EN PL

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

08.01.2015
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.