Definition

Risk minimization programme to prevent fetal exposure (e.g., contraception, testing, education). GVP XVI Addendum II requires effectiveness evaluation.

Example

PPP for isotretinoin: pregnancy test, contraception, and educational materials.

Regulatory source

GVP Module XVI Addendum II (2025)

Common mistakes

Not evaluating whether PPP actually reduces pregnancy exposure.

Inspector question

How do you measure effectiveness of your PPP?

Related terms