Read the untranslated law here: http://www.ris.bka.gv.at/Dokumente/BgblAuth/BGBLA_2013_I_48/BGBLA_2013_I_48.html
48. Federal law be changed with the medicines Act, the health and food safety Act, the new psycho-active substances Act and the anti-doping Act 2007
The National Council has decided:
Amendment to the medicines Act
The medicines Act-AMG, BGBl. No. 185/1983, amended by Federal Law Gazette I no. 114/2012, is amended as follows:
1. paragraph 1 para 1 and 2:
"(1)"medicinal product"(substances or preparations from the 1 to the application materials are in the or on the human or animal body and as having properties for treating or alleviating or for the prevention of human or animal diseases or pathological symptoms are determined, or 2. in the or applied to the human or animal body or administered to a human or an animal can, to either a) physiological functions by exerting a pharmacological" , immunological or metabolic action to restore, correct, or influence, or b) to serve as a basis for a medical diagnosis.
(2) medicinal products are items which contain a medicine or on which a medicinal product is applied and on or in the human or animal body intended for the application are."
2. § 1 par. 4 Z 1 and 2 is: "1 chemical elements, natural chemicals and chemical compounds obtained by processing on synthetic way, 2. plants, plant parts and plant components in any form, including materials obtained by extraction," 3. after are section 1 paragraph 4 following paragraph 4a and 4B:
"(4a)"Agents"are substances or mixtures of substances which are intended to be used in the manufacture of a medicinal product, and to be effective constituents of the medicinal product to active when they are used in drug manufacturing.
(4B) "Agent" is any part of a pharmaceutical product with the exception of the active substance and of the packing material. "
4. According to section 1, paragraph 24 be added following paragraph 25 and 26:
"(25)"Falsified medicinal product"is any medicinal product, in which the following has been forged: 1 his identity, including its packaging and labeling, its name or its composition on any components, including the AIDS and the content of these components, or 2 his origin, including manufacturer, country of origin, country of origin and authorisation or registration holder, or 3. the records and documents relating to the used channels."
"(26)" counterfeit "is an active substance, in which the following has been forged: 1 the labelling on the container with respect to the actual content, or 2. the records and documents relating to the participating manufacturers or the used channels."
5. paragraph 2 paragraph 3a:
"(3a)"Medicinal agents"one is economic area established who is authorized to carry on the business of the mediation of medicinal products for human in a Contracting Party to the European."
6 § 2 paragraph 3a is inserted after the following paragraph 3 b:
"(3B)"Bulk goods"is a drug that must be only bottled or packaged, to become the final product."
7 be inserted following paragraph 7a and 7B. According to section 2 paragraph 7:
"(7a)"Distance"means a contract using one or more means of communication.
(7B) "Means of communication" are means of communication which can be used to allow in particular printed materials with or without address, catalogues, press advertising with order form, prefabricated standard letters, long distance with people or machines as interlocutor, radio, Videophone, facsimile, tele-shopping, as well as publicly available electronic media, individual communications such as the Internet or electronic mail to the conclusion of a contract, without the simultaneous physical presence of the parties. "
8 paragraph 2 paragraph 10:
"(10) is"Manufacture"winning, the making of, the preparation, the working or processing, transfer including filling and packaging of medicinal products or active substances and marking of medicinal and investigational."
9 § 2 paragraph 11, first sentence, is:
"" Placing on the market"is the holding, the offering for sale or the transfer of drugs or substances."
10. in article 2, paragraph 13a is inserted after the word "Drug" the phrase "or agents".
11. According to section 2 paragraph 15 the following paragraph 15a is inserted:
"(15a)"Brokering of medicinal"are all activities with the exception of the wholesale trade, in connection with the supply or purchase of medicinal products, which consist of independently and on behalf of another natural or legal person to negotiate without obtaining ownership of these medicines or to deal physically with these drugs."
12 paragraph 2 paragraph 18:
"(18)"Effectiveness"is the suitability of a medicinal product, to fulfill the purposes referred to in article 1, paragraph 1."
13 paragraph 2 paragraph 21:
"(21)"Intermediate"is a drug that must go through one or more stages to become the bulk goods."
