Cancel a medicine's marketing authorisation or other licence

AI Summary

This regulatory guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the mandatory procedures for companies to cancel or withdraw marketing authorisations (MA), parallel import product licences, and traditional herbal remedy registrations. While this document is general guidance and does not specify a single company, inspection dates, or violations, it establishes the necessary regulatory framework for managing medicinal product exits from the UK market. To remove a product from the market, companies must submit the appropriate cancellation forms through the MHRA portal, the Central European System Platform (CESP), or via email. The agency enforces a limit of ten product licences per bulk cancellation form to ensure administrative efficiency. For pending applications or variations that a company no longer wishes to pursue, a specific withdrawal form must be emailed to the MHRA with a designated subject line. These required actions ensure that the MHRA's records remain accurate and that all products sold in the UK maintain valid legal status. Adherence to these administrative protocols is essential for companies to remain compliant with UK medicinal regulations during portfolio adjustments to their product portfolios.