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Standards [CURRENT]

BS EN ISO 27953-1

Health informatics. Individual case safety reports (ICSRs) in pharmacovigilance. Framework for adverse event reporting
Edition 2012-06-30

Standards [CURRENT]

BS EN ISO 27953-2

Health informatics. Individual case safety reports (ICSRs) in pharmacovigilance. Human pharmaceutical reporting requirements for ICSR
Edition 2012-06-30

Regulation

EUV 520/2012

Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council
Edition 2012-06-19

Regulation

EUV 1027/2012

Regulation (EU) No 1027/2012 of the European Parliament and of the Council of 25 October 2012 amending Regulation (EC) No 726/2004 as regards pharmacovigilance
Edition 2012-10-25

Regulation

EUV 1235/2010

Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products
Edition 2010-12-15

Corrigendum to Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products
Edition 2012-07-27

Regulation

EUV 2021/1281

Commission Implementing Regulation (EU) 2021/1281 of 2 August 2021 laying down rules for the application of Regulation (EU) 2019/6 of the European Parliament and of the Council as regards good pharmacovigilance practice and on the format, content and summary of the pharmacovigilance system master file for veterinary medicinal products
Edition 2021-08-02

Administrative provision

2001/571/EGEntsch

Commission Decision of 18 July 2001 on the national provisions notified by Germany in the field of pharmacovigilance
Edition 2001-07-18

Administrative provision

2010/84/EU

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 2010-12-15

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

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