Change Of The Medicines Act, The Drug Importation Act 2010, Tissue Safety Act, The Prescription Law And The Health And Food Safety Act

Original Language Title: Änderung des Arzneimittelgesetzes, des Arzneiwareneinfuhrgesetzes 2010, des Gewebesicherheitsgesetzes, des Rezeptpflichtgesetzes und des Gesundheits- und Ernährungssicherheitsgesetzes

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162. Federal law amending the Medicines Act, the Proprietary Medicinal Products Import Act 2010, the tissue safety law, the prescription law and the health and nutrition security law

The National Council has decided:

Article 1

Amendment of the Medicines Act

The Medicines Act-AMG, BGBl. No. 185/1983, as last amended by the Federal Law BGBl. I No 48/2013, shall be amended as follows:

1. § 1 (3) Z 1 reads as follows:

" 1.

Foodstuffs as referred to in Article 2 (1) and (2) of Regulation (EC) No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures on food safety, OJ C No. 1), as last amended by Regulation (EC) No 596/2009, OJ L 327, 30.4.2009, p. No. OJ L 188, 18.7.2009, p. 14,

2. § 1 para. 3 Z 9 reads:

" 9.

Substances or preparations of substances which are intended solely for the purpose of being applied in accordance with complementary medicinal methods, provided that they are not intended to fulfil the purposes of paragraph 1, unless it is appropriate to do so by: in respect of substances or preparations made of substances which are manufactured in accordance with homeopathic principles and methods of process, "

The second sentence of Section 2b (1) reads as follows:

"adverse reaction" of a veterinary medicinal product is a harmful and unintended reaction to the medicinal product which occurs at doses such as those normally used in animals for the prophylaxis, diagnosis or treatment of diseases or for the modification of a medicinal product. physiologic function. "

4. In § 7a (1), the word "approved" by the word "Approved" replaced.

5. In § 10 para. 3, the quote shall be "§ 24 (13)" by quoting " 14 " replaced.

6. In Section 10 (4) (2) (2), the quote is deleted "pursuant to § 24 (2) Z 7" .

7. § 10 (6) reads:

" (6) In the case of an amendment for a new application area of a medicinal product for human use, non-clinical or clinical studies relating to the new field of application of a well-established active substance have been carried out by the The Federal Office for Health and Safety (Bundesamt für Sicherheit im healthcare pursuant to paragraph 14) has been deemed to have been regarded as important in the case of an application in accordance with § 10 or Regulation (EC) No 1234/2008 concerning the examination of changes in the authorisation of medicinal products for human and veterinary use, OJ L 145, 31.5.2008. No. 7. as amended by Regulation (EU) No 712/2012, OJ L 327, 28.12.2012, p. No. OJ L 209, 4.8.2012 p. 4, one year not to be referred to this data. This exclusivity period cannot be cumulated. "

8. In § 10 para. 13, the quote shall be "pursuant to section 24 (2)" through the phrase "an authorisation" replaced.

9. § 10 para. 14 receives the sales designation "(15)" , according to paragraph 13 of the following paragraph 14 is inserted:

" (14) In the context of the examination of an amendment for a new field of application, the Federal Office for Safety in Health Care has to decide upon request.

1.

whether the new indications of significant clinical benefit are to be considered in comparison with the existing therapies and

2.

whether significant non-clinical or clinical studies have been carried out in connection with the new field of application in the case of an already well-established active substance. "

10. § 10c (4), (5) and (6) are:

" (4) proprietary medicinal products which comply with an authorisation granted in accordance with Regulation (EC) No 726/2004 and (1), (2) and (3), may only be placed on the market if they are accompanied by a German-language marking and use information. , and a German-language specialist information is available and a notification has been made to the Agency and the Federal Office for Safety in the Public Health Service. This report shall contain:

1.

the proof of entitlement to the application in accordance with § 9,

2.

the name and authorisation number of the proprietary medicinal product authorised in accordance with Regulation (EEC) No 726/2004;

3.

the contracting party to the Agreement on the European Economic Area, in which the imported proprietary medicinal product is marketed (home Member State),

4.

the name and address of the marketing authorisation holder;

5.

the name and address of the manufacturer;

6.

the package sizes intended for distribution in Austria,

7.

a declaration that the texts for external packaging, the primary packaging, the package leaflet and the technical information other than company-specific information do not deviate from the text of the labelling, the package leaflet and the technical information provided for in accordance with the Regulation (EEC) No 726/2004 authorised proprietary medicinal products.

