EMA Guideline on Good Pharmacovigilance Practices (GVP) Module XVI Addendum II

This Addendum to GVP Module XVI provides additional guidance for marketing authorization holders and competent authorities on data sources and methodologies for monitoring outcomes of risk minimization measures (RMM) in line with the principles for RMM effectiveness evaluation laid down in GVP Module XVI. Depending on the risk minimization objective, studies evaluating RMM effectiveness may integrate different quantitative measurements and qualitative research approaches to evaluate risk minimization outcomes for individual tools or sets of RMM described in GVP Module XVI. Risk knowledge, behavioural changes and health outcomes may be considered, and in this respect the guidance on objectives of effectiveness evaluation in GVP Module XVI should be followed. The Addendum also provides guidance on reporting the results of studies evaluating the effectiveness of RMM.