The current PLM eAF timeline:
13-11-2026
Updated PLM portal eAF timeline
The update timeline for the Product Lifecycle Management (PLM)
Portal electronic application form (eAF) for human variations is now available.
The timeline reflects:
- Strongly recommended use of the Human Variation eAF for
non-CAP procedures
from September 2025.
- Mandatory use of the Human Variation eAF for CAP
procedures from September
2026*
*For details on the exceptional cases where the interactive PDF eAF remains
accepted, please see the guidance.
10-11-2026
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 1.2.1.23 (released to production on 9 November
2026) is now available on the PLM portal and eSubmission
PLM Portal eAF.
27-10-2026
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 1.2.1.21
(released to production on 13 October) and 1.2.1.22
(released to production on 26 October 2026) is now available on the PLM portal and eSubmission
PLM Portal eAF.
20-10-2026
Marketing authorisation application and Variation
electronic application forms (eAF) for centrally authorised products -
naming convention reminder
Applicants and Marketing Authorisation Holders (MAHs) are
reminded that the prescribed naming convention for electronic application
forms (eAFs) must be followed. Compliance with this convention enables the
correct identification of eAF files within submission sequences received by
EMA and supports their automated processing.
For human medicinal products, the applicable naming
convention for marketing authorisation applications (MAAs) and Variations is
described in:
For veterinary marketing authorisation application (MAA)
submissions to EMA, the electronic Application Form (Vet MAA
interactive PDF eAF) included in the VNeeS package must also follow a
specific naming convention. The filename must contain the text
"ema-form-eaf".
Additional elements may be included in the filename, provided that the
string "ema-form-eaf" remains present.
Important:
- The string "ema-form-eaf" must be
used only for the MAA or Variation eAFs.
- No other file within the submission package should contain
"ema-form-eaf" in its filename.
EMA's internal systems (IRIS) identify the eAF through an automated search
for the string "ema-form-eaf". If the naming convention is
not followed, the system may be unable to correctly identify the eAF, which
could affect processing.
As part of the validation process, submissions will be checked for
compliance with this requirement. Where the naming convention has not been
respected, applicants may be requested to resubmit the package with the
correct filename.
Applicants are therefore strongly encouraged to verify the eAF filename
before submission to avoid validation issues and potential processing
delays.
01-09-2026
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 1.2.1.18
released to production on 31 August 2026 is now available on the
PLM portal
and eSubmission PLM
Portal eAF.
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)
Previous PLM eAF news can be found here
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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