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Regulation

EUV 2022/20

Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials
Edition 2022-01-07

Regulation

EUV 2022/1255

Commission Implementing Regulation (EU) 2022/1255 of 19 July 2022 designating antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans, in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council
Edition 2022-07-19

Regulation

AMPV

Verordnung zur Anwendung der Arzneimittelprüfrichtlinien (Arzneimittelprüfrichtlinien-Verordnung - AMPV)
Edition 2016-01-08

Regulation

EUV 2023/1182

Regulation (EU) 2023/1182 of the European Parliament and of the Council of 14 June 2023 on specific rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland and amending Directive 2001/83/EC
Edition 2023-06-14

Administrative provision

2001/83/EGBer

Corrigendum to directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
Edition 2014-08-12

Administrative provision

2011/62/EUBer

Corrigendum to directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products
Edition 2014-08-09

Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use
Edition 2015-03-19

Administrative provision

2012/26/EU

Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance
Edition 2012-10-25

Administrative provision

2010/84/EUBer

Corrigendum to Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use
Edition 2011-01-25

Administrative provision

2011/62/EU

Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products
Edition 2011-06-08

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