Module III – Pharmacovigilance inspections.pdf

8 September 2014 EMA/119871/2012 Rev 1* Guideline on good pharmacovigilance practices (GVP) Module III – Pharmacovigilance inspections (Rev 1) Draft finalised by the Agency in collaboration with Member States and 25 May 2012 submitted to ERMS FG Draft agreed by ERMS FG 30 May 2012 Draft adopted by Executive Director 22 June 2012 Start of public consultation 27 June 2012 End of consultation (deadline for comments) 24 August 2012 Revised draft in collaboration with Member States 23 November 2012 Revised draft agreed by ERMS FG 6 December 2012 Revised draft adopted by Executive Director as final 12 December 2012 Date for coming into effect 13 December 2012 Draft Revision 1* adopted by Executive Director as final 8 September 2014 Date for coming into effect of Revision 1 16 September 2014 *Note: Revision 1 contains the following: - Reference to the new Union procedures for pharmacovigilance inspections in III.B.5.. See websites for contact details European Medicines Agency www.ema.europa.eu The European Medicines Agency is Heads of Medicines Agencies www.hma.eu an agency of the European Union © European Medicines Agency and Heads of Medicines Agencies, 2014. Re