Assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in non-food-producing animal species - Scientific guideline

This concept paper proposes the development of a guideline to provide advice on data requirements and methodology for assessing the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product (VMP) in non-food-producing animal species to address regulatory requirements laid in Regulation (EU) 2019/6. 

In view of the experience and knowledge with antimicrobials for pets, the intended guideline will be developed with a focus on companion animals, although all non-food-producing animals are in scope.

Keywords: antimicrobial resistance (AMR), risk assessment, antimicrobial veterinary medicinal products, public health, companion animal species, pets, non-food-producing animal species

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Concept paper for the development of a guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in non-food-producing animal species

Draft: consultation closed Consultation dates: 14/11/2025 to 31/05/2026 Reference Number: EMA/CVMP/AWP/109142/2025 Summary:

This concept paper proposes the development of a guideline to provide advice on data requirements and methodology for assessing the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product (VMP) in non-food-producing animal species to address regulatory requirements laid in Regulation (EU) 2019/6. In view of the experience and knowledge with antimicrobials for pets, the intended guideline will be developed with a focus on companion animals, although all non-food-producing animals are in scope.

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