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
31-07-2023
Updated version of the eAF v1.26.0.0 (veterinary variation)
An updated version 1.26.0.0 of the veterinary variation eAFs is available starting with 24 July 2023.
A single change has been implemented to address a non-blocking bug (related to the formatting of the page).
It is recommended to use this latest form for new submissions (document properties date 24.07.2023). Please note that there is no version number change and that the release notes are not published for this minor change at this time.
18-07-2023
Use of PDF/A (For Industry representatives)
This communication is a reminder that, whilst awaiting mandatory use of PDF/A, its use is still strongly recommended to create any new documents. Only this approach ensures that electronic archives both on industry and agency side will contain exactly the same files as submitted because no further conversion to an archive format is needed. Note that postponing implementation until PDF/A is mandated brings further disadvantages as a growing number of legacy files may need to be converted for future submissions. As communicated earlier, the intent is to mandate the use of PDF/A once the new web-based electronic application forms (eAFs), which are currently established in the human domain and which contrary to the current eAFs can be compliant to PDF/A, are also rolled out in the veterinary domain.
For further information on the use of PDF/A, please see the following documents published on this page:
General FAQ relating to PDF/A (December 2021)
Statement of intent on the stepwise implementation of VICH GL53 on Electronic exchange of documents: electronic file format
15-06-2023
Planned maintenance of the eSubmission systems on 17 June 2023
Due to planned maintenance, the eSubmission systems (including eAF and PLM Portal eAF) will not be available on Saturday 17 June 2023, between 8:00 and 16:00. For any further information, please contact Service Desk.
21-04-2022
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.
22-12-2021
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.
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 (December 2021) Updated
- Change Control Process Download (07. 2020)
- Veterinary eSubmission Change Request Q&A Form Download (December 2021) Updated
Historical Documents
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. |
