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.
