The procedure to be followed when a batch of a vaccine finished product is suspected to be contaminated with bovine viral diarrhoea virus - Scientific guideline

This document outlines the procedure to be followed by the competent authorities when a batch of a vaccine is suspected to be contaminated with bovine viral diarrhoea virus (BVDV).

Keywords: vaccine, contamination, bovine viral diarrhoea virus

Current version

Guideline on the procedure to be followed when a batch of a vaccine finished product is suspected to be contaminated with bovine viral diarrhoea virus - Revision 2

Adopted Reference Number: EMA/CVMP/IWP/205351/2006 Rev. 2 Legal effective date: 01/04/2026

Document history - Revision 1

Guideline on the procedure to be followed when a batch of a vaccine finished product is suspected to be contaminated with bovine viral diarrhoea virus (Rev.1)

Adopted Reference Number: EMA/CVMP/IWP/205351/2006-Rev.1

Overview of comments received on 'Guideline on the procedure to be followed when a batch of a vaccine finished product is suspected to be contaminated with bovine viral diarrhoea virus’ (EMA/CVMP/IWP/205351/2006-Rev.1)

Reference Number: EMA/CVMP/IWP/342158/2015

Guideline on the procedure to be followed when a batch of a vaccine finished product is suspected to be contaminated with bovine viral diarrhoea virus

Draft: consultation closed Consultation dates: 27/01/2015 to 30/04/2015 Reference Number: EMA/CVMP/IWP/205351/2006-Rev.1 Summary:

The aim of this guideline is to outline the procedure to be followed by the Competent Authorities when a batch of a vaccine is suspected to be contaminated with bovine viral diarrhoea virus (BVDV). Considering the risk of BVDV in bovine serum, the highest risk will be with live and inactivated vaccines indicated for use in pestivirus susceptible species (bovine, porcine, ovine, caprine).

Document history - First version

Guideline on the procedure to be followed when a batch of a vaccine finished product is suspected to be contaminated with Bovine Viral Diarrhoea (BVD) virus

Adopted Reference Number: EMEA/CVMP/IWP/205351/2006 Legal effective date: 01/10/2008

Overview of comments received on draft guideline on the procedure to be followed when a batch is suspectedtobe contaminated with Bovine Viral Diarrhoea (BVD) virus

Reference Number: EMEA/123421/2008

Draft guideline on the procedure to be followed when a batch of a vaccine finished product is suspected to be contaminated with Bovine Viral Diarrhoea (BVD) virus

Draft: consultation closed Reference Number: EMEA/CVMP/IWP/205351/2006-CON.