Guidelines
Safety
Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to establish a microbiological ADI
VICH GL36(R2) (Safety: microbiological ADI) - February 2019 - Released for implementation at Step 7 in the regions by August 2019
Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to establish a microbiological ADI
VICH GL36(R) (Safety) May 2004 - Implemented in June 2013
Pre-approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance
VICH GL27 (Antimicrobial resistance: pre-approval) - Implemented in December 2004
Target Animal Safety for Pharmaceuticals
VICH GL43 (TAS Pharmaceuticals) – July 2008 - Implemented in July 2009
Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD)
VICH GL54 (Safety) November 2016 - For implementation by November 2017
Studies to evaluate the safety of residues of veterinary drugs in human food: Repeat-dose (chronic) toxicity testing
VICH GL37 (Safety: Repeat-dose chronic toxicity) May 2004 - Implemented in May 2005
Studies to evaluate the safety of residues of veterinary drugs in human food: General Approach to Testing
VICH GL33 (Safety: General Approach) - Final Revision 2 at step 9 - Implemented in February 2010
Studies to evaluate the safety of residues of veterinary drugs in human food: Developmental Toxicity Testing
VICH GL32 (Safety: Developmental Toxicity) October 2002 - For implementation in October 2003 (Except EU: later date) - Revision 1 of May 2004
Studies to evaluate the safety of residues of veterinary drugs in human food: Repeat-dose (90 days) Toxicity Testing
VICH GL31 (Safety: Repeat-dose Toxicity) October 2002 - Implemented in October 2003 - Revison 1 of May 2004
Studies to evaluate the safety of residues of veterinary drug in human food: carcinogenicity testing (Revision at Step 9)
VICH GL28 (Safety: Carcinogenicity) October 2004 - Implemented in March 2006
Studies to evaluate the safety of residues of veterinary drugs in human food: Genotoxicity Testing
VICH GL23(R) (Safety: Genotoxicity) October 2014 - Implemented in October 2015.
Studies to evaluate the safety of residues of veterinary drugs in human food: Reproduction Testing
VICH GL22 (Safety: Reproduction) June 2001 - Implemented on 1 August 2002 - Revision 1 of May 2004
Studies to evaluate the Metabolism and Residue Kinetics of veterinary drugs in food-producing species: Marker Residue Depletion studies to establish product withdrawal periods in aquatic species
VICH GL57 (MRK: Residue in Fish) - February 2019 - Released for implementation at Step 7 in the regions by February 2020
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
VICH GL 56 (MRK - Residues in Honey) - June 2018 - Released for implementation at step 7 in the regions by June 2019
Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Validation of analytical methods used in residue depletion studies
VICH GL49(R) (MRK) - January 2015 - Implemented in January 2016
Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Marker residue depletion studies to establish product withdrawal periods
VICH GL48(R) (MRK) - February 2015 - Implemented in January 2016
Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Comparative metabolism studies in laboratory animals
VICH GL47 (MRK) - February 2011 - Implemented in February 2012
Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Metabolism study to determine the quantity and identify the nature of residues
VICH GL46 (MRK) - February 2011 - Implemented in February 2012
Environmental Impact Assessment (EIAs) for Veterinary Medicinal Products (VMPs) - Phase II
VICH GL38 (Ecotoxicity Phase II) October 2004 - Implemented in October 2005
Environmental Impact Assessment (EIAs) for veterinary medicinal products (VMPs) - Phase 1
VICH GL6 (Ecotoxicity - Phase 1) June 2000 - Implemented in July 2001