International Recognition Procedure
How to use this new procedure for medicines licensing applications.
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Eligibility checker
Fill in the Eligibility Checker form.
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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.
Last updated 8 April 2024 + show all updates
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Multiple updates to 'supplementary information'.
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Added link to Fees Calculator.
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Added recording of 'MHRA International Recognition Webinar November 2023'.
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Added submission dates for Recognition B which align with CHM dates for New Active Substances (NAS).
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Added guidance on the Eligibility Checker and submitting your Marketing Authorisation application, IRP Product Lifecycle & eCTD guidance for MAs and Lifecycle.
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Additional guidance added to address common queries about the International Recognition Procedures.
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The webinar recording has been published.
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First published.