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欧盟定期安全性报告
15 April 2014
EMA/876333/2011 Rev 3*
Guideline on good pharmacovigilance practices (GVP)
Annex I - Definitions (Rev 3)
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 201
Draft Revision 3* finalised by the Agency in collaboration with Member 12 March 2014
States
Draft Revision 3 provided to ERMS FG 2 April 201
Draft Revision 3 adopted by Executive Director as final 15 April 201
Date for coming into effect of Revision 3* 28 April 201
*Note: Revision 3 includes the following:
- Amendments of definitions of Missing information (including its explanatory note) and Risk minimisation activity in
accordance with revision 1 of GVP Module V.
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, 201 .
Reproduction is authorised provided the source is acknowledged.
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