Transcription of Guideline on good pharmacovigilance practices (GVP)
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Guideline on good pharmacovigilance practices (GVP)
See websites for contact details European Medicines Agency Heads of Medicines Agencies The European Medicines Agency is an agency of the European Union European Medicines Agency and Heads of Medicines Agencies, 2017. Reproduction is authorised provided the source is acknowledged. 9 October 2017 EMA/876333/2011 Rev 4* Guideline on good pharmacovigilance practices (GVP) Annex I - Definitions (Rev 4) Date for coming into effect of first version 2 July 2012 Date for coming into effect of Revision 1 13 December 2012 Date for coming into effect of Revision 2 8 January 2014 Date for coming into effect of Revision 3 28 April 2014 Draft Revision 4* finalised by the Agency in collaboration with Member States 27 September 2017 Draft Revision 4 agreed by the EU Network pharmacovigilance Oversight Group (EU-POG) 4 October 2017 Draft Revision 4 adopted by Executive Director as final 9 October 2017 Date for coming into effect of Revision 4* 13 October 2017 *Note: Revision 4 includes the following: - Addition of the definition of Active substance as defined in Directive 2001/83/EC Art 1(3a).
- Addition of an explanatory note for Audit to clarify what is not regarded as audit in accordance with GVP Module IV Rev 1; - Addition of the definition of Biological medicinal product as defined in Directive 2001/83/EC, Annex 1, Part I,
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