A fee shall be paid to the Agency for the verification of compliance with the conditions laid down in Union law on medicinal products and in the marketing authorisations. Their design is governed by European Union law.

(5) The applicant shall be obliged to submit the application as referred to in paragraph 3 at the same time as the marketing authorisation holder or To display the registration holder. The same shall apply to the notification referred to in paragraph 4.

(6) If this is necessary for pharmaceutical safety reasons, the requirements for the labelling in paragraph 3 Z 12 with regard to the primary packaging may be deviated with the consent of the Federal Office for Safety in Health Care. "

11. In Section 15 (1), the word order shall be deleted "pharmacist's own proprietary medicinal products or" .

12. § 15 (6) reads:

" (6) The subject information as well as any change in the subject information in accordance with Regulation (EC) No 1234/2008 or in accordance with § § 24 or 25 shall be published by the Austrian Pharmacists ' Chamber with the participation of the Austrian Medical Association. The publication shall indicate the date of the preparation of the technical information, in the case of a change in the subject information, the date of the last change. "

Article 20 (3a) reads as follows:

" (3a) The Marketing Authorisation Holder The registration holder may request the amendment of the period provided for in paragraphs 2 and 3, which requires the consent of the Federal Office for Safety in the Health Care. "

14. § 21 (2) the following sentence is added:

" The reasons for this measure shall also be stated, in particular whether this measure is taken from the grounds set out in Article 116 or 117 (1) of Directive 2001 /83/EC. The agency should also be informed in the event of the year. "

15. § 24 together with headline reads:

" Changes of registered proprietary medicinal products and changes in the prescription status

§ 24. (1) Any change in the data that was relevant for the authorization pursuant to § 7a or the registration pursuant to § 11a or 12 shall be notified without delay to the Federal Office for Health Security.

(2) Changes in a proprietary medicinal product with regard to

1.

Name,

2.

qualitative and quantitative composition,

3.

Levy on a small scale,

4.

fields of application, with the exception of restrictions, and

5.

Dosage and method of administration

require approval by the Federal Office for Safety in Health Care.

(3) Changes

1.

the packaging of a proprietary medicinal product if the pack elements to be modified are in full contact with the proprietary medicinal product, and

2.

the labelling, package leaflet or information of a proprietary medicinal product with regard to:

a)

contra-indications,

b)

special warnings and precautions for use,

c)

Interactions with other medicinal products and other forms of interaction,

d)

Fertility, pregnancy and lactation,

e)

the effects on the ability to drive and use machines,

f)

Adverse reactions,

g)

overdose,

h)

common effects, and

i)

Wait Time

shall require the approval of the Federal Office for Health and Safety in the health care sector, unless these changes to the labelling, package leaflet or technical information are strictly necessary with a view to improving product safety.

(4) The consent referred to in paragraph 3 shall be deemed to have been granted if the amendment has not been contradicted within a period of six months.

(5) Changes to a proprietary medicinal product which do not fall under subsection 2 or 3 shall be notified to the Federal Office for Health Security.

(6) An application in accordance with paragraph 2 or 3 and a notification in accordance with paragraph 5 shall be accompanied by those documents which make it possible to assess the change.

(7) Changes in homeopathic proprietary medicinal products within the meaning of Section 11 (1) shall be notified to the Federal Office for Health and Safety in the health care sector, unless it is concerned with changes in the composition with regard to therapeutically relevant components or changes to the name, provided that these changes are not necessary due to the state of the art. A notification shall be sent to those documents which make it possible to assess the change. Changes in the composition with regard to therapeutically relevant components or the name, provided that these changes are not necessary due to the state of the art, are subject to a re-registration according to § 11.

