GVP-药物警戒体系及质量体系(模块一).pdf
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22 June 2012
EMA/541760/2011
Guideline on good pharmacovigilance practices (GVP)
Module I – Pharmacovigilance systems and their quality systems
Draft finalised by the Agency in collaboration with Member States and 19 January 2012
submitted to ERMS FG
Draft agreed by ERMS FG 24 January 2012
Draft adopted by Executive Director 20 February 2012
Released for consultation 21 February 2012
End of consultation (deadline for comments) 18 April 2012
Revised draft finalised by the Agency in collaboration with Member 20 June 2012
States
Revised draft agreed by ERMS FG 21 June 2012
Revised draft adopted by Executive Director as final 22 June 2012
Date for coming into effect 2 July 2012
See websites for contact details
European Medicines Agency www.ema.europa.eu The European Medicines Agency is
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