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Guidance

Importing investigational medicinal products into Great Britain from approved countries

Outlining the principles for the management and oversight of the import of investigational medicinal products (IMPs) to Great Britain from listed countries.

Updates to this page

From:
Medicines and Healthcare products Regulatory Agency
Published:
31 December 2020
Last updated:
12 February 2025
Show all updates

  1. Updated guidance document updated to take account of the EU implementation of the Clinical Trials Regulation No 536/2014 related to EU QP certification.

  2. Update to post-Brexit protocols

  3. New guidance on authorisations and procedures required for importing Investigational Medicinal Products to Great Britain from approved countries

  4. First published.

Documents

Importing investigational medicinal products (IMP) from countries on a list to Great Britain

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List of approved countries for clinical trials and investigational medicinal products

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Authorisations and procedures required for importing Investigational Medicinal Products to Great Britain from approved countries

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Details

Sponsors of UK clinical trials that import investigational medicinal products (IMPs) into Great Britain from outside the UK will need to review their existing supply chains.

Where the product is sourced from a country on the ‘approved country for import list’, this 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 trial sites. The list of approved countries will initially include all EU and EEA countries.

IMPs imported into Great Britain from outside the UK that have been QP certified in a listed country will not require recertification in Great Britain.

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

Contact

For further information, email our Customer Services Centre info@mhra.gov.uk or call 020 3080 6000. Alternatively, contact your trade association by emailing:

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