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Please note this is an extract of the original bulletin.

MHRA’s new International Recognition Procedure (IRP) goes live from 1 January 2024*

Page summary:
In partnership with other global regulators, IRP is expected to further help bring life-saving new medicines to UK patients.

Change made:
First published.

*Please note this update does not include medical and IVD devices.

Unfettered Access Procedure for marketing authorisations approved in Northern Ireland

Page summary:
Guidance for holders of Marketing Authorisations approved in Northern Ireland or the EU/EEA member states who want to bring a product to market in Great Britain.

Change made:
Added link to Fees Calculator.

 

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