Medicines: apply for a variation to your marketing authorisation

AI Summary

This guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the updated procedures for medicinal product variations, effective 1 January 2025, with new procedural categories applying from 15 January 2026. Operating under the Human Medicines Regulations 2012 and the incorporated EU Variations Regulation, the document defines how companies must manage changes to existing Marketing Authorisations (MAs) in the UK and Northern Ireland. Variations are categorized based on their impact: Type IA (minor administrative changes), Type IB (minor quality or testing changes requiring pre-approval), and Type II (major changes affecting safety or efficacy). Significant modifications, such as changes to active substances or delivery routes, require a new license application entirely. Marketing authorisation holders are required to submit all applications electronically using the eCTD format through the MHRA Portal or the Common European Submission Portal (CESP). Required actions include adhering to specific assessment timelines—ranging from 30 to 120 days—and providing comprehensive supporting documentation, including tracked changes to product information and standardized summary fragments. The guidance emphasizes that incorrect documentation or missed deadlines for responding to information requests will result in application rejection or invalidation.