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.
News
11-03-2021
A new version of the eSubmission Gateway XML delivery file is now available
An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced changes to the delivery file (addition of ‘nitrosamine related’ radio button for initial variation submissions (human domain only) and renaming the ‘Customer Reference’ field to ‘purchase order number’ for all relevant submission types and submission units (H&V).
Users should note that the delivery files created prior to the new release will not work after the go live..
08-03-2021
A new version of the eSubmission Gateway XML delivery file for veterinary changes is now available
An updated version of the eSubmission Gateway XML delivery file user interface for veterinary MRL and referral submissions is now available. This update has introduced changes to the delivery file (changes in the available submission units and mandatory use of customer number and Purchase Order number). .
Users should note that the delivery files created prior to the new release will not work after the go live..
28-01-2021
The Guideline on eSubmissions for Veterinary products has been updated to
version 2.7.1, applicable immediately. This minor change is Brexit related change in the list of
country codes in table 4.
This change has no impact on the validation rules and the current VNeeS Checker tool
(v2.6) remains unchanged..
01-12-2020
The VNeeS Q&A relating to eSubmission for Veterinary Applications has been updated.
05-10-2020
The Guideline on eSubmission for Veterinary products - version 2.7 entered into force on 01 October 2020.
31-03-2020
The updated VNeeS guideline version 2.7 is now available and will enter into force on 1st October 2020.
Previous news is available here.
Current Guidance
EMA eSubmission Gateway/ Web Client for Veterinary Procedures
Announcements
Guidance
Common Repository for Veterinary Procedures
More information about Common Repository can be found here.
Useful Links/Documents
EU Change Control Process
- Change Request Tracking table Download (07.2020) Updated
- Change Control Process Download (07. 2020) Updated
- Veterinary eSubmission Change Request Q&A Form Download (07. 2016)
Historical Documents
- 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
- eSubmission guideline Version 2.6 (09-2018) Download
- Terms of Reference (06. 2012) - Download
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. |
