Title f-27 LAWS reference
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CANADA • Title f-27 Laws • Part 21.1
Part 21.1 — Power to require information — serious risk
This section grants the Minister the authority to compel individuals to provide information regarding therapeutic products that may pose a serious risk to human health. It also permits the Minister to disclose confidential business information about such products without consent or notification, both when a serious risk is suspected and when the disclosure serves to protect or promote human health or public safety, particularly to specified governmental or advisory bodies.
What this part covers
- The Minister may order a person to provide information in their control if the Minister believes a therapeutic product may present a serious risk of injury to human health and the information is necessary to determine such risk.
- The Minister may disclose confidential business information about a therapeutic product without notifying the person or obtaining their consent if the Minister believes the product may present a serious risk of injury to human health.
- The Minister may disclose confidential business information about a therapeutic product without notifying the person or obtaining their consent if the purpose of the disclosure is related to the protection or promotion of human health or public safety.
- Disclosure of confidential business information for public health purposes may be made to a government, a person from whom the Minister seeks advice, or a person who carries out functions relating to the protection or promotion of human health or public safety.
- Government is defined to include federal, provincial, aboriginal, foreign state, and international organizations of states, as well as corporations named in Schedule III to the Financial Administration Act.
Sections in Part 21.1
Regulatory Context
This document sits within CANADA Laws and is most useful when linked to operational submission, quality, and inspection workflows.
CANADALaws