# Importing investigational medicinal products into Great Britain from approved countries

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/6802dfbf-b8dc-40bb-89ae-330516e07443
Type: Guidance
Published: December 31, 2020
Updated: February 12, 2025

> This MHRA guidance outlines the regulatory requirements for sponsors of clinical trials importing investigational medicinal products (IMPs) into Great Britain from 'approved countries,' which currently includes all EU and EEA members. Under this framework, any UK Manufacturing and Import Authorisation (MIA(IMP)) holder must establish a comprehensive assurance system to oversee their supply chains. The primary requirement is to verify that a Qualified Person (QP) in the listed country has certified the products before they are released to trial sites. A significant benefit of this policy is that IMPs already certified by a QP in an approved country do not require further recertification once they arrive in Great Britain, reducing redundant testing and administrative burdens. While the document does not list specific company violations or inspection dates, as it is a general policy directive rather than an enforcement action, it mandates that all trial sponsors review their supply chains immediately to ensure compliance with these oversight protocols. Organizations are encouraged to coordinate with trade associations like the ABPI or contact the MHRA directly to ensure their assurance systems meet the necessary legal standards for trial safety and product integrity.

---

## Content

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: 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

## Attachments

- [Importing investigational medicinal products (IMP) from countries on a list to Great Britain](/government/publications/importing-investigational-medicinal-products-into-great-britain-from-approved-countries/importing-investigational-medicinal-products-imp-from-countries-on-a-list-to-great-britain)
- [List of approved countries for clinical trials and investigational medicinal products](/government/publications/importing-investigational-medicinal-products-into-great-britain-from-approved-countries/list-of-approved-countries-for-clinical-trials-and-investigational-medicinal-products)
- [Authorisations and procedures required for importing Investigational Medicinal Products to Great Britain from approved countries](/government/publications/importing-investigational-medicinal-products-into-great-britain-from-approved-countries/authorisations-and-procedures-required-for-importing-investigational-medicinal-products-to-great-britain-from-approved-countries)