Updated Guidelines on Good Pharmacovigilance Practices (GVP)

On 14 March 2022 the EMA issued an introductory cover note updating the release of Addendum III of Module XVI on pregnancy prevention programs for public consultation.

This guidance on good pharmacovigilance practices (GVP) is organized into two types of chapters, namely Modules on pharmacovigilance processes and Product- or Population-Specific Considerations.

Today, a public consultation is launched for Addendum III of Module XVI on pregnancy prevention programs and other pregnancy-specific risk minimization measures. This new guidance defines the elements of a pregnancy prevention program and provides for deciding when such program is needed or other risk minimization measures are considered appropriate to avoid adverse pregnancy outcomes due to use of medicines and to preserve health of both the mother and the child.

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