Quality, safety and efficacy of bacteriophages as veterinary medicines - Scientific guideline
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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