14. in the section 4, paragraph 1 and 2, and article 6, paragraph 1, the phrase 'or agents' is inserted each after the word "Drug".
15 in § 4 par. 2 Z 1, the phrase is "the pharmacopoeia Act, Federal Law Gazette No. 195/1980," by the phrase "of the 2012 Pharmacopoeia Act, Federal Law Gazette I no. 44/2012," replaced.
16 in section 4 paragraph 2, the expression "Pharmacopoeia Act" No. 2 is replaced by the expression "Pharmacopoeia Act 2012".
17 in § 5 para 1 and article 6 par. 2 "Medicinal" inserted each after the word the phrase 'or agents'.
18 § 6 para 3 No. 1 is: "1. the medicinal efficacy or active ingredients, a property is attached, which is not sufficiently covered according to the current state of scientific knowledge or practical experience, or" 19. According to § 9a, para 1 No. 11 following Z 11a is inserted: '11a.
for human medicinal products manufacturer, written confirmation that he has; verifies the observance of good manufacturing practice for active substances through the local active ingredient manufacturers and found through audits the confirmation must include also the date of the audit,"20 § 9 c first sentence reads:
"An application for approval of a pharmaceutical speciality, a monograph of the pharmacopoeia in the sense of § 1 of the pharmacopoeia Act 2012 is equivalent to, but not the conditions of section 7 paragraph 2 is met, not in section 7 paragraph 9 and is subject to a registration in accordance with article 12 is not, documents pursuant to § 9a, para 1, no. 8, 12 to 15, 18 to 21, 24 to 27 and 29 to 31 must not be attached."
21. According to article 17, paragraph 5, the following paragraph 5a is inserted:
"(5a) on the outer packaging of medicinal products intended for use in humans, are to install security features, as well as a device to detect a possible manipulation of the outer packaging, provided that this article 54a of Directive 2001/83/EC on the Community code relating to medicinal products, OJ" No. L 311 of 28.11.2001 S 67, as last amended by the directive of 2011/62/EC, OJ No. L 174 of 01.07.2011 prescribed S 74, or determined on the basis of article 54a of the Directive 2001/83/EC. The Federal Minister for health, unless this is necessary for reasons of safety or compliance with Union legal obligations, which human medicinal products security features need to wear or not wear, as well as requirements over type, composition, properties, specifications, and other validation of security features in context more detailed provisions relating to the safety characteristics to adopt, in particular,".
22 § 17 para 6 first sentence reads:
"Paragraphs 1 to 3, 5 and 5a do not apply subject to the Z 1 of this paragraph for radioactive medicinal."
23. in § 17 paragraph 9 replaced the expression "para 1 to 5" with the expression "Paragraph 1 to 5a".
24 § 18B be added following paragraph 4:
"(4) the competent authority within the meaning of Regulation (EC) no 1394/2007 of the European Parliament and of the Council of 13 November 2007 on orphan medicinal products for advanced therapies and amending Directive 2001/83/EC is the Federal Office for security in the health care sector."
25 § 53 ABS 1 Z 13 is: "13 to work towards, to obtain prescription medicines at a distance."
26. pursuant to § 57 para 1 No. 6 following Z 6a is inserted: '6a.
"the Federal Ministry of the Interior, the he subordinate authorities and care facilities for emergency care, prevention and care operations, unless they need the drug to carry out their tasks," 27. In article 59 paragraph 2, the word "Authorisation holder" is replaced by the word "Holder of the registration".
28. in section 59 paragraph 9, the word "Order" is replaced by the word "Distance".
29 section 59 be added following paragraph 10 and 11:
"(10) the remote sales ban in accordance with paragraph 9 shall not apply to Austrian-registered or registered non-prescription human medicinal, by way of the remote paragraph 1 within Austria through public pharmacies, or 2.
be delivered to Austria through pharmacies another EEA Contracting Party, which are authorised under the applicable legislation to do so.
(11) the remote sales ban in accordance with section 9 does not apply to human medicinal products which comply with national legislation an EEA Contracting Party other, if they are there available without prescription, issued by way of distance selling through community pharmacies in the area these EEA Contracting Party."
