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 [...]

By | septiembre 4th, 2020|Noticias|0 Comments

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 [...]

By | julio 20th, 2020|Noticias|0 Comments

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 [...]

By | julio 11th, 2020|Noticias|0 Comments

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.

By | julio 10th, 2020|Noticias|0 Comments

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 [...]

By | noviembre 5th, 2019|Noticias|0 Comments

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 [...]

By | octubre 9th, 2019|Noticias|0 Comments

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, [...]

By | octubre 8th, 2019|Noticias|0 Comments