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eCTD v4.0

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The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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

23-02-2017

A defect in section 2 of variation eAF causing fields to overlap and an issue affecting the co-rapporteur field in the human MAA form have been detected and subsequently fixed. New version v.1.20.0.5 of the variation and MAA human forms and the updated release notes are now available below. Please note that the Data Exchange Standard (DES) has not changed in this release. The new versions of the forms can be used as of today and the version 1.20.0.5 will fully replace previous versions on1 March 2017. Please note that there is no change to Renewal and MAA vet forms – the version number 1.20.0.4 will remain for renewal and vet MAA forms.

Users of the variation form who are wishing to import data from v1.20.0.3 or earlier are reminded to remove all the scopes in section 3 before exporting the xml in to v1.20.0.5. as the format of the numbering has changed and will cause issue if not deleted before importing to the new version of the form.

07-02-2017

Updated versions of 4 electronic Application Forms (eAF v. 1.20.0.4 – initially called v1.21) are now available. This new release implements a large number of defect fixes and usability improvements. Please note that the Data Exchange Standard (DES) has not changed in this release.

15-11-2016

A video tutorial on How to complete an eAF based on version 1.20 is now available. Please see the“Guidance documents” section below for links to the presentation slides and the video. This material focuses on changes introduced in the version 1.20 of the form as well as some remaining known issues and workarounds.

01-10-2016

Applicants are reminded that the section 2 of the electronic Application Form (eAF) should be filled in with product details. The use of the footnote is only allowed for those applications that contain complex form and strength data where it may be impossible to enter details in the provided fields, for example complex vaccines. Footnote should not be used for applications where the product details can be entered in section 2. Convenient ‘clone’ function is now available reducing need to type similar information multiple times.

Forms

Currently accepted version of forms :

  • Variations and Human MAA: 1.20.0.3 and 1.20.0.5
  • Vet MAA and Renewal: 1.20.0.3 and 1.20.0.4

Please Note: eAFs should be filled out, signed and locked using Adobe Reader versions 10 and 11
For reviewing locked and signed forms we recommend using  Adobe Reader or Adobe Acrobat versions 10 and 11

Form Notice to Applicant Revision Electronic Forms version 1.20.0.5 Release Notes version 1.20.0.4

MAA-Human

Revision 12 MAA-Human Form v 1.20.0.5 23.02.2017 New MAA-H Release Notes 23.02.2017 New
Variation Revision June 2015 Variation Form v 1.20.0.5
23.02.2017 New
Variation Release Notes 23.02.2017 New
Renewal Revision June 2012 Renewal Form 07.02.2017 New Renewal Release Notes 07.02.2017 New

MAA-Vet

Revision 7.4 MAA-Vet Form 07.02.2017 New MAA-Vet Release Notes 07.02.2017 New

Release Milestone plan for eAF:

Milestone Date
Publication of eAF v1.20.0.4 07.02.2017
Publication of Hotfix eAF v1.20.0.5 for Variation and Human MAA 23.02.2017
Replacement of eAF v1.20.0.3 by v1.20.0.4 01/03/2017

Guidance Documents

Regulatory

Technical

Q & A

User Guidance Human & Vet Questions and Answers (14.06.2016)
Benchmark response times eAF performance
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)

eAF Term Request Form

If you need to request a missing substance or other term in order to complete an eAF, please use the eAF Term Request Form. Once completed, you will need to submit your form via email to: mdms@ema.europa.eu. For further information, please see the presentation: How to request additional terms in eAF

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 1.20 (effective from the 15 April 2016) XML Schema Definition version 1.20 (effective from the 15 April 2016)
DES 3.0 Technical Guide DES 3.0 technical guide N/A
eAF DES change summary DES change summary 07.06.2016 - N/A
Human MAA DES DES MAA-Human 09.03.2016 MAA-Human XSD 09.03.2016
Variation DES DES Variation 07.06.2016 -

Variation XSD 14.06.2016 -

Renewal DES Renewal 0./03.2016

Renewal XSD 09.03.2016

Vet MAA DES DES MAA-Vet 09.03.2016 MAA-Vet XSD 09.03.2016
Common Dictionary XSD Schema N/A

Common Dictionary 09.03.2016

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

 

 


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