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Drug Manufacturers

In order to market drugs in Canada, drug manufacturers must submit data to the federal government, which demonstrates the safety and efficacy of the drug. Information submitted to license a drug includes the drug substance, manufacturing process, safety and efficacy for the intended use, detailed protocol and results of in-house studies and field trials, and toxicity and residue data to assign appropriate withdrawal periods. If the information submitted complies with the requirements of the Food and Drugs Act and Regulations, a Notice of Compliance is issued for the manufacturer to sell the product in Canada for use under the conditions specified on the drug label.