The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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.
11-10-2021
Questions and Answers document on the Mandatory use of OMS for CAPs now available
An updated version of the Questions and Answers document to support applicants and Marketing Authorisation holders in the implementation of the mandatory use of OMS for CAPs can be found here.
Please note that a training webinar on OMS will be held on 21st of October 2021, where registered participants will have the opportunity to clarify any outstanding questions. The webinar will be recorded and made available after the event.
06-10-2021
Questions and Answers document on the Mandatory use of OMS for CAPs now available
The use of Organisational Maintenance Services (OMS) will become mandatory for Centrally Authorised Products (CAPs) from 1st of November 2021. A Questions and Answers document to support applicants and Marketing Authorisation holders is now available.
01-10-2021
eAF v1.25.0.0 now available
New version 1.25.0.0 of all four eAFs is now available for immediate use.
The main changes in this version of the forms relate to the implementation of the Medical Device Regulation Art 2(1) of Regulation (EU) 2017/745 and include other changes as implemented in the latest version of the NTA application forms.
The changes, in summary, are an updated section on Medical Devices in the human MAA form, addition of a new section on Medical Devices in the variation form, addition of new sections on parallel variations and on Harmonisation relating to National Variations. An incorrect business rule relating in the Renewal form for excipients has also been fixed in this version.
The version 1.25.0.0 can be used immediately, and it strongly recommended that it will be used for applications for products containing medical devices as soon as possible, however, the one-month transitional period will run until end of October after which the use of version 1.25.0.0 of the forms will become mandatory.
The version 1.24.0.1 has now been removed from the eAF website however users can continue to submit applications using this version until the end of October 2021.
Applicants are reminded that the version of the form should not be changed during an ongoing procedure.
And
Mandatory use of OMS in eAFs from 1st of November 2021
The use of OMS in the eAFs will become mandatory from 1st of November 2021. Please note that a release to remove the free text fields in the human forms for Centralised Procedure (v1.26.0.0) is planned for release in early December 2021.
Version 1.26.0.0 will be mandatory for use for human domain from 1st of January 2022.
Please note that this version cannot be used for veterinary submissions prior to 28th January 2022. For veterinary domain, there will be no transitional period and the version 1.26.0.0 will become mandatory on the 28th January 2022. The previous version of the forms should be used for already ongoing procedures and 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:
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 1.25.0.0, available for use from 1st of October 2021. Mandatory use from 1st of November 2021.
Q & A
| Questions and Answers document on Mandatory use of OMS |
CAPs OMS Mandatory Q&A 05.10.2021 New |
| Variation eAF v1.25.0.0 presentation on changes to users |
Presentation 01.10.2021 New |
| Variation eAF v1.24.0.1 presentation on changes to users |
Presentation 15.12.2020 |
| 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 1.25.0.0, available for use from 1st of October 2021. Mandatory use from 1st of November 2021.
Version 1.26.0.0, planned for December 2021. Human forms will be available for use immediately upon publication (1st December 2021. Veterinary forms for use from 28th of January 2022 only (cannot be used for submissions prior to 28th January 2022.
| Document |
Data Exchange Standard version 1.26.0.0 |
XML Schema Definition version 1.26.0.0 |
| DES 3.0 Technical Guide |
pending |
N/A |
| eAF DES change summary |
DES change summary October 2021 New DRAFT |
N/A |
| Human MAA DES |
pending |
pending |
| Variation DES |
pending |
Variation XSD October 2021 New DRAFT |
| Renewal |
pending |
pending |
| Vet MAA DES |
pending |
MAA-Vet XSD October 2021 New DRAFT |
| Common Dictionary XSD Schema |
N/A |
Common Dictionary 01.10.2021 New DRAFT |
For technical support, visit the EMA Service Desk portal: https://servicedesk.ema.europa.eu
Draft eAF Release schedule for 2021
Links
