Guidance

Exceptions and modifications to the EU guidance on good pharmacovigilance practices that will apply in a no-deal Brexit

This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP) in a no-deal Brexit.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 26 September 2019
• Last updated: 9 October 2019 — See all updates

This publication was withdrawn on 31 January 2020

For updated information on good pharmacovigilance practices see Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the MHRA.

Documents

GVP guidance note

PDF, 637 KB, 71 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 will no longer apply to the MHRA and UK MAHs or are to be read subject to modification in a no-deal Brexit.

Published 26 September 2019
Last updated 9 October 2019 + show all updates

1. 9 October 2019

   Change of text within Stay up to date box.

2. 26 September 2019

   First published.