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EU Electronic Application Forms

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Human eSubmission
eCTD v3.2
eCTD EU M1 specification

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eSubmission expert group
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eSubmission expert group documents

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External Links

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Systems:

Common Repository

eAF

eASMF
ePMF
CESP Delivery

eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

PAM submission form

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PSUR Repository

Industry access

NCA access
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Projects:

eCTD v4.0

CESSP Dataset Module (AF)

Paediatric submissions

SPOR

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The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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

26-11-2020

eAF issue with webservices

An issue relating to the eAF webservice update has affected availability of terms in the ‘Pharmaceutical Form’ field in all 4 forms. We have released a fix that has partially solved the issue; however, we are aware that there are still many combined pharmaceutical forms that are currently unavailable in the eAFs. Please note that as this issue affects the webservices to the form, not the form itself, also previous versions of the form are affected.

We are working on a further fix to solve this issue as soon as possible.

For any issues with the eAFs, please raise a call via the EMA service desk.

27-10-2020
eAF v1.24.0.0 important note to users

An updated version of the variation eAF v1.24.0.0 is now available. This release which does not change the form version number, provides a fix to the Adobe backwards compatibility issue and it should solve the issues some users have experienced with the scope selection dropdown list in section 3. This version also includes a change in the form validation rules for grouping of Type IA or Type IAIN variations.

Please ensure that upon opening the eAF you ‘trust’ the form by clicking the small exclamation mark at the top of the left-hand adobe pane and then selecting the trust option from the yellow banner which will open across the top of the forms. The drop-down menu’s will not work if the form has not been trusted.

The Presentations for applicants and NCAs on the release v1.24.0.0 have been updated and are available below.

For any issues with the eAFs, for example reporting missing scopes, please raise a call via the EMA service desk.

 

08-10-2020

eAF v1.24.0.0 important note to users

The variation form can only be used with Adobe Reader version DC. The functionalities in variation selection drop down list in section 3 will not work with older versions (e.g. reader 2017, X or XI).
Please ensure that if you have Adobe Acrobat or Acrobat Pro 2017, X or XI installed, you close all documents that have been opened using Acrobat/Acrobat Pro or documents that contain Adobe sign signature before opening the eAF using reader DC as these may prevent the drop down list of scopes in section 3 working as expected.
Please note that we are working hard to find a solution to this cross-interference issue as soon as possible.

Please ensure that upon opening the eAF you ‘trust’ the form by clicking the small exclamation mark at the top of the left-hand adobe pane and then selecting the trust option from the yellow banner which will open across the top of the forms. The drop-down menu’s will not work if the form has not been trusted.

The presentation on the release v1.24.0.0 has been updated and is available below.

For any issues with the eAFs, for example reporting missing scopes, please raise a call via the EMA service desk.

15-09-2020

Version 1.24.0.0 of all four electronic Application Forms (eAFs) is now available. The release v1.24.0.0 provides a major change in section 3 of the variation form by further integrating with RMS from SPOR (scopes and conditions and documentation). Some defects have been fixed in MAA human, MAA vet and renewal (H&V forms.

The new version is implemented with 3 months transitional period. Mandatory use of v1.24.0.0 will start on 16th December 2020.

More details can be found in the release notes and the updated Practical user guide for electronic Application Forms as well as the presentation on changes.
Please note that due to the major change in the variation form, data imports from older versions of the variation form will not work.
Applicants are reminded that the version of the form should not be changed during an ongoing procedure.

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 :

As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period.

