As of the 1st of January, a new version of the Human Variation eAF form is available and should be used for all human variation applications.

The changes are the result of updates to Variation Regulation and can be found here: Guidance on the application of the amended Variations Regulation from 1 January 2025 | European Medicines Agency (EMA)

The use of the new form (v1.27.0.0) is mandatory for all applications that have been started after the 1st of January 2025.

Procedures started before that date using the previous version (1.26.0.0), should be continued using that version of the form. Forms should not be changed during an ongoing procedure. 

Conclusions:

• Start of the procedure after January 1st 2025: Use the new version of eAF (v1.27.0.0)
• Start of the procedure before January 1st 2025: Do not change the form version during an ongoing procedure, if the old version (v1.26.0.0) was used, continue using that version until the end of the procedure 
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The updated version of the eAF is available at eSubmission: eAF