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Guidelines
- Impurities: Residual Solvents in new Veterinary Medicinal Products, Active Substances and Excipients (Revision 2)
Revised VICH GL18 (R2) Revised VICH GL18 (R2) (Quality) - April 2023 - For implementation at step 7 in the regions by April 2024 - VICH GL18(R2) - Comments at Step 4
(Quality - Impurities) - Harmonisation of criteria to waive Laboratory Animal Batch Safety Testing for vaccines for veterinary use
VICH GL 59 (Biologicals: LABST veterinary vaccines) - November 2020 - for implementation in the regions at Step 7 by November 2021 - VICH GL59 - Comments at Step 4
(Biologicals - LABST Veterinary Vaccines) - Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV
VICH GL58 (Quality - Stability) - November 2019 - for implementation at step 7 in the regions by November 2020 - 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 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 - VICH GL56 - Comments at Step 4
(MRK - Honey) - 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 - Harmonisation of criteria to waive target animal batch safety testing for live vaccines for veterinary use
VICH GL55 (Biologicals - TABST live vaccines) - May 2017 - for implementation in the regions at Step 7 by May 2018 - Harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use (Revision at Step 9)
VICH GL50 (R) (Biologicals - TABST inactivated vaccines) - May 2017 - for implementation in the regions at Step 7 by May 2018 - 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 - GL 30 - Maintenance Committee Procedure
VICH/16/053-rev1 - GL 30 - Impact of the species and breed vocabulary changes
VICH/16/054 - GL 30 Vocabulary Lists - Version 2 updated October 2016
VICH/16/55-Version 2 - Pharmacovigilance: VICH Step By Step Document (5 November 2014 - version 1.0.2)
VICH GL35 - VICH GL54 - Comments at Step 4
(Safety) - The supplement explanatory document to VICH GL52
VICH GL52 - Bioquivalence: Blood Level Bioequivalence Study
VICH GL52 (Bioequivalence) - October 2015 - Implemented in August 2016 - VICH GL52 - Comments at Step 4
(Bioequivalence) - VICH GL53 - Comments at Step 4
(EFF) - VICH GL51 - Comments at Step 4
(Pharmaceuticals - Quality: Stability Data) - VICH GL50 - Comments at Step 4
(Biologicals: TABST) - Electronic Exchange of Documents: Electronic File Format
VICH GL53 VICH GL53 (EFF) - February 2015 (corrected: September 2015) - Implemented in February 2016 - Decision Trees
VICH GL39 - Statistical evaluation of stability data
VICH GL51 (Phramaceuticals - Quality: Stability Data) - February 2013 - Implemented in February 2014 - Bracketing and matrixing designs for stability testing of new veterinary drug substances and medicinal products
VICH GL45 (Pharmaceuticals - Quality) - April 2010 - Implemented in April 2011 - Test Procedures and Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products
VICH GL40 (Biologicals - Quality) November 2005 - Implemented in November 2006 - Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances + Decision Trees
VICH GL39 (Pharmaceuticals - Quality) November 2005 - Implemented in November 2006 - Testing of residual moisture
VICH GL26 (Biologicals: Moisture) November 2000 - Implemented in May 2003 - Testing of residual formaldehyde
VICH GL25 (Biologicals: Formaldehyde) November 2000 - Implemented in May 2003 - Test for the detection of Mycoplasma contamination
VICH GL34 (Biologicals-Quality) - February 2013 - Implemented in February 2014 - Target Animal Safety for Veterinary Live and Inactivated Vaccines
VICH GL44 (TAS Biologicals) - July 2008 - Implemented in July 2009 - Target Animal Safety - Examination of Live Veterinary Vaccines in Target Animals for Absence of Reversion to Virulence - Annexes
