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The word based application forms (AF) have been replaced by electronic application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.
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. |
