Regulation On The Transfer Of Powers To Adopt Ordinances For The Regulation Of Procedures, Routing Of Copies, And Submission Of Documents Under The Medicines Act

Original Language Title: Verordnung zur Übertragung von Befugnissen zum Erlass von Rechtsverordnungen zur Regelung von Verfahren, Weiterleitung von Ausfertigungen und Einreichung von Unterlagen nach dem Arzneimittelgesetz

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Read the untranslated law here: http://www.gesetze-im-internet.de/amgbefugv/BJNR068200015.html

Regulation on the transfer of powers to adopt Ordinances for the regulation of procedures, routing of copies, and submission of documents under the medicines Act (AMG power regulation AMGBefugV) AMGBefugV Ausfertigung date: 04.05.2015 full quotation: "AMG power regulation of the 4th may 2015 (BGBl. I S. 682)" footnote (+++ text detection from: 19.5.2015 +++) input formula on the basis of section 80, sentence 1 number 1 to 3 and 4 to 6, sentence 2 and 5 of the German medicines Act , last by article 3 of the Act of December 17, 2014 (BGBl. I S. 2222) is has been modified in connection with § 1 paragraph 2 of the jurisdiction adjustment Act of 16 August 2002 (BGBl. I S. 3165) and the Organization Decree of 17 December 2013 (BGBl. I S. 4310) ordered the Ministry of health in consultation with the Federal Ministry of food and Agriculture: § 1 transfer of powers in section 80, sentence 1 number 1 to 3 and 4 to 6 of the German medicines Act , also in conjunction with § 80 set 5 of the medicines Act, included authorization to adopt legal regulations respectively on the Federal Institute for drugs and medical devices, the Paul-Ehrlich-Institut and the German Federal Office for consumer protection and food safety in the way transmitted, that each of these federal upper authorities shall adopt regulations for their area of competence by means of an Ordinance. Changes are excluded on the basis of article 35, paragraph 1 number 2 and (2), section 80, sentence 1 Nos. 1 and 2 of the German medicines Act adopted therapy allergens regulation amended.

Section 2 transitional provision the AMG submission Decree of 21 December 2000 (BGBl. I S. 2036), most recently by Article 353 of the Decree of 31 October 2006 (BGBl. I S. 2407) is has been modified, the regulation laying down requirements for the application for registration, renewal of the approval and registration of medicines of 21 December 1989 (BGBl. I S. 2547) and the AMG display regulation by September 12, 2005 (BGBl. I S. 2775) , by article 9 of the law of October 19, 2012 (Federal Law Gazette I p. 2192) is changed, are each amended force until May 18, 2015 continues to apply, as far as regulations are not in force pursuant to section 1.

Article 3 entry into force, expiry (1) this regulation enter into force on the day after the announcement.
(2) at the same time enter the AMG submission Decree of 21 December 2000 (BGBl. I S. 2036), most recently by Article 353 of regulation by October 31, 2006 (BGBl. I S. 2407) is has been modified, the regulation laying down requirements for the application for registration, renewal of the approval and registration of medicines of 21 December 1989 (BGBl. I S. 2547) and the AMG display regulation by September 12, 2005 (BGBl. I S. 2775) , by article 9 of the law of October 19, 2012 (Federal Law Gazette I p. 2192) is been changed except for power.