Last updated: 23 September 2026
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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 1.2.1.18 released to production on 31 August 2026 is now available on the PLM portal and eSubmission PLM Portal eAF.
EMA procedural advice for medicinal products intended exclusively for markets outside the European Union in the context of co-operation with the World Health Organisation (WHO)
You can view the updated document (Rev 5 18 August 2026) here.
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
Here, you can view the track changed (13 July 2026) and clean (18 August 2026) versions of the document.
Reminder: mandatory use of PLM web-based eAF for CAPs – 1 September 2026
As announced in April 2026, the European Medicines Agency (EMA) is introducing the mandatory use for CAPs as of 1 September 2026.
- From 1 September onwards, any human CAP variation submissions sent to EMA using the interactive PDF eAF will be rejected unless it is accompanied with a valid and justified technical reason preventing the use of the PLM web-based eAF (users are encouraged to review the full announcement made on 13 April 2026).
Before 1 September 2026, PLM portal eAF users should:
- Verify PMS data accuracy
- Ensure all users have the correct PLM Portal access and roles.
- Familiarise themselves with the PLM web-based eAF and available guidance materials.
- Practice creating submissions in the PLM portal.
- Draft forms can be created and deactivated if not submitted
Interactive PDF eAF may still be used for:
- Large applications (over ~200 medicinal products) due to current performance limitations.
- Medical Devices section issues.
- Known PMS or OMS data issues affecting form completion.
- Lack of PLM portal access or co-authoring capabilities.
- Other technical issues that prevent timely completion of the PLM web-based eAF
Additional guidance:
- Report resolvable issues through the EMA Service Desk: https://support.ema.europa.eu/esc
- Use the interactive PDF eAF if issue resolution or service desk response times risk missing submission deadlines.
- No service desk ticket is required for known limitations such as large applications, Medical Devices issues, or lack of PLM portal access.
How to justify the use of the interactive eAF PDF for Human variations for CAPs after 1 September
To justify the use of the interactive eAF PDF, a new radio button will be introduced in the Delivery File User Interface (eSubmissions preparation) on 12 August 2026, after 18:00 CET. It is mandatory to confirm the use of the PLM portal eAF for all human variations (Type IA, Type IAIN, Type IB and Type II), for “Initial” and “Validation response” submission units:
The details on how to generate a delivery file are included in the relevant guidance (User guide to XML delivery file creation)
AND
New version of the eSubmission Gateway XML delivery file to confirm the use of the PLM portal eAF, available starting with 12 August 2026, 18:00 CET
An updated version of the eSubmission Gateway XML delivery file user interface will be available starting with 12 August 2026, 18:00 CET. This update introduced in the delivery file for Human variations the option to confirm the use of the PLM portal eAF for the creation of the application form.
Updated user guidance is published in the relevant section.
Users should note that the delivery files created prior to the new release will not work after the go live.
You can view screenshots at the link below.
Source: eSubmission
Human MAA eAF v1.28.0.0 – minor version available
Minor version 1.28.0.0 of the interactive PDF electronic application form (eAF) for human marketing authorisation application is available on the eAF website.
- The new version brings a minor change, affecting the substances dropdown in section 2.6.1.
- The previously published version 1.28.0.0 should be exported and re-imported in the newly published PDF. The steps are explained in the following guidance, page 10: Technical User Guide for eAF.pdf.
Reminder: all the new form that are published need to ‘Trusted’. Follow the Practical user guide for electronic Application Forms (eAF) for human and veterinary products in the EU, page 11.
For the implementation timeline of the 1.28.0.0 MAA forms, please consult the news from 30 June.
Source: eSubmission
Guidance published by Member States on the implementation of the Falsified Medicines Directive
You can view the links to the guidance here.
Report and minutes 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 and minutes from the above meeting include (but are 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 discussed and agreed to update the letter of intent for variation worksharing
procedures.
- The revised template provides further clarification on the choice of reference authority and on the information applicants should provide.
- Comments from MSs and from the VRWP have been taken into consideration, where relevant.
- It was stressed that the letter of intent is used in a pre-procedural step to agree on a reference authority and for the MAH to obtain a procedure number.
- More comprehensive information on the application will be provided by the applicant in the application form at the time of submission and a decision on the acceptance of the worksharing application will only take place during the validation phase.
