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Human eSubmission
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Systems:

Common Repository

eAF

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Projects:

eCTD v4.0

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The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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

14-10-2022

Updated version of the eAF v1.26.0.0 (human variation) now available

An updated version 1.26.0.0 of the human variation eAFs is now available.

A single change has been implemented to emphasize the mandatory use of OMS for centralised procedure by updating the Declaration label in the Proposed section. There is a very limited impact to users of the forms. The use of the v1.26.0.0 is mandatory since 1st January 2022 (human).

Please note that an updated EMA practical guidance on the eAF for Type IA and IB variations is now available and this updated version of the guide addresses the use of this important declaration.

It is strongly recommended to use this latest version (document properties date 3.10.2022). Please note that there is no version number change.

Please note that the release notes are not published for this minor change at this time.

Human variations form updated timeline

Please find the September 2022 version of the DADI Human Variations Forms timeline, outlining the updated DADI BETA UAT timeframe. The UAT has started on 19th September and will end on the 30th September 2022.

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 version 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 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.

Form Notice to Applicant Revision Electronic Forms version Release Notes version

MAA-Human

Revision 15
September 2021

MAA-Human Form 1.26.0.0 (26-04-2022)

MAA-H Release Notes 1.26.0.0 (26-04-2022)
Variation Human Revision
September 2021
Variation Form 1.26.0.0 (14-10-2022)Updated

Variation Release Notes 1.26.0.0 (10-06-2022)

Renewal Revision February 2018 Renewal Form 1.26.0.0 (26-04-2022) Renewal Release Notes 1.26.0.0 (26-04-2022)

MAA-Vet *

Version 1 MAA-Vet Form 1.26.0.0 (26-04-2022) MAA-Vet Release Notes 1.26.0.0 (26-04-2022)

Variation Veterinary

Version 1 Variation Form 1.26.0.0 (14-06-2022) Variation Release Notes 1.26.0.0 (10-06-2022)
Summary of eAF changes in current release     Summary of changes 1.26.0.0 (10-06-2022)

*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 version 1.26.0.0 XML Schema Definition version 1.26.0.0
DES 3.0 Technical Guide DES 3.0 technical guide N/A
eAF DES change summary DES change summary 20.01.2022 Updated

N/A
Human MAA DES DES MAA-Human 01.12.2021

MAA-Human XSD 01.10.2021
Variation DES DES Variation 01.12.2021

Variation XSD 01.12.2021

Renewal DES Renewal 01.12.2021

Renewal XSD 28.09.2018

Vet MAA DES DES MAA-Veterinary 01.12.2021

MAA-Vet XSD 20.01.2022 Updated
Common Dictionary XSD Schema N/A Common Dictionary 20.01.2022 Updated

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

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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