 StPO) are not available, the guarantee shall be repealed immediately.

(2) In the context of the control of new psychoactive substances, the customs authorities may process personal data (§ 4 Z 9 of the Data Protection Act 2000, DSG 2000, BGBl. I n ° 165/1999) and transmit them to the competent law enforcement authorities to the extent that this is necessary for the fulfilment of their legal tasks. "

Article IV

Amendment of the Anti-Doping Federal Act 2007

The Anti-Doping Federal Act 2007-ADBG 2007, BGBl. I n ° 30/2007, as last amended by the Federal Law BGBl. I n ° 146/2009, shall be amended as follows:

In the first sentence of section 22b (1), the word shall be deleted. "provisional" as well as the last sentence.

Fischer

Faymann