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Please note this is an extract of the original bulletin.

International Recognition Procedure*

Page summary:
How to use this new procedure for medicines licensing applications.

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

MHRA fees*

Page summary:
Fees payable to the MHRA for 2023 to 2024

Change made:
Updated to include fees regarding International Recognition.

MHRA launches online Eligibility Checker tool for applications via the new  International Recognition Procedure (IRP)*

Page summary:
IRP is expected to further help bringing life-saving new medicines to UK patients from 1 January 2024

Change made:
First published.

*Note: The above updates do not include medical and IVD devices.

 

 

Tehelj