Change of https://www.gov.uk/government/publications/international-recognition-procedure

Change description : 2025-05-13 09:37:00: Updated validation checklist form [Guidance and regulationBrexit]

Showing diff : 2024-08-29 14:02:00.422179375 +00:00..2025-05-13 08:37:24.092463577 +00:00

Guidance

International Recognition Procedure

How to use the procedure for medicines licensing applications.

Update history

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.