VICH GL27 Guidance on the pre-approval information for registration of new veterinary medicinal products for food-producing animals with respect to antimicrobial resistance - Scientific guideline

This document provides harmonized technical guidance in the E.U., Japan and the U.S. for registration of antimicrobial veterinary medicinal products intended for use in food-producing animals. It applies to characterization of the potential for a given antimicrobial agent to select for resistant bacteria of human health concern.

Keywords: Registration of new veterinary medicinal products, food producing animals, antimicrobial resistance

Current effective version

VICH GL27: Guidance on the pre-approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance - Step 7

Adopted Reference Number: CVMP/VICH/644/01-FINAL Legal effective date: 15/12/2004