30 according to section 59, the following article 59a and heading shall be inserted:
§ 59a. (1) that allowed dispensing of human medicinal means of distance selling in accordance with section 59 para 10 Z 1 and paragraph 11 only through public pharmacies be used to satisfy the requirements laid down in paragraph 2 and 3.
(2) public pharmacies who intend to offer human medicinal products for sale to the public by way of distance selling, the Federal Office for security in the healthcare sector, specifying the name of the operator and the address to show the date of the commencement of the activity and the address of the Web pages used for this purpose including all information to identify have this prior to commencement of the activity. Changes to this information must be reported immediately.
(3) paragraph 2 need to Web pages in accordance with at least 1 the address and other contact data of the Federal Office for security in the healthcare sector have, 2 on each side of the Web page that refers to the offer of sale of human medicinal products by distance, the common logo under article 85 c paragraph 3 of Directive 2001/83/EC, which must include a link to the list in accordance with paragraph 4 No. 3 , clearly show, and 3 have a connection to the Internet portal of the Federal Office for security in health care in accordance with § 27 para. 4.
(4) the Federal Office for security in the health care sector has over the Internet portal in accordance with § 27 para. 4 to provide at least the following information: 1 information to the paragraph 3 of Directive 2001/83/EC, 3. a list of community pharmacies in accordance with information about the purpose of the common logos under article 85 c to be applied to the offer to the public for the sale of human medicinal products by distance selling legislation, 2nd para 1 as well as the addresses of their Web pages , 4. information on the risks for the health and the lives of people through human medicinal products illegally emitted by way of distance selling to the public, and 5 an overview of the EEA Contracting Parties where the dispensing of medicines through distance comparable security standards are the Austrian provisions updated at regular intervals.
(5) human medicinal products, which are delivered through distance, may be sent only in a quantity corresponding to normal personal needs and are said to Pack 1, transport and was to deliver, that their quality and effectiveness is not affected, and demonstrably be issued to 2nd person, communicated to the pharmacy public by the principal of the order of the.
(6) in the part of the ordering process a consultation about any interactions has to be carried out in accordance with the technical availability e-medication in accordance with § 16a Gesundheitstelematikgesetz 2012, Federal Law Gazette I no. 111/2012, to use it. The Federal Minister of health has further arrangements, from the technical availability by way of distance selling in the e-medication in accordance with § 16a Gesundheitstelematikgesetz 2012 to include also the purchase of medicinal products by regulation.
(7) the Federal Minister for health has further provisions with regard to the requirements for the distribution of human medicinal products through distance and their shipment, in particular about the order process, packaging, transport, storage, delivery, collection, adopted ensuring the pharmaceutical consulting and the need for a quality assurance system under consideration on the drug safety regulation.
31 paragraph 62 paragraph 1:
"(1) as far as it is necessary for the health and life of humans or animals required characteristics of the medicinal products or active substances and the supply of medicinal products or active substances to ensure that the Federal Minister of health has internal rules for businesses that manufacture medicinal products or active substances, control or bring in traffic, to adopt by regulation."
32. § 62 para 2 Nos. 1 and 2 is: "1. public pharmacies, in the framework of usual pharmacy operations in accordance with the pharmacy operating regulations 2005, BGBl. II manufacture No. 65/2005, amended, medicines, check or bring in traffic, checking 2. institution pharmacies that 2005 to medicines, within the framework of the usual pharmacy operation in accordance with the operational rules of the pharmacy or bring in traffic," 33. According to § 62 para 2 shall be inserted following paragraph 2a to 2 c:
"(2a) if public pharmacies give medicines through the normal operation of the pharmacy, at other public pharmacies, institution pharmacies or hospitals, it a corresponding permit pursuant to § 63 para 1. require This also applies to institution pharmacies that deliver medicines to other institution pharmacies or hospitals, except to those who operates the respective institution pharmacy.
(2B) at the Neuverblisterung of medicines an operating licence pursuant to § 63 para 1 for public pharmacies or institution pharmacies is required unless the neuverblisterten medicines are given to a beyond the usual operation of the pharmacy number of persons.
