PLM Portal eAF – January 2026 final version now available
The final “January 2026” version containing the new human variation classification, entering into force on 15 January 2026, is now available on the PLM Portal eAF.
- A single cut-off date for the entry into application (i.e., 15 January 2026) is set out in the final version of the Variations Guidelines.
- Until 15 January 2026, marketing authorisation holders should continue to rely on the current Variations Guidelines and on the specific procedural guidance.
- Please review this page for further details: Guidance on the application of the revised variations framework
- Findings related to the functionality of the form must be consolidated and submitted via an EMA eAF ticket.
- Findings related to the classification scopes (Section 3 of the eAF) must be raised through an RMS change request.
Note: The z-scopes are not visible yet in the new variation classification, they will be added soon.
Source: eSubmission