Please note that the following computer systems will be unavailable on Sunday, 4th December 2016 between 9.00hrs and 19.00hrs (UK Time) due to essential maintenance: PSUR and eSubmission Web User Interface - affecting parts of DREAM* Axway Gateway - affecting EudraVigilance and eSubmissions (* Due to essential folder re-structuring, colleagues working in the cabinet 01 [...]
The VNeeS format is becoming mandatory for ALL submissions in European procedures (CP, DCP and MRP) as of 1 January 2017, as detailed in the Annex to the eSubmission roadmap.
The eSubmission Roadmap describes the concept of Single Submission Portal which will be created by integration of the current Common European Submission Platform (CESP) and the EMA eSubmission Gateway. The EU Telematics Management Board has agreed that this single portal shall be built using the current CESP portal. This future system is currently referred to [...]
Updated versions of 4 electronic Application Forms (eAF v. 1.20.0.3) have been published following reported issues. The updated forms and related release notes are now available here. The User guide to the XML delivery file creation has been updated and is now available here.
Due to planned maintenance, the following eSubmission systems will not be available on Saturday 24 June 2023, between 8:00 and 18:00: Common Repository (Interface and API), PSUR Repository, Gateway FileHandler. For any further information, please contact EMA Service Desk.
PSUR/eSubmissions Web User Interface (to create the delivery file) will be unavailable between 18:00 and 19:00hrs on Thursday, 6 October 2016. However, Axway gateway will be available for all communities and any files submitted during that time will be put in a queue for processing when the deployments will be completed. If you have any [...]
Due to planned maintenance, the PSUR Repository will be available intermittently on Thursday 22 June 2023, between 17:00 and 20:00. For any further information, please contact EMA Service Desk.
The European Medicines Agency will be carrying out essential maintenance activities on the Gateway. Users may therefore find the Gateway unavailable during this time. Friday, 14th October from 20.00hrs (UK time) to Monday, 17th October, 6.00hrs (UK time) During this period, it will not be possible to send messages via the Agency's Gateway. Depending on [...]
An updated version of the eSubmission Gateway XML delivery file user interface is available starting with 20 June 2023, 18:00. This update introduces a change to the Human Domain only, adding new fields to flag Real World Data/Real World Evidence for selected types of submissions.
The Assembly of the International Council for Harmonisation (ICH) met in-person on 12 & 13 June 2023, in Vancouver, Canada in parallel of meetings of 14 Working Groups, and preceded by meetings of the ICH Management Committee and the MedDRA Management Committee.