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The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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

25-10-2021

Call for volunteers for testing eAF v1.26.0.0 veterinary variation and maa forms (reflecting the VMP-Reg)

The version 1.26.0.0 of the electronic Application Forms (eAFs) is planned for release on 1st December 2021 (for information only) and mandatory use from 28th of January 2022. The release v1.26.0.0 will provide a major change in both variation and maa forms for veterinary applications to align with the new Veterinary Regulation (VMP-Reg). These changes will be detailed in the release notes. User Acceptance Testing (UAT) is planned to support the release of this next version of the forms:
The testing by Industry and NCAs is planned to take place as follows:

  • Industry: from Fri 29/10/21 to Tue 09/11/21
  • NCAs*: from Wed 03/11/21 to Fri 12/11/21 (*Based on the eAFs received from Industry)
Please note that these dates are subject to change depending on the outcome of internal UAT. If you wish to participate in the UAT, please register by email with eSubprogofficer@ema.europa.eu .

13-10-2021

Updated versions of eAF v1.25.0.0 now available - bug fixes

Updated bug fix versions 1.25.0.0 of all four eAFs are now available for immediate use. The variation and renewal form proof of payment section has been fixed and in the Human and Veterinary MAA forms the OMS selection for the admin address in 2.5.1.a has now been fixed. More details can be found from the summary release notes.
If you have already started to fill in the form in a version where these issues are occurring, you can export the xml and import it into the newly published version. This should fix the issue.

11-10-2021

Questions and Answers document on the Mandatory use of OMS for CAPs now available

An updated version of the Questions and Answers document to support applicants and Marketing Authorisation holders in the implementation of the mandatory use of OMS for CAPs can be found here.

Please note that a training webinar on OMS will be held on 21st of October 2021, where registered participants will have the opportunity to clarify any outstanding questions. The webinar will be recorded and made available after the event.

06-10-2021

Questions and Answers document on the Mandatory use of OMS for CAPs now available

The use of Organisational Maintenance Services (OMS) will become mandatory for Centrally Authorised Products (CAPs) from 1st of November 2021. A Questions and Answers document to support applicants and Marketing Authorisation holders is now available.

01-10-2021

eAF v1.25.0.0 now available

New version 1.25.0.0 of all four eAFs is now available for immediate use.
The main changes in this version of the forms relate to the implementation of the Medical Device Regulation Art 2(1) of Regulation (EU) 2017/745 and include other changes as implemented in the latest version of the NTA application forms.

The changes, in summary, are an updated section on Medical Devices in the human MAA form, addition of a new section on Medical Devices in the variation form, addition of new sections on parallel variations and on Harmonisation relating to National Variations. An incorrect business rule relating in the Renewal form for excipients has also been fixed in this version.

The version 1.25.0.0 can be used immediately, and it strongly recommended that it will be used for applications for products containing medical devices as soon as possible, however, the one-month transitional period will run until end of October after which the use of version 1.25.0.0 of the forms will become mandatory.
The version 1.24.0.1 has now been removed from the eAF website however users can continue to submit applications using this version until the end of October 2021.
Applicants are reminded that the version of the form should not be changed during an ongoing procedure.

And

Mandatory use of OMS in eAFs from 1st of November 2021

The use of OMS in the eAFs will become mandatory from 1st of November 2021. Please note that a release to remove the free text fields in the human forms for Centralised Procedure (v1.26.0.0) is planned for release in early December 2021.
Version 1.26.0.0 will be mandatory for use for human domain from 1st of January 2022.
Please note that this version cannot be used for veterinary submissions prior to 28th January 2022. For veterinary domain, there will be no transitional period and the version 1.26.0.0 will become mandatory on the 28th January 2022. The previous version of the forms should be used for already ongoing procedures and applicants are reminded that the version of the form should not be changed during an ongoing procedure.

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 1.25.0.0, available for use from 1st of October 2021. Mandatory use from 1st of November 2021.

Form Notice to Applicant Revision Electronic Forms version Release Notes version

MAA-Human

Revision 15
September 2021

MAA-Human Form 1.25.0.0 (13-10-2021) Updated

MAA-H Release Notes 1.25.0.0 (01-10-2021) New
Variation Revision
September 2021
Variation Form 1.25.0.0 (01-10-2021) New Variation Release Notes 1.25.0.0 (01-10-2021) New
Renewal Revision February 2018 Renewal Form 1.25.0.0 (01-10-2021) New Renewal Release Notes 1.25.0.0 (01-10-2021) New

MAA-Vet

Revision 8 MAA-Vet Form 1.25.0.0 (13-10-2021)  Updated MAA-Vet Release Notes 1.25.0.0 (01-10-2021) New
Summary of eAF changes in current release     Summary of changes 1.25.0.0 (13-10-2021) Updated

Guidance Documents

Regulatory

Technical

Q & A

Questions and Answers document on Mandatory use of OMS CAPs OMS Mandatory Q&A 11.10.2021 New
Variation eAF v1.25.0.0 presentation on changes to users Presentation 01.10.2021 New
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 (Updated)

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 1.25.0.0, available for use from 1st of October 2021. Mandatory use from 1st of November 2021.

Document Data Exchange Standard version 1.25.0.0 (effective from 1st October 2021) XML Schema Definition version 1.25.0.0 (effective from 1st October 2021)
DES 3.0 Technical Guide DES 3.0 technical guide N/A
eAF DES change summary DES change summary 01.10.2021 Updated N/A
Human MAA DES DES MAA-Human 13.07.2018 MAA-Human XSD 01.10.2021 Updated
Variation DES

DES Variation 15.09.2020

Variation XSD 01.10.2021 Updated

Renewal

DES Renewal 13.07.2018

Renewal XSD 28.09.2018

Vet MAA DES

DES MAA-Vet 13.07.2018

MAA-Vet XSD 28.09.2018

Common Dictionary XSD Schema N/A Common Dictionary 01.10.2021 Uploaded

Version 1.26.0.0, planned for December 2021. Human forms will be available for use immediately upon publication (1st December 2021. Veterinary forms for use from 28th of January 2022 only (cannot be used for submissions prior to 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 pending N/A
eAF DES change summary DES change summary October 2021 New DRAFT

N/A
Human MAA DES pending pending
Variation DES pending

Variation XSD October 2021 New DRAFT

Renewal pending pending
Vet MAA DES pending MAA-Vet XSD October 2021 New DRAFT
Common Dictionary XSD Schema N/A Common Dictionary 01.10.2021 New DRAFT

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

Draft eAF Release schedule for 2021

eAF Release Schedule 2021

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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