Guidance for new Marketing Authorisation assessment routes in the UK following Brexit


Nasos Kipentzoglou, Analyst at Lightning Health takes a look at the different mechanisms to obtain marketing authorisation in the UK.

Following the end of the Brexit transition (1st January 2021), the MHRA has published guidance on the new marketing authorisation assessment routes available in the UK. There are now different mechanisms to obtain marketing authorisation including:

  • National Procedure (a 150-day procedure)
  • Rolling review
  • EC Decision Reliance Procedure (a 67-day procedure)
  • MR/DC Reliance Procedure (a 67-day procedure)
  • Unfettered Access from Northern Ireland (a 67-day procedure)

For international routes (collaborative procedures):

  • Access consortium
  • Project Orbis

In Northern Ireland, the EU centralised, decentralised, and mutual recognition procedures continue to apply.

Keep an eye out over the next few weeks for a series of publications and fact files where I will take a snapshot of these developments, starting on 9th March 2021 with the 150-day national procedure.

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Article published 4 March 2021.