eSubmission

Electronic submission of files from 01/01/2013
 
From 1st January 2013  the files introduced (pre-and post-authorisation) for veterinary medicinal products should be submitted electronically.
All electronic files introduced from 1st January 2013 must be submitted in accordance with the "e-submission guideline" national.

 

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, wich is empty but already structured  in the format described in version 2.1 - September 2011 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” – Belgium) and the Anses  (“Agence Nationale de Sécurité Sanitaire" – France) worked together to develop a technical validation tool , the “VNeeS Checker 2.3”. 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 martketing authorisation dossiers for medicines for veterinary use.

The “VNeeS Checker 2.3” (release date 11/06/2013) 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. A 'light' version is available, and can be downloaded on an external device.

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 the authorities.

The “VNeeS Checker 2.3” verifies in few seconds the compliance of a MA dossier based on respect of a set of criteria defined in the European guideline:
• Structure of the folder (directory 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 2.3 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 2.3 from 1 October 2015 of the European guideline (cfr. http://esubmission.ema.europa.eu/tiges/vetesub.htm) (link is external).

It includes the following changes :

  • Volumes 5 and 6 for immunological dossiers are taken into account (including verification of associated TOCs working hyperlinks, unreferenced files detection)
  • TOCs with hyperlinks built with the bookmarks pane are also now detected and checked
  • Possibility to choose the location of the report on any writable folder or device (so you could run the VNeeS Checker on a network driver, removable device, including when the dossier is steel on a CD/DVD)
  • Check the presence of external hyperlinks in the TOCs (e.g. websites) and produce an error

The developments of the “VNeeS Checker 2.3” will be coordinated with the future versions of the European guideline. The updated versions of the checker will also be downloaded free of charge. The “VNeeS Checker 2.3” 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 (link sends e-mail).

For more information about the license to use the VNeeS Checker 2.3 see: license VNeeS checker.

Since 01.10.2015 the VNeeS Guideline v2.3 (link is external) adapted with the updated validation checklist and checker (installer checker, light installer checker) and toc builder ( full installer,  light installer)  is come into effect in the EU.

Presentation e-submission workshop 22.03.2013

- e-submission ws deel 1

- e-submission ws deel 2

- e-submission ws deel 3

- e-submission ws deel 4

- e-submission ws deel 5

 On the 1.7.2016 the new VNeeS guideline v2.4, validation checklist and checker come into force. The guideline and validation checklist one finds here (http://esubmission.ema.europa.eu/tiges/vetesub.htm (link is external) and the tools (checker and experimental toc builder) can be found here.

Since 01.07.2017 the VNeeS Guideline v2.5 (link is external) is come into effect in the European Union. The version v 2.5 of the checker can be found here VneeS checker v 2.5 the light installer can be found here Vnees Light checker v 2.5.

 

Last updated on 18/07/2017