This Addendum to GVP Module XVI provides additional guidance to be followed by marketing authorisation holders and competent authorities on data sources and methods for monitoring outcomes of risk minimisation measures (RMM) in line with the guidance on RMM effectiveness evaluation in GVP Module XVI. Depending on the intended outcomes of RMM, studies evaluating RMM effectiveness may integrate different qualitative and quantitative measurements and research approaches (including mixed methods) to evaluate outcomes of RMM described in GVP Module XVI. Dissemination, risk knowledge, behavioural and health outcomes may be considered, and in this respect the guidance on objectives of RMM effectiveness studies in GVP Module XVI should be followed. The Addendum also provides guidance on the reporting of the results of RMM effectiveness studies.

The ENCePP Guide on Methodological Standards in Pharmacoepidemiology1 should be considered for further methodological guidance, and the Guidelines for Good Pharmacoepidemiology Practices of the International Society of Pharmacoepidemiology2 may provide additional guidance.