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Risk Management Plans

Explains the purpose and key components of Risk Management Plans (RMPs): safety specification, pharmacovigilance activities, risk-minimisation measures and effectiveness evaluation. Covers proactive lifecycle management and QPPV oversight considerations.

Risk Management Plans describe important safety concerns and activities used to monitor and minimise risks associated with medicinal products.

Purpose of an RMP

Risk Management Plans support proactive management of important identified and potential risks throughout the product lifecycle.

Key Components

Last reviewed: June 2026

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Last reviewed: 2026-06-07