Definition

Risk minimization interventions beyond routine labeling, such as educational materials, prescriber guides, or controlled access programs.

Example

Additional RMM for a high-risk biologic includes: prescriber training program, patient alert card, HCP guide with monitoring protocols, and pharmacy-level controls.

Regulatory source

EU GVP Module XVI

Common mistakes

Creating materials that duplicate labeling rather than providing actionable tools for risk management.

Inspector question

What additional RMMs do you have in place? How do you distribute and track their use?

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