Guidance

Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the MHRA

This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)

• From: Medicines and Healthcare products Regulatory Agency
• Published: 31 December 2020

Documents

Guidance note on good pharmacovigilance practices

PDF, 862 KB, 104 pages

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Details

GVP are a set of measures drawn up to facilitate the performance of pharmacovigilance in the EU.

GVP apply to marketing authorisation holders (MAHs), the European Medicines Agency and medicines regulatory authorities in EU member states. They cover medicines authorised centrally through the EMA as well as medicines authorised at national level.

This guidance describes the aspects of the EU guidance on GVP that no longer apply to the MHRA and UK MAHs, or are to be read subject to modification.

Published 31 December 2020