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The word based application forms (AF) have been replaced by electronic application
forms
(eAF), with new possibilities like electronic data import/export, data population within the
form,
online access to standardised catalogue terms, built in business rule validation, and support for
validation of form, etc. Implementation of mandatory use of the eAF is part of the HMA eSubmission roadmap.
The electronic forms and supporting technical documentation are available below.
News
Previous news can be found here.
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
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.
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.
28-11-2025
eAF v1.28.0.0 (Human Variation) final version now
available
A new updated version of the Human Variation eAF v1.28.0.0
is now available on the eAF.
This final version contains the new human variation
classification, which enters into force on 15 January 2026.
A single cut-off date for the entry into application (i.e., 15 January 2026)
is set out in the final version of the Variations Guidelines. Until 15
January 2026, marketing authorisation holders should continue to rely on the
current Variations Guidelines and on the specific procedural guidance.
Please review this page for further details: Guidance on the application of
the revised variations framework
Findings related to the functionality of the form must be consolidated and
submitted via an EMA eAF ticket.
Findings related to the classification scopes (Section 3 of the eAF) must be
raised through an RMS change request.
Note: The z-scopes are not visible yet in the new variation
classification, they will be added soon
12-11-2025
eAF v1.28.0.0 (Human Variation) now available for external
UAT (User Acceptance Testing)
A new UAT version of the Human Variation eAF v1.28.0.0 is now
available on the eAF website for testing purposes.
This UAT version contains the new human variation classification, which
enters into force on 15 January 2026. DO NOT USE this UAT form for
production submissions to authorities, until the final version will be
confirmed. Once confirmed, a new communication will be published on the
eSubmission website.
Use this form now just to test and familiarise with the new variation
classification.
Findings related to the functionality of the form must be consolidated and
submitted via an EMA eAF ticket.
Findings related to the classification scopes (Section 3 of the eAF) must be
raised through an RMS change request.
Note: The z-scopes are not visible yet in the new variation
classification,
they will be added soon.
Forms
Please note that applicants should use Adobe Reader or Adobe Reader DC for locking the
forms. Adobe Acrobat or Acrobat Pro DC should not be used for filling and locking the forms as
this
may cause issues when the locked forms are opened/viewed by the recipient who may be using Adobe
Reader/Adobe Reader DC.
Currently accepted versions of forms:
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.
Version 1.26.0.0
Human MAA
Renewal
Veterinary Variation
Version 1.26.0.1
Veterinary MAA
Version 1.27.0.0
Human Variation
*Application form for marketing authorisation for veterinary medicinal products according to Regulation EU 2019/6 and for specific variations requiring assessment1
1variations requiring assessment classified as changes of active substance(s), strength, pharmaceutical form, route of administration or food-producing target species in chapter I of EMA/CMDv Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations
Guidance Documents
Regulatory
Technical
Q & A
| Questions and Answers document on Mandatory use of OMS |
CAPs OMS Mandatory Q&A 11.10.2021 |
| Variation eAF v1.25.0.0 presentation on changes to users |
Presentation 01.10.2021 |
| Variation eAF v1.24.0.1 presentation on changes to users |
Presentation 15.12.2020 |
| User Guidance Human & Vet |
Questions and Answers 01.03.2019 |
| Variation eAF v1.24.0.0 presentation on changes (to applicants) |
Presentation26.10.2020
|
| Variation eAF v1.24.0.0 presentation on changes (to NCAs) |
Presentation26.10.2020
|
| eAF for industry |
Presentation |
| How to complete an eAF based on version 1.20 |
Presentation 15.11.2016 |
Multimedia webinars and training
eAF Term Request process
If you need to request a new substance in order to complete an eAF, please submit a request for substance insertion with the corresponding SmPC to the EMA Service Desk portal.
If you need to request a new term (e.g. pharmaceutical form or unit of measurement) or an update of an already existing term in order to complete the eAF, please submit a request through the Referential Management Services (RMS) of the SPOR portal providing as much supporting documentation as possible (e.g. name of the product concerned, SmPC, justification for the request, etc.). The ‘RMS Web User Manual’, which provides a step-by-step guide on how to submit change requests, can be found under the 'Documents' section of the RMS portal.
Please note that you need to be registered with SPOR prior to the submission of change requests. The ‘SPOR User Registration Manual’, which provides detailed information on how to register in SPOR, can be found under the 'Document' section of the RMS portal. The user guide for managing referential and organisation data in eAF is available here.
Technical Documents
The Data Exchange Standards and XML Schema Definitions published here are intended to allow software developers within other organisations to develop systems to process the electronic application form data and build equivalent systems, if required. The EMA will ensure that the latest versions of these documents are published here.
Current version of technical documents:
Version 1.26.0.0
Human forms available for use from 1st of December 2021. Mandatory use from 1st of January 2022.
Veterinary forms available for use from 28th January 2022. Mandatory use from 28th January 2022.
For technical support, visit the EMA Service Desk portal: https://support.ema.europa.eu/esc
Links
Archives
As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period. |
