Data requirements to support in-use stability claims for veterinary vaccines - Scientific guideline

This document outlines the data that should be provided in support of in-use shelf-life claims for veterinary vaccines. It aims to provide a framework which will enable applicants to maintain a consistent approach when generating data in support of allocating an appropriate in-use shelf-life to a veterinary vaccine, based on existing regulatory requirements.

Keywords: In-use shelf-life, in-use stability, potency, microbiological safety

Current effective version

Guideline on data requirements to support in-use stability claims for veterinary vaccines

Adopted Reference Number: EMA/CVMP/IWP/250147/2008 Legal effective date: 01/10/2010

Document history

Guideline on data requirements to support in-use stability claims for veterinary vaccines

Adopted Reference Number: EMA/CVMP/IWP/250147/2008 Legal effective date: 01/10/2010

Overview of comments received on ‘Guideline on data requirements to support in-use stability claims for veterinary vaccines’ (EMEA/CVMP/IWP/250147/2008-CONSULTATION)

Reference Number: EMA/81346/2010

Draft guideline on data requirements to support in-use stability claims for veterinary vaccines

Draft: consultation closed Reference Number: EMEA/CVMP/IWP/250147/2008-CON.

Concept paper on data requirements to support in use stability claims for immunological veterinary medicinal products

Reference Number: EMEA/CVMP/IWP/219089/2006-CON.