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eAF

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The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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.

29-01-2025

Updated eAF 1.27.0.0 Human Variation form

The Human Variation form v1.27.0.0 was updated on the 29 January 2025. The change follows the recent update of the new variation regulation; in the Declaration section in the parallel procedures sub-section, the table with the product/procedure details has been removed.

It is recommended to use this latest form for new submissions. Please note that there is no version number change and that the release notes will be updated and published in the relevant section of the eAF page.

05-12-2024

Updated Renewal and Variation Veterinary forms

The Renewal Form v1.26.0.0 and the Variation Veterinary Form 1.26.0.0 will be updated on 5 December 2024. The changes are related to a note text update, and there is no impact on the version or the structure of the form.

04-12-2024

Planned maintenance of eSubmission systems on 5 December 2024, 18:00 CET

Due to planned maintenance, the following eSubmission systems will not be available on Thursday 5 December 2024, between 18:00 and 24:00: Gateway XML delivery file user interface, Gateway Filehandler, Common Repository Web-UI and API, PSUR Repository Web-UI (both NCA and industry access) and API.

The maintenance includes various improvements and implementations:

  • Common Repository Web-UI - technology modernisation
  • Gateway XML delivery file user interface - various improvements and integrations for retrieval of data (e.g. procedures) from the internal EMA case management system (IRIS)
  • Gateway XML delivery file user interface - minor changes related to the new variation regulation (e.g. renaming of the submission mode from "IG" to "super-grouping")

Updated documentation will be published on the relevant pages of the eSubmission website. For any further information, please contact EMA Service Desk.

02-12-2024

Updated eAF v1.27.0.0 (Human Variation) now available, for use from 1 January 2025

An updated/corrected version of the eAF 1.27.0.0 (Human variation) is now available on the eSubmission website. The difference compared to the version published on the 27th of November is in the exported XML, which now correctly contains the super-grouping checkbox.

It is mandatory to use version 1.27.0.0 for all Human Variation applications with procedure start date after 1st of January 2025.

The version 1.26.0.0 for Human Variations will be removed from the eAF website, however, users can continue to submit applications using this version for procedures starting until 31 December 2024. Applicants are reminded that the version of the form should not be changed during an ongoing procedure. Please note that in case you need to provide an update to a form that has been submitted prior to 1st of January 2025, you should use the previous version (1.26.0.0).

27-11-2024

EMA encourages companies to submit type I variations for 2024 by end November 2024

EMA is advising marketing authorisation holders to submit type IA and type IAIN variations for 2024 no later than 30 November 2024. This will enable EMA to acknowledge the validity of the submissions before the Agency's closure between 20 December 2024 and 5 January 2025, within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008.

Marketing authorisation holders are advised to submit any type IB variations or groupings of type IBs and type IAs by 30 November 2024 for a start of procedure in 2024. For submissions received on or after 1 December 2024, the procedure may not start until January 2025.

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eAF v1.27.0.0 (Human Variation) now available, for use from 1 January 2025

In line with the amended Variation Regulation entering into force on the 1st of January 2025 ( Guidance on the application of the amended Variations Regulation from 1 January 2025 | European Medicines Agency (EMA) ), a new version of the Human Variation eAF v1.27.0.0 is now available on the eAF website.

It is mandatory to use version 1.27.0.0 for all Human Variation applications with procedure start date after 1st of January 2025.

The version 1.26.0.0 for Human Variations will be removed from the eAF website, however, users can continue to submit applications using this version for procedures starting until 31 December 2024. Applicants are reminded that the version of the form should not be changed during an ongoing procedure. Please note that in case you need to provide an update to a form that has been submitted prior to 1st of January 2025, you should use the previous version (1.26.0.0).

29-10-2024

Interactive PDF eAF technical documentation updated

An updated set of schemas were published under the "Technical Documents" section of eAF (interactive PDF), relevant for small changes in the XML schema definition for versions 1.26.0.0 and 1.26.0.1. The changes are reflected in the "eAF DES change summary" document.

