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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

Issue with eSubmission Gateway and its infrastructure

For the last few days, the EMA Gateway and surrounding infrastructure experienced an unplanned outage.  This has resulted in delays in acknowledgment communication as well as internal delays in submissions distribution. The service is now available but we request you do not resubmit packages as the process of sending acknowledgments is experiencing delays. Thank you for [...]

Por |2020-09-04T20:45:24+00:00septiembre 4th, 2020|Noticias|Sin comentarios

eAF v1.24.0.0 release milestone plan and updated release schedule for eAF now available

An updated release milestone plan and release schedule for the electronic Application Forms (eAF) are now available. Version 1.24.0.0 of all the 4 electronic Application Forms (eAFs) is planned for release in September 2020 with a 2 month transitional period, and mandatory use from November 2020. The release v1.24.0.0 will provide a major change into [...]

Por |2020-07-20T15:55:43+00:00julio 20th, 2020|Noticias|Sin comentarios

Weekend Maintenance

Users should be aware that due to essential maintenance work on EMA’s infrastructure, most of EMA’s computer applications, including most eSubmission systems will experience downtime between the hours of 18:00 on Friday, 17th July and 14:00 on Saturday, 18 July 2020. Please note that if you have submission deadline for your procedure on Friday, 17th [...]

Por |2020-07-11T15:02:45+00:00julio 11th, 2020|Noticias|Sin comentarios

Computer application maintenance

Essential maintenance work will be carried out to all eSubmission applications as part of EMA’s computer application maintenance work this weekend. As a result, eSubmission systems will be intermittently unavailable between 10:00hrs and 13:00hrs of Saturday, 11 July 2020. If you have any questions, please contact the EMA Service Desk.

Por |2020-07-10T14:44:42+00:00julio 10th, 2020|Noticias|Sin comentarios

A new version of the eSubmission Gateway XML delivery file now available

An updated version of the eSubmission Gateway XML delivery file user interface is now available. The eSubmission Gateway update has introduced an additional submission unit for PAM submissions and a mandatory selection of yes/no to indicate if a change of MAH is included in a response submission for MAA human and vet. Additionally some minor [...]

Por |2019-11-05T11:37:10+00:00noviembre 5th, 2019|Noticias|Sin comentarios

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 |2019-10-09T08:54:35+00:00octubre 9th, 2019|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 |2019-10-08T08:50:50+00:00octubre 8th, 2019|Noticias|Sin comentarios
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