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EU Electronic Application Forms

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Human eSubmission
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eSubmission expert group documents

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External Links

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Systems:

Common Repository

eAF

eASMF
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eSubmission Gateway & eSubmission Web Client

Delivery file UI

eSubmission Gateway

PAM submission form

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PSUR Repository

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Projects:

eCTD v4.0

DADI (eAF)

Paediatric submissions

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The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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

22-07-2021

Extended deadline for mandatory use of OMS in eAF

The EMA would like to inform applicants and Marketing Authorisation Holders (MAHs) of human and veterinary medicinal products that as part of the development of the Substance, Product, Organisation and Referential (SPOR) data management services, and in anticipation to the upcoming Digital Application Dataset Integration (DADI) project, the registration in Organisation Management Service (OMS) will become mandatory for new sites and organisations to be registered for a Medicinal Product as part of any regulatory procedure submitted to the Agency. This includes but is not limited to pre-submission phase activities (eligibility requests, pre-submission meeting requests, change in contact person requests, ...), marketing authorisation applications, line extensions and variations (type IA, IB and II) and renewals.

In order to allow applicants and MAHs to timely register in OMS, the previously communicated deadline of 1 August 2021 is extended until the end of September 2021. Early registration of site(s)/organisations in OMS is encouraged.



In the future, registering the site(s)/organisations in OMS will also become mandatory for national procedures. The Agency will provide additional information in due time.

The EMA would like to emphasise the importance of site registration in OMS before the regulatory submission. This will avoid any delay in the start of these applications as applicants will be requested to register the site(s)/organisations during validation and prior to the start of the procedure.

12-07-2021

Mandatory use of OMS in eAF for all CAP submissions

The EMA would like to inform applicants and Marketing Authorisation Holders (MAHs) that as part of the development of the Substance, Product, Organisation and Referential (SPOR) data management services, and in anticipation to the upcoming Digital Application Dataset Integration (DADI) project replacing the PDF format eAFs, the registration in Organisation Management Service (OMS) will become mandatory from the 1st of August 2021 for new sites and organisations to be registered for a Medicinal Product as part of any regulatory procedure submitted to the Agency. This includes but is not limited to pre-submission phase activities (eligibility requests, pre-submission meeting requests, change in contact person requests, ...), marketing authorisation applications, line extensions and variations (type IA, IB and II) and renewals.

The EMA would like to emphasise the importance of site registration in OMS before regulatory submissions. This will avoid any delay in the start of these applications as applicants will be requested to register the site(s)/organisations during validation and prior to the start of the procedure.

25-03-2020

Digital Application Dataset Integration (DADI) project

The European Medicines Regulatory Network has launched a new telematics project called the Digital Application Dataset Integration project (DADI) to modernise and improve use of the EU electronic Application Forms (eAFs). DADI has been established as the successor to the Common European Single Submission Portal (CESSP) phase 1 project.
More details are available here.

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:

For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

Version 1.24.0.1, available for use from 15th of December for procedures starting after 1st January 2021. Mandatory use from 16th of January 2021

Form Notice to Applicant Revision Electronic Forms version Release Notes version

MAA-Human

Revision 13

MAA-Human Form1.24.0.1 (15-12-2020) New

MAA-H Release Notes 1.24.0.1 (15-12-2020) New
Variation Revision February 2018 Variation Form 1.24.0.1 (15-12-2020)  New Variation Release Notes 1.24.0.1 (15-12-2020) New
Renewal Revision February 2018 Renewal Form 1.24.0.1 (15-12-2020) New Renewal Release Notes 1.24.0.1 (15-12-2020) New

MAA-Vet

Revision 8 MAA-Vet Form 1.24.0.1 (15-12-2020) New MAA-Vet Release Notes 1.24.0.1 (15-12-2020) New
Summary of eAF changes in current release     Summary of changes 1.24.0.1 (15-12-2020) New

Guidance Documents

Regulatory

Technical

Q & A

Variation eAF v1.24.0.1 presentation on changes to users Presentation 15.12.2020 New
User Guidance Human & Vet Questions and Answers 01.03.2019
Variation eAF v1.24.0.0 presentation on changes (to applicants) Presentation26.10.2020
Variation eAF v1.24.0.0 presentation on changes (to NCAs) Presentation26.10.2020
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:

Version 1.24.0.1, available for use from 15th of December for procedures starting after 1st January 2021, Mandatory use from 16th of January 2021

Document Data Exchange Standard version 1.24.01 (effective from 15. 12. 2020) XML Schema Definition version 1.24.0.1 (effective from 15.12.2020)
DES 3.0 Technical Guide DES 3.0 technical guide N/A
eAF DES change summary DES change summary 15.12.2020 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 15.12.2020 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

 

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.

 


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