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.
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