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

Read the untranslated law here: https://www.global-regulation.com/law/austria/2996254/nderung-des-arzneimittelgesetzes%252c-des-arzneiwareneinfuhrgesetzes-2010%252c-des--gewebesicherheitsgesetzes%252c-des--rezeptpflichtgesetzes-und-des-gesund.html

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162. Federal law that modifies the medicines Act, the drug importation Act 2010, the tissue Safety Act, the prescription Act and the health and food safety act

The National Council has decided:

Article 1

Amendment to the medicines Act

The medicines Act - AMG, BGBl. No. 185/1983, as last amended by Federal Law Gazette I no. 48/2013, is amended as follows:

1 § 1 paragraph 3 No. 1 is:



"1. food referred to in article 2 paragraphs 1 and 2 of Regulation (EC) No. 178/2002 laying down the General principles and requirements of food law, establishing the European authority for food safety and establishing procedures to food safety, OJ" No L 31 of the 1.2.2002 p. 1, last amended by Regulation (EC) No. 596/2009, OJ "No. L 188 of the astronomy page 14," 2. § 1 para 3 Z 9 is:



"9 substances or preparations from substances which are intended to be, if it does not serve, are intended to meet the purposes of paragraph 1, unless it is of substances or preparations of substances which are manufactured, according to homeopathic principles and techniques applied to complementary medical methods only" 3. § 2 of para 1 second sentence is:

"Side effect" of a veterinary medicinal product is a harmful and unintended response to the drug, which occurs at doses normally used in animals for the prophylaxis, diagnosis or therapy of disease or the modification of physiological function."

4. in Article 7a, paragraph 1 is replaced "approved" "approved" by the word.

5. in article 10, paragraph 3, the quote "§ 24 para 13" by the quote "Section 14" will be replaced.

6. in article 10, par. 4 Z 2 eliminates the quote "according to § 24 para 2 No. 7".

7 paragraph 10 section 6:

"(6) when an amendment for a new field of application of medicinal products in relation to a well-established substance non-clinical or clinical studies relating to the new field of application carried out, which were regarded by the Federal Office for security in health care in accordance with clause 14 as significant as can a request pursuant to section 10 or under Regulation (EC) No 1234 / 2008 concerning the examination of changes the approval of human and veterinary medicinal products" , OJ No. L 334 of December 12, 2008 page 7 as amended by the Regulation (EU) No. 712/2012, OJ No. L 209 of the 4.8.2012 p. 4, a year these data are referred. This exclusivity period is not cumulative."

8. in article 10, paragraph 13, the quote "according to § 24 para 2" is replaced by the phrase "a licence".

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

"(14) during the examination an amendment for a new field of application has to decide the Federal Office for security in the healthcare sector at the request of



1. whether the new application areas of significant clinical benefit in comparison with existing therapies are and 2. whether at a well-established active ingredient important non-clinical or clinical studies relating to the new field of application were carried out."

10 section 10c para 4, 5 and 6 are:

"(4) medicinal products, which one no. 726 / 2004 granted approval, as well as paragraph 1 in accordance with Nos. 2 and 3, may be placed in accordance with Regulation (EC) only in traffic, if they are equipped with a German-language labelling and instructions for use and a German specialist information and previously a message to the Agency and the Federal Office for security in health care is done. This message shall contain:



1. proof of eligibility for applicants in accordance with § 9, 2. name and registration number in accordance with Regulation (EEC) No. 726 / 2004 approved medicinal, 3. the Contracting Parties of the agreement on the European economic area, in which the imported medicinal is marketed (home Member State), 4. the name and address of the authorisation holder, 5. the name and address of the manufacturer, 6 the sizes provided for distribution in Austria , 7. a statement that the texts for outer packaging, primary packaging, instructions for use and technical information except company-specific data no textual marking, use information and prescribing information which pursuant to Regulation (EEC) No. 726 / 2004 approved medicinal differ.

There is a fee for the verification of compliance with the conditions, which are set in European Union law concerning pharmaceutical products and in the authorisations for the placing on the market, to be paid to the Agency. Their design depends on Union legislation.

(5) the applicant is required pursuant to subsection 3 to display simultaneously the submission the authorisation holder or holder of the registration. The same applies to the notification pursuant to paragraph 4.

(6) If this is necessary for reasons of safety, Z 12 with regard to the primary packaging may be waived with the consent of the Federal Office for security in healthcare requirements on the labelling in para 3."

11. in article 15, paragraph 1, the phrase is omitted ' its own pharmacy medicinal or ".

