anyone who received, purchased or used the affected product) about the recall, as applicable
If you read this guide and still have questions about your responsibilities, you may contact Health Canada.
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This guide provides information on how to comply with these rules. Introductionĭrug and natural health product companies are required to follow rules related to product recalls. To learn how to conduct recalls for medical devices, see the Medical Devices Recall Guide (GUI-0054). Use these actions when there is no health and safety risk and there is no contravention of the applicable legislation, or the product has not been distributed. This guide does not apply to product withdrawals or stock recovery. The requirements outlined in this guide apply to establishments that work with drugs or natural health products, such as: This guide covers the requirements for drug and natural health product recalls.
Therapeutic product – means a drug or device or any combination of drugs and devices, but does not include a natural health product within the meaning of the Natural Health Products Regulations įor more information about our approach to regulatory compliance and enforcement, including measures we may take to enforce the rules, refer to our Compliance and enforcement policy for health products (POL-0001). If Health Canada believes you are selling a drug that poses a serious or imminent risk to health, Health Canada may order a recall pursuant to paragraph 21.3(1)(a) of the Act.Ģ1.3 (1) If the Minister believes that a therapeutic product presents a serious or imminent risk of injury to health, he or she may order a person who sells the product to
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