- 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 in 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
7. Working Party on Variation Regulation (VRWP)
With reference to the deletion of the cover letter for type IA variations, MS were reminded that, as the only changes to the eAF are the new tick box for the annual update and the field for the first implementation date, it is not a requirement to use the updated eAF for type IA
submissions without a cover letter.
- The VRWP clarified that the December 2024 agreement on late-submitted type IA variations was intended as a general measure, and that such variations should not be automatically upgraded to Type IB. Member States still applying this approach will review it internally.
- The VRWP noted the updated BPG on Variation Worksharing (Chapter 7), adopted in June, and the related proposal to update the letter of intent for variation worksharing procedures.
- Merger of the current Type II variation Preliminary Variation Assessment Report (PVAR) and Final Variation Assessment Report (FVAR) templates into a single VAR template.
- The VRWP agreed to merge the current Type II variation Preliminary Variation Assessment Report (PVAR) and Final Variation Assessment Report (FVAR) templates into a single VAR template, providing one comprehensive document covering the procedural steps, requested changes within the variation and assessment of responses to the MSs requests for supplementary information.
- The CMDh endorsed the proposal.
- The combined VAR template will be published on the CMDh website replacing the PVAR, and the FVAR will be removed from the CMDh website.
- Industry concerns about NCAs changing the revision date format or date in package leaflets after the end of procedure
- The VRWP discussed industry concerns about NCAs changing the revision date format or date in package leaflets after the end of procedure, which may create discrepancies with already implemented artwork and lead to unnecessary reprinting and administrative burden.
- The group agreed that revision date formats recommended in the QRD template should be accepted and not changed by NCAs after the end of procedure.
- No update of guidance documents was considered needed.
- MSs also confirmed that reprinting of the product information would not be expected.
- During worksharing variations affecting several MAs, is the RMS expected to review the documentation for all individual dossiers?
- The VRWP discussed whether, in variation worksharing procedures affecting several MAs, the RMS is expected to review the documentation for all individual dossiers.
- The group agreed that responsibility for accurate and complete dossier submissions, including all relevant changes for the affected MAs, lies with the applicant, and that worksharing is intended to avoid duplicate assessments.
- It is expected that the same changes are included in all national dossiers so that the RMS only needs to perform the scientific evaluation of the proposed changes once and may request clarification if inconsistencies are identified but it is not required to systematically review or compare all individual dossiers.
- It was agreed that in case different dossier contents are identified after the end of procedure this might lead to a subsequent refusal of the worksharing application
- How should EMA-led worksharing procedures involving CAPs and purely national MAs, with no MRP/DCP be tracked?
- The VRWP discussed how EMA-led worksharing procedures involving CAPs and purely
- national MAs, with no MRP/DCP, should be tracked.
- MSs confirmed that they can follow such procedures through IRIS and agreed that additional manual entries or dummy records in CTS are not currently needed.
- BPG Chapter 7 will be updated accordingly.
- However, in the future, a link between CTS and PMS for purely national products could be helpful.
8. CEP 2.0
The CMDh discussed the Quality Working Party (QWP) response to the CMDh questions regarding the implementation
of CEP 2.0.
- QWP confirmed that the issue on specifications in CEP 2.0 will be addressed through the revision of the QWP Q&A “How to use a CEP”. MAH/FPM active substance specifications should generally align with the CEP 2.0 specification, with any differences justified in Module 3.
- QWP stressed that CEP holders must share sufficient information with MAHs/FPMs.
- QWP did not support the use of a declaration between the MAH and CEP holder.
- For CEP 2.0-related changes, MAHs/FPMs should assess the impact and, where applicable, submit type IA or IBvariation(s) as appropriate under the revised Variations Classification guideline.
9. Repeat-use procedure
The CMDh discussed if a MAH should be asked to submit a variation to update the dossier to
the latest version of the CEP in preparation for a RUP, even if the updated CEP has not yet
been implemented in the manufacturing process.
- It was noted that the need for MAHs to update their dossiers to the latest CEP version has been discussed extensively in the past in a cross-functional group, which resulted in the update of the EMA post-authorisation guidance, Question 7.2.4., which specifies that only the versions of the CEP which were used in the manufacturing process of a batch of finished product / AS need to be included in the dossier, provided that there are no quality and/or safety concerns that have led to the revision of the CEP.
- The CMDh had previously agreed to follow Question 7.2.4. without developing separate guidance.
- The CMDh agreed that the availability of a more recent CEP version that has not yet been
- implemented in the manufacturing process should not be considered a validation issue in a RUP application.