International Recognition Procedure
How to use the procedure for medicines licensing applications.
- From:
- Medicines and Healthcare products Regulatory Agency
- Published
- 30 August 2023
- Last updated
-
2913AugustMay20242025 — See all updates
Documents
IRP initial validation checklist
PDF, 177 KB, 2 pages
IRP lifecycle validation checklist: variation, renewal
PDF, 763 KB, 2 pages
validation checklist form
PDF, 713 KB, 2 pages
Details
Eligibility checker
Fill in the eligibility checker form.
See our guidance on how to complete the eligibility checker and submit your application before completing the above form.
You may also find it of benefit to review the full list of eligibility checker questions, which includes some guidance, before completing the form.
Please liaise with your IT department to ensure you can save PDFs before completing the form.
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.
Webinar
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.
MHRA International Recognition Webinar November 2023
MHRA International Recognition: post-launch updates webinar (youtube.com)
Updates to this page
Published 30 August 2023
Last updated 2913 AugustMay 2024
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Sign up for emails or print this page
Details
Eligibility checker
Fill in the eligibility checker form.
See our guidance on how to complete the eligibility checker and submit your application before completing the above form.
You may also find it of benefit to review the full list of eligibility checker questions, which includes some guidance, before completing the form.
Please liaise with your IT department to ensure you can save PDFs before completing the form.
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.
Webinar
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.
MHRA International Recognition Webinar November 2023
MHRA International Recognition: post-launch updates webinar (youtube.com)
Updates to this page
Sign up for emails or print this page
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.