Guidance

International Recognition Procedure

How to use this new procedure for medicines licensing applications.

Documents

Details

Eligibility checker

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The MHRA has created a new international recognition route for medicines utilising pre-existing approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States. This new framework will support patients in the UK with expedited access to safe and effective medicines that have been approved by trusted regulatory partners. From 1 January 2024, international recognition will sit alongside the MHRA’s current national procedures.

Webinar

The MHRA webinar provided potential applicants with the opportunity to increase their knowledge and understanding of the guidance on the International Recognition Procedure.

MHRA International Recognition Webinar November 2023

Published 30 August 2023
Last updated 5 January 2024 + show all updates
  1. Added link to Fees Calculator.

  2. Added recording of 'MHRA International Recognition Webinar November 2023'.

  3. Added submission dates for Recognition B which align with CHM dates for New Active Substances (NAS).

  4. Added guidance on the Eligibility Checker and submitting your Marketing Authorisation application, IRP Product Lifecycle & eCTD guidance for MAs and Lifecycle.

  5. Additional guidance added to address common queries about the International Recognition Procedures.

  6. The webinar recording has been published.

  7. First published.