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

Current effective version

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

Adopted Reference Number: EMA/CVMP/IWP/251741/2015 Rev. 1 Legal effective date: 09/03/2022

Document history - Revision 1 (current)

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

Adopted Reference Number: EMA/CVMP/IWP/251741/2015 Rev. 1 Legal effective date: 09/03/2022

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)

Reference Number: EMA/CVMP/IWP/408557/2021

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

Draft: consultation closed Consultation dates: 21/05/2021 to 23/07/2021 Reference Number: EMA/CVMP/IWP/251741/2015 Rev. 1 Summary:

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.

Document history - First version

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

Adopted Reference Number: EMA/CVMP/IWP/251741/2015 Summary:

According to Directive 2001/82/EC and relevant European Pharmacopoeia (Ph. Eur.) monographs (i.e. 0062, 0030, 5.2.4., 5.2.5.), immunological veterinary medicinal products and materials of biological origin used in their production should be demonstrated to be free from contamination with extraneous agents.

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...

Reference Number: EMA/CVMP/IWP/65876/2016 Summary:

Overview of comments

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

Draft: consultation closed Consultation dates: 17/07/2015 to 31/01/2016 Reference Number: EMA/CVMP/IWP/251741/2015 Summary:

According to Directive 2001/82/EC and relevant European Pharmacopoeia (Ph. Eur.) monographs (i.e. 24 Ph. Eur. 0062, 0030, 5.2.4., 5.2.5.), veterinary immunological medicinal products and biological origin materials used in their production should be demonstrated to be free from contamination with extraneous agents.