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
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VICH GL50: Harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use - Revision 1 (PDF/192.61 KB)
Adopted
First published: 27/06/2017
Last updated: 27/06/2017
Legal effective date: 01/05/2018
EMA/CVMP/VICH/582610/2009 -
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VICH GL50 Overview of comments: Harmonization of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use (PDF/97.55 KB)
First published: 27/06/2017
Last updated: 27/06/2017
VICH/12/056 -
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Draft VICH GL50: Harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use (PDF/195.51 KB)
Draft: consultation closed
First published: 26/02/2016
Last updated: 26/02/2016
Consultation dates: 26/02/2016 to 01/08/2016
EMA/CVMP/VICH/582610/2009
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VICH GL50: Harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use - First version (PDF/142.4 KB)
Adopted
First published: 13/03/2013
Last updated: 13/03/2013
EMA/CVMP/VICH/582610/2009 -
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VICH GL50 Overview of comments: Harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use - First version (PDF/188.12 KB)
First published: 29/05/2015
Last updated: 29/05/2015
VICH GL-50 -
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Draft VICH GL50: Testing harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use - First version (PDF/156.67 KB)
Draft: consultation closed
First published: 20/12/2011
Last updated: 20/12/2011
Consultation dates: 08/12/2011 to 12/06/2012
EMA/CVMP/VICH/582610/2009