Transcription of Guideline on good pharmacovigilance practices (GVP)
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Guideline on good pharmacovigilance practices (GVP)
9 October 2017. EMA/827661/2011 Rev 1*. Guideline on good pharmacovigilance practices (GVP). Module IX Signal management (Rev 1). Date of coming into effect of first version 2 July 2012. Draft Revision 1* finalised by the Agency in collaboration with Member 30 June 2016. States Draft Revision 1 agreed by the European Risk Management Facilitation 18 July 2016. Group (ERMS FG). Draft Revision 1 adopted by Executive Director 4 August 2016. Release for public consultation 8 August 2016. End of consultation (deadline for comments) 14 October 2016. Revised draft Revision 1 finalised by the Agency in collaboration with 27 September 2017. Member States Revised draft Revision 1 agreed by the EU Network pharmacovigilance 4 October 2017. Oversight Group (EU-POG). Revised draft Revision 1 adopted by Executive Director as final 9 October 2017. Date for coming into effect of Revision 1* 22 November 2017**.
Guideline on good pharmacovigilance practices (GVP) – Module IX (Rev 1) EMA/827661/2011 Rev 1 Page 2/25
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