# International Recognition Procedure

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/831731ed-eaba-48bd-90dd-8657b01585a3
Type: Guidance
Published: August 29, 2023
Updated: January 21, 2026

> How to use the procedure for medicines licensing applications.

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## Content

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)

## Attachments

- [Eligibility Checker and submitting your Marketing Authorisation application](/government/publications/international-recognition-procedure/eligibility-checker-and-submitting-your-marketing-authorisation-application)
- [International Recognition Procedure for Product Lifecycle](/government/publications/international-recognition-procedure/international-recognition-procedure-for-product-lifecycle)
- [eCTD guidance for marketing authorisation and post-authorisation applications](/government/publications/international-recognition-procedure/ectd-guidance-for-irp-mas-and-lifecycle)
- [IRP initial validation checklist](https://assets.publishing.service.gov.uk/media/66d068ce7c42acbece502c88/IRP_initial_checklist.pdf)
- [IRP lifecycle validation checklist: variation, renewal](https://assets.publishing.service.gov.uk/media/66a8f0cb0808eaf43b50d9e7/IRP-PostLicensingSubmissionChecklistV1.2.pdf)
- [International Recognition Procedure - supplementary information](/government/publications/international-recognition-procedure/international-recognition-procedure-supplementary-information)
- [Validation checklist form](https://assets.publishing.service.gov.uk/media/6822209ed9c9bb76078f7f6d/IRP-PostLicensingSubmissionChecklistV1.3.pdf)
- [International Recognition Procedure](/government/publications/international-recognition-procedure/international-recognition-procedure)