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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 鈥榓pproved country for import list鈥�, 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 [email protected] or call 020 3080 6000. Alternatively, contact your trade association by emailing:

• Association of the British Pharmaceutical Industry (ABPI): [email protected]
• British Generic Manufacturers Association (BGMA): [email protected]
• BioIndustry Association (BIA): [email protected]
• Clinical & Contract Research Association (CCRA): [email protected]
• Ethical Medicines Industry Group (EMIG): [email protected]
• Health Food Manufacturers鈥� Association (HFMA): [email protected]
• The National Pharmacy Association (NPA): [email protected]
• Proprietary Association of Great Britain (PAGB): [email protected]