Last updated: 22 October 2026
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Report from the CMDh meeting held on 13-14 October 2026
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. Regulation (EC) No 1234/2008 on variations
The CMDh has discussed a recommendation for the classification of an unforeseen variation.
- The CMDh agreed that the proposed change (“Deletion of a batch size of the finished product”) can be submitted as a type IA variation under Q.II.b.4.z (certain conditions apply).
- The outcome has now been be included in the CMDh list of Art. 5 recommendations and published on the CMDh website under “Procedural Guidance Variation > Article 5 recommendations”.
- You can view the updated list here.
2. Procedural advice on Validation of MR / Repeat-use / DC Procedures
The CMDh agreed an update of the procedural advice on validation of MR / Repeat-use / DC
Procedures.
- With the update the RMS is empowered to start the procedure, in the exceptional case where CMSs do not react to validation responses within a given timeframe.
- The updated guidance has now been be published on the CMDh website under “Procedural Guidance > Application for MA”.
- Here, you can view the track changed (July 2022) and clean (October 2026) versions of the guidance.
3. Data requested for New Applications, Variations and/or Renewals in the MRP/DCP
The CMDh agreed updates for the two compilation documents including data requested for new applications and for Variations and/or Renewals in the MRP/DCP, which include national requirements for submissions in some Member States.
- The concerned Member States have updated the document to classify the requested data as validation issue (preventing procedure start) or as non-validation issue (not preventing procedure start). Some requirements in some Member States have also been deleted.
- The updated documents have now been be published on the CMDh website under “Procedural Guidance > Application for MA” and “Procedural Guidance > Variations”, respectively.
- Here, you can view the track changed (June 2025) and clean (October 2026) versions of the Application for MA guidance.
- Here, you can view the track changed (October 2025) and clean (October 2026) versions of the Variations guidance.
4. Request form for RMS in DCP
The CMDh agreed an update of the common request form for RMS in DCP.
- A statement has been included that only correctly and fully completed forms will be considered. For applications under Art. 10a, applicants are requested to confirm if a suitable reference medicinal product for an application under Art. 10 is available on the EU market and, if so, justify the choice of Art. 10a.
- Additionally, for bioequivalence studies or other studies to support equivalence, the (expected) date of completion should be included in the form.
- Finally, for ASMFs, the ASMF number will be requested.
- The updated request has now been been published on the CMDh website under “Templates > Applications for MA”.
- Here, you can view the track changed (September 2025) and clean (October 2026) versions of the form.
5. MRP/RUP request form
The CMDh agreed an update of the MRP/RUP request form. The footnote regarding CEP related to the need for the submission of a variation to update the dossier with the latest version prior to the MRP/RUP has been updated.
- The requirements for the Environmental Risk Assessment (ERA) in module 1.6 have also been further specified.
- The updated version has now been published on the CMDh website under “Templates > MRP/RUP”.
- Here, you can view the track changed (April 2025) and clean (October 2026) versions of the request form.
6. New applications in the MRP and DCP starting September 2026
You can view the stats for the above on pages no 3 and 4 of the report.
Marketing authorisation application and Variation electronic application forms (eAF) for centrally authorised products – naming convention reminder
Applicants and Marketing Authorisation Holders (MAHs) are reminded that the prescribed naming convention for electronic application forms (eAFs) must be followed. Compliance with this convention enables the correct identification of eAF files within submission sequences received by EMA and supports their automated processing.
For human medicinal products, the applicable naming convention for marketing authorisation applications (MAAs) and Variations is described in:
- eCTD 3.2.2 – EU Module 1 Implementation Guide (v3.1.1, page 34); and
- The corresponding validation criteria, specifically the worksheet “File-folder structure and names.”
EMA’s internal systems (IRIS) identify the eAF through an automated search for the string “ema-form-eaf”. If the naming convention is not followed, the system may be unable to correctly identify the eAF, which could affect processing.
As part of the validation process, submissions will be checked for compliance with this requirement. Where the naming convention has not been respected, applicants may be requested to resubmit the package with the correct filename.
Applicants are therefore strongly encouraged to verify the eAF filename before submission to avoid validation issues and potential processing delays.
Source: eSubmission
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
Here, you can view the track changed (13 July 2026) and clean versions (5 October 2026) of the document with the above title. Responses to the following questions have been updated:
- 1.1. When shall I submit my Type IA/IAIN variation(s)?
- 3.8. How shall I present my application for a new or modified therapeutic indication?
- 3.11. How shall my Type II application be handled (timetable)?
- 3.13. Which post-opinion steps apply to my Type II variation and when can I implement the approved changes?
- 3.25. When will I get a PIP compliance statement?
- 4.12. How shall my Extension Application be handled (timetable)?
- 17.30. How shall I implement the outcome of a PSUSA procedure?
- 17.35. What fee should I pay and whom to contact if I have an issue related to the payment of fee and QPPV advice notes?
- 22.1. What is an Article 61(3) Notification?
- 22.3. When can I submit my 61(3) Notification?
Source: EMA
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
Here, you can view the track changed (18 August 2026) and clean versions (5 October 2026) of the document with the above title. Responses to the following questions have been updated:
- 6.1.6. What are the protection periods for orphan medicinal products?
- 6.2.1. Extension of the ten-year period of marketing protection in the case of new therapeutic indications (8 + 2 +1)
Source: EMA