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

This guideline provides advice on data requirements and methodology for assessing the public health risk from antimicrobial resistance in marketing authorisation applications for antimicrobial veterinary medicinal products (VMPs). Its scope extends to VMPs intended for food producing animal species and to the transmission of antimicrobial resistance to humans through the food chain or direct contact with treated animals.

Keywords: antimicrobial resistance (AMR), risk assessment, antimicrobial veterinary medicinal products

Current effective version

Final guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food- producing animal species

Adopted Reference Number: EMA/CVMP/AWP/706442/2013 Legal effective date: 01/08/2025

Overview of comments received on revised draft 'Guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food- producing animal species'

Reference Number: EMA/CVMP/AWP/702252/2018

Document history

Second draft guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animals

Draft: consultation closed Consultation dates: 27/07/2018 to 31/10/2018 Reference Number: EMA/CVMP/AWP/706442/2013

Overview of comments received on draft 'Guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animals' (E...

Reference Number: EMA/CVMP/AWP/598285/2015

Draft guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animals

Draft: consultation closed Consultation dates: 04/03/2015 to 31/08/2015 Reference Number: EMA/CVMP/AWP/706442/2013 Summary:

This guideline provides advice in regards to applications for marketing aAuthorisations for antimicrobial veterinary medicinal products on the data required and the methodology to be used for performing an assessment of the risk to public health from antimicrobial resistance due to use of the product.

Concept paper for a guideline on antimicrobial-resistance risk assessment

Draft: consultation closed Consultation dates: 18/01/2013 to 30/04/2013 Reference Number: EMA/CVMP/680258/2012 Summary:

The Committee for Medicinal Products for Veterinary Use (CVMP) intends to draft a guideline on antimicrobial-resistance risk assessment to be applied for all classes of antimicrobial agents. The guideline would apply to all new applications for marketing authorisations including extensions and some variations (where changed doses or new indications are claimed).