A defect in section 2 of variation eAF causing fields to overlap and an issue affecting the co-rapporteur field in the human MAA form has been detected and subsequently fixed. New version v.1.20.0.5 of the variation and MAA human forms and the updated release notes are now available. Please note that the Data Exchange Standard [...]
An updated version of the PSUR Repository NCA UI is now available. The new version of the PSUR Repository NCA User Interface provides a technical update only. Following the update, the PSUR Repository NCA UI has slightly different look and feel, however, there are no changes to the features and functionality of the system.
PSUR/eSubmissions Web User Interface (to create the delivery file) will be unavailable between 07.00 and 09.00hrs on Monday, 20 February 2017. However, the 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.
Updated versions of 4 electronic Application Forms (eAF v. 1.20.0.4 - initially called v1.21) are now available. This new release provides usability improvements and defect fixes with an aim to further improve user experience. Please note that the Data Exchange Standard (DES) has not changed in this release - the change in the release number [...]
A new change request tracking table is now available,
Member: Roselien Poppe Alternate: Sophie Colyn Federal Agency for Medicines and Health Products - FAMHP Avenue Galilée 5/03 1210 BRUSSELS
A presentation and recording is now available on the Mandatory use of eSubmission Gateway for all veterinary submissions to EMA
Due to planned maintenance and verification of the upcoming functionalities (including basic authentication), the Common Repository (API and Web UI) will not be available on Tuesday 5 July 2023, between 18:00 and 21:00. For any further information, please contact EMA Service Desk.
The ICH Reflection Paper which the ICH Assembly decided to progress at its recent meeting in Vancouver, Canada on 13 June 2023, is now available for public consultation until 30 September 2023 on the ICH website
Support to eSubmissions during EMA holidays; Please note that all EMA eSubmission systems are running as per normal during the EMA holiday. Submissions received via the eSubmission Gateway during the EMA closure are automatically uploaded to the Common Repository and the PSUR Repository as relevant. In case of technical issues, the EMA IT service desk [...]