Use of heat treatment to inactivate endogenous retroviruses in live immunological veterinary medicinal products - Scientific guideline

This document outlines the data requirements to be submitted by the marketing authorisation holder to introduce a heat treatment to inactivate endogenous retroviruses in the active substance for the production of live viral for immunological veterinary medicinal products (IVMPs) and to show the absence of negative impact of this treatment on the IVMP.

Keywords: Endogenous retrovirus, immunological veterinary medicinal product (IVMP), heat treatment

Current effective version

Reflection paper on the use of heat treatment to inactivate endogenous retroviruses in live immunological veterinary medicinal products

Adopted Reference Number: EMA/CVMP/IWP/37924/2014

Document history

Overview of comments received on 'Reflection paper on the use of heat treatment to inactivate retrovirus RD114 in live immunological veterinary medicinal products’ (EMA/CVMP/IWP/37924/2014)

Reference Number: EMA/CVMP/IWP/254504/2015

Reflection paper on the use of heat treatment to inactivate retrovirus RD114 in live immunological veterinary medicinal products (IVMPs)

Draft: consultation closed Consultation dates: 19/12/2014 to 31/03/2015 Reference Number: EMA/CVMP/IWP/37924/2014 Summary:

This guideline outlines the data requirements to be submitted by the marketing authorisation holder (MAH) to introduce a heat treatment to inactivate retroviruses in the active substance for the production of live viral vaccines for immunological veterinary medicinal products (IVMP) and to show the absence of negative impact of this treatment on the IVMP.