News
Previous DADI news can be found here
19-08-2026
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 1.2.1.17
released to production on 18 August 2026 is now available on the
PLM portal
and eSubmission PLM Portal eAF.
12-08-2026
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 date onwards, any human CAP variation
submissions sent to EMA using the interactive PDF eAF will be rejected unless it is
accompanied by 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:
In case the answer "No" is selected, the reason(s) for not using
the PLM eAF must be specified. 1 or more options from the dropdown can be
used:
In case "PMS Issue", "OMS issue" or "Other technical issue" are
selected, the EMA Service Desk ticket numbers must be given:
In case "Large application", "Medical Device" or "Access to PLM
eAF not yet in place" are selected, the EMA service desk number are not to
be filled in:
The details on how to generate a delivery file are included in
the relevant guidance (User guide to XML delivery file creation)
04-08-2026
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.
21-07-2026
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 1.2.1.15 released to production
on 20 July 2026 is now available on the eSubmission PLM Portal eAF web page.
and
PLM portal eAF and interactive PDF eAF human variation
known issue
The conditions and documentations for the variation scopes are
shown with their term name (short name, and for very few entries also
truncated) instead of the term description (long name).
For example, for Q.II.e.2.a, one of the conditions and one of the
documentations are both “truncated”:
This behaviour will be addressed in the upcoming period. The
users are encouraged to send the form as is, and to mention in the cover
letter that this is the current behaviour of the form, and that the
responsible EMA team will change it in a future version.
Please follow the eSubmission eAF page and the PLM portal release notes to
be notified of the resolution.
08-07-2026
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 1.2.1.14,
released to production on 07 July 2026, is now available on the eSubmission
PLM Portal eAF web page. The new version comes together with and the Annual
update checkbox and the FHIR version 2.2.6, previously announced.
24-06-2026
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 versions 1.2.1.12 and 1.2.1.13
(the most recent one released to production on 22 June 2026) is now
available on the eSubmission PLM Portal eAF web page.
and
PLM Portal FHIR XML version upgrade to 2.2.6 on 6 July 2026
18:00 CET
The PLM portal FHIR XML version will be updated to 2.2.6 on 6
July 2026, 18:00 CET. The new version introduces the following change: the
“Annual Update” notification will be reflected in the FHIR XML in the
following existing extension:
<input>
<type>
<coding>
<extension url="http://ema.europa.eu/fhir/extension/codeSystemName">
<valueString value="Procedure Detail Type" />
</extension>
<system value="http://spor.ema.europa.eu/v1/lists/200000027891" />
<code value="200000060060" />
<display value="Annual update" />
</coding>
</type>
<valueBoolean value="true" />
</input>
The existing FHIR package remains applicable.
The Release notes can be found here.
03-06-2026
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 1.2.1.11 released to production on 26 May 2026 is now
available on the eSubmission PLM Portal eAF web page.
13-05-2026
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 versions 1.2.1.8, 1.2.1.9 and 1.2.1.10
(the most recent one released to production on 11 May 2026) is now available
on the eSubmission PLM Portal eAF web page.
16-04-2026
Adoption survey for PLM Portal web-based electronic Application Form (eAF) users
As part of EMA’s commitment to continuous improvement, the eAF team has published an adoption survey to gather inputs and feedback on the PLM Portal web-based electronic Application Form (eAF), you can access the survey by clicking this link:
https://ec.europa.eu/eusurvey/runner/eAF_Change_Adoption_Survey.
This survey aims to assess your level of satisfaction with PLM Portal web-based eAF use, as well as your experience with user support resources and communication. It also aims to identify potential concerns or challenges and provide valuable insights to help the eAF team implement necessary improvements or mitigation measures.
We invite you to share your feedback on your experience as users of the PLM Portal web-based electronic Application Form (eAF) by filling in this adoption survey by 24 April 2026.
The survey will take only a few minutes to complete. Your responses will remain anonymous, and the results will not be publicly disclosed..
Your participation is highly appreciated, and we thank you in advance for your time and input.
13-04-2026
Mandatory Use of PLM Web-Based eAF for CAPs – 1 September 2026
The strongly recommended use of the PLM web-based electronic Application
Form (eAF) for Centrally Authorised Products (CAPs) has been in place since
July 2024. Over the past two years, submissions via the PLM eAF have steadily increased.
To continue advancing the adoption of the PLM web-based eAF, the European
Medicines Agency (EMA) will introduce mandatory use for CAPs as of 1 September 2026.
Why is this change being introduced?
The PLM web-based eAF enables faster and more accurate automated processing
of application forms. It also supports integration with other EMA systems,
contributing to a more efficient and streamlined submission and approval process.
By contrast, the interactive PDF eAF may present technical issues that can
lead to rejection of submissions. It is also slower to process and does not
support the same level of system integration as the web-based solution.
How to prepare for mandatory use
Before 1 September 2026, users of the PLM portal eAF are advised to:
What will happen after 1 September 2026?
From 1 September date onwards, any human CAP variation submissions sent to
EMA using the interactive PDF eAF will be rejected unless it is accompanied
by a valid and justified technical reason preventing the use of the PLM web-based eAF.
Possible technical reasons preventing the use of PLM eAF
The following known technical limitations may justify the use of the interactive PDF eAF:
-
Performance issues for large applications: The PLM portal currently has
performance limitations when handling large applications of over
approximately 200 medicinal products. Improvements for large applications
are planned for 2026.
-
Medical Devices section: a known issue in this section requires the continued use of the interactive PDF eAF.
