Import a human medicine

AI Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance detailing the mandatory licensing requirements for importing medicinal products into the United Kingdom. To legally import licensed medicines, companies must secure one or more specific authorizations: a Wholesale Distribution Authorisation (WDA(H)), a Manufacturer’s Licence, or a Marketing Authorisation (MA). The specific requirements depend on the origin of the medicine and whether it is destined for Great Britain or Northern Ireland. Notably, medicines containing controlled substances require additional clearance from the Home Office. The regulatory framework emphasizes quality assurance; a Qualified Person (QP) must certify that products meet Good Manufacturing Practice (GMP) standards before release. For importers in Great Britain, a Responsible Person for Import (RPi) may also be required. When dealing with unlicensed medicines, importers must hold a Manufacturer’s “Specials” Licence (MSL) and proactively notify the MHRA of their intent to import, allowing the agency to object if necessary. Key required actions for compliance include submitting formal license applications, ensuring all manufacturing sites pass MHRA site inspections, and verifying that all international suppliers are appropriately authorized. While this document is a general guidance and does not list specific company violations or inspection dates, it establishes that failure to maintain valid licenses or adhere to notification protocols for unlicensed goods precludes legal market access.