Definition

A comprehensive risk minimization program for teratogenic medicines to prevent fetal exposure through pregnancy testing, contraception, and patient counseling.

Example

The PPP requires: pregnancy test before each prescription, two forms of contraception, monthly prescriptions only, patient acknowledgment forms, and mandatory contraceptive counseling.

Regulatory source

EU GVP Module XVI

Common mistakes

Not monitoring compliance with PPP requirements or failing to track pregnancy outcomes despite the program.

Inspector question

How do you monitor PPP compliance? How do you handle pregnancies that occur?

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