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EU Electronic Application Forms

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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

CESSP Dataset Module (AF)

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The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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

29-06-2020

There is a short delay in the start of the UAT for the eAF v1.24.0.0 – new dates will be communicated very soon. If you wish to participate in the UAT, please register by email with eSubprogofficer@ema.europa.eu 

11-06-2020

eAF v1.24.0.0 release milestone plan and updated release schedule for eAF now available

An updated release milestone plan and release schedule for the electronic Application Forms (eAF) are now available below.

Version 1.24.0.0 of the variation and renewal electronic Application Forms (eAFs) is planned for release in September 2020 with a 2 months transitional period and mandatory use from November 2020. The release v1.24.0.0 will provide a major change into the section 3 of the variation form by further integrating with RMS from SPOR (scopes and conditions and documentation). 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 Mon 29/06/20 to Fri 03/07/20
    • NCAs*: from Mon 06/07/20 to Fri 10/07/20 (*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 

Further details on the release scope and the confirmed dates for the UAT will be provided soon.

31-03-2020

In the view that many applicants and MAHs are now working from home due to the Covid-19 situation, we would like to remind the users of the eAF functionality which may facilitate working during exceptional circumstances with variable internet bandwidths.

The electronic Application Forms can be saved directly from the eSubmission website to the users local machine and most fields can be filled in off-line, without access to internet. Only those fields that require substance/term related searches, and the use of OMS for address details requires connection to the internet. Validation feature and most dropdown lists are loaded to the form at the time when the form is opened and can be used even when the user is not connected to the internet enabling most of the form to be filled in without internet connection.

The performance of the forms with regards to the speed is unfortunately not optimal, mainly due to the technology used and the multiple business rules built in to the form, and hence, the network is working hard on the replacement of the PDF format forms with a web-based forms. The new web based forms for human and veterinary MAAs are planned for release later this year (timelines subject to change due to Covid-19 situation).

The eAFs are submitted as a part of the dossier which, for centralised procedure applications, must be submitted via the eSubmissions Gateway. In case the users are experiencing issues with the eAFs or preparing and sending submissions via the eSubmission Gateway or Web Client, we strongly recommend raising a ticket with detailed description of the issue via the EMA service desk portal.

It is important to include as many details as possible of the issue and, for example attaching screenshots or the form in question to aid investigation for the reasons of the issue.

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 :

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.

Form Notice to Applicant Revision Electronic Forms version Release Notes version

MAA-Human

Revision 13 MAA-Human Form 1.23.1.4 (09-12-2019) New MAA-H Release Notes 1.23.1.4 (09-12-2019) New
Variation Revision February 2018 Variation Form 1.23.1.3 (10-10-2019) Variation Release Notes1.23.1.3 (10-10-2019)
Renewal Revision February 2018 Renewal Form 1.23.1.3 (10-10-2019) Renewal Release Notes 1.23.1.3 (10-10-2019)

MAA-Vet

Revision 8 MAA-Vet Form 1.23.1.3 (10-10-2019) MAA-Vet Release Notes 1.23.1.3 (10-10-2019)
Summary of eAF changes in current release     Summary of changes 1.23.1.3 (09-12-2019) New

Release Milestone plan for eAF

Milestone

Date

Publication of eAF v1.24.0.0 Variation and Renewal (human/veterinary) 15/09/2020

Withdrawal of eAF v1.23.1.3 Variation and Renewal from the website

15/09/2020

Transitional period both eAF v1.23.1.3 and v1.24.0.0 Variation and Renewal are accepted by the EMA and NCAs

15/09/2020 – 15/11/2020

Mandatory use eAF v1.24.0.0 Variation and Renewal

16/11/2020

 

 

 

 

 

eAF and CESSP release schedule

 

Guidance Documents

Regulatory

Technical

Q & A

User Guidance Human & Vet Questions and Answers 01.03.2019
Benchmark response times eAF performance
eAF for industry Presentation
How to complete an eAF based on version 1.20 Presentation 15.11.2016

EudraVigilance system downtime – impact on PSUR Repository and the eAF

Document 05.10.2017

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:

Document Data Exchange Standard version 1.23.0.0 (effective from 13 July 2018) XML Schema Definition version 1.23.1.0 (effective from 28.09 2018)
DES 3.0 Technical Guide DES 3.0 technical guide N/A
eAF DES change summary DES change summary 13.07.2018 N/A
Human MAA DES DES MAA-Human 13.07.2018 MAA-Human XSD 28.09.2018
Variation DES DES Variation 13.07.2018

Variation XSD 28.09.2018

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 28.09.2018

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

 

 


1995-2020 European Medicines Agency | Disclaimer| For technical support, please visit the EMA Service Desk portal using your user credentials for a system hosted by EMA (except Eudravigilance). If you do not have an account or have forgotten your credentials, please click here