XVI.Add.II.4.1. Study registration

All non-interventional studies evaluating the effectiveness of RMM should be a priori registered in the HMA-EMA Catalogue of Real-World Data Studies11 . As for all non-interventional postauthorisation safety studies (PASS), the requirements for study reports, reporting of adverse reactions/events and data relevant to the risk-benefit balance of the studied medicinal product apply and should be reported by the organisation responsible for the conduct of the study in line with the requirements of GVP Module VIII.