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The word based application forms (AF) have been replaced by electronic application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.
06-05-2025
eAF v1.27.0.1 (Human Variation, interactive PDF) now available, for use
from 1 May 2025
A new version of the interactive PDF Human Variation eAF v.27.0.1 was published today,
6th of May 2025, bringing a small change in the exported XML data. No other changes are
introduced. It is highly recommended to use this latest version of the form.
Reminder:
A new version of the Human Variation eAF v1.27.0.1 is now available
on the eAF website.
The version should be used starting with 1st of May 2025.
The version allows the
selection of Reference Member State and Concerned Member State(s) when the type of
authorisation is 'National Authorisation' and the type of
application is
'Super-grouping'.
It is mandatory to use version 1.27.0.1 for all new Human Variation
procedures. The version 1.27.0.0 for Human Variations will be removed from the eAF
website, however, users can continue to submit applications using this version for
ongoing procedures. Applicants are reminded that the version of the form should
not be
changed during an ongoing procedure.
25-04-2025
eAF v1.27.0.1 (Human Variation) now available, for use from 1 May
2025
A new version of the Human Variation eAF v1.27.0.1 is now available on
the eAF website. The version can be used starting with 1st of May 2025. The version allows the selection of
Reference Member State and Concerned Member State(s) when the type of authorisation is
'National Authorisation' and the type of application is 'Super-grouping'.
It is mandatory to use version 1.27.0.1 for all new Human Variation
procedures. The version 1.27.0.0 for Human Variations will be removed from the eAF
website, however, users can continue to submit applications using this version for
ongoing procedures. Applicants are reminded that the version of the form should
not be changed during an ongoing procedure.
13-02-2025
Production go-live for submissions of human variations web-based eAFs for non-CAPs
As previously announced through our
Product Lifecycle Management (PLM) newsletter
(27/01/2025) the EMA is pleased to confirm as of Tuesday 11 February 2025, the human variations web-based electronic Application Form (eAF) is open for first use for non-Centrally Authorised Products* (non-CAPs) within the
PLM Portal.
Please note that the
interactive PDF eAF
remains available for use for all variation procedures and while the PLM Portal eAF is now available
for use for all procedure types, there are some technical limitations, and in these cases the applicants are requested to use the interactive pdf forms.
* Products authorised throughout mutual recognition procedure (MRP), decentralised procedure (DCP) and national procedure (NAP)
29-01-2025
Updated eAF 1.27.0.0 Human Variation form
The Human Variation form v1.27.0.0 was updated on the 29 January 2025. The change
follows the recent update of the new variation regulation; in the Declaration section in
the parallel procedures sub-section, the table with the product/procedure details has
been removed.
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 will be updated
and published in the relevant section of the eAF page.
05-12-2024
Updated Renewal and Variation Veterinary forms
The Renewal Form v1.26.0.0 and the Variation Veterinary Form 1.26.0.0 will be updated on 5 December 2024. The changes are related to a note text update, and there is no impact on the version or the structure of the form.
04-12-2024
Planned maintenance of eSubmission systems on 5 December 2024, 18:00 CET
Due to planned maintenance, the following eSubmission systems will not be available on Thursday 5
December 2024,
between 18:00 and 24:00: Gateway XML delivery file user interface, Gateway Filehandler, Common
Repository Web-UI
and API, PSUR Repository Web-UI (both NCA and industry access) and API.
The maintenance includes various improvements and implementations:
- Common Repository Web-UI - technology modernisation
- Gateway XML delivery file user interface - various improvements and integrations for
retrieval of data (e.g. procedures) from the internal EMA case management system (IRIS)
- Gateway XML delivery file user interface - minor changes related to the new variation regulation (e.g.
renaming of the submission mode from "IG" to "super-grouping")
Updated documentation will be published on the relevant pages of the
eSubmission website.
For any further information, please contact EMA Service Desk.
