New routes to marketing approval in Great Britain

As of 1st Jan 2021, Great Britain stopped following the EU centralised procedure for marketing authorisations. There are now many more routes to achieve marketing approval across the UK, GB and Northern Ireland as listed below:

  • Innovative Licensing and Access Procedure
  • Rolling review
  • National procedure
  • EC Decision Reliance Procedure
  • MR/DC Reliance Procedure
  • Unfettered Access from Northern Ireland
  • MA via the Access consortium
  • MA via Project Orbis


In Northern Ireland, the EU centralised, decentralised, and mutual recognition procedures continue to apply.
In addition to our global coverage updates, Prioritis continue to monitor the transition in the UK to support our clients. For more information on any of these procedures or any other country please get in touch at

For more information, feel free to contact us