Data requirements for the replacement of established master seeds (MS) already used in authorised immunological veterinary medicinal products (IVMPS) by new master seed of the same origin - Scientific guideline
Table of contents
This document applies to the replacement of a vaccine organism (e.g. virus, bacteria, fungus) master seed by a master seed of the same origin. It applies also to the replacement of the master cell seed used to produce a vaccine organism by a master cell seed of the same origin.
Keywords: Master seeds, immunological veterinary medicinal product (IVMP)
-
List item
Overview of comments received on draft guideline on the requirements for the replacement of established Master Seeds (MS) already used in authorised immunological veterinary medicinal products (PDF/93.23 KB)
First published: 20/07/2009
Last updated: 20/07/2009
EMEA/CVMP/IWP/409485/2009 -
List item
Draft guideline on data requirements for the replacement of established Master Seeds (MS) already used in authorised Immunological Veterinary Medicinal Products (IVMPs) (PDF/61.97 KB)
Draft: consultation closed
First published: 17/03/2008
Last updated: 17/03/2008
EMEA/CVMP/IWP/105504/2007-CON. -
List item
Concept paper on preparation of master seeds to replace established master seeds already used in authorised Immunological Veterinary Medicinal Products (IVMPS) (PDF/48.01 KB)
First published: 20/07/2006
Last updated: 20/07/2006
EMEA/CVMP/IWP/205712/2006-CON.