14-10-2024

Non-Centrally Authorised Products now available in the PLM Portal eAF

The EMA is pleased to announce that the non-Centrally Authorised Products* (non-CAPs) data are now available in the Human variation web-based eAF within the Product Lifecycle Management (PLM) Portal.

Please note that, due to system limitations and pending future improvements, the web-based eAF cannot currently be used for submissions to the National Competent Authorities. However, the web eAF is fully functional for the submission of variations of CAPs, including EMA-led worksharing variations containing CAPs and non-CAPs.

Please join the training session on 17 October 2024 10:00 - 11:30 (CEST).

Please see an updated version of the draft PLM Portal eAF guide to navigation is now available.

03-06-2024

PMS Product UI Now Live on the PLM Portal

The PMS Product User Interface (PUI) was launched on 31 May 2024, in read-only mode on Product Lifecycle Management (PLM) Portal. Registered users are now able to view Centrally Authorised Product - (CAP) data in the PUI (Nationally Authorised Product (NAP) data will be available in early Q3 2024).

Please note that the eAF users have now automatically access to the PUI. Consult these guidance documents and join the 3 June 2024 training session to prepare for registration & navigation of PUI.

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

Form Notice to Applicant Revision Electronic Forms version Release Notes version

MAA-Human

Revision 15
September 2021
MAA-Human Form 1.26.0.0 (06-12-2023) MAA-H Release Notes 1.26.0.0 (06-12-2023)
Variation Human Revision
September 2021
Variation Form 1.27.0.0 (29-01-2025) Updated Variation Release Notes 1.27.0.0 (27-11-2024)
Renewal Revision February 2018 Renewal Form 1.26.0.0 (05-12-2024) Renewal Release Notes 1.26.0.0 (28-11-2023)

MAA-Vet *

Version 1 MAA-Vet Form 1.26.0.1 (10-04-2024) MAA-Vet Release Notes 1.26.0.1 (12-04-2024)

Variation Veterinary

Version 1 Variation Form 1.26.0.0 (05-12-2024) Variation Release Notes 1.26.0.0 (28-11-2023)
Summary of eAF changes in current release     Summary of changes 1.26.0.0 (28-11-2023)
Summary of changes 1.26.0.1 (12-04-2024)
Summary of changes Human Variation 1.27.0.0 (27-11-2024)

*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 webinar with NCAs – initial MAA Multimedia webinar 10.11.2015
eAF webinar with NCAs – variation and renewal Multimedia webinar 25.11.2015
1st eAF training for industry Multimedia webinar 01.12.2015
2nd eAF training for industry Multimedia webinar 12.01.2016
How to complete an eAF based on version 1.20 Training video 15.11.2016
Using Referential and Organisation data in eAF Webinar presentation 28.11.2017
Using Referential and Organisation data in eAF Webinar PDF 29.06.2018

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.

Document Data Exchange Standard XML Schema Definition
DES 3.0 Technical Guide DES 3.0 technical guide N/A
eAF DES change summary DES change summary 20.01.2022
DES change summary (1.26.0.0 and 1.26.0.1) 29.10.2024
Human Variation DES change summary (1.27.0.0) 27.11.2024
N/A
Human MAA DES DES MAA-Human (1.26.0.0) 01.12.2021 MAA-Human XSD (1.26.0.0) 29.10.2024
Variation DES DES Variation (1.26.0.0) 01.12.2021

Variation XSD (1.27.0.0) 27.11.2024
Renewal DES Renewal (1.26.0.0) 01.12.2021

Renewal XSD (1.26.0.0) 29.10.2024

Vet MAA DES DES MAA-Veterinary (1.26.0.0) 01.12.2021

MAA-Vet XSD (1.26.0.1) 29.10.2024
Common Dictionary XSD Schema N/A Common Dictionary (1.26.0.0) 29.10.2024
Common Dictionary (1.26.0.1) 29.10.2024
Common Dictionary (1.27.0.0) 27.11.2024

For technical support, visit the EMA Service Desk portal: https://support.ema.europa.eu/esc

Links

Archives

Announcements End of Pilot announcement
  Mandatory use of the eAF
Regulatory information User testing of electronic application forms underway

 

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.

 


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