Last updated: 13 December 2025
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Checklist for the submission of day 215 translations for post-opinion linguistic review – human
You can view the document with the above title, here.
For initial marketing authorisations and line extension applications the applicant/MAH submits the day 215 translations for a post-opinion linguistic review in one Eudralink message to the European Medicines Agency qrd@ema.europa.eu with a copy to the Product Shared Mailbox.
Source: European Medicines Agency
PLM Portal eAF – updated Q&A document
The PLM Portal eAF Q&A has been revised to incorporate questions gathered during the 2025 webinars and Q&A sessions.
- The newly added questions are clearly marked with the label “Nov ’25” for ease of identification.
- It is highly recommended to review this document before initiating the creation of a PLM Portal eAF for a human variation, as well as during or after completion, should you have any inquiries or encounter difficulties.
- Doing so ensures compliance with the latest guidance and supports the efficient resolution of potential issues.
Source: eSubmission
EU eCTD v4.0 – Forward compatibility pilot for CAPs to be announced in 2026
EMA is planning to start the Pilot Phase 3 on Forward Compatibility for the Centrally Authorised Products in 2026.
All eCTD v4.0 tool vendors are strongly encouraged to ensure that their tools are ready to support Forward Compatibility in early 2026.
Further information and details how to participate will be published on the eSubmission website in Q1 2026.
AND
EU eCTD v4.0 – Validation criteria v1.1 – open for comments
The eCTD v4.0 EU Validation Criteria is under review. The draft updated validation criteria v1.1 is now available for your comments. Please send your feedback via email to eCTD4consultation@ema.europa.eu by 31st December 2025.
Source: eSubmission
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