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
English (EN) (342.38 KB - PDF)
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
English (EN) (342.38 KB - PDF)
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)
English (EN) (158.58 KB - PDF)
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
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.
English (EN) (341.91 KB - PDF)
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
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.
English (EN) (176.31 KB - PDF)
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...
Overview of comments
English (EN) (229.37 KB - PDF)
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
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.
English (EN) (213.71 KB - PDF)