Requirements for the production and control of immunological veterinary medicinal products - Scientific guideline

This guidance provides information on items to be considered for the production and control of all immunological veterinary medicinal products.

Keywords: Production, control, immunological veterinary medicinal product (IVMP), live, inactivated, mammalian, bacterial vaccines, viral vaccines, avian, bovine, pigs, cats, dogs, ovine, caprine, equine, fish, immunosera and colostrum substitutes, antimicrobial preservatives, complete inactivation

Current version

Guideline on requirements for the production and control of immunological veterinary medicinal products - Revision 2

Adopted Reference Number: EMA/CVMP/IWP/206555/2010-Rev.2 Legal effective date: 16/12/2022

Document history - Revision 2

Guideline on requirements for the production and control of immunological veterinary medicinal products - Revision 2

Adopted Reference Number: EMA/CVMP/IWP/206555/2010-Rev.2 Legal effective date: 16/12/2022

Overview of comments received on 'Guideline on requirements for the production and control of immunological veterinary medicinal products’ (EMA/CVMP/IWP/206555/2010-Rev.2)

Reference Number: EMA/CVMP/IWP/157851/2022

Draft guideline on requirements for the production and control of immunological veterinary medicinal products - Revision 2

Draft: consultation closed Consultation dates: 19/01/2022 to 28/03/2022 Reference Number: EMA/CVMP/IWP/206555/2010-Rev.2

Concept paper for the revision of the guideline on requirements for production and control of immunological veterinary medicinal products - Revision 2

Draft: consultation closed Consultation dates: 25/06/2021 to 30/09/2021 Reference Number: EMA/CVMP/IWP/284316/2021 Summary:

This concept paper addresses the need for revision of the ‘Guideline on production and control of immunological veterinary medicinal products’ (EMA/CVMP/IWP/206555/2010-Rev.1)

Document history - Revision 1

Guideline on requirements for the production and control of immunological veterinary medicinal products - Revision 1

Adopted Reference Number: EMA/CVMP/IWP/206555/2010 Rev. 1 Summary:

This document provides information on items to be considered for the production and control of all immunological veterinary medicinal products (IVMPs). The guideline outlines important items related to the quality, safety and efficacy parts of the marketing authorisation dossier that are not sufficiently defined in the requirements of Annex I of Directive 2001/82/EC and the European Pharmacopoeia (Ph. Eur.). Therefore compliance with this guideline (and the above mentioned regulatory documents) provides an assurance that the IVMP will be considered satisfactory by all the Member States.

Draft guideline on requirements for the production and control of immunological veterinary medicinal products - Rev.1

Draft: consultation closed Consultation dates: 17/07/2015 to 31/01/2016 Reference Number: EMA/CVMP/IWP/206555/2010-Rev.1 Summary:

The guideline was revised to include a new annex (annex 2) entitled “The approach to demonstrate freedom from extraneous agents as part of the production and control of immunological veterinary medicinal products for mammalian species and finfish”, and replace the table of extraneous agents to be tested for in relation to the general and species-specific guidelines on production and control of mammalian veterinary vaccines (7BIm10a).

Overview of comments received on ‘Guideline on requirements for the production and control of IVMPs’ (EMA/CVMP/IWP/206555/2010-Rev.1) including Annex 2 on the approach to demonstrate freedom from extraneous agents

Reference Number: EMA/CVMP/IWP/74071/2016 Summary:

Overview of comments

Document history - First version

Guideline on requirements for the production and control of immunological veterinary medicinal products

Adopted Reference Number: EMA/CVMP/IWP/206555/2010 Summary:

This document provides information on items to be considered for the production and control of all immunological veterinary medicinal products (IVMPs).

Draft guideline on requirements for the production and control of immunological veterinary medicinal products

Draft: consultation closed Consultation dates: 30/03/2011 to 30/09/2011 Reference Number: EMA/CVMP/IWP/206555/2010

Overview of comments received on 'guideline on requirements for the production and control of immunological veterinary medicinal products' - First version

Adopted Reference Number: EMA/CVMP/IWP/913310/2011

Document history - Superseded (relates to Annex 2)

Table of extraneous agents to be tested for in relation to the guideline on requirements for the production and control of immunological veterinary medicinal products

Draft Consultation dates: 15/11/2012 to 31/05/2013 Reference Number: EMA/CVMP/IWP/105112/2011

Table of extraneous agents to be tested for in relation to the general and species-specific guidelines on production and control of mammalian veterinary vaccines

Adopted Reference Number: 7BIm10a Volume 7 Legal effective date: 01/09/1994