A pregnancy prevention programme (PPP) is a set of routine and additional risk minimisation measures (RMM) that aims at minimising exposure to a medicinal product during pregnancy (see GVP Module XVI). More specifically, the aim of a PPP is to prevent the exposure of the unborn child by ensuring that female (adolescent and adult) patients are not pregnant at the start of treatment and to ensure that they do not become pregnant during the course of treatment, or also during a defined period after the treatment has been discontinued. A PPP is to be considered in situations where the product has the potential for a teratogenic effect or an adverse effect on the (neuro)development of the child through exposure in-utero (where in this document reference is made to teratogenicity, it is meant, for the ease of reading, to include (neuro)developmental effects). A full description of the elements of the PPP is provided in XVI.Add.III.3.. Although rarely required, a PPP could also include targeting male patients when there is evidence that use of a medicinal product by the biological father can have a teratogenic effect via semen during conception.

As described in XVI.Add.III.2., selected pregnancy-specific routine RMM (see CHMP Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: From Data to Labelling1) and, possibly, additional RMM may be required instead of a PPP.