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.
Updated General FAQ relating to eSubmission for Veterinary Applications is now available
The General FAQ relating to eSubmission for Veterinary Applications has been updated and is now available below.
Updated final version of the VNeeS specification 3.0 now available
A final, clean version (v3.0) of the draft guideline on the specifications for provision of an electronic submission (eSubmission) for veterinary medicinal products (Draft VNeeS guideline) is now available. The updates have been implemented to align with the VMP-Regulation (EU) 2019/6.
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 (December 2021) Updated
- Change Control Process Download (07. 2020)
- Veterinary eSubmission Change Request Q&A Form Download (December 2021) Updated
For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.