EU Telematics PIM _
 

EU Electronic Application Forms

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Home

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Human eSubmission

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Veterinary esubmission
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eSubmission CMB

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CMB Documents
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External Links

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Systems:

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Common Repository

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eAF

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CESSP

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eASMF
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ePMF
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CESP
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eSubmission Gateway & eSubmission Web Client

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Delivery file UI

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eSubmission Gateway

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PAM submission form

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PSUR Repository
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Industry access

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NCA access
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eCTD

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eCTD v4.0

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EU Module 1

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Paediatric submissions

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SPOR

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The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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

Previous news can be found here.

13-04-2018

The eAF guidance for how to request new substances and terms has been updated. Please refer to the eAF Term Request Form section below.

07-03-2018

Essential maintenance to computer applications

The eAF will be impacted by essential maintenance to SPOR data services on Saturday, 10 March and Sunday, 11 March 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.

16-02-2018

New versions of the 4 electronic Application Forms (eAF v. 1.22.0.1) and the related release notes are now available. This new version is a hotfix release v1.22.0.1 of the forms and can be used as of today, 16th February 2018. The version of the form should not be changed during an ongoing procedure.

15-02-2018

As of 15 February 2018 version 1.22 of the four electronic Application Forms (eAFs) are mandatory. Older versions of the forms will no longer be supported.

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 Release Notes version

MAA-Human

Revision 12 MAA-Human Form v1.22.0.1
16.02..2018 New
MAA-H Release Notes 16.02..2018 New
Variation Revision June 2015 Variation Form v1.22.0.1
16.02..2018 New
Variation Release Notes 16.02..2018 New
Renewal Revision June 2015 Renewal Form v1.22.0.1
16.02..2018 New
Renewal Release Notes16.02..2018 New

MAA-Vet

Revision 7.5 MAA-Vet Form v1.22.0.1
16.02..2018 New
MAA-Vet Release Notes 16.02..2018 New
Summary of eAF changes in current release     Summary of changes 15.12.2018 New

Release Milestone plan for eAF:

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

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

eAF Term Request Form Updated

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 - https://servicedesk.ema.europa.eu/

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 1.22.0.1
(effective from the 16 Feb 2018)
XML Schema Definition version 1.22.0.1
(effective from the 16 Feb 2018)
DES 3.0 Technical Guide DES 3.0 technical guide N/A
eAF DES change summary DES change summary 16.02.2018 New N/A
Human MAA DES DES MAA-Human 15.11.2017 MAA-Human XSD 16.02.2018 New
Variation DES DES Variation 15.11.2017 Variation XSD 16.02.2018 New
Renewal DES Renewal 15.11.2017 Renewal XSD 16.02.2018 New
Vet MAA DES DES MAA-Vet 15.11.2017 MAA-Vet XSD 16.02.2018 New
Common Dictionary XSD Schema N/A Common Dictionary 16.02.2018 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