Updates:

  • 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)