(2c) where is assessment of exceeding the usual pharmacy operation referred to in paragraph 2a and 2B - if applicable - particularly to examine: 1 the production and distribution volume of pharmaceutical products, 2. the hazard potential of the production process, 3. the frequency of deliveries of medicines, and 4. the number of with neuverblisterten drugs an average persons per year provided.
The Federal Office for security in the health care sector has taking on drug safety and the technical and personnel facilities of a public pharmacy or agency Pharmacy regulation more to enact regulations for the examination and assessment of the criteria referred to in no. 1 to 4. The regulation is to be published on the website of the Federal Office for security in healthcare. The Federal Office for security in healthcare has exceeding the usual pharmacy operation with notice to determine."
34. § 62 para 3 No. 1 is: "1. manufacture, placing on the market, import and export of medicinal products or active substances," 35. Article 62 par. 3 No. 2 is: "2. nature and extent of inspection of medicinal products or substances, such as lead a control laboratory," 36. According to article 62, paragraph 3, the following paragraph 3a is inserted:
"(3a) in the regulation referred to in paragraph 1 may the Federal Minister of health in consultation with the Federal Minister of finance to implement Union legislation adopted customs surveillance at the import and export of substances, to ensure these comply with the good manufacturing and distribution practices for active ingredients. It may also be stipulated which substances within the meaning of Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and the common customs tariff, OJ No. L 256 07 09 1987 S 1, as last amended by the Regulation (EU) No. 155/2012, OJ No. L 50 of the 23.02.2012 come p. 1, for the monitoring by the customs in question."
37. in section 63 para 1, "Medicinal" is inserted after the word the phrase "or of medicines and drugs".
38. under article 63, the following article 63a is inserted:
"section 63a. (1) establishments in accordance with section 62, paragraph 1, which produce only active ingredients, bring in traffic or control, have to make an application for a permit at least 60 days before the intended commencement of their activity at the Federal Office for security in healthcare. The application documents shall be attached, which have to contain at least the following information: 1. name or business name and permanent address, 2. substances to be manufactured, placed on the market or controlled, and 3. information about the premises and technical equipment.
(2) the Federal Office for security in the health care sector can perform an operations review the applicant on the basis of a risk assessment. If the Federal Office for security in healthcare announces an operations review the applicant within 60 days of receipt of the documents referred to in paragraph 1, the activity may be made on only after permit of the Federal Office for security in healthcare. The Federal Office for security is evident in health care within a period of 60 days, the request shall be deemed approved. If the conditions for approval are not met, the Federal Office for security in the health care sector has to determine this by decision.
(3) any changes that may affect the quality or safety of the manufactured, marketed, or controlled substances, shall require a permit of the Federal Office for security in healthcare.
(4) §§ 64-66a, 67 paragraph 1 with respect to the periodic review, 69 and 71 apply to establishments referred to in paragraph 1, mutatis."
39. in § 64 para 1 and 3, article 65, paragraph 1 and article 66 the phrase 'or agents' is inserted each after the word "Drug"."
40. paragraph 64 paragraph 5:
"(5) the Federal Office for security in healthcare has the data about the approval for the production and the placing on the market of medicinal products or substances in accordance with section 63, paragraph 1, section 63a, paragraph 2 or 3, or section 65 paragraph 1 into the database of the Union in accordance with article 111 paragraph 6 of Directive 2001/83/EC to enter."
41. According to section 66a, the following paragraph is inserted 66B:
"§ 66 b." The authorisation in accordance with article 65, paragraph 1, article 63, paragraph 1 or section 63a, paragraph 2 or 3 should be repealed if the holder of the operating licence is waived for this."
42. paragraph 67 paragraph 1:
(1) that has Federal Office for security in health care establishments in accordance with article 62, paragraph 1 prior to issuance of a permit in accordance with article 63, paragraph 1, or, if necessary, prior to issuance of a permit in accordance with article 65, paragraph 1, and subsequently on the basis of a risk assessment periodically to check whether the provisions of this section or the regulations adopted on the basis of this section are met and the necessary for the health and life of humans or animals nature of medicinal products or active substances is guaranteed. The Federal Minister of health may authorize the provincial governors through regulation, to check such types of operations in the concerned State, where this is justified on the basis of the product range in terms of drug safety."
