Guidance

International Recognition Procedure

How to use this new procedure for medicines licensing applications.

From:
Medicines and Healthcare products Regulatory Agency
Published
30 August 2023
Last updated
320 OctoberNovember 2023 — See all updates

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 IRP MAs and Lifecycle

HTML

Details

Eligibility checker

Fill in the Eligibility Checker form.

Please see our guidance before completing the above form.

Please liaise with your IT department to ensure you can save PDFs before completing the form.

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.

Webinars

The

Published MHRA30 webinar,August provided2023
Last potentialupdated applicants20 withNovember the2023 + show opportunityall toupdates

  1. Added knowledgeguidance on the Eligibility Checker and understandingsubmitting ofyour theMarketing guidanceAuthorisation onapplication, theIRP InternationalProduct RecognitionLifecycle Procedure.

    Webinar& recordingeCTD –guidance 14for SeptemberMAs 2023and Lifecycle.

    https://youtu.be/9azwcZoR0XM