Draft VICH GL56 studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: study design recommendations for residue studies in honey for establishing maximum residue limits and withdrawal periods

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Download document Draft VICH GL56 studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: study design recommendations for residue studies in honey for establishing maximum residue limits and withdrawal periods
Reference number EMA/CVMP/VICH/176637/2014
Status draft: consultation open
First published 2017-02-24
Last updated 2017-02-24
Consultation start date 2017-02-24
Consultation end date 2017-07-31
Email address for submissions vet-guidelines@ema.europa.eu

Summary

The objective of this guidance is to provide study design recommendations which will facilitate the universal acceptance of the generated residue depletion data to fulfill the national or regional requirements in order to establish appropriate maximum residue limits (MRLs) or other safe limits in honey following the treatment of honeybees with veterinary medicinal products, or to justify withdrawal periods in honey for registration purposes when an MRL already exists.