Guidance

Importing investigational medicinal products from approved countries after Brexit

Importing investigational medicinal products for use in clinical trials if there's a no-deal Brexit.

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The UK is leaving the EU. This page tells you how to prepare for Brexit and will be updated if anything changes.

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Sponsors of UK clinical trials that source investigational medicinal products (IMPs) from an EEA State will need to review their existing supply chains.

Action for sponsors of UK clinical trails using IMPs imported from countries on an ‘approved country for import’ list

You will require a UK Manufacturing and Import Authorisation (MIA(IMP)) holder to put in place an assurance system to check these IMPs have been certified by a Qualified Person (QP) in a listed country, before release to the trial. This list is initially all EU and EEA countries.

IMPs that have been QP certified in a listed country will not require recertification in the UK.

The purpose of this guidance is to describe the principles for the management and oversight of the import of IMPs to the UK from listed countries.

There will be a one-year transition period following the date of the UK’s exit from the EU to implement this guidance.

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

Published 11 March 2019
Last updated 10 October 2019 + show all updates
  1. Updated page title and summary to clarify that this guidance applies if there’s a no-deal Brexit. The rest of the page has not changed.
  2. Change of text within Stay up to date box.
  3. First published.