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EU Electronic Application Forms

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Human eSubmission
eCTD v3.2
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eSubmission expert group documents

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External Links

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Systems:

Common Repository

eAF

eASMF
ePMF
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eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

PAM submission form

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PSUR Repository

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The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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

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.

24-03-2020

Computer application maintenance weekend 28-29 March 2020

Essential maintenance work will be carried out to all Telematics applications as part of EMA’s computer application maintenance work during the last weekend in March.  As a result, eAF will be unavailable to users between 18:30hrs on Friday, 27th March and 08:00hrs on Monday, 30th March 2020

09-12-2019

Version 1.23.1.4 of the Human Marketing authorisation Application (maa) electronic Application Form (eAF) is now available. The release v1.23.1.4 is a bug fix release to correct business rules implementation in sections 1.4 and 1.5. Further details are available on the release notes. This bug fix release does not affect the Data Exchange Standard (DES). Applicants are reminded that the version of the form should not be changed during an ongoing procedure.

10-10-2019

Version 1.23.1.3 of the 4 electronic Application Forms (eAF) is now available. This release (v1.23.1.3) is a bug fix release to correct a number of issues which affect the forms. Further details are available in the release notes. This bug fix release does not affect the Data Exchange Standard (DES).
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 :

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 v1.23.1.4 maa 09/12/2019

Withdrawal of eAF v1.23.1.3 maa from the website

09/12/2019

Transitional period - 1.23.1.4 maa is accepted by the EMA and NCAs

09/12/2019 – 11/01/2020

Mandatory use eAF v1.23.1.4 maa

13/01/2020

 

 

 

 

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 Form

If you need to request a missing 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 a request for an update of an already existing term in order to complete the eAF, please submit a request through the SPOR Portal - http://spor.ema.europa.eu/rmswi/#/ providing as much supporting documentation as possible (e.g. name of the product concerned, SmPC, etc.). Please note you need to be registered with SPOR prior to submission of change requests: https://register.ema.europa.eu/identityiq/login.jsf. 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