The Veterinary Harmonisation Group, an evolution of the former TIGes‑Veterinary Sub Group, is a subgroup of the eSubmission CMB and is made up of representatives from National Competent Authorities, the EMA and Industry. Its objective is to develop and implement standards for the submission of electronic information in the context of European veterinary medicines approval procedures.
A revised Change control process document is now available in section EU Change control process below. It is accompanied by a recommended template for submissions of change requests or questions relating to the VNeeS guidance, validation criteria or tools.
An updated version of the eSubmission Gateway user interface to create XML delivery files for submissions via the eSubmission Gateway and the Web Client is now available. This new version will distinguish between the ‘submission types’ (initial marketing authorisation, renewal, variation type II etc.) and the ‘submission unit types’ (initial submission, validation response, response etc.) and further clarify some submission types such as post-authorisation measures, resulting in an extended and more logical functionality. The change for veterinary submissions takes place in parallel to a similar change on the human side. Please check the section “EMA eSubmission Gateway/ Web Client for Veterinary Procedures” below for an updated user guide to XML delivery file creation.
An upgrade to the VNeeS checker version 2.4.b has been published on the websites of the French competent authority (ANSES-ANMV) and will soon be published on the website of the Belgian competent authority (FAGG-AFMPS) - see links under Current Guidance. The updates are related to the technical implementation, i.e. (i) include a change in dealing with uppercases in the filenames to avoid issues with case insensitive file systems, (ii) leading dots in the paths of the hyperlinks are accepted and (iii) technical details of checking of the hyperlinks in the bookmarks pane is strengthened. These are purely technical improvements which do not change submission requirements for applicants.
- An eSubmission Gateway user interface to create XML delivery files for submissions via the eSubmission Gateway and the Web Client is now available. The use of the delivery files is initially introduced as a pilot, covering the majority of submission types for both human and veterinary domains. Use of delivery files will become mandatory for Human Centralised Procedure submissions in line with the mandatory use of the updated eCTD EU M1 in October 2016. Use of the filenaming conventions will be phased out after a transitional period for all other procedure types.
Until 30 June 2016, only the VNeeS Guideline version 2.3, validation checklist version 2.3 and checker version 2.3b should be used but applicants are advised to use internally in parallel the version 2.4 of the VNeeS Guideline, validation checklist and checker to familiarise themselves with this new version until it enters into force on 1 July 2016. Any feedback should be sent to email@example.com
EMA eSubmission Gateway/ Web Client for Veterinary Procedures
EU Change Control Process
- Change Control Process Download (July 2016) New
- Veterinary eSubmission Change Request Q&A Form Download (July 2016) New
- Terms of Reference (2006)- Download
- E-submission Roadmap (2009)- Download
- eSubmission guideline Version 1.0 (October 2009) Download
- eSubmission guideline Version 2.0 (February 2011) Download
- eSubmission guideline Version 2.2 (January 2013) Download
- Terms of Reference (June 2012) - Download
- Change Control Process (December 2011) Download
For further input and/or comments on these FAQs, please contact the EMA