Title f-27 LAWS reference
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CANADA • Title f-27 Laws • Part 21.3
Part 21.3 — Minister’s powers — risk of injury to health
This section grants the Minister powers to address therapeutic products posing a serious or imminent risk to health, including ordering recalls, product relocation, or corrective actions. It prohibits the sale of products under recall unless specifically authorized by the Minister, and outlines conditions for such authorization and for conviction related to non-compliance.
What this part covers
- The Minister may order a person who sells a therapeutic product to recall it if it presents a serious or imminent risk of injury to health.
- The Minister may order a person who sells a therapeutic product to send it to a specified place if it presents a serious or imminent risk of injury to health.
- The Minister may order a person who sells a therapeutic product to request corrective action from the owner/user and then take that action, if accepted, as an alternative to recall.
- No person shall sell a therapeutic product that the Minister has ordered to be recalled, unless authorized.
- The Minister may authorize a person to sell a therapeutic product, with or without conditions, even if it has been ordered to be recalled.
- A person authorized to sell a recalled therapeutic product must sell it in accordance with any conditions established by the Minister.
- A person cannot be convicted for selling a recalled product unless they were notified of the recall order or reasonable steps were taken to notify affected persons.
Sections in Part 21.3
Regulatory Context
This document sits within CANADA Laws and is most useful when linked to operational submission, quality, and inspection workflows.
CANADALaws