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 - Scientific guideline

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.

Keywords: Honey, 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

Current effective version

VICH GL56 on 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 -...

Adopted Reference Number: EMA/CVMP/VICH/176637/2014 Legal effective date: 01/06/2019

Document history

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...

Draft: consultation closed Consultation dates: 24/02/2017 to 31/07/2017 Reference Number: EMA/CVMP/VICH/176637/2014 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.