Title f-27 LAWS reference
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CANADA • Title f-27 Laws • Part 21.32
Part 21.32 — Power to require tests, studies, etc.
The Minister has the authority to compel holders of therapeutic product authorizations to conduct tests, studies, or monitor product experience, and to provide the resulting information, to gather additional data on a product's health and safety effects.
What this part covers
- The Minister may order the holder of a therapeutic product authorization to compile information about the therapeutic product.
- The Minister may order the holder of a therapeutic product authorization to conduct tests or studies on the therapeutic product.
- The Minister may order the holder of a therapeutic product authorization to monitor experience in respect of the therapeutic product.
- The holder of a therapeutic product authorization must provide the Minister with the information or the results of the tests, studies, or monitoring.
Sections in Part 21.32
Regulatory Context
This document sits within CANADA Laws and is most useful when linked to operational submission, quality, and inspection workflows.
CANADALaws