Quality, safety and efficacy of bacteriophages as veterinary medicines - Scientific guideline
Table of contents
This document reflects the need for a guideline on quality, safety and efficacy of bacteriophages as veterinary medicines. While the Annex II of Regulation (EU) 2019/6 lays down some requirements for veterinary medicinal product specifically designed for bacteriophage therapy, there is a need for a more specific guidance applicable to these products.
Keywords: Novel therapies, bacteriophages, phages
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Guideline on quality, safety and efficacy of veterinary 5 medicinal products specifically designed for phage 6 therapy (PDF/533.1 KB)
Draft: consultation closed
First published: 27/01/2023
Consultation dates: 27/01/2023 to 31/05/2023
EMA/CVMP/NTWP/32862/2022 -
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Concept paper on quality, safety and efficacy of bacteriophages as veterinary medicines (PDF/204.27 KB)
Draft: consultation closed
First published: 28/01/2022
Consultation dates: 28/01/2022 to 29/04/2022
EMA/CVMP/NTWP/438290/2021