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VICH Consultations

• Consultation on VICH guideline 51: statistical evaluation of stability data (step 4)
• Consultation on revised VICH guideline 36: Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish a microbiological acceptable daily intake (ADI) (step 4)
• Consultation on VICH guideline 35: Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data (step 4)
• Consultation on VICH GL 43: Target Animal Safety for Veterinary Pharmaceutical Products, (Step 4)
• Consultation on VICH GL 30: Pharmacovigilance of veterinary medicinal products: Controlled Lists of Terms, (Step 4)
• Consultation on VICH GL 24 : Pharmacovigilance of veterinary medicinal products: management of Adverse Event Reports (AERs), (Step 4)
• Consultation on VICH GL 42 : Pharmacovigilance of VMPs: Data Elements for Submission of Adverse Event Reports, (Step 4)
• Consultation on VICH GL 3 (R) : Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision), (Step 4)
• Consultation on VICH GL 41 - Target Animal Safety: Examination of Live Veterinary Vaccines in Target Animals for Absence of Reversion to Virulence, (Step 4)
• Consultation on VICH GL 40: Specifications - New Biotechnological/Biological Veterinary Medicinal Products, (Step 4)
• Consultation on VICH GL 39: Specifications - New Veterinary Drug Substances and New Medicinal Products, (Step 4)
• Consultation on VICH GL38 : Environmental Impact Assessment (EIAs) for Veterinary Medicinal Products (VMPs) - Phase II (Step 4)
• Adoption of VICH GL 37: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food - Repeat-Dose Chronic Toxicity Testing
• Adoption of VICH GL 36: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food - General Approach to Establish a Microbiological ADI
• Adoption of GL 28: Studies to Evaluate The Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing
• Consultation on VICH GL 11: Impurities in New Veterinary Medicinal Products (Revision), (Step 4)
• Consultation on VICH GL 10 (R) : Impurities in New Veterinary Drugs Substances (Revision), (Step 4)