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.

Published 26 September 2019

From:: Medicines and Healthcare products Regulatory Agency

Documents

GVP guidance note

PDF, 620KB, 71 pages

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Details

Stay up to date

The UK will leave the EU on 31 October. This page tells you how to prepare for Brexit. It will be updated if anything changes, including if a deal is agreed.

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.