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

Note that this reflection paper is no longer valid

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 

Document history

Reflection paper on off-label use of antimicrobials in veterinary medicine in the European Union - First version - Obsolete

Adopted Reference Number: EMA/CVMP/AWP/237294/2017

Overview of comments received on 'Reflection paper on off-label use of antimicrobials in veterinary medicine in the European Union' (EMA/CVMP/AWP/237294/2017) - First version

Reference Number: EMA/CVMP/AWP/30098/2018

Draft reflection paper on off-label use of antimicrobials in veterinary medicine in the European Union - First version

Draft: consultation closed Consultation dates: 25/07/2017 to 31/01/2018 Reference Number: EMA/CVMP/AWP/237294/2017