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EU Electronic Application Forms

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Home

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Human eSubmission
eCTD v3.2
eCTD EU M1 specification

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Veterinary eSubmission
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eSubmission expert group
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eSubmission expert group documents

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External Links

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Systems:

Common Repository

eAF

eASMF
ePMF
CESP Delivery

eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

PAM submission form

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PSUR Repository

Industry access

NCA access
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Projects:

eCTD v4.0

DADI (eAF)

Paediatric submissions

SPOR

eSignatures

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The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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

14-06-2022

Updated versions of the eAF v1.26.0.0 (bug fix version) now available

Updated versions 1.26.0.0 of the human and veterinary variation eAFs are now available. The changes implemented in this version are business rule corrections only, relating to mandatory use of OMS for centralised procedure and business rule in section 4b Paediatrics in the human variation form. 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) and 28th January 2022 (veterinary).

It is strongly recommended to use this latest version (document properties date 30.05.2022).
Please note that there is no version number change.

10-06-2022

Updated versions of the eAF v1.26.0.0 (bug fix version) go-live on 14th June 2022

Updated versions 1.26.0.0 of the human and veterinary variation eAFs will be released on the eAF website on Tuesday 14th June 2022.
The changes implemented in this version are business rule corrections only, relating to mandatory use of OMS for centralised procedure and business rule in section 4b Paediatrics in the human variation form. 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) and 28th January 2022 (veterinary).

It is strongly recommended to use this latest version (document properties date 30.05.2022). Please note that there is no version number change.

26-04-2022

Updated versions of the eAF v1.26.0.0 (bug fix version) now available

An updated human and veterinary MAA forms, Variation forms and the updated Renewal form are ready for immediate use. The changes implemented in this version are bug fixes and business rule corrections only and there is a limited impact to users. The use of the v1.26.0.0 is mandatory since 1st January 2022 (human) and 28th January 2022 (veterinary).

It is strongly recommended to use this latest version (document properties date 26.04.2022).

Please note that there is no version number change.

31-03-2022

Updated versions of the eAF v1.26.0.0 (bug fix version) now available

Updated versions 1.26.0.0 eAFs are now available. An updated human and veterinary MAA forms, Renewal form and veterinary variation form are ready for immediate use. The changes implemented in this version are minor bug fixes only and they do not affect most users. The use of the v1.26.0.0 is mandatory since 1st January 2022 (human) and 28th January 2022 (veterinary) and the users can select if they wish to continue using the previously published version or the updated version (there is no version number change or any changes to the Data Exchange Standard (DES)).

More details can be found from the release notes. Please note that there are no updated release notes for the veterinary variation form, however, there has been a very minor change to fix the UPD Product Identifier field length to allow inclusion of the UUID.

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 (14-06-2022) Updated

Variation Release Notes 1.26.0.0 (10-06-2022) Updated

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) Updated Variation Release Notes 1.26.0.0 (10-06-2022)  Updated
Summary of eAF changes in current release     Summary of changes 1.26.0.0 (10-06-2022) Updated

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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