Last updated: 5 March 2026
To view updates, click on the ‘+’ sign below.
Plasma Master File (PMF) requirements. Questions and Answers for PMF Holders
This Q&A was updated on 19 January 2026 due to Editorial deletion of Section Alert limits Q.8 and 9 consequence of CHMP adoption of Draft chapter 9 of guideline on epidemiological data on blood transmissible infections.
You can access the Epidemiological data on blood transmissible infections – Scientific
guideline | European Medicines Agency (EMA) here.
Report and minutes from the CMDh meeting held on 27-28 January 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 and minutes from the above meeting include (but are not restricted to) the following items):
1. Guidance on the application of the revised variations framework
Handling of type IA variations not submitted before 15 January 2026
On 15 January 2026, the new Variation Guidelines (including updated variation classifications) came into force.
- All variations submitted after this date should follow the new guideline.
- If, unexpectedly, a MAH identifies one or more Type IA variations that were implemented before 15 January 2026 but not submitted by that date, the delayed Type IA variations should be submitted promptly and without any further delay as an “early annual update”, using the old eAF and in accordance with the previous (2013) classification guideline.
- The MAH should ensure that all Type IA variations that were implemented before 15 January 2026 are included in this submission.
- Further guidance on the application of the revised variations framework can be found on the CMDh webpage and in this blog post.
2. Questions and Answers on generic applications
The CMDh has agreed an update of the CMDh Questions and Answers on generic applications. Q&A 8.b. has been reviewed to clarify the requirements on compatibility and administration of generic medicinal products via enteral tubes.
The updated document has now been published on the CMDh website under “Questions and Answers”. Here, you can view the track changed (October 2025) and clean (January 2026) versions of the document.
3. The worksharing procedure for the assessment of Active Substance Master File (ASMF)
The CMDh has agreed an update of the guidance document on worksharing procedure for the
assessment of Active Substance Master File (ASMF) prepared by the ASMF WG.
The document was revised:
- to delete references to the ASMF summary
- clarify that national procedures should be also included in the repository,
- add references to the Q&A document on ASMF and
- to bring it in line with the revised EC Variations Guidelines.
The updated document has now been published on the CMDh website under “CMDh > CMD Working Parties / Working Groups > Working Group on Active Substance Master File Procedures”.
Here, you can view the track changed (May 2024) and clean (December 2025) versions of the document.
4. New applications in the MRP and DCP started in December 2025.
At this link you can view the stats (tabulated on pages 3 and 4 of the report) as bar charts.
5. Experience with complex variation groupings
MSs exchanged experiences in handling of large complex variations, submitted either as large
grouped variations or as single variation applications affecting multiple SmPC sections.
- CMDh would like to remind applicants of the importance of clearly describing and supporting proposed variations changes in line with the Q&A on Variations.
- While a harmonisation of the product information is welcome and can be done in worksharing as a single type II C.4 variation, this is based on the fact that the changes are already approved in at least one MS, and the changes must be accompanied by the relevant documentation (data) package/justification.
- In line with Q4.21 a statement should be included in the eAF clearly highlighting that the variation applied for is a worksharing application for harmonisation of national product information.
- Alternatively, if the proposed changes are new and not a harmonisation, then the requirements of Q4.14 and Q4.17 must be met.
- Each ‘trigger’ in a variation application results in a single variation which may be submitted in a grouped application, e.g. one grouped type II variation application of three type II variations C.4 and must be clearly explained under the scope and background for change and supported by the relevant data package.
- Examples of separate triggers could include: literature investigations, database investigations, new study results etc. For each of these triggers a single variation is expected.
- Additionally, MAHs should clearly indicate the ‘trigger’/origin of that new information in the clinical overview and add a comment in the proposed PI submitted for assessment to
- highlight the relevant trigger for the amendment.
- To elaborate further on the above, when adapting the product information to an updated core company datasheet (CCDS), each ‘trigger’ for an update in the CCDS should be mentioned in the scope of the application form and should be classified according to the variation guideline.
- The identified triggers can be combined in a grouped variation application.
- Adhering to this guidance will improve variation handling and efficiency.
6. Medical Device Regulation
The CMDh discussed the requirements for informed consent applications (Art. 10c) of integral
drug device combinations (iDDC), if the MA referred to was submitted prior to 26 May 2021
(i.e. before the Medical Device Regulation (MDR)) and in compliance with the Medical Device
Directive (MDD).
- Reference was made to the joint EMA/CMDh Q&A document regarding medicines used in combination with medical devices and previous CMDh discussions on informed consent applications.
- It was discussed in 2015 that it is expected that for an informed consent application, the original MA is updated according to current legislation.
- However, it was also agreed that the MDR is not intended to apply retrospectively, and it was further noted that for an Art. 10c application, only Module 1 is expected.
- Therefore, unless there are significant changes to the medical device component of the already authorised product, there is no need to update the dossier in line with the MD Regulation, i.e. to provide a Notified Body opinion.
