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Human eSubmission
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Systems:

Common Repository

eAF

eASMF
ePMF
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eSubmission Gateway & eSubmission Web Client

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PSUR Repository

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eCTD v4.0

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Paediatric submissions

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The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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

03-10-2018

The eAF User Guidance Human & Vet Q&A has been updated and can also be found under the section “Guidance documents / Q&A”.

02-10-2018

New versions of the 4 electronic Application Forms (eAF v. 1.23.1.0) and the related release notes are now available. This new version is a hotfix release of the forms and can be used as of 28th September 2018.

The current versions (v1.23.1.0) of the forms can be used and will fully replace the version 1.22.0.1 after a transitional period, on 15 October 2018 as detailed in the eAF Release Milestone plan. The version of the form should not be changed during an ongoing procedure.

23-08-2018

Essential maintenance to computer applications

The eAF will be impacted by essential maintenance to SPOR data services on between 08:00-18:00 hrs (UK time) Saturday, 25 August 2018. The eAF will be impacted for the ATC code field (MAA human and vet and the renewal form) and for the areas where Organisations and Locations are used (however manual input of data is allowed for these areas). There is no impact to the Variation application form. All other dropdown menus for controlled terminology will continue to work during this maintenance activity.

06-08-2018

The regulatory user guides for the electronic application form  for a marketing authorisation (Human and Veterinary) have been updated, see section Guidance documents / Regulatory.

13-07-2018

New versions of the 4 electronic Application Forms (eAF v. 1.23) and the related release notes are now available.

This release includes further integration with OMS for organisation data in proposed and present part of Variation form and other NTA changes. This new version, 1.23 of the forms can be used as of today (13th July 2018) and will fully replace the version 1.22.0.1 after transitional period, on 15 October 2018. The version of the form should not be changed during an ongoing procedure.

01-06-2018

Version 1.23 of the electronic Application Forms (eAFs) will become available on 13 July 2018. The release v1.23 will provide further integration with OMS from SPOR (Organisational/address data) and NTA changes, User Acceptance Testing (UAT) is planned to support the release of this next version of the forms:

  • The testing by Industry and NCAs will take place
    • Industry: from Mon 11/06/18 to Fri 18/06/18
    • NCAs*:   from Mon 19/06/18 to Fri 22/06/18   (*Based on the eAFs received from Industry)

If you wish to participate, please register by email with eSubprogofficer@ema.europa.eu.  A feedback form for consolidated comments will be provided to you following your registration. Please follow Summary of changes, document which shows clearly before and after areas and changes to eAF that focus on test scenarios for current UAT. UAT version of Summary of changes will be sent via email with UAT package. Final version will be published on website later (13 July 2018).

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 1.23.1.0 Release Notes version

MAA-Human

Revision 13 MAA-Human Form 28.09.2018 New MAA-H Release Notes 28.09.2018 New
Variation Revision February 2018 Variation Form 28.09.2018 New Variation Release Notes 28.09.2018 New
Renewal Revision February 2018 Renewal Form 28.09.2018 New Renewal Release Notes 28.09.2018 New

MAA-Vet

Revision 8 MAA-Vet Form 28.09.2018 New MAA-Vet Release Notes 28.09.2018 New
Summary of eAF changes in current release     Summary of changes 28.09.2018 New

Release Milestone plan for eAF

Note: The milestones for the planned mandatory use of OMS within the eAF and CESP Dataset Module are currently under review and will be published soon.

Guidance Documents

Regulatory

Technical

Q & A

User Guidance Human & Vet Questions and Answers 01.10.2018 - Updated
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 New

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 New

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 New N/A
Human MAA DES DES MAA-Human 13.07.2018 New MAA-Human XSD 28.09.2018 New
Variation DES DES Variation 13.07.2018 New

Variation XSD 28.09.2018 New

Renewal DES Renewal 13.07.2018 New Renewal XSD 28.09.2018 New
Vet MAA DES DES MAA-Vet 13.07.2018 New MAA-Vet XSD 28.09.2018 New
Common Dictionary XSD Schema N/A Common Dictionary 28.09.2018 New

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