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The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised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.
07-12-2023
Updated eAF v1.26.0.0 (Human MAA) and v1.26.0.1 (Vet MAA) now available
Updated v1.26.0.0 Human MAA eAF is now available on the eAF website. The form is ready for immediate use. The change implemented in this version is a minor bug fix (related to Annex 5.19).
It is strongly recommended to use this latest version (document properties date 27.10.2023). Please note that there is no version number change and that the release notes are published in the relevant section of the eAF webpage.
Updated v1.26.0.1 Vet MAA eAF is now available for immediate use.
The changes in this version relate to label and text changes only. Additionally, the version number has updated from v1.26.0.0 to v1.26.0.1.
The version 1.26.0.1 can be used immediately, and it is strongly recommended that it will be used for all new applications as soon as possible, however, the one-month transitional period will run until 8th of January 2024 after which the use of version 1.26.0.1 for the Veterinary MAA form will become mandatory.
The version 1.26.0.0 has now been removed from the eAF website however users can continue to submit applications using this version until 7th of January 2024.
Please note that as there are no technical changes, it is possible to import the xml from version 1.26.0.0 into version 1.26.0.1 to avoid any need for manual effort.
Applicants are reminded that the version of the form should not be changed during an ongoing procedure, please note that if you need to provide an updated form for a procedure that has started prior to 8th of January, you should use the previous version.
Updated release notes are published in the relevant sections of the eAF webpage.
30-11-2023
Updated version of the eAF v1.26.0.0 (variation and renewal)
An updated version 1.26.0.0 of the Variation and Renewal (both Human and Veterinary) eAF is available starting with 28 November 2023, 18:00 CET.
A change has been implemented to allow Non-Current terms to be selected in the "Pharmaceutiacal form" lists.
It is recommended to use this latest form for new submissions. Please note that there is no version number change and that the release notes were updated and published in the relevant section of the eAF page.
04-10-2023
Updated user guide for the eAF for MAA available on the CMDh website
A new version of the joint EMA/CMDh User guide for the electronic application form for a Marketing Authorisation is available on the CMDh website.
Human variations form updated timeline
Please find the September 2022 version of the DADI Human Variations Forms timeline, outlining the updated DADI BETA UAT timeframe. The UAT has started on 19th September and will end on the 30th September 2022.
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 1.26.0.0
Human forms available for use from 1st of December 2021. Mandatory use from 1st of January 2022.
Veterinary forms available for use from 28th January 2022. Mandatory use from 28th January 2022.
*Application form for marketing authorisation for veterinary medicinal products according to Regulation EU 2019/6 and for specific variations requiring assessment1
1variations requiring assessment classified as changes of active substance(s), strength, pharmaceutical form, route of administration or food-producing target species in chapter I of EMA/CMDv Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations
Guidance Documents
Regulatory
Technical
Q & A
| Questions and Answers document on Mandatory use of OMS |
CAPs OMS Mandatory Q&A 11.10.2021 |
| Variation eAF v1.25.0.0 presentation on changes to users |
Presentation 01.10.2021 |
| 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
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| 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
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 1.26.0.0
Human forms available for use from 1st of December 2021. Mandatory use from 1st of January 2022.
Veterinary forms available for use from 28th January 2022. Mandatory use from 28th January 2022.
For technical support, visit the EMA Service Desk portal: https://servicedesk.ema.europa.eu
Links
Archives
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. |
