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 [...]
The release schedule for the update of the electronic Application Forms (eAFs) is now available and can be found here. The next release, version 1.21 will deliver defect fixes and usability improvements and is planned for user acceptance testing in January 2017 and for deployment in February 2017.
We are pleased to inform you that an updated version of the PSUR Repository NCA UI is going live on the 3rd of July 2023.
VNeeS guideline v 2.5 and validation checklist v2.5 have been published and will enter into force in June 2017. With this new version 2.5, rules for technical validation remain unchanged, therefore the current VNeeS Checker v.2.4b (validation tool) will remain valid from June 2017.