Risk Management Plan (RMP)

A Risk Management Plan (RMP) is a detailed description of the risk management system of a medicinal product. It identifies or characterizes the product’s safety profile, indicates how its risks will be prevented or minimized in patients, plans for studies and other activities to gain more knowledge about the safety and efficacy of the product, and includes an assessment of the effectiveness of risk minimization measures. In the European Union, companies must submit an RMP to the European Medicines Agency at the time of application for a marketing authorization and RMPs are continually modified and updated throughout the lifetime of the medicine as new information becomes available.

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