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

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Medicines Healthcare Products Regulatory Agency

February 11

11:33 2025

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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 11 February 2025 +show all updates

11 February 2025
Updated 'Guidance note on good pharmacovigilance practices'.
7 February 2025
Changed to add latest version of Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders and the licensing authority
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.
31 December 2020
First published.

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