Last updated: 13 August 2026
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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
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 1.2.1.16 released to production on 3 August 2026 is now available on the eSubmission PLM Portal eAF web page.
Guidance published by Member States on the implementation of the Falsified Medicines Directive
You can view the links to the guidance here.
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