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.
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 [...]
The EU eCTD Module 1 Specification has been updated to reflect clarifications and the updated version 3.0.4 is available for immediate use. Release notes with practical information on changes are provided below. There are no changes to the DTD in this version (version 3.0.1 is still valid), and the validation criterion was not changed as [...]
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 [...]
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 [...]
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).
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 [...]
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 [...]
Please be informed that the VHG reached a decision regarding mandatory use of the PDF/A format in VNeeS, starting after the transition period when the CESP dataset module becomes mandatory for all submission types. The current planning in the new version of the eSubmission Roadmap that was recently adopted by HMA currently says that the [...]
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.