12 paragraph 15 paragraph 6:

"(6) the technical information and any changes in the prescribing information in accordance with Regulation (EC) No 1234 / 2008 or in accordance with §§ 24 or 25 are to publish by the Austrian Chamber of pharmacists in cooperation with the Austrian Medical Association." The publication has the date of the preparation of the technical information, assign the last modified date in the event of a change in the prescribing information."

13 paragraph 20 paragraph 3a:

"(3a) the authorisation or registration holder the change of the period provided for in paragraph 2 and 3 may apply to what require the consent of the Federal Office for security in the health care sector."

14 21 para 2 the following sentence is added to §:

"While the reasons for this measure to indicate are, particularly whether this measure for the reasons referred to in article of 116 or 117 paragraph 1 of Directive 2001/83/EC is. If so the Agency also be informed."

15 paragraph 24 together with the heading:

"Change registered medicinal and prescription status change

Section 24 (1) is any modification of data that were decisive for the permit according to § 7a or registration according to § 11a or 12, inform the Federal Office for security in healthcare.

(2) changes a pharmaceutical speciality with regard to



1 name, 2. qualitative and quantitative composition, 3. tax on a smaller scale, 4 applications, except their restrictions, and 5. dosage and type of application require the approval by the Federal Office for security in healthcare.

(3) changes



1 the packaging of a pharmaceutical speciality, if the packing elements to be modified with the medicinal fully fitting in continuous contact, and 2 the marking, instructions or technical information of a pharmaceutical speciality with regard to a) contraindications, b) Special warnings and precautions for use, c) interactions with other medicinal products and other forms of interaction, d) fertility, pregnancy and lactation, e) effects on the ability to drive and the ability to use machines , f) side effects, g) overdose, h) habituation effects, and i) latency are subject to approval by the Federal Office for security in the healthcare sector, unless these changes of marking, instructions or technical information are required only in terms of improved product safety.

(4) the consent is considered according to para 3 given, if not within a period of six months is contradicted the change.

(5) changes to a medicinal, not covered by paragraph 2 or 3, are to report to the Federal Office for security in healthcare.

(6) those documents are a request referred to in paragraph 2 or 3, and a notification in accordance with paragraph 5 to join, which enable an assessment of the modification.

(7) changes homeopathic medicinal products in the sense of § 11 para 1 are the Federal Office for security in the healthcare system to register, unless it's changes to the composition in terms of therapeutically relevant constituents or to changes of name, unless these changes not due to the State of the science are required. Those documents are a message to join, which enable an assessment of the change. Changes of composition in terms of therapeutically relevant constituents or of the name, unless these changes not due to the State of the science are required, subject to a re-registration in accordance with section 11.

(8) any modification of the data which were decisive for a medicinal prescription status is immediately to inform the Federal Office for security. Changes the prescription shall require the approval of the Federal Office for security in healthcare, unless it's a prescription setting resulting from expiry of prescription required position according to § 2 para 1 of the prescription Act, Federal Law Gazette No. 413/1972.


(9) approved a request for prescription status on the basis of significant non-clinical or clinical trials by the Federal Office for security in the healthcare sector, so a prescription status of medicinal products other marketing authorisation holder with same active ingredient is not possible within one year after this decision based on this data."

16 § 24a para 1 introduction is:

"The approval of a change referred to in Regulation (EC) No 1234 / 2008 or in accordance with section 24 is"

17 paragraph 25 No. 2:



"2. those who have moved to the rights to the medicinal, a transfer Declaration as well as all under Regulation (EC) No 1234/2008 or releases required according to § 24 ' 18. According to § 25, 25a the following paragraph and heading shall be inserted:

"The sale periods after modification or transfer

Section 25a. (1) medicinal, where changes in accordance with Regulation (EC) No 1234 / 2008 or in accordance with §§ 24 or 25 are, without this change



1 by the pharmaceutical entrepreneur within one year after regulatory approval or announcement of this change, 2 others to submit are entitled to the respective expiry date of the pharmaceutical speciality in traffic, unless unless this transition period is unacceptable for reasons of drug safety.

(2) the holder of an authorisation for distribution in the parallel import have all to safeguard the match in accordance with § 10 c within the period which the pharmaceutical entrepreneur in accordance with paragraph 1 is granted to reproduce. necessary changes"

19. in article 29, paragraph 3, the phrase "the person" is replaced by the phrase "of the subject 's".

20. in article 36 Z 6 is the word "People" with the word "Subject" and in § 36 Z 7 replaces the word "People" with the word "Subjects".