(8) Any changes in the data which were decisive for the prescription status of a proprietary medicinal product shall be notified without delay to the Federal Office for Security. Changes to the prescription requirement require the approval of the Federal Office for Safety in the Health Care, unless it is a recipe exemption, which is due to out-of-force steps of the prescription position according to § 2 (1) of the German Federal Ministry of Health and Safety. Prescription-based law, BGBl. No 413/1972.

(9) If a request for release of a prescription is approved by the Federal Office for Safety in Health on the basis of significant non-clinical or clinical trials, then within one year of the legal force of this decision may be based on the Data shall not be used for the release of medicinal products from other marketing authorisation holders with the same active substance. "

16. § 24a para. 1 Introduction reads:

"The authorisation of an amendment as provided for in Regulation (EC) No 1234/2008 or in accordance with § 24 of this Regulation"

17. § 25 Z 2 reads:

" 2.

from the person to whom the rights to the proprietary medicinal product have been transferred, a declaration of acceptance, and any communications required pursuant to Regulation (EC) No 1234/2008 or in accordance with Section 24 of this Regulation "

18. In accordance with § 25, the following § 25a and title shall be inserted:

" Sales periods after change or transfer of law

§ 25a. (1) proprietary medicinal products subject to amendments in accordance with Regulation (EC) No 1234/2008 or in accordance with § § 24 or 25 may not be amended without this amendment.

1.

by the pharmaceutical operator within one year of the official approval or notification of this amendment,

2.

from other persons entitled to charge up to the respective expiry date of the proprietary medicinal product

shall be placed on the market unless this transitional period is not acceptable for reasons of safety in the pharmaceutical sector.

(2) holders of a marketing authorisation for parallel import shall have all the amendments necessary to ensure compliance within the meaning of Section 10c within the time limit granted to the pharmaceutical entrepre in accordance with paragraph 1 of this Article, to be completed. "

19. In Section 29 (3), the phrase "the test person" through the phrase "the Review Participant" replaced.

20. In § 36 Z 6, the word "subjects" by the word "Review Participants" and in § 36 Z 7 the word "subjects" by the word "Review participants" replaced.

21. § 75m reads:

" § 75m. (1) Admission holders are obliged to inform the Federal Office for Safety in the Health Care and the Agency if new or altered risks exist or if it is recognized that the benefit-risk ratio of proprietary medicinal products is changed. Both positive and negative results of clinical trials, which may be related not only to those mentioned in the authorisation, but to all fields of application and population groups, and non-interventional studies, shall be considered as having a positive effect on the clinical trials. , as well as information on the use of the proprietary medicinal product, which goes beyond the provisions of the authorisation. Conclusions drawn from assessments and recommendations published in accordance with Article 26 of Regulation (EC) No 726/2004 on the European Internet portal for medicinal products are also to be taken into account. Furthermore, authorisation holders are obliged to immediately notify all restrictions and prohibitions by the competent authorities of any State in which the proprietary medicinal product is placed on the market.

(2) In the event of an application for annulment of the authorisation or in the event of failure to apply for an extension of the authorisation, the holder of the authorisation shall state the reasons for this measure, in particular: whether this measure is taken from the grounds set out in Article 116 or 117 (1) of Directive 2001 /83/EC.

(3) The marketing authorisation holder shall also be obliged to suspend the marketing of the proprietary medicinal product and any application for the withdrawal of an authorisation, or to terminate the marketing of the medicinal product on the basis of any temporary or definitive cessation of the marketing of the medicinal product, or Non-application for an extension of an authorisation to be disclosed in a third country of the reasons referred to in Article 116 or 117 (1) of Directive 2001 /83/EC. "

22. In § 82b (4), after the words "To obtain" Insert a dash.

23. § 83 (1) Z 4 reads:

" 4.

the holder of an authorization pursuant to § 7a or the holder of a registration of a proprietary medicinal product violates the obligation to provide notification of § 24 (1), (2), (5) or (7), "

Section 84 (1) Z 5 reads as follows:

" 5.

