Replacement of cell lines used for the production of immunological veterinary medicinal products (IVMPs) - Scientific guideline

This document outlines the data requirements to be submitted by the marketing authorisation holder to replace the cell line as host system for production of immunological veterinary medicinal products without significant changes to the production process or finished product specifications.

Keywords: Cell line replacement, immunological veterinary medicinal product (IVMP), cell line, data requirements

Current effective version

Reflection paper on the replacement of cell lines used for the production of immunological veterinary medicinal products

Adopted Reference Number: EMA/CVMP/IWP/37620/2014

Document history

Overview of comments received on 'Reflection paper on the replacement of cell lines used for the production of immunological veterinary medicinal products’ (EMA/CVMP/IWP/37620/2014)

Reference Number: EMA/CVMP/IWP/254498/2015

Reflection paper on the replacement of cell lines used for the production of immunological veterinary medicinal products (IVMPs)

Draft: consultation closed Consultation dates: 19/12/2014 to 31/03/2015 Reference Number: EMA/CVMP/IWP/37620/2014 Summary:

This reflection paper outlines the data requirements to be submitted by the marketing authorisation holder (MAH) to replace the cell line as host system for production of immunological veterinary medicinal products (IVMPs) without significant changes to the production process and maintaining finished product specifications.