Guidance on Importing Investigational Medicinal Products (IMPs) into Great Britain

New guidance outlines the procedures and requirements for importing Investigational Medicinal Products (IMPs) into Great Britain for clinical trials.

Key Requirements:

• Approved Import Countries: IMPs from EU and EEA countries require UK MIA(IMP) holder oversight.
• Qualified Person (QP) Certification: A QP in a listed country must certify IMPs before release.
• Oversight & Compliance:
• A UK MIA(IMP) holder verifies QP certification.
• Written agreements define responsibilities between involved parties.
• Batch Certification: A batch certificate or statement of certification must be verified before shipment.
• Storage in Great Britain: IMPs may be stored in distribution hubs but must remain segregated until QP certification is confirmed.
• These regulations ensure compliance, quality, and safety for clinical trial supplies in Great Britain.

Region: European Union

Source: https://www.gov.uk/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