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.
A new version of eSubmission XML Delivery File UI is now available, extending the use of XML delivery files to Maximum Residue Limits (MRL) and veterinary Periodic Safety Update Report (PSUR) submissions. Guidance on the new functionalities is included in the updated User guide to XML delivery file creation.
In anticipation of mandatory use of eSubmission Gateway/Web Client for veterinary procedural submissions to EMA, a follow-up Q&A Session for Industry – Mandatory Use of eSubmission Gateway will be held on 12 January 2017, from 13:00 to 15:00 UK time. Applicants are invited to raise any questions they may still have transitioning to the mandatory use.
To register or send a query, please contact eAFwebinaremail@example.com. Please use REGISTRATION or QUERY in your message title as applicable.
A statement of intent on an extension of Common Repository to all veterinary submissions
in the centralised procedure has been published.
The use of XML delivery files for all Veterinary submissions will become mandatory on 1 April 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.
As of 1 January 2017 it will be mandatory for applicants to make all veterinary procedural submission to EMA via the eSubmission Gateway/Web Client portal. In preparation, a training Webinar for Industry – Mandatory Use of eSub Gateway for veterinary submissions to EMA will be held on 1 December 2016 from 12:00 to 14:00 UK time.
This webinar will cover a wide range of topics from Gateway registration through submission process for all veterinary submission types (vet CAP submissions, ASMFs, MRLs, vet PSURs and referrals). The training material will then be published on the eSubmissions website.
To register or send a query, please contact eAFwebinarfirstname.lastname@example.org . Please use REGISTRATION or QUERY in your message title as applicable.
A revised Change control process document is now available in section EU Change control process below. It is accompanied by a recommended template for submissions of change requests or questions relating to the VNeeS guidance, validation criteria or tools.
An updated version of the eSubmission Gateway user interface to create XML delivery files for submissions via the eSubmission Gateway and the Web Client is now available. This new version will distinguish between the ‘submission types’ (initial marketing authorisation, renewal, variation type II etc.) and the ‘submission unit types’ (initial submission, validation response, response etc.) and further clarify some submission types such as post-authorisation measures, resulting in an extended and more logical functionality. The change for veterinary submissions takes place in parallel to a similar change on the human side. Please check the section “EMA eSubmission Gateway/ Web Client for Veterinary Procedures” below for an updated user guide to XML delivery file creation.
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.
- An eSubmission Gateway user interface to create XML delivery files for submissions via the eSubmission Gateway and the Web Client is now available. The use of the delivery files is initially introduced as a pilot, covering the majority of submission types for both human and veterinary domains. Use of delivery files will become mandatory for Human Centralised Procedure submissions in line with the mandatory use of the updated eCTD EU M1 in October 2016. Use of the filenaming conventions will be phased out after a transitional period for all other procedure types.
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
EU Change Control Process
- 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