VICH GL41 (TAS Biologicals) July 2007 - Implemented in July 2008 - 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 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 - 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 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 - Pharmacovigilance of Veterinary Medicinal Products - Management of Periodic Summary Update Reports
VICH GL29 (Pharmacovigilance) June 2006 - Implemented in June 2007 - Pharmacovigilance of veterinary medicinal products: management of adverse event reports (AERs)
VICH GL24 (Pharmacovigilance) - October 2007 - Implemented in December 2015 - Pharmacovigilance of Veterinary Medicinal Products: controlled list of terms
VICH GL30 (Pharmacovigilance) June 2010 - Pharmacovigilance of Veterinary Medicinal Products: Data Elements for Submission of Adverse Events Reports (AERs)
Revised VICH GL42 (R1) (Pharmacovigilance: Data Elements) - March 2023 - For implementation at step 7 in the regions by March 2024 - Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data
Revised VICH GL35 (R1) (Pharmacovigilance: ESTD) - March 2023 - For implementation at step 7 in the regions by March 2024 - 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 - Efficacy of Anthelmintics: Specific Recommendations for Poultry
VICH GL21 (Anthelmintics: Poultry) June 2001 - Implemented in July 2002 - Efficacy of Anthelmintics: Specific Recommendations for Feline
VICH GL20 (Anthelmintics: Feline) June 2001 - Implemented in July 2002 - Efficacy of Anthelmintics : Specific Recommendations for Canine
VICH GL19 (Anthelmintics: Canine) June 2001 - Implemented in July 2002 - Stability testing of new biotechnological/biological veterinary medicinal products
VICH GL17 (Quality - Stability: biotechnologicals/biologicals) June 2000 - Implemented in July 2001 - Efficacy of Anthelmintics : Specific Recommendations for Swine
VICH GL16 (Anthelmintics: Swine) June 2001 - Implemented in July 2002 - Efficacy of Anthelmintics : Specific Recommendations for Equine
VICH GL15 (Anthelmintics: Equine) June 2001 - Implemented in July 2002 - Efficacy of Anthelmintics : Specific Recommendations for Caprines
VICH GL14 (Anthelmintics: Caprines) November 1999 - Implemented in June 2001 - Impurities in New Veterinary Medicinal Products (Revision)
VICH GL11(R) (Quality - Impurities Substances) – Implemented in January 2008 - Efficacy of Anthelmintics : Specific Recommendations for Bovines
VICH GL12 (Anthelmintics: Bovines) November 1999 - Implemented in June 2001 - Impurities in New Veterinary Drug Substances (Revision)
VICH GL10(R) (Quality - Impurities Substances) – Implemented in January 2008 - Stability Testing for Medicated Premixes
VICH GL8 (Quality - Stability premixes) November 1999 - Implemented in June 2001 - Environmental Impact Assessment (EIAs) for veterinary medicinal products (VMPs) - Phase 1
VICH GL6 (Ecotoxicity - Phase 1) June 2000 - Implemented in July 2001 - Stability Testing: Photostability Testing of New Drug Substances and Products
VICH GL5 (Quality - Stability) - Implemented in May 2000 - Validation of analytical procedures : Methodology
VICH GL2 (Validation methods) - Implemented in October 1999 - Efficacy of Anthelmintics: General Requirements
VICH GL7 (Anthelmintics General) November 2000 - Implemented in June 2001 - Validation of analytical procedures : Definition and Terminology
VICH GL1 (Validation definitions) - Implemented in October 1999 - Efficacy of Anthelmintics : Specific Recommendations for Ovines
VICH GL13 (Anthelmintics: Ovines) November 1999 - Implemented in June 2001 - Good Clinical Practices
VICH GL9 (GCP) June 2000 - Implemented in July 2001 - Stability Testing: Requirements for New Dosage Forms
VICH GL4 Annex to the VICH guidelines on Stability Testing for New Drugs and Products (Quality - Stability) - Implemented in May 2000 - Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision)
VICH GL3(R) (Quality - Stability) – Implemented in January 2008