VICH GL22 Safety studies for veterinary drug residues in human food: reproduction studies - Scientific guideline
Table of contents
This document aims to ensure international harmonisation of reproduction testing, which is appropriate for the evaluation of risks to reproduction from long-term, low-dose exposures, such as may be encountered from the presence of veterinary drug residues in food. It provides guidance on the core requirement for a multigeneration study for those veterinary medicinal products that leave residues in human food.
Keywords: VICH, consumer safety, reproduction toxicity, residues of veterinary drugs in human food