VICH GL50 Harmonisation of criteria to waive target animal batch safety testing for inactivated 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 inactivated immunological veterinary medicinal products in regions where it is required.

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

Current effective version

VICH GL50: Harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use - Revision 1

Adopted Reference Number: EMA/CVMP/VICH/582610/2009 Legal effective date: 01/05/2018

Document history - Revision 1

VICH GL50: Harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use - Revision 1

Adopted Reference Number: EMA/CVMP/VICH/582610/2009 Legal effective date: 01/05/2018

VICH GL50 Overview of comments: Harmonization of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use

Reference Number: VICH/12/056

Draft VICH GL50: Harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use

Draft: consultation closed Consultation dates: 26/02/2016 to 01/08/2016 Reference Number: EMA/CVMP/VICH/582610/2009 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.

Document history - First version

VICH GL50: Harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use - First version

Adopted Reference Number: EMA/CVMP/VICH/582610/2009 Summary:

Submission of batch safety test data from target or laboratory animals is a requirement for batch release of immunological veterinary medicinal products (IVMPs) in the regions participating in the VICH.

VICH GL50 Overview of comments: Harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use - First version

Reference Number: VICH GL-50

Draft VICH GL50: Testing harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use - First version

Draft: consultation closed Consultation dates: 08/12/2011 to 12/06/2012 Reference Number: EMA/CVMP/VICH/582610/2009