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.
08-02-2020
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.
|