Assessment of public health risks related to antimicrobial resistance acquired via the environment, resulting from the use of a veterinary medicinal product - Scientific guideline

This concept paper provides background to the intended development of a scientific approach for use in the evaluation of the risk for humans exposed to antimicrobial resistance via the environment, originating from use of veterinary medicinal products. It is intended to provide advice on how relevant dossier requirements outlined in Regulation (EU) 2019/6 (e.g., Article 8(2)) may be fulfilled.

Keywords: Antimicrobial resistance, environmental risk assessment, food-producing animal species, companion animals, veterinary medicinal product

Current version

Concept paper for the development of a reflection paper on the assessment of public health risks related to antimicrobial resistance acquired via the environment, resulting from the use of a veterinary medicinal product

Draft: consultation openConsultation dates: 16/04/2025 to 31/10/2025Reference Number: EMA/CVMP/ERA/75412/2023Summary:

This concept paper provides background to the intended development of a scientific approach for use in the evaluation of the risk for humans exposed to antimicrobial resistance via the environment, originating from use of veterinary medicinal products. It is intended to provide advice on how relevant dossier requirements outlined in Regulation (EU) 2019/6 (e.g., Article 8(2)) may be fulfilled.

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