43. in article 67 par. 2 and 3, the phrase 'or agents' is inserted each after the word "Drug".
44. paragraph 67 paragraph 4:
"(4) the Federal Office for security in the health care sector can perform in third countries operating inspections of manufacturers of medicinal products, to determine whether they were produced in accordance with standards and controls, which are at least equivalent to the standards of good manufacturing practice laid down by the European Union. The Federal Office for security in the health care sector can perform in the presence of suspected reasons of a breach of the requirements of this section or the regulations adopted on the basis of this section when for manufacturers established in third countries or distributors of drugs operation checks. The Federal Office for security in the health care sector has to cooperate with the Agency in coordinating operation checks in third countries and to inform them about the planned and conducted operation checks."
45. According to article 67, paragraph 4 shall be added following paragraph 5 to 7:
"(5) the Federal Office for security in the health care sector can produce the excipients in the presence of suspected reasons of a breach of the provisions of this section or the regulations adopted on the basis of this section on farms, or introduce, perform operating checks. The Federal Office for security in the health care sector can perform also in the premises of the marketing authorisation holders, holders of registration or medicinal intermediaries operating checks.
(6) operation can performs checks in accordance with paragraph 1 and 4, as well as operating checks pursuant to paragraph 5 of establishments that produce AIDS or introduce, also at the request of another Member State, the Commission or the Agency. Without prejudice to any agreements concluded between the European Union and countries which are not Contracting States of the agreement on the European economic area, the Federal Office for security in the healthcare sector, may ask to a manufacturer in the country, which is not a Contracting State of the agreement on the European economic area, to undergo a review of operation according to the specifications of the European Union
(7) the Federal Office for security in the health care sector has of plants, medicinal, or 2. 1 active ingredients, make check or bring carried out according to the guidelines of the European Commission article 111a of Directive 2001/83/EC and thereby cooperate with the Agency through exchange of information on planned and conducted operation checks in traffic. operating checks"
46. § 68 para 1 Nos. 1 and 2 are: "1. establishments referred to in article 62, paragraph 1 and 2 equipment and means of transport of such establishments, have been commissioned by establishments referred to in article 62 par. 1 of the storage or transport if they can be used for the storage or transport of medicinal products or active substances," 47. § 68 para 4 second sentence reads:
"The writings have 51 of Directive 2001/82/EC or article 111a of Directive 2001/83/EC to content of the guidelines published by the Commission pursuant to article."
48. paragraph 68 para 5:
"(5) the Federal Office for security in the health care sector has to issue a certificate about 90 days after completing a review of the operation, if the operations review has revealed that the company complies with the provisions of this section, the regulations adopted on the basis of this section and of the operating licence. 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 to have the form and content of the certificate. If these conditions are not fulfilled, the Federal Office for security in the health care sector has to determine this within the period by a decision. The certificate is to take back, if it is later known that the conditions have not been. It is to be revoked if the conditions are no longer met."
49. § 68 para 5 is added the following paragraph 6:
"(6) the Federal Office for security in the health care sector has to enter the certificates issued by him in accordance with paragraph 5 to the database of the Union in accordance with article 111 paragraph 6 of Directive 2001/83/EC. In this database, the Federal Office for security in healthcare has also information about businesses that this federal law or regulations adopted on the basis of this Federal Act do not comply with the regulations, to enter. This applies also for the registration and deletion of medicinal agents."
50th under § 71, the following article 71a and heading shall be inserted:
section 71a. (1) a drug agent who has a seat in Austria, has to sign his name, the company name and his permanent address the Federal Office for security in healthcare. Any modification of this data is reported by the medicinal agents to immediately. The Federal Office for security in the health care sector has to keep a record about the messages of medicinal agents. This is to make publicly available on the website of the Federal Office for security in healthcare.
