An updated version of the eSubmission Gateway XML delivery file web UI is now available. This version delivers new functionality to create delivery files for MRL and veterinary PSUR submissions as well as functionality to create delivery files for human PASS 107o submissions, PASS 107n, PASS 107o and PASS 107q submissions for Nationally Authorised Products and submissions for Ancillary Medicinal Products in medical devices.
The User guide to the XML delivery file creation and the Release notes have been updated and are now available here.
The use of eSubmission Gateway / Web Client will become mandatory for all Veterinary submissions on 1 January 2017. The procedural announcement and presentation from the training held on 1 December 2016 are available here.
The use of XML delivery files for all Veterinary submissions will become mandatory on 1 April 2017. The Statement of Intent is available here.
The Common Repository will be extended to all veterinary submissions in the centralised procedure. The Statement of Intent is available here.
The use of VNeeS format for all veterinary submissions in European procedures (CP, DCP and MRP) will become mandatory as of 1 January 2017. Details are available in the Annex to the eSubmission roadmap.
Essential maintenance to computer systems during the weekend
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 /H-PUSA area might receive warning messages. Please avoid working in this area on Sunday 4th Dec, if possible. All other areas of DREAM will be available as usual.)
A statement of intent is published regarding the replacement of electronic Application Forms by CESSP. More information on the CESSP project is available here.
As of 1 January 2017 it will be mandatory for applicants to make all veterinary procedural submission to EMA via the eSubmission Gateway/Web Client portal. In preparation, a training Webinar for Industry – Mandatory Use of eSub Gateway for veterinary submissions to EMA will be held on 1 December 2016 from 13:00 to 15:00 UK time. For details see the Veterinary esubmission website.
An updated version of the Common Repository is now available for the NCAs. The Common Repository contains all Centralised Procedure eCTD format submissions and is accessible to all NCAs. The update user guide is now available for NCAs. The updated Q&A document is now available here.
The Practical User Guide for Electronic Application Forms (eAF) for human and veterinary medicinal products in the EU has been updated and is available here.
Previous news is available here