Methods found suitable within the European Union for demonstrating freedom from extraneous agents of the seeds used for the production of immunological veterinary medicinal products - Scientific guideline
This document provides guidance on the cells and methods to be used for the detection of extraneous agents of the veterinary immunological medicinal products and biological origin materials used in their production.
Keywords: Extraneous agents, immunological veterinary medicinal product, cells, methods
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Reflection paper on methods found suitable within the EU for demonstrating freedom from extraneous agents of the seeds used for the production of immunological veterinary medicinal products (PDF/342.38 KB)
Adopted
First published: 17/09/2021
Legal effective date: 09/03/2022
EMA/CVMP/IWP/251741/2015 Rev. 1 -
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Overview of comments received on 'Reflection paper on methods found suitable within the EU for demonstrating freedom from extraneous agents of the seeds used for the production of immunological veterinary medicinal products' (Revision 1) (PDF/158.58 KB)
First published: 17/09/2021
EMA/CVMP/IWP/408557/2021 -
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Draft reflection paper on methods found suitable within the EU for demonstrating freedom from extraneous agents of the seeds used for the production of immunological veterinary medicinal products (PDF/341.91 KB)
Draft: consultation closed
First published: 25/05/2021
Consultation dates: 21/05/2021 to 23/07/2021
EMA/CVMP/IWP/251741/2015 Rev. 1
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CVMP reflection paper on methods found suitable within the European Union for demonstrating freedom from extraneous agents of the seeds used for the production of immunological veterinary medicinal products (PDF/176.31 KB)
Adopted
First published: 19/12/2016
Last updated: 19/12/2016
EMA/CVMP/IWP/251741/2015 -
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Overview of comments received on 'CVMP reflection paper on methods found suitable within the European Union for demonstrating freedom from extraneous agents of the seeds used for the production of immunological veterinar... (PDF/229.37 KB)
First published: 19/12/2016
Last updated: 19/12/2016
EMA/CVMP/IWP/65876/2016 -
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Draft CVMP reflection paper on methods found suitable within the EU for demonstrating freedom from extraneous agents of the seeds used for the production of immunological veterinary medicinal products (PDF/213.71 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/251741/2015