Unfettered access procedure for marketing authorisations approved in Northern Ireland

AI Summary

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on the Unfettered Access Procedure (UAP) for marketing authorizations (MAs). Operating under the Human Medicines Regulations 2012 and the Windsor Framework, the guidance outlines how medicines authorized in Northern Ireland can gain access to the Great Britain market. Starting January 1, 2025, the MHRA will transition from issuing Great Britain-only licenses to granting single UK-wide MAs, which will necessitate the revocation of pre-existing Northern Ireland-only authorizations for the same product. Eligible companies—specifically Marketing Authorisation Holders established in Northern Ireland—must submit a technical dossier identical to the one approved in Northern Ireland. Key requirements include a formal cover letter declaring conformity, inclusion of all previous assessment reports, and adherence to updated rules regarding European procedures. The MHRA intends to complete these assessments within a 70-day timeframe, assuming no major objections arise. Required actions for applicants involve registering via the MHRA portal, paying applicable fees, and ensuring compliance with pediatric and orphan medicine regulations. Failure to provide a complete dossier or meet technical standards may result in the application being moved to a slower, standard national review process.