(2) the Federal Office for security in the health care sector has an endorsement to exhibit at the request of the registration. The registry is by a decision to deny or delete if the specified conditions are not met in this federal law or on the basis of a regulation adopted pursuant to this Federal Act or have subsequently disappeared.
(3) the Federal Minister for health may adopt further provisions with regard to the requirements for the activities of the brokering of medicinal through regulation, in particular on documentation requirements and measures of quality assurance."
51. the heading of § 75q is as follows:
"Lack of quality, counterfeit medicines"
52. According to § 75q section 7 the following paragraph 8 is added:
"(8) paragraph 2 to 4, 6 and 7 shall apply for fake medicines mutatis mutandis."
53. the heading before section 77 is as follows:
"Monitoring and protection measures"
54. the following sentence is added to § 78a:
"For the compulsory enforcement of a provisional seizure § is at 78 b."
55. According to Article 78a, the following paragraph is inserted 78 b:
"§ 78. refuses to tolerate the business or business owner or his authorised representative, the surveillance provided for in this federal law or protective measures are, this can be enforced."
56. in the XIII. section b are inserted after the section heading "Sanctions" following §§ 82 until 82d including headings:
"Judicially punishable acts
Article 82 b (1) who is drugs, active ingredients, or excipients with the intentional fakes (§ 1 para. 25 and 26), that it be left to another one, to punish up to three years imprisonment.
(2) is also to be punished, who offers another fake pharmaceuticals, active ingredients, or excipients, gives or leaves or with the intent of stock holds off, or introduces that it be left to another.
(3) a person who commits an offence under subsection 1 or 2 as a doctor, dentist, veterinarian, pharmacist, dentist or midwife, is to punish up to five years imprisonment.
(4) likewise is to punish, who according to paras 1 or 2 with the intention of commits an offence, to gain a continuous revenue through their recurring inspection and is ever been sentenced for such an offence.
(5) a person who commits the offence (para. 4) as a doctor, dentist, veterinarian, pharmacist, dentist or midwife, is to punish up to ten years imprisonment.
(6) the offence has under paragraph 1 or 2 the death or serious bodily injury (article 84, paragraph 1 StGB) a greater number of people, the perpetrators with imprisonment of five shall be punished up to fifteen years.
(7) who is the trade package or another document, that refers to a medicinal product, a substance or an excipient, forges with the intent, or falsified, that the document to will, used to defer to another fake pharmaceuticals, active ingredients, or excipients, — if the perpetrator not under paragraph 1 or 2 to punish is - to punish with imprisonment up to one year.
(8) who entices another to do this or else contributes, that this him or a member (§ 72 StGB) fake medicines gives, so that they are applied on him or the family, is not to punish according to para 1 to 7.
§ 82c. (1) fake medicines, active ingredients, excipients and documents (§ 82 para 7 b) are - if not already the requirements of confiscation pursuant to section 26 of the Criminal Code - also retract, when no specific person for an offence under section tracked 82 b or may be sentenced, unless because or the designated make believable a lawful purpose and provides guarantee that is brought to the medicinal product, the active ingredient, the excipient or document not in traffic.
(2) for the procedure are the sections 443 to 446 of the code of criminal procedure (StPO), Federal Law Gazette 1975 No. 631/1975, in accordance with. For the application of the Ccrp fake medicines, drugs to treat AIDS and documents as objects, which owns is generally prohibited.
Back-up power and obligations of customs authorities
§ 82d. (1) if certain facts to suggest, that fake pharmaceuticals, active ingredients, excipients or documents (§ 82 para 7 b) be transported to / from Austria, so are the Customs authorities empowered to ensure this. By ensuring they have to report to the competent public prosecutor's Office without delay. This, explains that the requirements of ensuring (§ 110 StPO) are not available, is to repeal the guarantee immediately.
"(2) in connection with the control of counterfeit 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, Federal Law Gazette I no. 165/1999) and these provide the competent law enforcement authorities, as far as this is necessary to fulfil their statutory task."
