欧盟定期安全性报告.pdf

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.