Medicinal products which are subject to authorization pursuant to § § 7 of the authorisation or are subject to authorisation, without authorisation or authorisation, or not in accordance with the authorisation, In the case of an authorisation in the country of residence or for the purpose of the tax on the territory of the country, or which does not comply with the conditions laid down in § 18 (3) or (4), § 19a (1) or § 24a (2), "

Section 84 (1) Z 11 is deleted, Z 12 reads:

" 12.

Medicinal products subject to authorisation in accordance with § 7 of the Authorisation of the European Communities, which are made available in the territory of the country or which are subject to domestic surcharges which have not been accepted or rejected in accordance with Regulation (EC) No 1234/2008, "

26. § 84 para. 1 Z 14 reads:

" 14.

the obligation under Section 24 (8) is not fulfilled, "

27. § 84 para. 1 Z 15 reads:

" 15.

the obligations under § 25a are not fulfilled, "

28. § 94h (3) is deleted.

29. § 95 is added to the following paragraph 13:

" (13) § § 10 para. 3, 4, 6, 13, 14 and 15, 15 para. 6, 20 para. 3a, 24, 24a, 25, 25a, 83 para. 1 Z 4, 84 para. 1 Z 5, 12, 14 and 15 of this federal law in the version of the Federal Law BGBl. I n ° 162/2013 shall enter into force on 4 August 2013; at the same time, Section 84, paragraph 1, Z 11 shall not enter into force. "

30. The point at the end of Section 97 Z 30 shall be replaced by a paint; the following Z 31 shall be added:

" 31.

Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012, amending Directive 2011 /83/EC as regards pharmacovigilance, OJ L 327, 30.12.2011, p. L No 299 of the 27. October 2012, S 1. "

Article 2

Amendment of the Proprietary Medicinal Products Import Act 2010

The Medicinal Products Import Act 2010-AWEG 2010, BGBl. I Nr.79/2010, as last amended by the Federal Law BGBl. I No 65/2011, shall be amended as follows:

1. In Section 5 (3), the word "to" .

2. § 6 (1) reads:

"(1) The placing of medicinal products authorised or manufactured in a Contracting Party of the EEA may only be effected for the purposes of Article 5 (1) and (2) and shall be subject to a notification in accordance with § 3." provided that paragraph 2 of this article is not otherwise intended. "

Section 6 (2) reads as follows:

" (2) In the case of medicinal products for clinical or non-clinical trials or clinical trials in the case of medicinal products referred to in paragraph 1, no notification shall be required. In the case of medicinal products for clinical or non-clinical trials or clinical trials approved or manufactured in Switzerland and transported from Switzerland to Austria, there is no need for any Message. "

4. § 6 (3) reads:

"(3) A notification as referred to in paragraph 1 shall be made no later than two months after the date of the application."

5. § 6 (5) reads:

"(5) In the case of re-export, the target State for which the respective medicinal product is intended to be designated shall be designated."

6. In § 14 (7), the word "approved" by the word "approved" replaced.

6a. In accordance with Section 14 (7), the following paragraph 8 is added:

" (8) If blood products are medicinal products for clinical or non-clinical trials authorised or manufactured in a Contracting Party of the EEA, no notification is required. This shall also apply if blood products are medicinal products for clinical or non-clinical trials which have been approved or manufactured in Switzerland and are transported from Switzerland to Austria. "

7. The previous text of § 16 receives the sales designation "(1)" ; the following paragraph 2 is added:

" (2) § § 12 to 15 shall not apply to the importation or the movement of blood products, provided that:

1.

the medicinal products authorised in Austria are concerned, or

2.

They are proprietary medicinal products which do not require approval pursuant to Section 8 (1) (2) to (5) or § 8a (1) of the Medicines Act. "

8. § 26 (5), the following paragraph 6 is added:

" (6) At the time of the entry into force of this Federal Act in the version of the Federal Law BGBl. I No 162/2013 existing reporting obligations shall remain unaffected. "

Article 3

Amendment of the tissue safety law

The tissue safety law-GSG, BGBl. I n ° 49/2008, as last amended by the Federal Law BGBl. I n ° 108/2012, shall be amended as follows:

1. § 16 (6) the following sentence is added:

"The Federal Office is obliged to make these reports publicly available on the Internet on the homepage of the Federal Office for Health Security."

