Variations to marketing authorisations (MAs)

AI Summary

This MHRA guidance outlines the procedures for marketing authorisation (MA) variations in the UK, reflecting changes effective from January 1, 2025, under the Windsor Framework. The regulatory framework is governed by the Human Medicines Regulations 2012 and the incorporated Variations Regulation (EC) No 1234/2008. Key updates include the conversion of Great Britain MAs into UK-wide authorisations and the cessation of EU Union authorisations in Northern Ireland. For UK-wide purely national variations, companies must follow national procedures or utilize the International Recognition Procedure (IRP). Products managed under Mutual Recognition or Decentralised Procedures (MRP/DCP) where Northern Ireland is a concerned member state require GB to align with the Reference Member State decision unless the MHRA objects within 30 days. The guidance maintains the use of existing EU classification guidelines for variation types (Type IA, IB, II, or Extension) until further notice. Marketing authorisation holders are required to submit variations through the correct pathways, ensuring that pending applications are transitioned according to their specific MA type. Failure to align with these procedures may result in the withdrawal of products from specific regions or the need for restricted NI-only authorisations. For technical support, the MHRA provides a dedicated contact for variation-related queries.