Medicines, medical devices and blood regulation and safety
Marketing authorisations, variations and licensing guidance: detailed information
Subscriptions
New applications
- Apply for a licence to market a medicine in the UK
- Medicines: apply for a parallel import licence
- Apply for the early access to medicines scheme (EAMS)
- Supply unlicensed medicinal products (specials)
- Advanced therapy medicinal products: regulation and licensing
- Decentralised and mutual recognition reliance procedure for marketing authorisations
- Unfettered Access Procedure for marketing authorisations approved in Northern Ireland
- European Commission (EC) Decision Reliance Procedure
- Procedural advice for Northern Ireland on applications for European Commission Centralised Marketing Authorisations
- 150-day assessment for national applications for medicines
- Rolling review for marketing authorisation applications
- Guidance on Project Orbis
- Access Consortium
Post-licensing
- Medicines marketing authorisation: change of ownership
- Medicines: apply for a variation to your marketing authorisation
- Renew: marketing authorisation for a human medicine
- Cancel a medicine's marketing authorisation or other licence
- Patient group directions (PGDs)
- Periodic Safety Update Reports (PSURs) for medicinal products
- Sunset clause: request for public health exemption
- Apply to release a vaccine or a blood product to market