Definition

Risk minimization measure beyond the SmPC/PL; e.g., educational materials, PPP, controlled access. GVP XVI requires effectiveness evaluation.

Example

Pregnancy Prevention Programme with prescriber guide and patient card.

Regulatory source

GVP Module XVI Rev 3 & Addendum II

Common mistakes

Implementing aRMM without plan to evaluate effectiveness.

Inspector question

What aRMMs do you have and how do you evaluate their effectiveness?

Related terms