Medicines marketing authorisation: change of ownership

AI Summary

This guidance outlines the mandatory process for transferring Marketing Authorisation (MA) ownership for medicinal products within the United Kingdom, overseen by the Medicines and Healthcare products Regulatory Agency (MHRA). To initiate a Change of Ownership (COA), applicants must first obtain a new product licence (PL) number corresponding to the relevant territory: UK-wide, Great Britain (PLGB), or Northern Ireland (PLNI). Submissions must adhere to electronic Common Technical Document (eCTD) standards and be transmitted via the Central European Systems Platform (CESP) or the MHRA portal. Essential documentation includes an individual application form for each product, a detailed cover letter, and a confirmation letter from the dosage form manufacturer. Furthermore, applicants must provide a cancellation letter for the existing licence, a declaration of marketing status, and updated patient information leaflets and labels. Notably, the MHRA prohibits any changes to patient information during this process other than those identifying the new owner and licence number; unauthorised changes will result in invalidation. Regarding safety monitoring, the new owner must update pharmacovigilance system details, including the Qualified Person Responsible for Pharmacovigilance (QPPV), either during the application or within 14 days of the grant. The MHRA typical processing window is 42 days. Failure to respond to validation queries within 10 working days leads to application cancellation and forfeiture of fees. This regulatory framework ensures that the legal responsibility for medicine safety and quality is seamlessly transferred while maintaining accurate public-facing information.