International Recognition Procedure
How to use this new procedure for medicines licensing applications.
Documents
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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.
JoinThe ourMHRA webinarwebinar, provided potential applicants with the opportunity to increase their knowledge and understand of the guidance on the International Recognition
Thursday, 14Procedure.
Webinar September,recording 11:00– -14 12:00September BST.2023
Last updated 3 October 2023 + show all updates
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The webinar recording has been published.
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First published.
Update history
2026-07-14 15:38
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 4.3New section added for Validation in Section 5Additional 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 8.4Additions to guidance on Reference Medicinal Products and Comparator Products for bioequivalence or therapeutic equivalence testing can be found in Section 8.8New section with contact details for relevant departments at the MHRA can be found in Section 11.
2026-01-21 16:51
Updated dates indicating the submission deadlines for IRP Route B applications in the IRP Guidance
2025-09-17 08:44
Page updated to align with guidance on UK-wide Licensing.
2025-05-13 09:37
Updated validation checklist form
2024-08-29 15:01
Updated ‘IRP initial validation checklist’ after reports of users experiencing problems with some of the check-boxes.
2024-07-30 15:28
Updated ‘IRP lifecycle validation checklist’.
2024-07-09 14:15
Updated International Recognition Procedure and eCTD guidance
2024-05-24 17:02
Updated guidance documents: International Recognition Procedure and International Recognition Procedure – supplementary information, and added new webinar link
2024-04-08 13:47
Multiple updates to ‘supplementary information’.
2024-01-05 10:12
Added link to Fees Calculator.
2023-12-20 16:02
Added recording of ‘MHRA International Recognition Webinar November 2023’.
2023-12-08 08:38
Added submission dates for Recognition B which align with CHM dates for New Active Substances (NAS).
2023-11-20 00:01
Added guidance on the Eligibility Checker and submitting your Marketing Authorisation application, IRP Product Lifecycle & eCTD guidance for MAs and Lifecycle.
2023-11-06 13:04
Additional guidance added to address common queries about the International Recognition Procedures.
2023-10-03 11:20
The webinar recording has been published.
2023-08-30 12:04
First published.