7. CEP letter of access
The CMDh discussed a question from Medicines for Europe regarding the need to provide a
CEP letter of access (LoA) in case of variations for revisions of the CEP, when the LoA was
previously submitted for older versions of the same CEP.
- Some MSs stated that a LoA also needs to be provided with variations for CEP revision, while others considered that in the above situation the LoA would not need to be submitted again.
- There was no majority to drop the requirement to submit a LoA in these cases.
- The current guidance will therefore remain in place.
- The outcome of the discussion will be communicated to IPs.
8. Multilingual packaging and expression of strength in medicinal product name
The CMDh discussed a query from a MAH. Following the closure of the DCP, the MAH wanted
to apply for multilingual packaging. However, this was not possible as different expressions
of strength were agreed between the ES and PT product during the DCP, which precludes
multilingual packaging.
- The expression of strength was discussed during the DCP, but no agreement could be reached due to national rules and harmonisation of the national market.
- Although a harmonised approach is desirable, it was noted that the expression of strength is a national issue.
- A possibility could be for the MS involved to agree to include both expressions of strength in the MLP, if no safety issue is apparent (as outlined in the BPG on Multilingual Packaging).
- The concerned MSs will discuss this option (Action: PT, ES). Feedback on the outcome will be provided to the MAH.
9. Reference to CEP number and CEP revision number in individual eCTD sections
The CMDh discussed a query from a MAH if reference should be made to the CEP number and
the CEP revision number in each individual CTD S. section as per the QWP Q&As on how to
use a CEP in the context of a MAA or a MAV.
- While some NCAs request the inclusion of such a reference as per the QWP guidance, most MSs considered that inclusion of the CEP number and revision number in all sections is not necessary and reference to another CTD section containing the CEP and revision number can be made instead.
- The CMDh agreed to request QWP to update the guidance accordingly. A question will be prepared for the February CMDh meeting.
- Feedback will be provided to the MAH.
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
Here, you can view the track changed (Dec 2025) and clean (15 Jan 2026) versions of this document.
The bulk of the track changes appear to be in the section 7 Classification of changes with an updated date of November 2025.
Source: EMA
Validation Checklist for Type II (non)clinical variations
You can view the checklist here.
The checklist should be completed and submited it as a word document as part of the working documents with your application for type II clinical, non-clinical and RMP variations
Source: EMA
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.2.1.4 released to production on 19 January 2026 is now available on the eSubmission PLM Portal eAF web page.
Deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications 2026/2027
You can view the document with the above title, here.
Source: EMA
Factsheet – Revolutionising Clinical Trials
You can view the factsheet here.
Source: European Commission
Decentralised Procedure – Requests to act as RMS
The document with the above title has been updated (Jan 2026). You can view it here.
Source: HMA
European Shortages Monitoring Platform (ESMP) update: Expansion in progress | ESMP webpage reorganisation | New ESMP factsheets and updated FAQs
As part of EMA’s ongoing commitment to enhance the European Shortages Monitoring Platform (ESMP) and support its users, the ESMP is expanding with new functionalities, and the development work is progressing. In addition, new and revised support materials are now available on the ESMP webpage, which has been reorganised with some content moved to two dedicated subpages.
ESMP expansion
The ESMP is expanding to include new tools and features that will better support stakeholders in preventing, managing, and mitigating medicine shortages:
- Voluntary solidarity mechanism workflow (for Member States): Implementation of a data submission and management workflow in the ESMP that allows Member States to flag critical national shortages of specific medicines, enabling other Member States to indicate available stock that could potentially be redistributed.
- Critical shortage reporting workflow (for Member States): This feature builds on the current reporting of critical shortages by NCAs to EMA and streamlines the submission and management of critical shortage notifications.
- Vulnerability assessment methodology testing (for the MSSG): In line with the upcoming pharmaceutical legislation reform, this functionality will support the MSSG in testing and automating a new methodology to identify vulnerabilities in the supply chains of medicines. It will allow step-by-step testing and provide initial large-scale analysis using defined indicators.
New ESMP webpage subpages
The ESMP webpage content has been revised and some content reorganised into two dedicated subpages:
- ESMP guidance, training materials and events page – hosting all user and implementation guidance, training materials and information on ESMP events.
- ESMP interoperability page – focused on information on the platform’s interoperability with national and pharmaceutical industry systems.
New and updated resources
To further support stakeholders in fulfilling their reporting obligations new concise factsheets and updated FAQs are available:
- ESMP Factsheets: four one-page summaries of MAHs and NCAs reporting obligations and processes in times of routine shortages, crises, or MSSG-led preparedness actions.
- ESMP FAQs: revised and expanded, with update details available in the revision history table.
Source: eSubmission
Overview of timetables 2026 CMDh 60-day procedures for MRP/DCP applications
You can view the overview of timetables here.
Source: HMA