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Regulatory Information
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Resources for You
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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 - 279KB)
- 07/01/1999 VICH GL2 - Validation of Analytical Procedures: Methodology: Final Guidance (PDF - 47KB)
- 11/21/2007 VICH GL3(R) - Stability Testing Of New Veterinary Drug Substances (PDF - 224KB)
- 05/01/1999 VICH GL4 - Stability Testing of New Veterinary Dosage Forms (PDF - 8KB)
- 05/01/1999 VICH GL5 -Stability Testing-Photostability Testing of New Veterinary Drug Substances and Medicinal Products (PDF - 36KB)
- 03/07/2001 VICH GL6 - EIA's for Veterinary Medicinal Products - Phase I (PDF - 45KB)
- 10/11/2001 VICH GL7 - Effectiveness of Anthelmintics: General Recommendations (PDF - 29KB)
- 03/01/2000 VICH GL8 - Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products on Stability Testing for Medicated Premixes (PDF - 14KB)
- 05/09/2001 VICH GL9 - Good Clinical Practices (PDF - 64KB)
- 11/21/2007 VICH GL10(R) - Impurities In New Veterinary Drug Substances (PDF - 179KB)
- 11/21/2007 VICH GL11(R) - Impurities in New Veterinary Medicinal Products (PDF - 185KB)
- 03/26/2001 VICH GL12 - Efficacy of Anthelmintics: Specific Recommendations for Bovines (PDF - 30KB)
- 03/26/2001 VICH GL13 - Efficacy of Anthelmintics: Specific Recommendations for Ovines (PDF - 30KB)
- 03/26/2001 VICH GL14 - Efficacy of Anthelmintics: Specific Recommendations for Caprines (PDF - 31KB)
- 06/27/2002 VICH GL15 - Specific Recommendations for Equine (PDF - 187KB)
- 06/27/2002 VICH GL16 - Specific Recommendations for Porcine (PDF - 185KB)
- 03/26/2001 VICH GL17 - Testing of New Biotechnological/Biological Products (PDF - 41KB)
- 05/15/2001 VICH GL18 Residual Solvents in New Veterinary Medicinal Products (PDF - 57KB)
- 06/27/2002 VICH GL19- Specific Recommendations for Canine (PDF - 188KB)
- 06/19/2002 VICH GL20 - Specific Recommendations for Feline (PDF - 186KB)
- 06/19/2002 VICH GL21 - Specific Recommendations for Poultry-Gallus Gallus (PDF - 227KB)
- 07/27/2006 VICH GL22 -Safety Studies for Veterinary Drug Residues in Human Food: Reproduction Studies (PDF - 107KB)
- 07/27/2006 VICH GL23 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (PDF - 86KB)
- 05/01/2006 VICH GL24 - Management of Adverse Event Reports (AER's) (PDF - 261KB)
- 04/27/2004 VICH GL27 - Pre-Approval for Registration of New VMPs for Food-Producing Animals to Antimicrobial Resistance (PDF - 204KB)
- 07/27/2006 VICH GL28 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing, (PDF - 79KB)
- 12/12/2001 VICH GL29 - Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs) (PDF - 83KB)
- 06/20/2007 VICH GL30 - Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms (PDF - 97KB)
- 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 - 250KB)
- 07/27/2006 VICH GL32 - Developmental Toxicity Testing (PDF - 218KB)
- 03/17/2009 VICH GL33 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Testing (PDF - 158KB)
- 08/30/2006 VICH GL36 - Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI (PDF - 177KB)
- 07/27/2006 VICH GL37 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing (PDF - 262KB)
- 01/09/2006 VICH GL38 - EIA's for Veterinary Medicinal Products, Phase II (PDF - 613KB)
- 06/14/2006 VICH GL39 - Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances (PDF - 301KB)
- 06/14/2006 VICH GL40 - Test Procedures/Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Product (PDF - 245KB)
- 05/01/2006 VICH GL42 - Pharmacovigilance of Veterinary Medicinal Products: Data Elements for Submission of Adverse Event Reports (PDF - 241KB)
- 04/24/2009 VICH GL43 - Target Animal Safety for Veterinary Pharmaceutical Products (PDF - 241KB)
- 07/21/2009 VICH GL45 - Bracketing and Matrixing Designs For Stability Testing of New Veterinary Drug Substances and Medicinal Products (PDF - 168KB)
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