Last updated: 29 November 2025
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European Medicines Agency post-authorisation procedural advice for users of the centralised procedure – FAQ updated
Here you can view the track changed (15 July 2025) and clean (26 November 2025) versions of the document.
All of the following have been updated:
- 1.1. When shall I submit my Type IA/IAIN variation(s)?
- 1.2. Can I (super-)group the submission of Type IA/IAIN variations? Can
- they be grouped with other types of variations
- 1.4. How shall I present and submit my Type IA/ IAIN Variation(s)?
- 1.15. Who should I contact if I have a question when preparing my application or during the procedure?
- 2.1. What changes are considered Type IB variations?
- 2.4. How shall I present and submit my Type IB Variation?
- 2.6. When do I need a linguistic review for changes in the product information?
- 2.7. How shall my Type IB variation be handled (timetable)?
- 2.10. How should I submit revised product information? In all languages?
- 2.11. What changes will trigger new EU number(s) (additional presentation(s))?
- 2.14. Who should I contact if I have a question when preparing my application or during the procedure?
- 3.1. What changes considered Type II variations?
- 3.2. Do I need to notify the Agency of my intention to submit a Type II variation application?
- 3.3. Which Committee will take the lead in the assessment of a Type II variation?
- 3.4. Is the Co-Rapporteur involved in Type II Variations?
- 3.5. Is the PRAC Rapporteur involved in Type II variations?
- 3.7. How shall I present my Type II Variation application?
- 3.8. How shall I present my application for a new or modified therapeutic indication?
- 3.10. When shall I submit my Type II variation?
- 3.12. How should parallel Type II variations that affect the product information be handled?
- 3.17. What changes will trigger new EU number(s) (additional presentation(s))?
- 3.21. Do I need to confirm the maintenance of my orphan designation when applying for a Type II variation?
- 3.22. Can a non-orphan therapeutic indication be added to an already authorised orphan medicinal product?
- 3.23. Can a new indication based on less comprehensive data be added to an already authorised medicinal product?
- 3.24. Do I need to address any paediatric requirements in my Type II variation application?
- 3.25. When will I get a PIP compliance statement?
- 3.26. How and when can I withdraw my Type II variation application?
- 4.12. How shall my Extension Application be handled (timetable)?
- 4.18. Do I need to address any paediatric requirements in my extension application?
- 5.2. What groups of variations would be considered acceptable?
- 6.1. What is worksharing and what types of variations can be subject to worksharing?
- 6.7. How will variation applications under worksharing be handled (timetable)? What will be the outcome of the evaluation of a variation application under worksharing?
- 6.8. How and when will the marketing authorisations be updated following a worksharing procedure? When can I implement the approved changes?
- 9.1. Can I change the (Invented) Name of my CAP?
- 9.3. How shall I present my IN change application?
- 13.2. Under which procedure should I submit my non-interventional imposed PASS?
- 13.10. How shall I implement the outcome of a non-interventional imposed PASS final study report procedure?
- 14.2. How and where the PAES imposed in accordance with the Commission Delegated Regulation will be reflected in the marketing
- authorisation?
- 14.4. When should I submit my imposed PAES protocol?
- 15.8. When shall I submit my PAM?
- 16.4. Which variation classification will apply for my RMP updates?
- 16.6. Can I group my RMP updates?
- 17.30. How shall I implement the outcome of a PSUSA procedure?
- 18.3. How shall I present my article 46 paediatric study application at
- submission?
- 19.1. What is a Transfer of Marketing Authorisation?
- 19.13. Can I change the name of a medicinal product as part of a transfer
- application?
Updated PLM Portal eAF Release notes now available – 25 November 2025
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.2.1.1 released to production on 24 November 2025 is now available on the eSubmission PLM Portal eAF page.
Important:
- Please note that the design for adding a scope in a PLM Portal eAF was updated.
- Read the instructions on how to add a new scope in the release notes for version 1.2.1.1.
- In a future update, adding a scope and its details (procedure type, conditions, documentation) will be further enhanced.
Source: eSubmission
Report from the CMDh meeting held on 11-13 November 2025
The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each meeting and are usually published in the week following the CMDh meeting. The reports therefore only contain a subsection of the complete CMDh agenda and are used for a more timely communication of the most important outcomes.
The CMDh minutes are a full record of the CMDh meetings (minus redaction of confidential content). They are adopted at the following CMDh meeting and subsequently published.
Acronyms and abbreviations used in the report and minutes are available here.
The report from the above meeting includes (but is not restricted to) the following items:
1. Recommendation to applicants to use RMS validation checklist prior to submission of a DCP
To support applicants in the preparation and submission of compliant initial marketing authorisation applications in DCP and to minimise validation issues arising from missing documentation, it is strongly recommended that applicants use the RMS validation checklist as a ‘self-assessment’ tool prior to dossier submission.
- This recommendation has now also been included in the CMDh Best Practice Guide on the compilation of the dossier for new applications submitted in Mutual Recognition & Decentralised procedures.
- The document has also been updated to include information on the need to provide bridging data in Art. 10a applications.
- The updated document will be published on the CMDh website under “Procedural Guidance > Application for MA”
A link will be provided once the document becomes available.
2. Update of templates for Public Assessment Report and related guidance
Following the publication of the update of the DCP D70 Overview assessment report template including instructions, to include further standardised wording to guide assessors, after the October CMDh meeting, the CMDh has now also agreed related updates to the DCP D70 Overview assessment report template (empty), the PAR template (empty) when prepared based on the FAR and the instructions for the RMS when preparing the PAR based on the FAR.
The updated documents will be published on the CMDh website under “Templates > Assessment Reports > DCP” and “Templates > Assessment Reports > Public AR”, respectively.
- UPDATE – Instructions for RMS when preparing the PAR based on the FAR
- UPDATE – PAR template (empty) – when prepared based on FAR
- UPDATE – D70 Overview AR Template (empty)
3. New applications in the MRP and DCP started in October 2025.
At this link you can view the stats (tabulated on pages 4 and 5 of the report) as bar charts.
4. CMDh Best Practice Guide on the compilation of the dossier for New Applications submitted in Mutual Recognition and Decentralised Procedures
Here you can view the track changed (September 2025) and clean (November 2025) versions of the document.
5. Presentations from the 19 November 2025 meeting with Interested Parties
Links to the presentations are provided below:
CMDh – CTS Overview
CMDh – MAWP
EUCOPE – DCP Slot Booking
CMDh – Slot Booking
EUCOPE – Variations
EFPIA – Variations Worksharing
CMDh – FAQs on Revised Variations Regulation and Classification Guideline from Industry
EUCOPE – ERA Experience & Challenges
MfE – CEP 2.0
Source: HMA
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 – 10 November 2025
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