RMPs provide information on the medicine’s safety profile and describes the risk management system, including how identified risk will be prevented or minimised, plans for post authorisation studies or other activities (e.g. registries, education materials) to establish more thorough understanding of its safety and efficacy, and how the effectiveness of risk-minimising measures will be measured.
All new marketing authorisation applications for products within the European Union (EU) must include an RMP. For existing products without an RMP, one might be required with any application involving a significant change to the MA.
RMPs are living documents, to be maintained by the MAH as new information becomes available. They can be requested by EMA or the national competent authority (NCA) and will need to be submitted when the risk management system is modified e.g. change to benefit-risk profile or on meeting a PV or risk-minimisation milestone.
RMP guidance is covered in Module V of GVP and the EMA provides guidance on its format in the EU. RMP summaries are publicly available for centrally authorised medicines on the EMA website.
