Guidance

Importing investigational medicinal products into Great Britain from approved countries

Importing investigational medicinal products for use in clinical trials

• From: Medicines and Healthcare products Regulatory Agency
• Published: 31 December 2020
• Last updated: 22 December 2021 — See all updates

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. There is a one-year transition period from 1 January 2021.

Contact

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

• Association of the British Pharmaceutical Industry (ABPI): regulatory@abpi.org.uk
• British Generic Manufacturers Association (BGMA): info@britishgenerics.co.uk
• BioIndustry Association (BIA): regulatory@bioindustry.org
• Clinical & Contract Research Association (CCRA): mail@ccra.org.uk
• Ethical Medicines Industry Group (EMIG): info@emig.org.uk
• Health Food Manufacturers’ Association (HFMA): pennyviner@btconnect.com
• The National Pharmacy Association (NPA): independentsvoice@npa.co.uk
• Proprietary Association of Great Britain (PAGB): regulatory@pagb.co.uk

Published 31 December 2020
Last updated 22 December 2021 + show all updates

1. 22 December 2021

   Update to post-Brexit protocols

2. 7 July 2021

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

3. 31 December 2020

   First published.