Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with chapter P.III on pharmacovigilance for the use of medicines by pregnant and breastfeeding women

On 11 December 2019 the EMA updated the guidelines on GVP.

New legislation for pharmacovigilance applies in the EU since July 2012, and to support its implementation, a set of guidelines for the conduct of pharmacovigilance in the EU has been developed which, as they have been adopted, replaced the previous set in Volume 9A of the Rules Governing Medicinal Products in the EU.

This new guidance on GVP is organised into two types of chapters, namely Modules on pharmacovigilance processes and Product- or Population-Specific Considerations.

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