Report from the CMDh meeting held on 24-25 March 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. CMDh guidance documents related to variations (Report pg 2)
The CMDh agreed to update the following:
- CMDh Q&A on Variations – Here, you can view the track changed (Oct 2025) and clean (Mar 2026) versions of the document.
- the Position paper common grounds seen for invalidation/delaying day 0 for variations – Here, you can view the track changed (Oct 2025) and clean (Mar 2026) versions of the document.
- Examples for acceptable and not acceptable groupings for MRP/DCP products – Here, you can view the track changed (Oct 2025) and clean (Mar 2026) versions of the document.
- the Preliminary Variation Assessment Report Template – Here, you can view the track changed (Feb 2025) and clean (Mar 2026) versions of the document.
These guidance documents have been revised to reflect the principles of the recently published Q&A 7.3.1 in the European Medicines Agency post authorisation procedural advice for users of the centralised procedure, which addresses the impact of changes in the clinical use of a product on quality documentation.
- During its February meeting, the CMDh agreed on the possibility of accepting the grouping of Type IA and Type IAIN variations outside the annual update of Type IA variations, provided that the changes are very clear and obviously related.
- In line with this agreement, the CMDh has now updated:
- the CMDh BPG for the Processing of (Super-)Grouped Applications in MRP (Chapter 6) – Here, you can view the track changed (Oct 2025) and clean (Mar 2026) versions of the document.
- the Examples for acceptable and not acceptable groupings for MRP/DCP products – Here, you can view the track changed (Oct 2025) and clean (Mar 2026) versions of the document.
- In addition, the CMDh agreed to update the CMDh BPG for the allocation of the Mutual Recognition variation number for Type I notifications, Type II variations, grouping and worksharing (Chapter 1), to clarify the allocation of procedure numbers for annual update of Type IA variations. Here, you can view the track changed (Oct 2025) and clean (Mar 2026) versions of the document
- The updated guidance documents have now been published on the CMDh website under “Procedural Guidance> Variation”. Links are also provided above.
2. CMDh guidance documents related to Paediatric Worksharing procedures (Report pg 2)
The CMDh agreed an update of the following in order to bring them in line with the
new EC guidelines on the details of the various categories of variations and operation of the
procedures:
- The Best Practice Guide for Article 45 and 46 paediatric worksharing procedure – Here, you can view the track changed (Feb 2025) and clean (Mar 2026) versions of the document.
- Questions and Answers on the Paediatric Regulation – Here, you can view the track changed (Feb 2025) and clean (Mar 2026) versions of the document.
In addition, the BPG has been updated to clarify that, when submitting a variation toupdate the product information, the variation cover letter should clearly state that the proposedchanges are based on the results of the paediatric Article 46 study.
- In such cases, no parallel paediatric worksharing procedure will be started.
- The updated guidance documents have now been be published on the CMDh website under “Paediatric Regulation > Guidance Documents”. Links are also provided above.
3. Guidance for preparation of Public Assessment Reports (Report pg 3)
The CMDh agreed on an update of its guidance for preparation of Public Assessment Reports:
- D70 Overview AR template (empty) – Here, you can view the track changed (Nov 2025) and clean (Mar 2026) versions of the document.
- D70 Overview AR template (incl. instructions) – Here, you can view the track changed (Oct 2025) and clean (Mar 2026) versions of the document.
- Instructions for RMS when preparing the PAR based on the FAR (MAr 2026)
- PAR template (empty) (Mar 2026).
- The documents have been updated to include reference to the requirement for applicants to comply with the applicable EU legislation on clinical trials of medicinal products for human use, as relevant to their specific application.
- The guidance and template documents have now been published on the CMDh website under “Templates >Assessment Reports > Public AR”. Links are also provided above.
4. CMDh position paper on the use of mobile scanning and other technologies to be included in the labelling and/or package leaflet in order to provide information about the medicinal product (Report pg 3)
The CMDh agreed an update of the position paper on the use of mobile scanning and other
technologies to be included in the labelling and/or package leaflet, along with its annexes (see links below), in order to clarify the conditions under which applicants/MAHs may include links to statutory information hosted on platforms created and operated by third parties.
- The documents have been revised to provide updated information on all aspects of the inclusion of mobile technologies for products applied for/authorised via MRP/DCP.
- The EMA QRD Working Group and the EC have been consulted on certain aspects of the update to ensure an aligned approach with products authorised via the centralised procedure, as much as possible.
- The updated documents have now published on the CMDh website under “Procedural Guidance > General Information”. Links have also been provided below.
Here, you can view the track changed and clean versions of the following:
- Position paper on the use of mobile scanning and other technologies to be included in the labelling and/or package leaflet, track changed (Oct 2023) and clean (Mar 2026) versions.
- Annex 2 – Applicant’s declaration template (Mar 2026)
5. New applications in the MRP and DCP started in February 2026 (tabulated on pages 5 and 6 of the report)
At this link you can view the stats as bar charts.
CTIS technical issues: no fee for resubmission of clinical trial applications
As of 1 January 2026, sponsors will not be charged a fee for the Clinical Trial Regulation safety assessment and ethics committee assessment when a clinical trial application must be resubmitted due to technical issues in the Clinical Trials Information System, provided that these issues occurred after validation.
- In exceptional cases, technical issues in the the Clinical Trials Information System (CTIS) require the resubmission of a clinical trial application, even after validation.
- As of 1 January 2026, sponsors will not be charged a fee for the CTR safety assessment and ethics committee assessment when a clinical trial application must be resubmitted due to technical issues in the Clinical Trials Information System.
- This fee exemption applies only if the content of the resubmission package is identical to the validated submission package of the original application.
Follow the instructions at the link below to request a fee exemption .
Source: FAHMP