Last updated: 14 November 2025
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Classification of a product as intended for a limited market and eligibility for authorisation under Article 23 of Regulation (EU) 2019/6 (Applications for limited markets)
In respect of the above, guidance and a Q&A have been published.
Source: EMA
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.2.1.0 released to production on 10 November 2025 is now available on the PLM Portal eAF web page.
- Please note that for the PLM Portal eAF, The UAT for the new variation classification is now available by selecting “UAT January 2026” from the “Form version” field.
- This UAT version contains the new human variation classification.
- DO NOT USE this form for production submissions to authorities, until the final version will be confirmed.
- Once confirmed, the name of the version will change from “UAT January 2026” to “January 2026”. Use this PLM Portal form now just to test and familiarise with the new variation classification.
Source: eSubmission
eAF v1.28.0.0 (Human Variation) now available for external UAT (User Acceptance Testing)
A new UAT version of the Human Variation eAF v1.28.0.0 is now available on the eAF website for testing purposes.
- This UAT version contains the new human variation classification, which enters into force on 15 January 2026.
- DO NOT USE this UAT form for production submissions to authorities, until the final version will be confirmed.
- Once confirmed, a new communication will be published on the eSubmission website.
- Use this form now just to test and familiarise with the new variation classification.
- 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.
Source: eSubmission
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
The document with the above title has been updated and republished (28 October 2025). You can view it here.
There are updates to the following sections in Sep-Oct 2025:
- 1.6. What will be the legal basis for my application?
- 2.4. What is the procedure for appointment of Rapporteurs/Co-Rapporteurs and their assessment teams?
- 2.7. How should I notify a change in the contact person and/or intended submission date of my application?
- 3.5.6. What template should I use for the RMP submission? Rev. Oct 2025
- 3.5.7. When and how will the full RMP be published?
- 3.5.11. How is the assessment of an educational program as additional risk minimisation handled?
- 3.5.13. How will my RMP be reviewed?
- 3.5.14. Can I submit after the opinion a version of the RMP to reflect the last-minute changes made during the CHMP?
- 5.1.11. Can EMA assessment or inspection documents be shared with regulators outside the EU?
Member states contact points for translations review
Version 6.9 (Nov 1 2025) of the guidance with the above title has been published. You can view it here.
eCTD v4.0 – EU Controlled Vocabularies v3 now available
A new version of the EU eCTD v4.0 controlled vocabularies (v3) is now available, in both MS Excel (.xlsx) and genericode (.xml) formats.
- The changes compared to the previous version are highlighted in the MS Excel document, and marked with new/updated, accordingly.
- Please note that previous versions of the EU controlled vocabularies are still valid.
Source: eSubmission