Variations to marketing authorisations (MAs)
How the MHRA processes variations to marketing authorisations.
-
-
Medicines: apply for a variation to your marketing authorisation
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
-
Guidance: Innovative Licensing and Access Pathway (ILAP)
The Innovative Licensing and Access Pathway (ILAP) is focused on getting the most transformative new medicines to patients in the UK health system more quickly.
-
Guidance: AI Airlock Simulation Workshops
Key insights of three simulation workshops from the AI Airlock pilot testing programme. Please note that these documents are not formal guidance.
-
Guidance: AI Airlock Phase 2 Cohort
Phase 2 of the Airlock will include seven additional technologies spanning AI-powered clinical note taking, advanced cancer diagnostics, eye disease detection tools, and obesity treatment support systems.
-
Guidance: AI Airlock Sandbox Pilot Programme Report
The MHRA’s AI Airlock pilot phase ran between April 2024 and March 2025. This report does not constitute formal MHRA guidance.
-
AI tools that could detect diseases earlier selected for next phase of MHRA’s ‘AI Airlock’ programme
Seven emerging AI healthcare technologies have been selected for the second phase of the MHRA’s AI Airlock programme.
-
Professor James Levine: When policy becomes medicine
How regulation can spark life-saving innovation.
-
17th Annual Sentinel Initiative Public Workshop – 11/06/2025
The U.S. Food and Drug Administration, under a cooperative agreement with the Duke-Margolis Institute for Health Policy, is hosting the 16th Annual Sentinel Initiative Public Workshop on November 6, 2025 -
Lupin Limited Unit 3 – 07/17/2025
Lupin Limited Unit 3 – 07/17/2025. Country: India. Record Type: 483 -
Hetero Labs Limited, Unit-IX – 09/26/2025
Hetero Labs Limited, Unit-IX – 09/26/2025. Country: India. Record Type: 483 -