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
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Guideline on requirements for the production and control of immunological veterinary medicinal products - Revision 2 (PDF/292.94 KB)
Adopted
First published: 24/06/2022
Legal effective date: 16/12/2022
EMA/CVMP/IWP/206555/2010-Rev.2 -
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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) (PDF/267.22 KB)
First published: 24/06/2022
EMA/CVMP/IWP/157851/2022 -
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Draft guideline on requirements for the production and control of immunological veterinary medicinal products - Revision 2 (PDF/332.71 KB)
Draft: consultation closed
First published: 28/01/2022
Consultation dates: 19/01/2022 to 28/03/2022
EMA/CVMP/IWP/206555/2010-Rev.2 -
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Concept paper for the revision of the guideline on requirements for production and control of immunological veterinary medicinal products - Revision 2 (PDF/152.68 KB)
Draft: consultation closed
First published: 25/06/2021
Consultation dates: 25/06/2021 to 30/09/2021
EMA/CVMP/IWP/284316/2021
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Guideline on requirements for the production and control of immunological veterinary medicinal products - Revision 1 (PDF/210.56 KB)
Adopted
First published: 19/12/2016
Last updated: 19/12/2016
EMA/CVMP/IWP/206555/2010 Rev. 1 -
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Draft guideline on requirements for the production and control of immunological veterinary medicinal products - Rev.1 (PDF/222.5 KB)
Draft: consultation closed
First published: 17/07/2015
Last updated: 17/07/2015
Consultation dates: 17/07/2015 to 31/01/2016
EMA/CVMP/IWP/206555/2010-Rev.1 -
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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 (PDF/165.71 KB)
First published: 19/12/2016
Last updated: 19/12/2016
EMA/CVMP/IWP/74071/2016
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Guideline on requirements for the production and control of immunological veterinary medicinal products (PDF/101.31 KB)
Adopted
First published: 21/06/2012
Last updated: 21/06/2012
EMA/CVMP/IWP/206555/2010 -
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Draft guideline on requirements for the production and control of immunological veterinary medicinal products (PDF/150.58 KB)
Draft: consultation closed
First published: 30/03/2011
Last updated: 30/03/2011
Consultation dates: 30/03/2011 to 30/09/2011
EMA/CVMP/IWP/206555/2010 -
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Overview of comments received on 'guideline on requirements for the production and control of immunological veterinary medicinal products' - First version (PDF/214.54 KB)
Adopted
First published: 21/06/2012
Last updated: 21/06/2012
EMA/CVMP/IWP/913310/2011
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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 (PDF/100.26 KB)
Draft
First published: 19/11/2012
Last updated: 19/11/2012
Consultation dates: 15/11/2012 to 31/05/2013
EMA/CVMP/IWP/105112/2011 -
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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 (PDF/143.63 KB)
Adopted
First published: 01/09/1994
Last updated: 01/09/1994
Legal effective date: 01/09/1994
7BIm10a Volume 7