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

Current version

PDF iconSecond draft guideline

End of consultation: 31/10/2018

Reference numberEMA/CVMP/AWP/706442/2013
Published27/07/2018
Keywordsantimicrobial resistance (AMR), risk assessment, antimicrobial veterinary medicinal products
DescriptionThis 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 species and to the transmission of antimicrobial resistance to humans through the food chain or direct contact with treated animals.


Document history

First version

Current version

PDF iconSecond draft guideline

PDF iconOverview of comments


PDF iconDraft guideline


PDF iconConcept paper

Published: 27/07/2018
End of consultation: 31/10/2018


Published: 27/07/2018

Published: 04/03/2015


Published: 18/01/2013


Related content


How useful was this page?

Add your rating