Regulation on the delegation of powers to the adoption of legal regulations governing procedures, the forwarding of copies and the filing of documents in accordance with the Medicines Act (AMG-delegated powers-AMGdeleggV)

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AMGpowers

Date of delivery: 04.05.2015

Full quote:

" AMG powers ordinance of 4 May 2015 (BGBl. I p. 682) "

Footnote

(+ + + Text evidence from: 19.5.2015 + + +) 

  

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Input formula

On the basis of § 80 sentence 1 number 1 to 3 and 4 to 6, sentences 2 and 5 of the Medicines Act, most recently by Article 3 of the Law of 17 December 2014 (BGBl. 2222), in conjunction with Section 1 (2) of the Jurisdiction Adjustment Act of 16 August 2002 (BGBl). I p. 3165) and the Organizational Decree of 17 December 2013 (BGBl. I p. 4310), the Federal Ministry of Health also decrees in agreement with the Federal Ministry of Food and Agriculture: Unofficial table of contents

§ 1 Transfer of powers

The authorization for the enactment of legal regulations contained in § 80 sentence 1 number 1 to 3 and 4 to 6 of the Medicines Act, also in conjunction with § 80 sentence 5 of the Medicines Act, shall in each case be applied to the Federal Institute for Drugs and Drug Law. Medical devices, the Paul-Ehrlich-Institut and the Federal Office for Consumer Protection and Food Safety transfer the fact that each of these federal authorities, by means of a legal regulation, will issue regulations for their area of responsibility. Exceptions are amendments to the therapeutic allergens regulation issued pursuant to section 35 (1) (2) (2) and (2) and § 80 (1) (1) (1) and (2) of the German Medicines Act (Medicines Act). Unofficial table of contents

§ 2 Transitional provision

The AMG submission regulation of 21 December 2000 (BGBl. 2036), as last amended by Article 353 of the Regulation of 31 December 2008. October 2006 (BGBl. 2407), the Regulation laying down requirements for the application for authorisation, renewal of the authorisation and registration of medicinal products of 21 December 1989 (BGBl. 2547) and the AMG Display Ordinance of 12 September 2005 (BGBl. 2775), as defined by Article 9 of the Law of 19. October 2012 (BGBl. I p. 2192) have been amended to continue to apply in their version until 18 May 2015, in so far as the provisions of Section 1 are not in force. Unofficial table of contents

§ 3 Entry into force, external force

(1) This Regulation shall enter into force on the day following the announcement. (2) At the same time, the AMG submission regulation of 21 December 2000 (BGBl. 2036), as last amended by Article 353 of the Regulation of 31 December 2008. October 2006 (BGBl. 2407), the Regulation laying down requirements for the application for authorisation, renewal of the authorisation and registration of medicinal products of 21 December 1989 (BGBl. 2547) and the AMG Display Ordinance of 12 September 2005 (BGBl. 2775), as defined by Article 9 of the Law of 19. October 2012 (BGBl. I p. 2192), except for the force.