Section 37 is added to the following paragraph 5:

"(5) The obligation pursuant to § 16 (6) second sentence shall apply for the first time to the reports for the calendar year 2012."

Article 4

Amendment of the Prescription Care Act

The prescription law, BGBl. No 413/1972, as last amended by the Federal Law BGBl. I No 50/2012, shall be amended as follows:

1. In Section 1 (3a), the reference "Section 24 (3) of the Medicines Act" by reference "Section 24 (9) of the Medicines Act" replaced.

1a. In § 3 (1) (lit). b becomes the word "Drug" by the word "medicinal product" replaced.

2. In § 3, para. 1 lit. c will be the phrase "the name" through the phrase "the name" replaced.

3a. According to § 3, the following § 3a is inserted:

" § 3a. (1) If a patient requires a prescription to use it in another Contracting Party to the Agreement on the European Economic Area, the latter shall contain at least:

a)

the name and details of the professional qualification and place of occupation of the person entitled to prescribe in accordance with § 1, including his e-mail address and telephone number or fax number with international pre-selection,

b)

the name and date of birth of the person for which the medicinal product is intended;

c)

the international non-proprietary name (INN) recommended by the World Health Organisation, if an INN exists for the medicinal product, or the relevant chemical name,

d)

the pharmaceutical form, quantity and strength of the medicinal product prescribed;

e)

the dosing schedule,

f)

the date of issue and

g)

the signature or qualified electronic signature of the prescribing person.

(2) By way of derogation from paragraph 1 lit. c has the recipe, however, to contain the name of the medicinal product according to § 1 para. 15 pharmaceutical law if

1.

is a biological medicine in accordance with § 1 para. 11a of the Medicines Act; or

2.

the prescribers consider it necessary for medical reasons. In this case, the recipe also has a short justification to contain why the name is used in accordance with § 1 paragraph 15 of the Medicines Act. "

3b. § 4 (5) receives the sales designation "(6)" ; the following paragraph 5 is inserted:

"(5) The provisions of paragraphs 1 to 4 shall also apply to prescriptions issued in other Contracting Parties to the Agreement on the European Economic Area for cross-border use and to be submitted for submission in Austria."

3. § 5 (2) Z 6 reads:

" 6.

a professional representative of the Austrian Agency for Health and Food Safety; "

4. In § 5 (5) the word "Officials" by the word "Staff" replaced.

5. The heading before § 7b reads:

'Implementation of Union law'

6. The point at the end of Section 7b Z 3 shall be replaced by a stroke; the following Z 4 and 5 shall be added:

" 4.

Directive 2011 /24/EU of the European Parliament and of the Council of 9 March 2011 on the exercise of patients ' rights in cross-border healthcare (OJ L 327, 27.11.2011, p. OJ L 88, 4.4.2011, p. 45);

5.

Commission Implementing Directive 2012/52/EU of 20 December 2012 laying down measures for the facilitation of the recognition of medical prescriptions issued in another Member State (OJ L 327, 28.12.2012, p. OJ L 356, 22.12.2012, p. 68).

Article 5

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 n ° 80/2013, shall be amended as follows:

1. In § 6a (1) Z 2, the quote shall be: " Medicinal goods import law 2002, BGBl. I No.28, " by quoting " Medicinal goods import law 2010, BGBl. I No.79/2010 " replaced.

2. § 8 para. 2 Z 4 reads:

" 4.

Quality assurance, in particular through the establishment of quality criteria for microbiological laboratories and through the management of reference centres for technical quality assurance in the context of the application of ionising radiation to humans medical purposes; "

3. § 12 (3) last sentence reads:

" The increase in the base grant pursuant to Section 1a serves also for expenses arising from the tasks according to § § 6a and 8 (2) Z 13 to 16 and the related tasks from § 8 (3), (6) and (7) and is to be borne exclusively by the Federal Ministry of Health, where the first twelfth of this increase is to be transferred in 2012, by way of derogation from paragraph 2, only on 1 February 2012. "

Fischer

Faymann