-
PMS data issues: A full list of known PMS issues is
available in the PMS FAQ document
(page 16), including expected resolution timelines.
Examples include: duplicated products or packages, duplicated entries, truncated product names.
Applicants should review this list and follow recommended actions before submitting a support ticket.
-
OMS data issues: Issues in the intermediate data layer (dataverse)
may impact organisational data used in the eAF. A platform-level review is ongoing.
Existing and future workarounds aim to address synchronisation issues, including those related to contact persons and proof of payment.
-
Lack of access to the PLM portal: Some organisations have not yet enabled co-authoring or
provided access to all required users (e.g. in worksharing scenarios). In such cases, the interactive PDF eAF remains the only viable option.
-
Other (unknown) technical issues: Unlisted technical issues
may also be accepted, provided they are flagged on time and impede the correct finalisation
of a PLM portal form. If users encounter issues close to a submission deadline that block the completion of the PLM web-based eAF, they may use the interactive PDF eAF.
Further details on how to justify the exceptional use of the PDF eAF will be communicated prior to the beginning of the Mandatory use for CAPs.
Additional guidance
-
Users should raise a service desk ticket for issues that may be resolvable
(e.g. PMS, OMS, or newly identified issues): https://support.ema.europa.eu/esc
-
Requests will be handled based on priority and order of receipt, with feedback provided on resolution timelines.
-
If the estimated resolution time conflicts with a submission deadline, applicants should use the interactive PDF eAF.
-
If service desk response times are longer than expected, the interactive PDF eAF may be used.
For known limitations such as large applications, Medical Devices issues, or lack of
PLM portal access, users are not required to raise a service desk ticket.
Please follow the PLM portal and eSubmission for updates on the mandatory use of the
PLM portal eAF for CAPs and on how to report any impediments.
27-03-2026
Interactive PDF electronic Application Forms (eAFs) not
available for use between 10 April 10:00 CET and 12 April
16:30 CET due to planned maintenance
Due to planned maintenance in SMS, OMS, and RMS,
the interactive PDF eAFs (human and veterinary variation
forms, MAA forms, and the renewal form) will be unavailable
from 10 April, 10:00 CET until 12 April, 16:30 CET.
To avoid any disruption, please make sure to submit all forms with
deadlines scheduled around these dates before the planned
maintenance period begins.
The PLM Portal eAF will remain fully functional
during this period. However, please note that because OMS will not be
available for updates between 9 April, 14:00 CET and 12 April, 16:30 CET,
the OMS data displayed in the PLM Portal eAF will reflect the
status as of 9 April, 14:00 CET.
All systems are expected to return to full functionality on
12 April, 16:30 CET.
For more details on how other systems are affected, please refer to the
relevant EMA webpages.
For any further information, please contact
EMA Service Desk
19-03-2026
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 1.2.1.7 released to production on 16 March 2026 is now
available on the eSubmission PLM Portal eAF web page.
04-03-2026
Reminder - New variation classification in eAF
The updated Variation Regulation Classification Guideline has been made
available in both the interactive pdf eAF v1.28.0.0 and in the PLM Portal
web-based variation form January 2026 version. The users are reminded to
verify the accuracy and content of the selected scopes (including the
conditions and documentation), before submitting
the form to the relevant health authorities. In case of any discrepancies, a ticket should be raised
Request RMS Service - Employee Center.
18-02-2026
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 1.2.1.6 released to production on 16 February 2026
is now available on the eSubmission PLM Portal eAF web page.
03-02-2026
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 1.2.1.5 released to production on 02 February 2026
is now available on the eSubmission PLM Portal eAF web page.
20-01-2026
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.
07-01-2026
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 1.2.1.3 released to production on
06 January 2026 is now available on the eSubmission PLM Portal eAF web page.
16-12-2025
New variation classification in eAF - reminder for cut-off date 15 January 2026
The updated Variation Regulation Classification Guideline has been made available in the interactive pdf eAF
v1.28.0.0 and in the PLM Portal web-based variation form January 2026 version.
Applicants are reminded that applications using the v1.28.0.0 or the January 2026 version of the form must not be submitted to the EMA prior to 15th January 2026 CET 00:00. Applications received before the 15th January 2026 will be rejected, and the application must be resubmitted on or after the 15th January 2026.
For any exceptions to these rules and applicability for different scope types must be reviewed on the following EMA dedicated page: Guidance on the application of the revised variations framework | European Medicines Agency (EMA)
AND
New variation classification in eAF - Q&A session - 8 January 2026 10:00 - 11:00 CET
The updated Variation Regulation Classification Guideline has been made available in the interactive pdf eAF
v1.28.0.0 and in the PLM Portal web-based variation form January 2026 version.
To support this change, the EMA eAF team will host a Q&A Clinic on 8 January 2026 10:00 - 11:00 CET dedicated to addressing your questions about the eAF form functionalities related to the new variation classification. To register, please use the following link: Q&A eAF registration - 8 January 2026.
AND
PLM Portal eAF - reminder for FHIR XML attachment
Applicants are reminded that eAFs generated in the PLM Portal need to have the FHIR XML attached when submitted to health authorities. The applicants need to check that all PLM Portal eAFs contain the FHIR XML before adding them to the eCTD package. For more information, please consult the eAF - Guidance Documents
PLM Portal eAF documentation:
PLM Portal eAF:
PLM Portal eAF FHIR:
PLM Portal eAF training videos and training sessions:
PLM Portal eAF training videos and training sessions
For the UK, as from 1.1.2021, EU Law applies only to the territory of
Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.
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