The Veterinary Harmonisation Group (VHG) is a subgroup of the eSubmission expert group 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 documents are approved by the eSubmission expert group before publication.
Please be informed that the VHG reached a decision regarding mandatory use of the PDF/A format in VNeeS, starting after the transition period when the CESP dataset module becomes mandatory for all submission types. The current planning in the new version of the eSubmission Roadmap that was recently adopted by HMA currently says that the CESP dataset module will be live for all procedures before the end of 2021 and then becomes mandatory 6 months after.
Relevant documents, i.e. VNeeS guideline and VNeeS checker tool will be updated and published 6 months before mandatory use of PDF/A.
The updated Q&A on PDF/A format is now available.
Reminder of mandatory use of VNeeS for all submissions in National Procedures by 01 January 2019.
According to the Annex 3 to the HMA eSubmission Roadmap on the implementation of mandatory VNeeS format for Veterinary regulatory submissions, the use of VNeeS only for all submissions in National Procedures will be mandatory from Q1 2019.
Guideline on eSubmissions for Veterinary products – version 2.6 now in force.
Commission Implementing Regulation (EU) 2017/12 of 6 January 2017 regarding the form and content of the applications and requests for the establishment of maximum residue limits in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council came into force on 27 January 2017.
With VNeeS version 2.6 now in force, the structure of the electronic dossier has been brought in line with structure described in the Commission Implementing Regulation.
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)
- 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
- eSubmission guideline Version 2.5 (06.2017) Download
- Terms of Reference (06. 2012) - Download