02-12-2024
Updated eAF v1.27.0.0 (Human Variation) now available, for use from 1 January
2025
An updated/corrected version of the eAF 1.27.0.0 (Human variation) is now available on the
eSubmission website.
The difference compared to the version published on the 27th of November is in the
exported XML, which now
correctly contains the super-grouping checkbox.
It is mandatory to use version 1.27.0.0 for all Human Variation applications with procedure start
date after 1st of January 2025.
The version 1.26.0.0 for Human Variations will be removed from the eAF website, however, users
can continue to
submit applications using this version for procedures starting until 31 December 2024. Applicants
are reminded
that the version of the form should not be changed during an ongoing procedure.
Please note that in case you
need to provide an update to a form that has been submitted prior to 1st of January
2025, you should use the
previous version (1.26.0.0).
27-11-2024
EMA encourages companies to submit type I variations for 2024 by end November
2024
EMA is advising marketing authorisation holders to submit type IA and type IAIN
variations
for 2024 no later than 30 November 2024.
This will enable EMA to acknowledge the validity of the submissions before the Agency's closure
between 20 December 2024 and 5 January 2025,
within the 30-day timeframe set out in Article 14 of
Commission Regulation (EC) No 1234/2008.
Marketing authorisation holders are advised to submit any type IB variations or groupings of type
IBs
and type IAs by 30 November 2024 for a start of procedure
in 2024. For submissions received on or after 1 December 2024, the procedure may not start until
January 2025.
and
eAF v1.27.0.0 (Human Variation) now available, for use from 1 January 2025
In line with the amended Variation Regulation entering into force on the 1st of
January
2025 (
Guidance on the application of the amended Variations Regulation from 1 January 2025 |
European
Medicines Agency (EMA)
), a new version of the Human Variation eAF v1.27.0.0 is now available on the
eAF
website.
It is mandatory to use version 1.27.0.0 for all Human Variation applications with procedure start
date
after 1st of January 2025.
The version 1.26.0.0 for Human Variations will be removed from the eAF website, however, users
can
continue to submit applications using this version for procedures
starting until 31 December 2024. Applicants are reminded that the version of the form should
not be
changed during an ongoing procedure.
Please note that in case you need to provide an update to a form that has been submitted prior to
1st of January 2025, you should use the previous version (1.26.0.0).
29-10-2024
Interactive PDF eAF technical documentation updated
An updated set of schemas were published under the "Technical Documents" section of
eAF
(interactive PDF), relevant for small changes in the XML schema definition for versions 1.26.0.0
and
1.26.0.1.
The changes are reflected in the "eAF DES change summary" document.
14-10-2024
Non-Centrally Authorised Products now available in the PLM Portal eAF
The EMA is pleased to announce that the non-Centrally Authorised Products*
(non-CAPs) data are now available in the Human variation web-based eAF
within the Product Lifecycle
Management
(PLM) Portal.
Please note that, due to system limitations and pending future improvements, the
web-based eAF
cannot currently be used for submissions to the National Competent Authorities.
However,
the web eAF is fully functional for the submission of variations of CAPs, including EMA-led
worksharing variations containing CAPs and non-CAPs.
Please join the training session on 17 October 2024 10:00 - 11:30
(CEST).
Please see an updated version of the draft PLM
Portal eAF guide to navigation is now available.
03-06-2024
PMS Product UI Now Live on the PLM Portal
The PMS Product User Interface (PUI) was launched on 31 May 2024, in read-only mode on
Product Lifecycle Management
(PLM)
Portal. Registered users are now able to view Centrally Authorised Product - (CAP) data
in the PUI
(Nationally Authorised Product (NAP) data will be available in early Q3 2024).
Please note that the eAF users have now automatically access to the PUI. Consult these guidance
documents and join the 3 June 2024 training session to prepare for registration & navigation of PUI.
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 versions 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 MAA
Renewal
Veterinary Variation
Version 1.26.0.1
Veterinary MAA
Version 1.27.0.0
Human Variation
*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
|
| 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://support.ema.europa.eu/esc
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. |
