Regulatory Information
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Veterinary International Conference on Harmonization (VICH) Guidance Documents
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VICH Guidances
- 07/01/1999
VICH GL1 - Validation of Analytical Procedures: Definition and Terminology (PDF - 65KB) - 07/01/1999
VICH GL2 - Validation of Analytical Procedures: Methodology: Final Guidance (PDF - 168KB) - 11/21/2007
VICH GL3(R) - Stability Testing Of New Veterinary Drug Substances (PDF - 228KB) - 05/01/1999
VICH GL4 - Stability Testing of New Veterinary Dosage Forms (PDF - 65KB) - 05/01/1999
VICH GL5 -Stability Testing-Photostability Testing of New Veterinary Drug Substances and Medicinal Products (PDF - 76KB) - 03/07/2001
VICH GL6 - EIA's for Veterinary Medicinal Products - Phase I (PDF - 106KB) - 10/11/2001
VICH GL7 - Effectiveness of Anthelmintics: General Recommendations (PDF - 64KB) - 03/01/2000
VICH GL8 - Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products on Stability Testing for Medicated Premixes (PDF - 33KB) - 05/09/2001
VICH GL9 - Good Clinical Practices (PDF - 260KB) - 11/21/2007
VICH GL10(R) - Impurities In New Veterinary Drug Substances (PDF - 176KB) - 11/21/2007
VICH GL11(R) - Impurities in New Veterinary Medicinal Products (PDF - 196KB) - 03/26/2001
VICH GL12 - Efficacy of Anthelmintics: Specific Recommendations for Bovines (PDF - 65KB) - 03/26/2001
VICH GL13 - Efficacy of Anthelmintics: Specific Recommendations for Ovines (PDF - 58KB) - 03/26/2001
VICH GL14 - Efficacy of Anthelmintics: Specific Recommendations for Caprines (PDF - 66KB) - 06/27/2002
VICH GL15 - Specific Recommendations for Equine (PDF - 119KB) - 06/27/2002
VICH GL16 - Specific Recommendations for Porcine (PDF - 118KB) - 03/26/2001
VICH GL17 - Testing of New Biotechnological/Biological Products (PDF - 82KB) - 11/02/2011
VICH GL18 Residual Solvents in New Veterinary Medicinal Products (PDF - 164KB) - 06/27/2002
VICH GL19- Specific Recommendations for Canine (PDF - 130KB) - 06/19/2002
VICH GL20 - Specific Recommendations for Feline (PDF - 128KB) - 06/19/2002
VICH GL21 - Specific Recommendations for Poultry-Gallus Gallus (PDF - 121KB) - 07/27/2006
VICH GL22 -Safety Studies for Veterinary Drug Residues in Human Food: Reproduction Studies (PDF - 74KB) - 07/27/2006
VICH GL23 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (PDF - 73KB) - 05/01/2006
VICH GL24 - Management of Adverse Event Reports (AER's) (PDF - 121KB) - 04/27/2004
VICH GL27 - Pre-Approval for Registration of New VMPs for Food-Producing Animals to Antimicrobial Resistance (PDF - 109KB) - 07/27/2006
VICH GL28 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing, (PDF - 60KB) - 12/12/2001
VICH GL29 - Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs) (PDF - 94KB) - 06/20/2007
VICH GL30 - Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms (PDF - 68KB) - 11/12/2003
VICH GL31 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food Repeat Dose (90 Day) Toxicity Testing (PDF - 166KB) - 07/27/2006
VICH GL32 - Developmental Toxicity Testing (PDF - 52KB) - 03/17/2009
VICH GL33 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Testing (PDF - 102KB) - 09/14/2011
VICH GL35 - Electronic Standards for Transfer of Data (PDF - 306KB) - 06/02/2011
VICH GL36 - Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI (PDF - 293KB) - 07/27/2006
VICH GL37 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing (PDF - 75KB) - 01/09/2006
VICH GL38 - EIA's for Veterinary Medicinal Products, Phase II (PDF - 427KB) - 06/14/2006
VICH GL39 - Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances (PDF - 277KB) - 06/14/2006
VICH GL40 - Test Procedures/Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Product (PDF - 192KB) - 05/01/2006
VICH GL42 - Pharmacovigilance of Veterinary Medicinal Products: Data Elements for Submission of Adverse Event Reports (PDF - 167KB) - 04/24/2009
VICH GL43 - Target Animal Safety for Veterinary Pharmaceutical Products (PDF - 261KB) - 07/21/2009
VICH GL45 - Bracketing and Matrixing Designs For Stability Testing of New Veterinary Drug Substances and Medicinal Products (PDF - 168KB) - 09/15/2011
VICH GL46 - Metabolism Study to Determine the Quantity and Identify the Nature of Residues (PDF - 141KB) - 09/15/2011
VICH GL47 - Comparative Metabolism Studies In Laboratory Animals (PDF - 105KB) - 09/15/2011
VICH GL48 - Marker Residue Depletion Studies to Establish Product Withdrawal Periods (PDF - 190KB) - 09/15/2011
VICH GL49 - Validation of Analytical Methods Used in Residue Depletion Studies (PDF - 244KB) - 04/04/2012
VICH GL51 - Statistical Evaluation of Stability Data (PDF - 97KB)
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