The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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
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 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
For technical support, visit the EMA Service Desk portal: https://servicedesk.ema.europa.eu
Links
