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

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)

Current effective version

Guideline on 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

Adopted Reference Number: EMEA/CVMP/IWP/105504/2007 Legal effective date: 01/02/2010

Document history

Concept paper on the revision of the guideline on data requirements for the replacement of established master seeds (MS) already used in authorised immunological veterinary medicinal products (IVMPs) by new MS of the same origin

Draft: consultation open Consultation dates: 26/06/2026 to 30/09/2026 Reference Number: EMA/CVMP/IWP/385637/2025 Summary:

The proposed guideline will replace the “Guideline on 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“ (EMEA/CVMP/IWP/105504/2007) and the “Reflection paper on the replacement of cell lines used for the production of immunological veterinary medicinal products” (EMA/CVMP/IWP/37620/2014).

Comments should be provided using the template. The completed comments form should be sent to [e-mail]

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

Reference Number: EMEA/CVMP/IWP/409485/2009

Draft guideline on data requirements for the replacement of established Master Seeds (MS) already used in authorised Immunological Veterinary Medicinal Products (IVMPs)

Draft: consultation closed Reference Number: EMEA/CVMP/IWP/105504/2007-CON.

Concept paper on preparation of master seeds to replace established master seeds already used in authorised Immunological Veterinary Medicinal Products (IVMPS)

Reference Number: EMEA/CVMP/IWP/205712/2006-CON.