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EU Electronic Application Forms

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Delivery file UI

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eSubmission Gateway

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Industry access

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eCTD

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eCTD v4.0

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EU Module 1

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The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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

19-09-2016

Use of the eAF v1.20 is now mandatory. Use of previous versions is accepted only for ongoing applications – the version of the form should not be changed in the middle of the procedure.

19-08-2016

Updated versions of 4 electronic Application Forms (eAF v. 1.20.0.2) have been published following reported issues. Use of the version 01.20 will become mandatory after an extended transitional period on19 September 2016.

Forms

Currently accepted version of forms :

  • Initial MAA Human and Vet, Variations and Renewal: 1.20,1.20.0.1 and 1.20.02
    We strongly recommend using the latest version of the forms where possible.

Please Note: eAFs should be 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 Release Notes version 1.20

MAA-Human

Revision 12 MAA-Human Form 19/08/2016 New MAA-H Release Notes 19/08/2016 New
Variation Revision June 2015 Variation Form 19/08/2016 New Variation Release Notes 19/08/2016 New
Renewal Revision June 2012 Renewal Form 19/08/2016 New Renewal Release Notes 19/08/2016 New

MAA-Vet

Revision 7.4 MAA-Vet Form 19/08/2016 New MAA-Vet Release Notes19/08/2016 New

Guidance Documents

Regulatory

Technical

Q & A

User Guidance Human & Vet Questions and Answers (14/06/2016) New
Benchmark response times eAF performance
eAF for industry Presentation

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) - NEW

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 - New N/A
Human MAA DES DES MAA-Human 09/03/2016 MAA-Human XSD 09/03/2016
Variation DES DES Variation 07/06/2016 - New

Variation XSD 14/06/2016 - New

Renewal DES Renewal 09/03/2016

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

 

 


© 1995-2016 European Medicines Agency | Disclaimer| For technical support, visit the EMA Service Desk portal: https://servicedesk.ema.europa.eu