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Guidance

International Recognition Procedure

How to use the procedure for medicines licensing applications.

Updates to this page

From:
Medicines and Healthcare products Regulatory Agency
Published:
30 August 2023
Last updated:
9 October 2026
Show all updates

  1. Added new validation checklist form to IRP page

  2. Updated IRP lifecycle validation checklist form

  3. 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.

  4. Updated dates indicating the submission deadlines for IRP Route B applications in the IRP Guidance

  5. Page updated to align with guidance on UK-wide Licensing.

  6. Updated validation checklist form

  7. Updated 'IRP initial validation checklist' after reports of users experiencing problems with some of the check-boxes.

  8. Updated 'IRP lifecycle validation checklist'.

  9. Updated International Recognition Procedure and eCTD guidance

  10. Updated guidance documents: International Recognition Procedure and International Recognition Procedure - supplementary information, and added new webinar link

  11. Multiple updates to 'supplementary information'.

  12. Added link to Fees Calculator.

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

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

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

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

  17. The webinar recording has been published.

  18. First published.

Documents

International Recognition Procedure

HTML

International Recognition Procedure - supplementary information

HTML

Eligibility Checker and submitting your Marketing Authorisation application

HTML

International Recognition Procedure for Product Lifecycle

HTML

eCTD guidance for marketing authorisation and post-authorisation applications

HTML

IRP initial validation checklist

PDF, 177 KB, 2 pages

IRP contact form

MS Word Document, 127 KB

This file may not be suitable for users of assistive technology.

Request an accessible format
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

IRP pre-submission advice form

MS Word Document, 127 KB

This file may not be suitable for users of assistive technology.

Request an accessible format
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Validation checklist form

PDF, 750 KB, 2 pages

This file may not be suitable for users of assistive technology.

Request an accessible format
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

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)

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