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Human eSubmission
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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

Industry access

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Projects:

eCTD v4.0

CESSP

Paediatric submissions

SPOR

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The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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

15-04-2019

A webinar providing an update of the CESSP phase 1 project (converting the current eAFs into web based forms) will be held on 7 May 2019 from 10:00 to 11:30 CET. This webinar is aimed for applicants (from pharmaceutical industry). A separate session aimed for regulators will be be organised in near future.

Please note that participation in this webinar is on first come first serve basis as the maximum capacity of the virtual meeting room is limited to 200 participants. If multiple users from your organisation are attending, please share the connection with your colleagues.

The webinar will be recorded and the recording will be made available on the CESSP webpage after the webinar.

Please join the webinar in the virtual meeting room on 7th of May at 10:00 CET: https://connect.ema.europa.eu/webinar/.

How to login is availble here.

10-04-2019

The applicants are reminded that eAFs should be edited and signed using Adobe Reader. Using Adobe Acrobat Pro may lead to issues when the regulators review the applications using Adobe Reader and this may lead to validation issues and delays in processing the applications. More information can be found in the eAF Q&A document.

28-03-2019

The release notes for MAA Human and Veterinary electronic Application Forms (eAF) and the Renewal eAF have been updated to reflect new known issues.

26-03-2019

eAF dropdown lists not working?

Users are reminded that the eAFs will need to be ‘trusted’ in order for the dropdown lists to work. To ‘trust’ the forms, please click the exclamation mark on the top of the left hand pane and select ‘options’ to open the trust options. Select ‘trust this document always’ to proceed.

15-03-2019

Version 1.23.1.2 of the 4 electronic Application Forms (eAF) is now available. This release v1.23.1.2 is an unplanned hotfix release to fix 3 issues that affected the functioning of the forms. More details on the fixes are available on the release notes. This hotfix release does not affect the Data Exchange Standard (DES).

This new version (v1.23.1.2) of the forms will fully replace the versions 1.23.1.0 and 1.23.1.1 after transitional period, on 4 April 2019. The version of the form should not be changed during an ongoing procedure.

04-02-2019

Version 1.23.1.1 of the 4 electronic Application Forms (eAF) is now available. This release v1.23.1.1 is a bug fix release providing usability improvements and technical defect fixes. This bug fix release does not affect the Data Exchange Standard (DES).

This new version (v1.23.1.1) of the forms will fully replace the version 1.23.1.0 after transitional period, on 4 April 2019. The version of the form should not be changed during an ongoing procedure.

01-02-2019

Update of the eAF user guidance Q&A

The eAF user guidance Q&A has been updated and can be found in the“Guidance documents / Q&A” section.

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 :

Form Notice to Applicant Revision Electronic Forms version 1.23.1.2 Release Notes version

MAA-Human

Revision 13 MAA-Human Form (15-03-2019) New MAA-H Release Notes 1.23.1.2 (28-03-2019) New
Variation Revision February 2018 Variation Form (15-03-2019) New Variation Release Notes1.23.1.2 (15-03-2019) New
Renewal Revision February 2018 Renewal Form (15-03-2019) New Renewal Release Notes 1.23.1.2 (28-03-2019) New

MAA-Vet

Revision 8 MAA-Vet Form (15-03-2019) New MAA-Vet Release Notes 1.23.1.2 (28-03-2019) New
Summary of eAF changes in current release     Summary of changes 1.23.1.2 (15-03-2019) New

Release Milestone plan for eAF

Milestone Date

Publication of eAF v1.23.1.1

04/02/2019

Withdrawal of eAF v1.23.1.0 from the website

04/02/2019

Publication of eAF v1.23.1.2

15/03/2019

Withdrawal of eAF v1.23.1.1 from the website 15/03/2019
Transitional period 1.23.1.0, 1.23.1.1 and 1.23.1.2 are accepted by the EMA and NCAs 04/02/2019 – 03/04/2019
Mandatory use eAF v1.23.1.2 04/04/2019

 

 

 

 

 

 

 

eAF and CESSP release schedule

Guidance Documents

Regulatory

Technical

Q & A

User Guidance Human & Vet Questions and Answers 01.03.2019 NEW
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

 

 


© 1995-2018 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