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 MRLs and withdrawal periods

Current effective version

PDF iconAdopted guideline

Reference numberEMA/CVMP/VICH/176637/2014
Effective from01/06/2019
KeywordsHoney, bees, veterinary medicinal products (VMPs), minor use minor species (MUMS), VICH, maximum residues limits (MRLs), study design, metabolism and residues kinetics, food producing species, withdrawal periods

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 (MRL) 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.


Document history

First version

Current version

PDF iconAdopted guideline


PDF iconDraft guideline

Published: 27/07/2018
In operation: 01/06/2019 - present


Published: 24/02/2017


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