Definition

A comprehensive document describing the safety profile, pharmacovigilance activities, and risk minimization measures for a medicinal product.

Example

The RMP for a new anticoagulant includes: safety specification identifying bleeding risk, pharmacovigilance plan for additional data collection, and risk minimization measures including an HCP guide.

Regulatory source

EU GVP Module V

Common mistakes

Creating static RMPs that aren't updated as new safety information emerges.

Inspector question

How often do you review and update your RMPs? What triggers an RMP update?

Related terms