Last updated on 2 July 2026
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Report from the CMDh meeting held on 23-25 June 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 not restricted to) the following items:
1. Deletion of requirement to provide cover letters for type IA variations
The CMDh has agreed to delete the requirement to provide cover letters for type IA variations, starting from 1 July 2026.
The following guidance documents have been updated to reflect the change:
- Requirements on submissions for variations and renewals within MRP and national
procedures - BPG on the use of eCTD in the MRP/DCP
- Cover letter for variation applications in MRP
- Questions and answers on variations
- BPG for the allocation of the MRP variation number for Type I notifications, Type II
variations, grouping and worksharing (Chapter 1) - BPG for the processing of Type IA minor variations (notifications) in MRP (Chapter 3)
- BPG for the processing of grouped applications in MRP (Chapter 6)
The guidance documents will be published on the CMDh website under “Procedural Guidance > Variations”, “Procedural Guidance > eSubmissions”, “Templates > Variations” and “Questions and Answers”, respectively.
Links will be provided once the documents become available.
- The tick box regarding annual update of type IA variation(s) has been removed from the cover letter template and will be included in the variation application form.
- The EMA/CMDh explanatory notes on variation application form (Human medicinal products only) have been updated to reflect the change.
- The document will be published once the updated variation application form is published.
- In addition, the document is updated to provide further clarification on how products should be listed in section 2 of the application form and to provide further guidance on the information to be included for grouped variation.
Source: HMA
2. Update of Questions & Answers on QP declaration
The CMDh agreed an update of the joint Questions & Answers on QP declaration.
- The document has been brought in line with the new Variations Guideline.
- Other minor changes have been included.
- Answers for human and veterinary medicinal products have been aligned where possible.
- The updated document will be published on the CMDh website under “Questions & Answers”
A link will be provided here once the document becomes available.
3. Best Practice Guide on Variation Worksharing (Chapter 7)
The CMDh agreed an update of the BPG on Variation Worksharing (Chapter 7). Further clarifications on the choice of the reference authority and the pre-submission activities have been added.
The updated document will be published under “Procedural Guidance > Variation
A link will be provided here once the document becomes available.
4. Update of (Public) Assessment Report Templates
The CMDh agreed an update of the following (public) assessment report templates:
- DCP D70 Overview AR template (incl. instructions)
- DCP D70 Overview AR template (empty)
- Instructions for RMS when preparing the PAR based on the FAR
- PAR template (empty) when prepared based on FAR
New standard wording for the non-clinical aspects has been added to be used, where relevant.
The templates will be published on the CMDh website under “Templates > Assessment Reports > DCP” and “Templates > Assessment Reports > Public Assessment Report”, respectively.
Links will be provided here once the documents become available.
5. Update of Questions & Answers – Post-Brexit
The CMDh agreed an update of its Post-Brexit Q&As.
- The information on reference medicinal products authorised in the UK has been clarified in the document.
- The updated document will be published on the CMDh website under “Questions & Answers”
A link will be provided here once the document becomes available.
6. New applications MRP and DCP started in May 2026
You can view the stats for the above on pages 5 and 6 of the report.
Human MAA eAF v1.28.0.0 – timeline for implementation
Versions 1.28.0.0 of the interactive PDF electronic application form (eAF) for human marketing authorisation application are available on the eAF website, together with the associated release notes.
- Industry must use the updated eAFs, Version 1.28.0.0, for any new CAP MAA application submitted to EMA from 28 July 2026.
- The forms can be used for new MAA applications submitted to the NCAs for NP, MPR, DCP and SRP procedures from 1st September 2026.
- It will be mandatory to use the updated forms for all new MAA submissions to the NCAs from 1 January 2027.
- Applicants are reminded that the version of the form should not be changed during an ongoing procedure.
You can better view the timelines at the link below.
Source: eSubmission