Mises à jour :

• Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with final revision 3 of Module XVI on risk minimisation measures and its Addendum II on their effectiveness evaluation, and revision 5 of Annex I on definitions
• Guideline on good pharmacovigilance practices (GVP) Module XVI – Risk minimisation measures (Rev 3)
• Guideline on good pharmacovigilance practices (GVP): Module XVI Addendum II – Methods for evaluating effectiveness of risk minimisation measures
• Guideline on good pharmacovigilance practices: Annex I – Definitions (Rev. 5)

https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/good-pharmacovigilance-practices-gvp