57. § 83 para 1 No. 3 is: "3. medicinal para 5a or 9 in traffic brings contrary to section 17 or section 17a or a regulation referred to in article 17,' 58. § 83 para 1 is Z 5:" 5. drug contrary to the sections 57, 58 and 59 or contrary to a tax authority established by Regulation pursuant to article 59, paragraph 3, or contrary to section 59a para 5 or 6 or the requirements of a regulation in accordance with section 59a para 5 is out ', ' 59. Following Z 5a is inserted after article 83, paragraph 1 Z 5: '5a.
Medicinal offers, contrary to section 59a para 1 to 3 in respect of distance contracts' 60. In § 83 para 1, Z 8 the phrase "or section 63a, paragraph 1" is inserted after the expression "section 62, paragraph 1".
61. § 83 para 1 Z 14 is: '14 the reporting obligations pursuant to §§ 75 g, 75n or 75q injured,' 62. According to article 83, paragraph 1 Z 14 following Nos. 15 and 16 are attached: "15 carries out the activity of a medicinal agent without the conditions pursuant to section 71a, paragraph 1 or contrary to the requirements of a regulation in accordance with section 71a, para 3, or 16 as medicinal agent of his obligation according to § 94i, subsection 5 does not comply with."
63. section 84 subsection 1 No. 2 is: "2. manufactures medicinal products or active substances or bring in traffic of § 4 para 1 and 2 do not comply with the quality requirements or contravenes the prohibitions of section 3," 64. Article 84, paragraph 1 Z 24, 25 and 25a is: "24 an operation in the sense of leading articles 62, paragraph 1 or 63a para. 1 contrary to an operational rules adopted pursuant to article 62, paragraph 1 or one pursuant to § 64 3 , section 66 or section 69, paragraph 1 Z 2 does not meet prescribed rest, section 1 or section 63a paragraph 1 without a permit within the meaning of § 63 leads 25 a company within the meaning of § 62 para 1, section 63a, paragraph 2 or article 65, paragraph 1 or a permit within the meaning of § 64 paragraph 4 exceed 25a.
as with the transport of medicinal products or active substances of officer contravenes the obligations incumbent on the basis of a regulation in accordance with article 62, paragraph 1"65. In the section 84, paragraph 1, Nos. 29 and 30 is respectively inserted the phrase "or section 63a, paragraph 1" after the expression "section 62, paragraph 1".
66. paragraph: 85b
"§ 85 b." The Federal Office for security in the health sector and the institutions according to § 76a over their request to secure the exercise of powers pursuant to §§ 47 paragraph 6 and 7a, 56a, 67 to 69, 75f, 76-76 b, 77 to 78 b in the context of their legitimate sphere of competence help to have the organs of public security."
67. According to § 94 h is inserted 94i the following section together with the heading:
"Transitional provisions to the Act Federal Law Gazette I no. 48/2013"
§ 94i. (1) for medicinal products, which prior to this Federal Act in the version of Federal Law Gazette I no. 48/2013 as Pharmacopoeia monograph according to § 9 c were approved and meet the requirements for registration as traditional herbal medicinal pursuant to § 12, must be submitted the documentation referred to in § 12a at other termination of authorisation 2. January 2016 the Federal Office for security in the healthcare sector at the latest. No timely template, takes place the products may be brought until the expiry of the 31 December 2016 in traffic. The Federal Office for security in healthcare has the extinction by ruling to determine. Holder of the authorisation submits an application for registration as traditional herbal medicinal, 2nd January 2016 the authorisation remains valid until the decision of the Federal Office for security in healthcare through the application to the registry. Medicinal products installed at this time already may be placed further in traffic until the relevant expiry date of the medicinal.
(2) § 17 paragraph 5a in the version of Federal Law Gazette I no. 48/2013 effective three years after the publication of the delegated Act of the European Commission in accordance with article 54 of Directive 2001/83/EC in the official journal of the European Union. The Federal Minister of health has by regulation paragraph 5a in the Federal Law Gazette Part II to make known the date of publication of the delegated Act, as well as the date of application of article 17.
