Guidance on handling of Decentralised and Mutual Recognition Procedures which are approved or pending

AI Summary

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance regarding the management of marketing authorisations (MAs) for products within the UK, specifically focusing on the relationship between Northern Ireland (NI) and Great Britain (GB) under the Decentralised (DCP) and Mutual Recognition Procedures (MRP). While no specific company or inspection dates are cited, this applies to all Marketing Authorisation Holders (MAHs) operating in these territories. The regulatory framework, anchored in the Human Medicines Regulations 2012, permits national UK-wide MAs even if concurrent EU applications exist where NI is a Concerned Member State. MAHs have three primary options for managing their licenses: maintaining a unified UK-wide MA with NI as a CMS (the default), opting out of the EU procedure for NI to maintain a purely national UK MA, or splitting the licenses into separate NI and GB authorisations. Required actions for MAHs seeking to consolidate or amend licenses include submitting a formal application through the MHRA Submission Portal. This requires a comprehensive cover letter, a Summary of Product Characteristics (SmPC), updated Patient Information Leaflets (PIL), and revised labeling featuring new PL numbers. For pending applications, the MHRA typically processes conversions within 30 days of the national phase, while granted cases are handled within 42 days. MAHs must implement updated packaging within six months of approval. This guidance ensures continuity of medicine supply while accommodating the differing regulatory statuses of GB and NI.