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Updated EU M1 eCTD Specification

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 [...]

Por |2021-03-12T16:00:00+00:00marzo 12th, 2021|Noticias|Sin comentarios

A new version of the eSubmission Gateway XML delivery file is now available 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 [...]

Por |2021-03-11T16:00:00+00:00marzo 11th, 2021|Noticias|Sin comentarios

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 [...]

Por |2021-03-11T16:00:00+00:00marzo 11th, 2021|Noticias|Sin comentarios

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 [...]

Por |2021-03-04T16:00:00+00:00marzo 4th, 2021|Noticias|Sin comentarios

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 [...]

Por |2021-03-04T13:00:00+00:00marzo 4th, 2021|Noticias|Sin comentarios

VHG reached a decision regarding mandatory use of the PDF/A format in VNeeS

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 [...]

Por |2021-02-12T15:05:26+00:00febrero 12th, 2021|Noticias|Sin comentarios
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