The Veterinary Harmonisation Group, an evolution of the former TIGes‑Veterinary Sub Group, is a subgroup of the eSubmission CMB 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 VNeeS Q&A relating to eSubmission for Veterinary Applications has been updated.
General FAQ relating to PDF/A has been published.
15 June 2017
A statement of intent on the stepwise implementation of VICH GL53 on Electronic exchange of documents: electronic file format has been published. and is available here.
1 April 2017
The use of XML delivery file is now mandatory for all veterinary electronic submissions via eSubmission Gateway/WebClient. All veterinary electronic submissions coming to the European Medicines Agency (EMA) should contain a relevant XML delivery file which should be included in the submission package. This eliminates the need to follow specific filenaming conventions when naming submission ZIP packages sent to the EMA.
A dedicated User guide to XML delivery file creation as well as multimedia training is provided below (see section ‘EMA eSubmission Gateway/ Web Client for Veterinary Procedures’).
VNeeS guideline v 2.5 and validation checklist v2.5 have been published and will enter into force in June 2017. With this new version 2.5, rules for technical validation remain unchanged, therefore the current VNeeS Checker v.2.4b (validation tool) will remain valid from June 2017.
The VNeeS format is becoming mandatory for ALL submissions in European procedures (CP, DCP and MRP) as of 1 January 2017, as detailed in the Annex to the eSubmission roadmap.
An upgrade to the VNeeS checker version 2.4.b has been published on the websites of the French competent authority (ANSES-ANMV) and will soon be published on the website of the Belgian competent authority (FAGG-AFMPS) - see links under Current Guidance. The updates are related to the technical implementation, i.e. (i) include a change in dealing with uppercases in the filenames to avoid issues with case insensitive file systems, (ii) leading dots in the paths of the hyperlinks are accepted and (iii) technical details of checking of the hyperlinks in the bookmarks pane is strengthened. These are purely technical improvements which do not change submission requirements for applicants.
Until 30 June 2016, only the VNeeS Guideline version 2.3, validation checklist version 2.3 and checker version 2.3b should be used but applicants are advised to use internally in parallel the version 2.4 of the VNeeS Guideline, validation checklist and checker to familiarise themselves with this new version until it enters into force on 1 July 2016. Any feedback should be sent to email@example.com
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 (06.2017) New
- Change Control Process Download (07. 2016)
- Veterinary eSubmission Change Request Q&A Form Download (07. 2016)
- Terms of Reference (2006)- Download
- E-submission Roadmap (2009)- 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
- Terms of Reference (06. 2012) - Download
- Change Control Process (12.2011) Download