Type IA Annual Reporting in the UK

Following on from our News Article: “You need to apply Type IA Annual Reporting in the EU in 2025” we can further advise that the MHRA has also adopted the EU changes in relation to Type IA variations for UK products.

 

This means that the MHRA do also require the submission of Annual Updates for Type IA variations, and these should be submitted nationally, unless the Type IA variations are submitted as part of a group with other variations applied for via the International Recognition Procedure (IRP).

 

IRP Variations:

You can use IRP during the lifecycle of UK products that have been initially authorised or subsequently varied via standalone;

• National route
• Decentralised and mutual recognition reliance procedure (MRDCRP) route
• European Commission (EC) Decision Reliance Procedure (ECDRP) route

 

Conversely, where a product has been authorised via IRP, it is acceptable to submit standalone national post-authorisation procedures, including variations.

 

Variations submitted via IRP should be classified according to MHRA guidance on variations to MAs. To facilitate lifecycle management of the MA, variations should be submitted as soon as possible after approval by the Reference Regulator (RR).

 

The MHRA will be publishing updated guidance on Annual Updates very shorty. So, watch this space for a more detailed overview when it becomes available.

 

 

Written by

Fiona Downey