Guidance

Guidance on pharmacovigilance procedures in the event of a no-deal Brexit

This guidance summarises our approach to pharmacovigilance in the event of no-deal Brexit.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 18 March 2019
• Last updated: 9 October 2019 — See all updates

This publication was withdrawn on 24 February 2020

For current information on pharmacovigilance procedures see European Medicines Agency: Post-authorisation

Documents

Updated guidance on pharmacovigilance procedures in the event the UK leaves the EU without a deal

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Details

This guidance will apply from exit day in line with the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019.

Published 18 March 2019

Last updated 9 October 2019 + show all updates

1. 9 October 2019

   Major changes to content, including two new sections (9 and 10).

2. 9 October 2019

   Change of text within Stay up to date box.

3. 18 March 2019

   First published.