Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs), ‘grandfathering’ and managing lifecycle changes

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK's stand-alone medicines and medical devices regulator. Existing Centralised Procedure (CAP) Marketing Authorisations (MAs) have been automatically converted into UK MAs effective in Great Britain, and remain valid for marketing in Northern Ireland. Manufacturers can choose to opt-out of this conversion process by notifying the MHRA in writing, which will result in the revocation of their UK MA. The MHRA has developed a new national portal for submissions, and manufacturers are required to submit an initiating eCTD sequence within one year starting on 1 January 2021, including a cover letter, electronic application form, and current approved documentation. Variations, renewals, and Article 61(3) notifications will be reviewed by the MHRA after the baseline is processed. The marketing authorisation holder for a UK MA must be established in the UK or EU/EEA.