VICH GL55 Harmonisation of criteria to waive target animal batch safety testing for live vaccines for veterinary use - Scientific guideline

This document provides internationally harmonised recommendations for criteria on data requirements to waive target animal batch safety testing of live veterinary vaccines in regions where it is required.

Keywords: VICH, target animal batch safety, live vaccines, veterinary

Current effective version

VICH GL55: Harmonization of criteria to waive target animal batch safety testing for live vaccines for veterinary use - First version

Adopted Reference Number: EMA/CVMP/VICH/313610/2013 Legal effective date: 01/05/2018

Document history

VICH GL55 Overview of comments: Harmonization of criteria to waive target animal batch safety testing for live vaccines for veterinary use - First version

Reference Number: VICH/12/056

Draft VICH GL55: Harmonisation of criteria to waive target animal batch safety testing for live vaccines for veterinary use

Draft: consultation closed Consultation dates: 26/02/2016 to 01/08/2016 Reference Number: EMA/CVMP/VICH/313610/2013 Summary:

Submission of batch safety test data from target or laboratory animals is a requirement for batch release of veterinary vaccines in most regions participating in the VICH.