New versions (2.5 and 2.6) of the VNeeS checker are available for the electronic submission of marketing authorisation application files for medicines for veterinary use.
From 1st January 2013 the files submitted in the framework of pre- and post‑authorisation procedures for medicines for veterinary use must be submitted electronically, in accordance with the nationa e-submission guideline .
Since 1st January 2010 the national competent authorities (NCAs) responsible for the evaluation of applications for marketing authorisation for medicines for veterinary use have been applying the eSubmission guideline. Two tools have been developed to facilitate this process.
. File stricture
To help applicants compile their electronic files, , a compressed folder, wich is empty but already structured in the format described in version 2.1 - September 2011 of the European guidelines, is available in zip format.
After downloading and decompressing the archive, the applicant just needs to add the pdf files as requested.
. Checker (free of charge)
The Belgian Federal Agency for Medicines and Health Products (FAMHP) and the French Agence nationale du médicament vétérinaire (ANMV), which is part of the Agence nationale de sécurité sanitaire (ANSES) worked together to develop a technical validation tool: the VNeeS Checker.
This tool can be downloaded free of charge and is made available for the industry and for NCAs responsible for the evaluation of the marketing authorisation files for medicines for veterinary use. The VNeeS Checker is easy to install and to use. With a few clicks, this tool assesses the technical quality of your file and generates a report that can be instantly displayed and saved as an HTML file.
This technical validation tool operates on Windows (XP/Vista/7/10). A light version is available, and can be downloaded on an external device such as a USB flash drive (memory stick).
The checker allows both:
- National competent authorities responsible for the evaluation of the marketing authorisation files for medicines for veterinary use to assess the technical admissibility of the file submitted in electronic format, by means of a detailed technical analysis, measuring the quality of the file, prior to its evaluation;
- marketing authorisation applicants for medicines for veterinary use to verify the quality of the electronic format of the marketing authorisation file during its compiling phase, especially before its transmission to the authorities.
The VNeeS Checker verifies in a few seconds the compliance of a marketing authorisation file, based on respect of a set of criteria defined in the European guideline:
• file structure (VNeeS directory tree);
• naming convention for folders and files;
• maximum size of files in the marketing authorisation file;
• version of the files in PDF-formaat.
The specifications of the VNeeS Checker are based on the European guideline implemented following the work carried out by the Telematics Implementation Group – Veterinary subgroup (TIGes-VetSub), a specific workgroup set up by the European Commission.
Versions of the VNeeS Checker
The current version of the VNeeS Checker is based on version 2.5 (1st July 2017) of the European guideline.
The developments of the VNeeS Checker will be coordinated with the future versions of the European guideline. The updated versions of the checker can also be downloaded free of charge.
On 1st July 2017 the VNeeS Guideline v2.5 and the corresponding technical validation checklist have been published. Both documents came into force in January 2018. Version 2.5 of the checker (VneeS checker v 2.5), of the light installer (Vnees Light checker v 2.5) and of the VNeeS TOC builder is also available on the FAMHP website.
On 1st March 2018 the new VNeeS guideline v2.6 and the corresponding technical validation checklist have been published. This version will come into force on 1st September 2018. Version 2.6 of the checker, of the light installer, of the VNeeS TOC builder and of the VNeeS TOC builder light version is already available on the FAMHP website.
Be aware that version 2.6 of the checker will only come into force on 1st September 2018. Until then, please continue to use version 2.5.
More information about the VNeeS Checker 2.5 user license.