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Veterinary eSubmission

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General FAQ

Documentation

The TIGes Veterinary subgroup was set up in September 2006 with the objective of developing and implementing standards for the submission of electronic information in the context of European veterinary medicines approval procedures.

Current Guidance

• Guideline on eSubmissions for Veterinary Products - version 2.1 (Effective September 2011)
• VNeeS Checker (Updated September 2011)
  • National Agency for Veterinary Medicinal Products in France (ANMV)
  • Federal Agency for Medicines and Health Products in Belgium (FAGG-AFMPS)
• Templates for folder structure (2011)
  • Agencia Española de Medicamentos y Productos Sanitarios
• eSubmission Validation checklist (February 2011) Download
• Frequently Asked Questions (FAQ)NEW

EU Change Control Process

• Change Control Process (Updated December 2011) Download
• Change Request Tracking table (December 2011) Download

General TIGes Veterinary Documents

• Terms of Reference - Download
• E-submission Roadmap - Download

Historical Documents

• eSubmission guideline Version 1.0 (October 2009) Download
• eSubmission guideline Version 2.0 (February 2011) Download
• Change Control Process (November 2010) Download
• The douments/ presentations from the e-submission workshop held at the European Medicines Agency on May 7 2009 and December 4 2009 can be found here

For further input and/or comments on these FAQs, please contact EMA