(3) pursuant to sections 59, para 10 Z 1 and 59a par. 1 to 4 as amended by Federal Law Gazette I no. 48/2013 apply one year after the publication of implementing acts of the European Commission in accordance with article 85 c (3) of Directive 2001/83/EC in the official journal of the European Union. The Federal Minister of health has by regulation to make known the date of publication of the implementing acts, as well as the date of application of article 59 paragraph 10 Z 1 and 59a par. 1 to 4 in the Federal Law Gazette Part II.
(4) enterprises within the meaning of section 62, paragraph 1, the active ingredients make, check or bring in traffic and were granted before entry into force of this federal law as amended by Federal Law Gazette I no. 48/2013 pursuant to § 63 para 1, deemed to be granted in accordance with article 63a, par. 2.
(5) pharmaceutical intermediaries who I no. 48/2013 have begun their activity before entry into force of this federal law in the version of Federal Law Gazette, must register within two months after the announcement of the Federal Act Federal Law Gazette I no. 48/2013 at the Federal Office for security in the health service in accordance with section 71a."
68. § 96 para 2 subpara 2 is: "2. § 76b - provided is a guarantee or seizure in proceedings according to the code of criminal procedure (StPO), BGBl. No. 631, 1975 - and § 82, 82c and 85a of this Federal Act § the Federal Minister for Justice," 69. Article 96 par. 2 3 is appended following Z: '3. § of the 82d is the Federal Minister of finance' 70. The point is replaced at the end of article 97 Z 29 by a comma, following Z 30 is appended: "30 the directive 2011/62/EC of the European Parliament and of the Council of 8 June 2011 for amending the Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of counterfeit drugs entering the legal supply chain, OJ" "No. L 174 of 01.07.2011 S 74."
Change of health and food safety act
The health and food safety act - GESG, Federal Law Gazette I no. 63/2002, as last amended by Federal Law Gazette I no. 112/2011, is amended as follows:
1. the point is replaced at the end of Article 6a, paragraph 1 Z 8 by a comma, following Z 9 shall be added: "9 monitoring distribution of human medicinal means of distance selling through public pharmacies in accordance with section 59a of the medicinal products act."
2. According to section 12a paragraph 1, the following paragraph 1a is inserted:
"(1a) section 1 with respect to the payment of duty by self calculation does not apply, unless the respective legal advocacy of the taxpayer on the basis of an agreement with the Federal Office for security in the health service pay the poor for their members in the form of an annual contract. The amount of the annual allowance has to be in aligned with revenue expected to be achieved in the way of calculating self."
Amendment to the new psycho-active substances Act
The new psycho-active substances Act, NPSG, Federal Law Gazette I no. 146/2011, is amended as follows:
1 in § 5 para 1, the phrase is replaced "if not already a confiscation of the criminal code takes place pursuant to section 26" "if not already the requirements of confiscation StGB § 26" with the phrase.
2. paragraph 5 paragraph 2:
"(2) for the procedure are the sections 443 to 446 of the code of criminal procedure (StPO), Federal Law Gazette 1975 No. 631/1975, in accordance with. Is for the application of the StPO a new psycho-active to treat substance as subject, which owns is generally prohibited. "
3. paragraph 7 together with the heading:
"Freezing powers and obligations of the Customs authorities
7. (1) if certain facts that suggest that new psychoactive transported substances in order to / from Austria, that they be applied to achieve a psychoactive effect in the human body, so the Customs authorities are authorized to ensure this. By ensuring they have to report to the competent public prosecutor's Office without delay. This, explains that the requirements of ensuring (§ 110 StPO) are not available, is to repeal the guarantee immediately.
"(2) in connection with the control of new psycho active substances, the Customs authorities may process personal data (§ 4 Z 9 of the data protection Act 2000, DSG 2000, Federal Law Gazette I no. 165/1999) and these provide the competent law enforcement authorities, as far as this is necessary to fulfil their statutory task."
Amendment of the anti-doping - Federal Act 2007
The anti-doping - federal law 2007 - ADBG 2007, Federal Law Gazette I no. 30/2007, amended by the Federal Act Federal Law Gazette I no. 146/2009, is amended as follows:
In section 22b 1 accounts for in the first sentence the word "preliminary" and the last sentence.
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