When the EMA announced the new EU Variations Regulation changes in mid-2025 (read more in the previous Fusion blogs: EU variations guidance and Type IA Annual update), the main question everyone asked was: “Would the MHRA follow and adopt the new EU variations guidance and Type IA annual reporting?”
We now know that the answer is “Yes”, but consequences of the implementation continue to emerge.
The MHRA has adopted the new guidance on procedures and categories of variations and this has come into effect from 15 January 2026.
In other words, anything submitted after this date to the MHRA should use the new variation change codes, which have significantly changed with more simplified numbering. All “A” codes have now transitioned to “E” codes, and all “B” codes are now “Q”.
What happens if a variation is an IRP and approved before 15 January 2026?
For Type IB and Type II IRP variations, submitted on or after 15 January, the new application form (v1.28 or later) and variations categories should be used even if the Reference Regulator is the EMA or an EU Member State and the variation was approved using the previous variations guidance. Submitting the old form and change codes after 15 January 2026 would likely result in a VCR and delay the validation.
What happens to Type IA variations – they are standalone National submissions?
For Type IA variations, the IRP route does not apply, but the Type IA Annual Update reporting was also adopted by the MHRA from the amended EU guidance on submitting Type IA annual updates.
More importantly, if a Type IA variation was implemented before 15 January 2026, but not submitted by this cut off date, it is regarded as a late submission, post implementation and would need to be submitted as a default Type IB variation to obtain an approval from the MHRA.
All Type IA variations that were implemented after 15 January 2026 can be submitted as a bundled Type IA Annual Reporting depending on the implementation dates or as a standalone Type IA immediate notification.
We will be running a series of blogs about some of the key updates that have come out of this new Regulation.
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.
