What is the new process for Type IA Variations in the EU – Annual Reports?
Following the implementation of the Delegated Regulation (EU) 2024/1701, on 1 January 2025, there are now changes to the process for submitting Type IA variations.
If your Type IA variation was implemented in 2024:
- it may be submitted no later than 12 months after implementation.
- this system allows ‘annual reporting’ of these variations – not mandatory
- multiple Type IA variations can be submitted if they too have been implemented during the previous 12 months
So, there’s no real change to the current process. You could always submit Type IAs as an annual report, if you chose to.
The difference now, is when your Type IA variation is implemented from 1 January 2025 onwards:
- the wording has changed from ‘may be’ to ‘should/shall be’, i.e. this is becoming mandatory for Type IA to be submitted as a ‘Type IA annual update’
- submit within 12 months, after the oldest implementation date
- one single submission, including ALL minor variations during that time period
group together multiple Type IA variations - submit no earlier than 9 months after the earliest implementation date
- submit no later than 12 months after the earliest implementation date
e.g. you have 3 Type IA variations to the same MA implemented 20 Jan 2025:
- Submit the annual update grouping
- earliest date is Sep 2025 (9 months after 20 Jan 2025)
b. deadline is 20 Jan 2026 (12 months after 20 Jan 2025)
In Summary, the change will only impact ways of working from around Q3 2025 onwards.
Fusion’s top tip
Set up a tracking system for your implementation dates to ensure that you collate these Type IA variations over the year and ensure no deadlines are missed.
Note:
You can still, however, group a Type IA with other IAIN, IB, or II changes, only where it is an acceptable grouping CMDh Examples for groupings for MRP DCP and EMA Guideline for Grouping of Variations.
Also you can still submit a Type IA super-grouping, where you are making a change to multiple MA’s.
There are exceptional cases when you can submit an individual submission immediately after implementation when it is justified e.g. according to Chapter 6 of the CMDh Best Practice Guide on Variations, such as:
- to mitigate a shortage
- in relation to a public health concern
- an update dossier is needed prior to a routine site inspection or a MAH transfer
Therefore these are identified as Type IAIN notifications.
UK impact: Please note that we are talking EU here, not UK. As of now, the MHRA has not mandated the adoption of all amendments from the EU’s Variations Regulation 2024/1701. Please be aware that Type IA variations are to be submitted within 12 months of implementation, but the MHRA does not mandate an annual update system as described in the EU regulation – YET. However, recent intelligence shows that the MHRA are looking to align to the EU and will shortly provide a draft guidance update for applicants to comment on.
If you would like to discuss how Fusion Pharma can support you with Variations, please email us at hello@fusion-pharma-limited.com or phone us on +44 (0) 203 1379 799.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.
