Report from the CMDh meeting held on 21-22 July 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. Updated version of the Variation Authorisation Application form (eAF)
Minor version 1.28.1.0 of the interactive PDF electronic application form (eAF) for human variation application is available on the eAF website, together with the associated release notes.
- The new version brings the annual update checkbox (and the earliest implementation date), mandatory use of OMS for 3 sections and a small bug fix. The changes are included in the release notes for 1.28.0.0.
- The form can be used for new human variation applications submitted to EMA and NCAs from 3 August 2026.
- It will be mandatory to use the updated form for all new human variation submissions from 24 August 2026.
- Applicants are reminded that the version of the form should not be changed during an ongoing procedure
- In addition, the EMA/CMDh explanatory notes on variation application form (Human medicinal products only) has been updated to reflect the change. The updated document will has now been published under “Procedural Guidance > Variations”.
- Here, you can view the track changed and clean (July 2026) versions of the document.
2. Letter of intent for variation worksharing procedures
The CMDh agreed to update the Letter of intent for variation worksharing procedures. The revised document provides further clarification on the choice of reference authority and on the information applicants should provide.
- The updated document has now been published under “Templates > Variation”.
- Here, you can view the track changed (March 2019) and clean (July 2026) versions of the document.
3. Best Practice Guide on Variation Worksharing (Chapter 7)
The CMDh agreed on a minor update to the BPG on Variation Worksharing (Chapter 7) to clarify which worksharing procedures are included in CTS.
- The updated document has now been published under “Procedural Guidance > Variation.
- Here, you can view the track changed (June 2026) and clean (July 2026) versions of the document.
4. Type II variation assessment report
The CMDh agreed to merge the current Type II variation Preliminary Variation Assessment Report (PVAR) and Final Variation Assessment Report (FVAR) templates into one single VAR template.
- The updated template will give a complete overview of the procedural steps, all changes requested within the variation, and the assessment of the responses to the MSs request for supplementary information.
- The FVAR template will therefore be removed from the CMDh website.
- The updated VAR template will be published on the CMDh website under “Templates > Assessment Reports > Variations.
- Here, you can view the track changed (March 2026) and clean (July 2026) versions of the document.
5. MRP/DCP statistics in the first semester of 2026
Statistics regarding the first semester of 2026 and referring to new applications in MRP and DCP, according to the 5-levels of classification of the MRP/DCP Communication Tracking System database, has now been published on the CMDh website. You can view them here.
- They include information on variation worksharing procedures, CMDh referrals and rapporteurships in paediatric worksharing procedures under Art. 45 and 46 of the Paediatric Regulation.
- The CMDh statistics will also include more detailed information on variation procedures for monitoring the impact of the new Variation Regulation in Member States.
6. New applications n the MRP and DCP starting June 2026
You can view the stats for the above on pages no 4 and 5 of the report.
Source: HMA