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Human eSubmission

TIGes

Documentation

Projects:

Central Repository

eCTD

eAF

EU Module 1

eSubmission Gateway and eSubmission Web Client

eCTD NMV/RPS

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 2.2 (Updated January 2013, effective July 2013)

• VNeeS Checker (Version 2.2)
  • 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 - version 2.2 (Updated January 2013) Download
• Frequently Asked Questions (FAQ)(Updated January 2013)
• G-TOC recommendations (January 2013)

Useful Links

• Correlation table CTD - NtA structure
• Guidance for e-submissions to EMA

EU Change Control Process

• Change Control Process (Updated December 2011) Download
• Change Request Tracking table (Updated January 2013) Download

General TIGes Veterinary Documents

• Electronic Application Forms – For Variations and Renewals
• Terms of Reference - Download (June 2012)
• E-submission Roadmap - Download (June 2012)

Historical Documents

• Terms of Reference (2006)- Download
• E-submission Roadmap (2009)- Download
• eSubmission guideline Version 1.0 (October 2009) Download
• eSubmission guideline Version 2.0 (February 2011) Download
• Change Control Process (November 2010) Download
• The documents/ presentations from the e-submission workshop held at the European Medicines Agency on May 7, 2009 and December 4, 2009 can be found here
• Guideline on eSubmissions for Veterinary Products - version 2.1 - Download

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