Off-label use of antimicrobials in veterinary medicine in the European Union - Scientific guideline

The reflection paper, prepared by EMA's Committee for Medicinal Products for Veterinary Use (CVMP) and its Antimicrobial Working Party (AWP), aims to define off-label use and to better understand the underlying reasons for the practice in relation to the use of antimicrobials. However, data on the off-label use of antimicrobials in veterinary medicine in the EU is currently too limited to allow a full assessment of the impact of these prescriptions on the spread of AMR and the associated risks for human and animal health.

Keywords: off-label use, antimicrobials, antimicrobial resistance, veterinary medicines