Sponsors of UK clinical trials that import investigational medicinal products (IMPs) into Great Britain (GB) 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 include a UK Manufacturing and Import Authorisation (MIA(IMP)) holder putting 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 GB from outside the UK that have been QP certified in a listed country will not require re-certification in GB.
The update contains new information for Northern Ireland.
Further information is available here on:
- Import of IMPs from an approved country
- Oversight process
- Supply of IMP to GB clinical trial site
- Reference and retention samples
- Importing non-IMP for use in a clinical trial