Definition

EMA revision (2025) to GVP Module XVI on risk minimization; adds guidance on effectiveness evaluation of risk minimization measures and pregnancy prevention programmes.

Example

Evaluating effectiveness of a PPP via surveys and prescriber feedback.

Regulatory source

EMA GVP Module XVI Rev 3 & Addendum II (2025)

Common mistakes

Not implementing effectiveness studies for aRMMs as per addendum.

Inspector question

How does GVP XVI Addendum II affect your RMP and aRMM evaluation?

Related terms