To facilitate the submission of regulatory information concerning marketing authorisations application for medicinal products to National Competent Authorities and EMA as well as to streamline the business process, standards for electronic submissions have been developed.
For human medicinal products, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) developed an electronic exchange standard called electronic Common Technical Document (eCTD). This standard is based on “M4: The Common Technical Document (CTD)” in its various parts.
The current electronic version was developed by the eCTD Implementation Working Group and released as version 3.2 in February 2004. The European Union applies the eCTD Specification in the European region and has completed it with the European Module 1.
Preparation of the next major version (version 4.0) is now ongoing within the ICH.
For more information, please refer to the eCTD v.3.2, eCTD EU M1 specification and eCTD v.4.0 webpages.
For veterinary medicinal products, a specific EU standard, Veterinary Non-eCTD electronic Submissions (VNeeS), that is based on the EU Notice to Applicants format for veterinary applications, has been developed.
For more information, please refer to the Veterinary eSubmission webpage.
The EU standards and related guidance documents are developed and maintained by the different key user groups and approved by the eSubmission expert group before publication.
For technical support, visit the EMA Service Desk portal using your user credentials for a system hosted by EMA (except Eudravigilance). If you do not have an account or have forgotten your credentials, please click here.
DADI project update is now available here. This update includes a timeline for the first forms to be released, a list of features of the human variation form and an updated questions & answers document.
02-08-2021
Updated release schedule for eAF now available
An updated release schedule for the electronic Application Forms (eAF) is now available here.
And
Call for volunteers for eAF v1.25.0.0 (reflecting the updated Medical Devices regulation)
The version 1.25.0.0 of the electronic Application Forms (eAFs) is planned for release at the end of September 2021 with a short 1-month transitional period and mandatory use from 1st of November 2021. The release v1.25.0.0 will provide a major change into the section 2.2.4 of the human MAA form as well as adding similar section in the human variation form. Additionally, there are other minor changes across all forms. These changes will be detailed in the release notes. User Acceptance Testing (UAT) is planned to support the release of this next version of the forms:
The testing by Industry and NCAs is planned to take place as follows:
Industry: from Tue 24/08/21 to Wed 01/09/21
NCAs*: from Mon 30/08/21 to Fri 03/09/21 (*Based on the eAFs received from Industry)
Please note that these dates are subject to change depending on the outcome of internal UAT. If you wish to participate in the UAT, please register by email with eSubprogofficer@ema.europa.eu.
Further details on the release scope and the confirmed dates for the UAT will be provided soon.
An updated release milestone plan and release schedule for the electronic Application Forms (eAF) will be published shortly.
And
Updated technical documents for eAF v1.25.0.0 now available
Updated draft DES summary and draft XSD files for the forms are now available on the eAF website here.
22-07-2021
Extended deadline for mandatory use of OMS for all CAP submissions
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.
16-07-2021
Updated draft version of the VNeeS specification v3.0 now available
An updated version (v3.0) of the draft guideline on the specifications for provision of an electronic submission (eSubmission) for veterinary medicinal products (Draft VNeeS guideline) and further information is now available here.
12-07-2021
Mandatory use of OMS in eAF for all submissions to EMA
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, 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 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.
17-06-2021
DADI Project Questions and Answers now available
The European Medicines Regulatory Network's Digital Application Dataset Integration (DADI) project has released a Questions and Answers (Q&A) document with further details about the purpose and scope of the project.
The project team aims to follow up in the coming month with further details, including key milestones, the full list of features and the first draft of the FHIR message.
All EMA IT systems unavailable from 18 to 20 June 2021
EMA will be performing essential maintenance to components of our IT infrastructure during the weekend of 18 to 20 June. The work will start at 18:00 on Friday, 18 June, and finish by 23:59 on Sunday, 20 June. From 18:30 on Friday, 18 June to 18:30 on Saturday, 19 June, all EMA systems will be unavailable.
The EMA corporate website will remain available during this period but it may not be possible to access any other EMA-hosted website or online application.
The EMA product emergency hotline and phone number for notifying EMA of suspected quality defects or product recalls will operate as usual during this period.
