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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. 28 July 2017 EMA/873138/2011 Rev 2* Guideline on good pharmacovigilance practices (GVP) Module VI Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2) Date for coming into effect of first version 2 July 2012 Date for coming into effect of Revision 1 16 September 2014 Draft Revision 2* finalised by the Agency in collaboration with Member States 15 July 2016 Draft Revision 2 agreed by the European Risk Management Facilitation Group (ERMS FG) 26 July 2016 Draft Revision 2 adopted by Executive Director 4 August 2016 Release for public consultation 8 August 2016 End of consultation (deadline for comments)

Guideline on good pharmacovigilance practices (GVP) Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2) Date for coming into effect of first version 2 July 2012 Date for coming into effect of Revision 1 16 September 2014

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