V.B.9. RMP part VI “Summary of the risk management plan”

A summary of the RMP for each authorised medicinal product shall be made publicly available and shall include the key elements of the risk management plan [REG Art 26(1)(c), DIR Art 106(c), IR Art 31(1)].

Part VI of the RMP shall be provided by the marketing authorisation applicant/holder for medicinal products which have an RMP, regardless of whether they are centrally or nationally authorised in the EU. Based on the information contained in part VI of the RMP, for centrally authorised medicinal products, the Agency should publish the RMP summary on the EMA website at the time of the European Commission decision together with the other documents of the European public assessment report (EPAR) of that medicinal product. For nationally authorised medicinal products, a summary of the RMP should be published on the national competent authorities’ websites.

The RMP summary should be updated when important changes are introduced into the full RMP. Changes should be considered important if they relate to the following:

• new important identified or potential risks or important changes to or removal of a safety concern;
• inclusion or removal of additional risk minimisation measures or routine risk minimisation activities recommending specific clinical measures to address the risk;
• major changes to the pharmacovigilance plan (e.g. addition of new studies or completion of ongoing studies).

The audience of RMP summaries is very broad. To ensure that the summary can satisfy the different needs, it should be written and presented clearly, using a plain-language approach7 . However, this does not mean that technical terms should be avoided. The document should clearly explain its purpose and how it relates to other information, in particular the product information (i.e. the SmPC, the PL and the labelling).

The summary of the RMP part VI should be consistent with the information presented in RMP part II modules SVII, SVIII and RMP parts III, IV and V. It should contain the following information:

• the medicinal product and what it is authorised for;
• summary of safety concerns and missing information;
• routine and additional risk minimisation measures;
• additional pharmacovigilance activities.