Formatted Table Template implementation in the XML delivery files – now live

A new version of the eSubmission Gateway XML delivery file user interface is now available. Following this release the use of the Formatted Letter template will become obsolete as of 1st January 2020. This will concern all EMA Human and Veterinary submissions (including PSUSA procedures) and after this it will be optional for applicants to [...]

Por |2023-09-10T04:57:15+00:00septiembre 10th, 2023|Noticias|Sin comentarios

Essential maintenance to computer applications on Wednesday 09-10-2019

PSUR and eSubmissions Web User Interface (to create the delivery file) will be unavailable between 07:00-09:00hrs (CEST) on Wednesday, 9 October 2019. However, the EMA gateway will remain available for all communities throughout and any files submitted during that time will be queued for processing when the work is complete. If you have any questions, [...]

Por |2023-09-09T04:49:23+00:00septiembre 9th, 2023|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 |2023-09-07T04:29:37+00:00septiembre 7th, 2023|Noticias|Sin comentarios

Reminder on the working documents provided within the eCTD submissions

As per the structure of the eCTD, the product information should be provided in pdf format within Module 1.1.3. However it is occasionally necessary to provide, in addition to the PDF requirement, product information or the Module 2 documents in Word format. These files should be provided outside of the eCTD structure, in a separate [...]

Por |2023-09-06T04:29:07+00:00septiembre 6th, 2023|Noticias|Sin comentarios

Vendor Readiness Survey

The ICH M8 EWG would like to assess the readiness of eCTD v4.0 Vendors and their development and/or readiness to deliver a production ready eCTD v4.0 solution. We request that the eCTD v4.0 Vendor Readiness Survey be completed by September 15, 2019.

Por |2023-09-05T04:26:57+00:00septiembre 5th, 2023|Noticias|Sin comentarios
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