21 paragraph: 75m

"§ 75 m." (1) authorisation holder are required to inform the Federal Office for security in the health care sector and the Agency, if there are new or changed risks or if recognized, that the benefit risk balance of medicinal products has changed. There are both positive and negative results of clinical trials, which relate not only to those referred to in the approval, but on all application areas and population groups, and non - interventional studies, as well as information on an application of the medicine specialty, which goes beyond the terms of the authorisation, to take into account. Conclusions from evaluations and recommendations, which are published according to article 26 of Regulation (EC) No. 726/2004 on the European Internet portal for medicines, to take into account are also. Marketing authorisation holder are also obliged to inform without delay all restrictions and prohibitions by the authorities of each State where the pharmaceutical speciality in traffic is placed.

(2) authorisation holder have the Federal Office for security in the health care sector and the Agency in the case of an application for annulment of the approval or failure to request of a renewal of the authorisation the reasons for this measure to specify, in particular whether this measure for the reasons referred to in article of 116 or 117 paragraph 1 of Directive 2001/83/EC takes place.

(3) marketing authorisation holder are required to announce any temporary or permanent setting of the placing on the market of the medicinal and every request for waiver of approval or failure to request of an extension of an approval the Federal Office for security in the health care sector and the Agency which paragraph 1 of Directive 2001/83/EC takes place in a third country from the article 116 or 117 reasons given."

22. in article 82 a comma is inserted after the words "to provide" b paragraph 4.

23 § 83 para 1 No. 4 is:



"4. as holder of a permit violated according to § 7a or holder of a registration of a medicinal, the duty of section 24 para 1, 2, 5 or 7" 24 Article 84, paragraph 1 is Z 5:



"5. medicinal products in accordance with §§ 7 of the admission or 7a of the permit are subject to without approval or permission or not according to the approval or permit in Germany gives or provides for the levy in the domestic or pursuant to § 18 paragraph 3 or 4, § 19a does not meet requirements prescribed 1 or § 24a, para 2 para," 25 article 84, paragraph 1 does not apply Z 11, Z 12 is :



"Were, 12 medicinal products which are subject to, are in the domestic or holds for sale domestically, where changes have been made in accordance with § 7 of admission not in accordance with Regulation (EC) No 1234/2008 accepted or rejected" 26 article 84, paragraph 1 Z 14 is:



"14. the obligation according to § 24 para 8 does not meet," 27 Article 84, paragraph 1 Z 15 is:



"15. the obligations according to § 25a does not meet," 28 § 94 h para 3 is omitted.

29 § 95 13 the following paragraph is added:

"(13) § 10 par. 3, 4, 6, 13, 14 and 15, 15 paragraph of 6, 20 paragraph 3a, 24, 24a, 25, 25a, 83 para 1 No. of 4, 84 para 1 Nos. 5, 12, 14 and 15 of this Federal Act in the version of Federal Law Gazette I no. 162/2013 with 4 August 2013 into force;" "at the same time ABS § 84.1 Z 11 override."

30. the point is replaced a comma at the end of the article 97 Z 30; following Z 31 is added:



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

Article 2

Amendment of the drug importation Act 2010

The drug importation Act 2010 - Abraham 2010, Federal Law Gazette I Nr. 79/2010, last amended by Federal Law Gazette I no. 65/2011, is amended as follows:

1. in article 5, par. 3 eliminates the word "to".

2. paragraph 6 ABS. 1:

"(1) that may spend by in a Contracting Party to the EEA approved or manufactured medicinal products only for purposes in accordance with § 5 par. 1 and 2 take place and requires a message according to § 3 - if paragraph 2 does not use other -."

3. paragraph 6 subsection 2:

"(2) unless it is spend of medicaments according to para 1 to medicaments for clinical or non-clinical tests or clinical trials, there are no message. Unless it is medicinal products for clinical or non-clinical tests or clinical trials, which have been approved or established in Switzerland and be transported from Switzerland to Austria, there are also no message."

4. paragraph 6 ABS. 3:

"(3) a notification referred to in paragraph 1 shall be effected no later than two months after the introduction."

5. paragraph 6 ABS. 5:

"(5) in the case of re-exportation is the target State, for which the respective medicinal product is intended to call."

6. in the section 14 paragraph 7 is replaced "approved" "approved" by the word.

6a. the following paragraph 8 is added to § 14 paragraph 7:

"(8) if it is spend blood products medicinal products for clinical or non-clinical tests, which have been approved or established in a Contracting Party to the EEA requires no message. This also applies, if it is for blood products to proprietary medicinal products for clinical or non-clinical tests, which have been approved or established in Switzerland and be transported from Switzerland to Austria."

