Report from the CMDh meeting held on 15-17 September 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. Best Practice Guide for the processing of (super-)grouped applications in MRP (Chapter 6)
The CMDh agreed a minor update of the BPG for the processing of (super-)grouped applications in MRP (Chapter 6).
- It was agreed that it may also be acceptable to submit individual type IA variations to
- update the regulatory dossier prior to the submission of a MRP or line extension (in addition to e.g. RUP).
- The updated document has now been published under “Procedural Guidance > Variation”.
- Here, you can view the track changed (June 2026) and clean (September 2026) versions of the document.
Source: HMA
2. Timetables for MRP/DCP applications referred to the CMDh for the 60-days referral procedure in 2027
The CMDh has adopted an updated guidance document for MRP/DCP applications referred to the CMDh for the 60-days referral procedure in 2027, in accordance with Article 29(1) of Directive 2001/83/EC, as amended, and Article 13 of Regulation (EC) No 1234/2008.
- The updated guidance document has now been published on the CMDh website under “CMDh-Referrals”. You can view it here.
Source: HMA
3. Recommendations on submission dates for applicants of the DCP and MRP
The CMDh has adopted updated guidance documents with the timetables for MRP/DCP applications to be submitted in 2027.
- The updated guidance documents have now been be published on the CMDh website under “Procedural guidance > Application for MA > MRP/DCP”.
- Here, you can view the Recommendations on submission dates in 2027 for Applications of the DCP and the – Recommendations on submission dates in 2027 for Applications of the MRP
4. New applications in the MRP and DCP starting July-August 2026
You can view the stats for the above on pages no 3 and 4 of the report.
Source: HMA
Guidance published by Member States on the implementation of the Falsified Medicines Directive
Here is a compilation of links to guidance published by Members States on implementation of Falsified Medicines Directive.
Source: HMA
EudraVigilance – European database of suspected adverse reactions related to medicines: User Manual for online access via the adrreports.eu portal
You can veiw version 2.2 of the manual with the above title here.
This manual provides instructions on how to use the adrreports.eu portal to obtain access in EudraVigilance to reports of suspected adverse reactions (also referred to as undesirable effects or side effects) related to medicines.
Source: EMA