Version 1.24.0.0, available for use from 15th of September, Mandatory use from 16th of December 2020

Form Notice to Applicant Revision Electronic Forms version Release Notes version

MAA-Human

Revision 13 MAA-Human Form 1.24.0.0 (15-09-2020) New MAA-H Release Notes 1.24.0.0 (15-09-2020) New
Variation Revision February 2018 Variation Form 1.24.0.0 (26`0-2020)Updated Variation Release Notes 1.24.0.0 (15-09-2020) New
Renewal Revision February 2018 Renewal Form 1.24.0.0 (15-09-2020) New Renewal Release Notes 1.24.0.0 (15-09-2020) New

MAA-Vet

Revision 8 MAA-Vet Form 1.24.0.0 (15-09-2020) New MAA-Vet Release Notes 1.24.0.0 (15-09-2020) New
Summary of eAF changes in current release     Summary of changes 1.24.0.0 (15-09-2020) New

Version 1.23.1.3 and 1.23.1.4, available for use until 15th December 2020

Form Notice to Applicant Revision Electronic Forms version Release Notes version

MAA-Human

Revision 13 MAA-Human Form 1.23.1.4 (09-12-2019) MAA-H Release Notes 1.23.1.4 (09-12-2019)
Variation Revision February 2018 Variation Form 1.23.1.3 (10-10-2019) Variation Release Notes1.23.1.3 (10-10-2019)
Renewal Revision February 2018 Renewal Form 1.23.1.3 (10-10-2019) Renewal Release Notes 1.23.1.3 (10-10-2019)

MAA-Vet

Revision 8 MAA-Vet Form 1.23.1.3 (10-10-2019) MAA-Vet Release Notes 1.23.1.3 (10-10-2019)
Summary of eAF changes in current release     Summary of changes 1.23.1.3 (09-12-2019)

Release Milestone plan for eAF

Milestone

Date

Publication of eAF v1.24.0.0 Variation and Renewal (human/veterinary), MAA human and MAA vet 15/09/2020
Transitional period eAF v1.23.1.3, v1.23.1.4 and v1.24.0.0 Variation, Renewal and MAA (human and veterinary) are accepted by the EMA and NCAs

15/09/2020 – 15/12/2020

Mandatory use eAF v1.24.0.0 – all 4 eAFs (variation, renewal, MAA human and veterinary)

16/12/2020

 

 

 

 

 

eAF and CESSP release schedule

 

Guidance Documents

Regulatory

Technical

Q & A

User Guidance Human & Vet Questions and Answers 01.03.2019
Variation eAF v1.24.0.0 presentation on changes (to applicants) Presentation26.10.2020 Updated
Variation eAF v1.24.0.0 presentation on changes (to NCAs) Presentation26.10.2020 Updated
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
Using Referential and Organisation data in eAF Webinar presentation 28.11.2017
Using Referential and Organisation data in eAF Webinar PDF 29.06.2018

eAF Term Request process (Updated)

If you need to request a new 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 an update of an already existing term in order to complete the eAF, please submit a request through the Referential Management Services (RMS) of the SPOR portal providing as much supporting documentation as possible (e.g. name of the product concerned, SmPC, justification for the request, etc.). The ‘RMS Web User Manual’, which provides a step-by-step guide on how to submit change requests, can be found under the 'Documents' section of the RMS portal.

Please note that you need to be registered with SPOR prior to the submission of change requests. The ‘SPOR User Registration Manual’, which provides detailed information on how to register in SPOR, can be found under the 'Document' section of the RMS portal. 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 1.24.0.0 (effective from 15 September 2020) XML Schema Definition version 1.24.0.0 (effective from 15.09 2020)
DES 3.0 Technical Guide DES 3.0 technical guide N/A
eAF DES change summary DES change summary 15.09.2020 New N/A
Human MAA DES DES MAA-Human 13.07.2018 MAA-Human XSD 28.09.2018
Variation DES DES Variation 15.09.2020 New

Variation XSD 15.09.2020 New

Renewal DES Renewal 13.07.2018 Renewal XSD 28.09.2018
Vet MAA DES DES MAA-Vet 13.07.2018 MAA-Vet XSD 28.09.2018
Common Dictionary XSD Schema N/A Common Dictionary 15.09.2020 New

Technical documents for v1.23.1.3 and v1.23.1.4, available for use until 15th September 2020

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

Variation XSD 28.09.2018

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

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

 

 


1995-2020 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