Guidance: International Recognition Procedure

How to use the procedure for medicines licensing applications.

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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 MHRA’s current national procedures.

The MHRA webinar held on 23 November 2023 provided potential applicants with the opportunity to increase their knowledge and understanding of the guidance on the International Recognition Procedure. A follow-up webinar in April 2024 presented post-launch updates and latest information about the new route.

Updated IRP lifecycle validation checklist form

New section on scope for the International Recognition Procedure can be found in Section 2. Additional clarifying guidance on IRP timetable extensions can be found in Section 4.3 New section added for Validation in Section 5 Additional information added to Section 7 on how to apply, to reflect step by step process and options for pre-submission support. Clarity on eligibility for ATMPS can be found in Section 8.4 Additions to guidance on Reference Medicinal Products and Comparator Products for bioequivalence or therapeutic equivalence testing can be found in Section 8.8 New section with contact details for relevant departments at the MHRA can be found in Section 11.