Use of heat treatment to inactivate endogenous retroviruses in live immunological veterinary medicinal products - Scientific guideline
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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
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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) (PDF/118.51 KB)
First published: 17/09/2015
Last updated: 17/09/2015
EMA/CVMP/IWP/254504/2015 -
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Reflection paper on the use of heat treatment to inactivate retrovirus RD114 in live immunological veterinary medicinal products (IVMPs) (PDF/98.72 KB)
Draft: consultation closed
First published: 19/12/2014
Last updated: 19/12/2014
Consultation dates: 19/12/2014 to 31/03/2015
EMA/CVMP/IWP/37924/2014