Extension of the shelf life for the antigen stocks during the type II variation assessment - Scientific guideline

This document includes the CVMP statement on the sterility testing at the end of the proposed shelf-life for variations affecting the extension of the shelf–life for antigen stocks in immunological veterinary medicinal products.

Keywords: Sterility testing, shelf-life, antigen stock, immunological veterinary medicinal product (IVMP)

Current effective version

Public statement committee for medicinal products for veterinary use meeting of 16-18 May 2006

Reference Number: EMEA/CVMP/168467/2006