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.
The VNeeS Checker version 2.6 (entering into force September 2018) has now been published. See the section Future Guidance below.
Stepwise implementation towards mandatory use of the Common Repository for veterinary submissions
The use of the Common Repository by National Competent Authorities (NCAs) to retrieve veterinary submissions will be mandatory from 1st June 2018. Until this time, a transition period is ongoing, whereby the use of the Common Repository is being implemented in a stepwise approach, as indicated in the Dossier requirements for submission of marketing authorisation and maximum residue limit (MRL) applications to the European Medicines Agency and to members of the Committee for Medicinal Products for Veterinary use (CVMP) (EMA/466102/2007)
An updated version of the eSubmission Gateway XML delivery file user interface is now available. The eSubmission Gateway update will introduce improvements and new fields to the user interface. This change is a further step towards integration of the XML delivery file and the Formatted Table Template; however this release does not affect yet the use of the Formatted Table Template.
Please note that the delivery files created prior to the new release should work following the deployment of the new versions.
One of the new fixtures will be introduction of Brexit Related procedure indicator.
Users can indicate if the change is a Brexit related procedure. This is applicable to initial submissions for the following submission types:
- Variations Type IA (H & V)
- Variations Type IAIN (H & V)
- Variations Type IB (H & V)
- Variations Type II (H & V)
- Transfer MA (H & V)
- Notification 61-3 (H only)
The guideline on eSubmissions for Veterinary products – version 2.6 has now been published. It will enter into force on 1 September 2018 - see links under section “Future Guidance” below.
The update is related to alignment with the eSubmission roadmap and forthcoming CESP dataset module, clarification on upper-case file extension, update of CMDv reference guidance, addition of a pass/fail criterion related to hidden files, update of the MRL dossier structure. As those updates will change submission requirements for applicants, i.e. technical validation criteria will not be identical, the version 2.6 will be valid only when entering into force from 1st September 2018.
The VNeeS Q&A relating to eSubmission for Veterinary Applications has been updated
Previous news is available here.
EMA eSubmission Gateway/ Web Client for Veterinary Procedures
Common Repository for Veterinary Procedures
More information about Common Repository can be found here.
EU Change Control Process
- Change Request Tracking table Download (02.2018) Updated
- Change Control Process Download (07. 2016)
- Veterinary eSubmission Change Request Q&A Form Download (07. 2016)
- Terms of Reference (2006)- Download
- eSubmission guideline Version 1.0 (10. 2009) Download
- eSubmission guideline Version 2.0 (02. 2011) Download
- eSubmission guideline Version 2.2 (01. 2013) Download
- eSubmission guideline Version 2.4 (12. 2015) Download
- Terms of Reference (06. 2012) - Download