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
• Last updated: 30 December 2024 — See all updates

Documents

Guidance note on good pharmacovigilance practices

PDF, 1.53 MB, 112 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
Last updated 30 December 2024 + show all updates

1. 30 December 2024

   Updated to reflect the changes to UK legislation implementing new arrangements for medicines following agreement of the Windsor Framework, and the European Union updates to GVP module XVI. Addendum II Updated to include new contact details.

2. 31 December 2020

   First published.