7. the existing text of section 16 will receive the sales designation (1); the following paragraph 2 is added:

"(2) sections 12 to 15 do not apply to the import of or the introduction of blood products, unless"



1. it is medicinal products approved in Austria, or 2 it is medicinal, requiring Z 2 to 5 or section 8a, paragraph 1, of the drug law of no approval in accordance with article 8, paragraph 1."

8 § 26 para 5 is added the following paragraph 6:

"(6) at the time of entry into force of this federal law as amended by Federal Law Gazette I no. 162 / 2013 existing reporting obligations remain unaffected."

Article 3

Change of tissue Safety Act

The tissue safety law - GSG, Federal Law Gazette I no. 49/2008, last amended by Federal Law Gazette I no. 108/2012, is amended as follows:

1 16 paragraph 6 the following sentence is added to §:

"The Federal Office is obliged to make public these reports on the Internet on the website of the Federal Office for security in the health care sector."

2. § 37 the following paragraph 5 is added:

"According to § 16 para 6 second sentence concerns (5) the obligation for the first time the reports for the calendar year 2012."

Article 4

Amendment of the prescription Act

The prescription law, BGBl. No. 413/1972, as last amended by Federal Law Gazette I no. 50/2012, is amended as follows:

1. in article 1, paragraph 3a is the reference "section 24 para 3 medicines Act" by the reference "section 24 paragraph 9 drug law" replaced.

1a. in article 3, paragraph 1 lit. b the word "Drug" is replaced by the word "Drug".

2. in article 3, paragraph 1 lit. c is replaced by the phrase "the name" the phrase "the name".

3A. the following Article 3a is inserted after article 3:

'section 3a. (1) a patient requires a recipe to use it in another party of the agreement on the European economic area, this must at least contain:



a)

his E-mail address and telephone or fax number with international prefix, b along with the name, as well as information on the professional qualifications and the justified pursuant to section 1 to prescribe based) the name and date of birth of the person for which the medicinal product is intended, c) the international non-proprietary name recommended by the World Health Organisation (INN), if there is an INN for the medicinal product, or the relevant chemical name, d) the dosage form , Amount and strength of the prescribed medicinal, e) the dosing schedule, f) the date of issue and g) the signature or qualified electronic signature of the prescribing.

(2) by way of derogation from paragraph 1 lit. (c) has the recipe to include the name of the medicinal product in accordance with § 1 para 15 medicines Act, but if



1 it is a biological medicinal pursuant to section 1 paragraph 11a of the medicines Act or the prescribing it considers 2. medical reasons necessary. In this case the recipe has also a short justification to include why uses the name pursuant to § 1 para 15 Drug Act."

Gets the paragraph designation (6); 3B. § 4 paragraph 5 the following paragraph 5 is inserted:

"(5) paragraphs 1 to 4 shall apply by analogy to recipes that have been issued in other parties of the agreement on the European economic area for cross-border use and be presented in Austria to submit."

3. § 5 para 2 No. 6 is:



"6. a competent representative of the Austrian Agency for health and food security;"

4. in article 5, paragraph 5, the word "Official" is replaced by the word "Staff".

5. the heading before section 7 is b:

"Implementation of Union law"

6. the point is replaced a semicolon at the end of section 7B No. 3; following Nos. 4 and 5 are added:



"4. Policy 2011/24/EC of the European Parliament and of the Council of 9 March 2011 on patient rights in cross-border health care (OJ L 88 of the astronomy, p. 45);

5. implementing directive 2012/52/EC of the Commission of 20 December 2012 with measures to facilitate the recognition of medical prescriptions issued in another Member State (OJ (L 356 vondem 22.12.2012, S. 68). "

Article 5

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. 80/2013, is amended as follows:

1. in Article 6a, paragraph 1 Z 2 is the quote "drug importation Act 2002, Federal Law Gazette I Nr. 28," by the quote "drug importation Act 2010, Federal Law Gazette I Nr. 79/2010," replaced.

2. § 8 par. 2 No. 4 is:



"4. quality assurance, in particular through the creation of quality criteria for microbiological laboratories, as well as through the management of centres of reference for technical quality assurance in the context of the application of ionizing radiation on humans for medical purposes."

3. § 12 para 3 last sentence reads:

"Increasing the base allocation in accordance with paragraph 1a serves Z 13 to 16 and the related tasks of article 8, para. 3, 6 and 7 also for expenses of the tasks according to the sections 6a and 8 paragraph 2 and is to wear, where to transfer the first one twelfth of this boost in 2012 - by way of derogation from paragraph 2,-until on 1 February 2012 only by the Federal Ministry of health."

Fischer

Faymann