Technical validation of the electronic marketing authorisation (MA) files for medicines for veterinary use

To facilitate the processing of the MA applications of the medicines for veterinary use submitted in electronic format, the Federal Agency for Medicines and Health Products (FAMHP) and the National Agency for Veterinary Medicinal Products (ANMV) in France worked together to develop a technical validation tool, called the "VNeeS Checker” to define the technical quality of the files. It can be downloaded free of charge.

Since 1st January 2010 the national competent authorities (NCA) responsible for the evaluation of applications for marketing authorisation for medicines for veterinary have been applying the eSubmission guideline. Two tools have been developed to facilitate this process: the first is the compressed folder structure and the second a free "checker". To assist applicants in the creation of their electronic dossiers a compressed folder, which is empty but already structured in the format described in version 1.0 - October 2009-Rev.1 of the European guidelines, is available. Following the download and decompression of the archive, the applicant is invited to put the "pdf" files in their proper position.

To facilitate the processing of the MA applications submitted in electronic format, the FAMHP (“Federal Agency for Medicines and Health Products”) and the ANMV (of the ANSES (“Agence Nationale de Sécurité Sanitaire” – France)) worked together to develop a technical validation tool , the "VNeeS Checker”.

This tool can be downloaded free of charge from the website of ANSES and FAMHP. It is made available to applicants and NCA’s in charge of the evaluation of the marketing authorisation dossiers for medicines for veterinary use.

The "VNeeS Checker" is a technical validation tool of the electronic MA dossiers. The tool is straightforward to install and to use, allowing with a few clicks to define the technical quality of a dossier and to produce a report that can be instantly displayed and saved as an HTML file.
It allows both:

National competent authorities responsible for the evaluation of the MA dossiers of medicines for veterinary use to define the technical admissibility of the dossier submitted in electronic format by means of a detailed technical analysis, measuring the quality of the dossier, prior to its evaluation;

Applicants to verify the quality of the electronic format of the MA dossier during its construction phase, but especially before its transmission to authorities.

The "VNeeS Checker" verifies in few seconds the compliance of a MA dossier based on respecting a set of criteria defined in the European guidelines:
• Structure of the folder (directories tree of the VNeeS)
• Naming convention for folders and files
• Maximum size of files in the MA file
• Version of PDF files

The specifications of the "VNeeS Checker" are based on the European guideline implemented in the work carried out by the TIGes VetSub Group, a workgroup specifically set up by the European Commission.The current version of the VNeeS Checker is based on version 1.0 - October 2009 - Rev.1 of the Europeanguideline(C.F. http://esubmission.emea.europa.eu/tiges/vetesub.htm ). 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.

The "VneeSChecker” operates with Windows (XP/Vista/7). For any comments or assistance regarding its use, an email can be sent to the ICT support department of the FAMHP:ict-support@afmps.be .
For more information about the license to use the VNeeS Checker see: License Checker VNeeS.

In Belgium, the electronic format "VNeeS"is notmandatory for veterinary applications. We encourage electronic submissions but can accept all formats.

 

 

 

 

 

 

Last updated on
04/04/2011