Insights

The European Medicines Agency has finalized the Guideline on Good Pharmacovigilance Practices (GVP) Module XVI Addendum I, addressing risk minimization measures for medicinal products with embryo-fetal risks. This guidance, effective 29 August 2025, aims to prevent or minimize exposure of an embryo or fetus to teratogenic substances.

Intended actions to prevent exposure of an embryo/fetus to a medicinal product with embryo-fetal risks include:

• Risk counselling to be conducted by a healthcare professional for female patients who have reproductive potential
• Actions to avoid becoming pregnant or contraceptive measures for female patients taking the medicinal product
• Pregnancy testing to ensure excluding pregnancy before initiating the treatment
• Supervised treatment by experienced or specialist physicians, including regular medication reviews
• Avoiding blood and semen/sperm donation while taking the medicinal product, as this may expose a pregnant female recipient to risk

Intended actions if exposure of an embryo/fetus to a medicinal product with embryo-fetal risks may have occurred include:

• Interrupting the treatment
• Switching to suitable alternative treatment
• Dose reduction
• Specific prenatal monitoring

Risk minimization measures applied to embryo-fetal risks include:

• routine measures such as visual warnings on packaging (e.g., "Can seriously harm an unborn baby") and disallowing free samples
• additional measures such as educational/safety advice materials tailored for healthcare professionals and/or patients and pregnancy prevention programmes (a combination of intended actions and risk minimization measures) for high-risk substances.

RPN will provide any further update and is available to provide full support for pharmacovigilance activities.