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The Word based application forms (AF) are being 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.
The implementation is part of the HMA eSubmission roadmap.

The electronic forms and their supporting technical documentation are available below.

News

July 1 2015

  • The use of the electronic Application Forms (eAF) is now mandatory for all Human and Veterinary Centralised Procedure submissions. After this date the EMA will no longer accept non-eAF application forms.

    Please note that if you have an ongoing procedure which has started prior to the 1st of July, you can provide updated application forms in the previous format – there is no need to convert the existing applications to the eAF format for these ongoing applications.

  • eAF mandatory use reminder

Forms

Current version of forms : version 1.18

Form Notice to Applicant Revision

Electronic Forms version 1.18 (effective from the 3rd August 2015)

Release Notes version 1.18 (effective from the 3rd August 2015)

MAA-Human

Revision 10.1

MAA-Human Form 07/07/2015 New

MAA-H Release Notes 07/07/2015 New

Variation

Revision July 2013

Variation Form 07/07/2015 New

Variation Release Notes 07/07/2015 New

Renewal Revision October 2012 Renewal Form 07/07/2015 New

Renewal Release Notes 07/07/2015 New

MAA-Vet

Revision 7.3

MAA-Vet Form 07/07/2015 New

MAA-Vet Release Notes 07/07/2015 New

Guidance Documents

Regulatory

Technical

Q & A

User Guidance Human & Vet Questions and Answers (01/07/2015) New
Benchmark response times eAF performance

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 1.18 (effective from the 3rd August 2015 XML Schema Definition version 1.18 (effective from the 3rd August 2015)
DES 3.0 Technical Guide DES 3.0 technical guide N/A
Human MAA DES DES MAA-Human 01/06/2015 New MAA-Human XSD 01/06/2015 New
Variation DES DES Variation 01/06/2015 New

Variation XSD 01/06/2015 New

Renewal DES Renewal 01/06/2015 New

Renewal XSD 01/06/2015 New

Vet MAA DES DES MAA-Vet 01/06/2015 New MAA-Vet XSD 01/06/2015 New
Common Dictionary XSD Schema N/A

Common Dictionary 01/06/2015 New

If you have any questions regarding these electronic application forms, please contact the eAF service desk with your query: eaf@ema.europa.eu.

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

Future versions

Release milestone plan for eAF:

Milestone Date
Publication of eAF V 01.19 03/11/15
Replacement eAF V 01.18 by 01.19 30/11/15
Publication of eAF V 01.20 08/03/16
Replacement eAF V 01.19 by 01.20 04/04/16

If you have any questions regarding these electronic application forms, please contact the eAF service desk with your query: eaf@ema.europa.eu.

Links

Archives

Announcements End of Pilot announcement
  Mandatory use of the eAF
Regulatory information User testing of electronic application forms underway
 
 


© 1995-2015 European Medicines Agency | Last update: 01-07-2015 | Contact: esubmission@ema.europa.eu