21-04-2021
Planned maintenance of the eSubmission Gateway and the eSubmission Gateway Web client
(Production Axway Gateway) this weekend
The Production Axway Gateway (eSubmission Gateway and the Web Client) will be
unavailable from Friday 23/04 at 18:00 until Monday 26/04 at 06:00 due to essential maintenance.
For any further information, please contact Service Desk
and
Essential maintenance to SPOR data services - 24 April 2021
Essential maintenance is scheduled to be carried out to SPOR data services -
between 8:00-12:00 on Saturday 24 April. Applications consuming real-time RMS data (PSUR
Repository, MMS-e, EudraGMDP, EudraCT, EU PAS (ENCepp) and eAF Web Application) will be
affected, as well as internal or external access to SPOR portal. For any further information,
please contact Service Desk
15-04-2021
All EMA IT systems unavailable from 16 to 18 April 2021
All European Medicines Agency (EMA) information technology (IT) systems apart from the corporate website
(www.ema.europa.eu) will be intermittently unavailable
from 18:00 on Friday 16 April to 11:00 on Sunday 18 April 2021 (Central European Summer Time, CEST),
due to essential maintenance.The EMA corporate website will remain available during this period but it
may not be possible to access any other EMA-hosted website or online application.
The EMA product emergency hotline and phone number for notifying EMA of suspected quality defects or product recalls will operate as usual during this period.
09-04-2021
Updated eCTD EU M1 specification now available
The eCTD EU Module 1 specification has been updated. The updated EU M1 spec v3.0.4 and the related release notes are available here. There are no changes to the DTD and hence
this version enters into force as of date of publication and can be used immediately. It is recommended
to use the new version as soon as possible.Please note that the release notes
provide practical information on the changes and it is strongly recommended to review the
release notes to fully understand the changes made in the specification.
25-03-2021
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.
11-03-2021
A new version of the eSubmission Gateway XML delivery file is now available
An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced changes to the delivery file (addition of ‘nitrosamine related’ radio button for initial variation submissions (human domain only) and renaming the ‘Customer Reference’ field to ‘purchase order number’ for all relevant submission types and submission units (H&V).
The details on the changes are provided in the related release notes which are available here and the updated user guide is available here.
Users should note that the delivery files created prior to the new release will not work after the go live
08-03-2021
A new version of the eSubmission Gateway XML delivery file for veterinary changes is now available
An updated version of the eSubmission Gateway XML delivery file user interface for veterinary MRL and referral submissions is now available. This update has introduced changes to the delivery file (changes in the available submission units and mandatory use of customer number and Purchase Order number). The details on the changes are provided in the related release notes which are available here and the updated user guide is available here
Users should note that the delivery files created prior to the new release will not work after the go live
04-03-2021
A new version of the eSubmission Gateway XML delivery file for veterinary changes is planned for release in the evening of 8th March 2021
An updated version of the eSubmission Gateway XML delivery file user interface for veterinary MRL and referral submissions is planned for release in the evening of 8th March 2021. This update will introduce changes to the delivery file (changes in the available submission units and mandatory use of customer number and Purchase Order number).
Users should note that the delivery files created prior to the new release will not work after the go live.
04-03-2021
A new version of the eSubmission Gateway XML delivery file planned for release in the evening of 11th March 2021
An updated version of the eSubmission Gateway XML delivery file user interface is planned for release in the evening of 11th March 2021. This update will introduce changes to the delivery file (addition of nitrosamine related radio button for initial variation submissions and renaming the Customer Reference field to PO number for all relevant submission types and submission units.
Users should note that the delivery files created prior to the new release will not work after the go live.
08-02-2021
Updated version of the VNeeS specification now available
The Guideline on eSubmissions for Veterinary products has been updated to version 2.7.1, applicable immediately. This minor change is Brexit related change in the list of country codes in table 4.
This change has no impact on the validation rules and the current VNeeS Checker tool (v2.6) remains unchanged.
16-01-2021
Mandatory use of eAF v1.24.0.1
It is now mandatory to use the version 1.24.0.1 of all four eAFs.
The term United Kingdom has been removed from the EU/EEA country grouping on 1st of January 2021 for selection in any version of the forms (in the fields where EU/EEA countries are listed).
Applicants are reminded that the version of the form should not be changed during an ongoing procedure.
For any issues with the eAFs, for example reporting missing scopes, please raise a call via the EMA service desk
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.
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