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Drugs and Health Products
Consultations
Current Consultations
- Consultation - Guidance Document on Classification of Veterinary Drugs and Animals Feeds [2013-02-06]
- Consultation on revised VICH guideline 23: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity testing (step 4) [2013-01-21]
- Consultation on the new Prescription Drug List [2012-12-24]
- Release of Quality Overall Summary - Chemical Entities (QOS-CE) for New Drug Submissions and Abbreviated New Drug Submissions and Certified Product Information Document - Chemical Entities (CPID-CE) (2012-11-01)
Past Consultations
- Consultation on VICH guideline 51: statistical evaluation of stability data (step 4)
- Consultation - Maximum residue limit (MRL) proposal for Amprolium, Bacitracin, Cloxacillin, Dichlorvos, Erythromycin, Gamithromycin, Meloxicam, Novobiocin, Penicillin G, and Toltrazuril
- 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 revised guideline 18: Quality-Impurities: Residual solvents in New Veterinary Medicinal Products, Active Substances and Excipients (step 4)
- Consultation on VICH guideline 46: 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 (step 4).
- Consultation on VICH guideline 47: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Comparative metabolism studies in laboratory animals (step 4)
- Consultation on VICH guideline 48: Studies to evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-producing Animals: Marker Residue Depletion Studies to establish Product Withdrawal Periods (step 4)
- Consultation on VICH guideline 49: Guidelines for the Validation of Analytical Methods used in Residue Depletion Studies (step 4)
- Consultation - Maximum residue limit (MRL) proposal for Amoxicillin, Neomycin, Ormetoprim, Tetracycline, Chlortetracycline, Oxytetracycline, Tilmicosin, Tricaine Methanesulfonate, Tulathromycin and Zoalene
- Food and Drug Regulations - Project Number 1621 - Schedule F Amendment
- Consultation - Maximum residue limit (MRL) proposal for Albendazole, Fenbendazole, Flunixin, Zilpaterol, Doramectin, Emamectin, Ivermectin, Moxidectin, Streptomycin, Dihydrostreptomycin and Gentamicin sulphate
