Questions and answers on management of extraneous agents in immunological veterinary medicinal products (IVMPs) - Scientific guideline

This document concerns the management of extraneous agents in immunological veterinary medicinal products (IVMPs)

Keywords: Extraneous agents, immunological, veterinary medicinal products, IVMPs

Current effective version

Questions and answers on management of extraneous agents in immunological veterinary medicinal products (IVMPs)

Reference Number: EMA/CVMP/IWP/669993/2019 Summary:

Freedom from extraneous agents (EAs) is a high priority for any medicinal product. For any IVMP placed on the market in the EU, freedom from EAs (bacteria, mycoplasma, fungi and viruses) shall be demonstrated according to the requirements of the European Pharmacopoeia (Ph. Eur.).