Title f-27 LAWS reference
Explore the full hierarchy of this title across chapters, subchapters, and parts.
Select a part from the tree to begin
Browse chapters and parts on the left to load sections
CANADA • Title f-27 Laws • Part 21.8
Part 21.8 — Health care institutions to provide information
Prescribed health care institutions are required to report serious adverse drug reactions or medical device incidents involving therapeutic products to the Minister. This reporting must adhere to specified timelines and procedures, and the definition of 'therapeutic product' for this context excludes natural health products.
What this part covers
- A prescribed health care institution shall provide the Minister with prescribed information.
- The information must pertain to a serious adverse drug reaction involving a therapeutic product.
- The information must pertain to a medical device incident involving a therapeutic product.
- The information must be provided within the prescribed time.
- The information must be provided in the prescribed manner.
- The information must be in the control of the health care institution.
- For the purpose of this subsection, a therapeutic product means a drug or device or any combination thereof.
- For the purpose of this subsection, a therapeutic product does not include a natural health product as defined in the Natural Health Products Regulations.
Sections in Part 21.8
Regulatory Context
This document sits within CANADA Laws and is most useful when linked to operational submission, quality, and inspection workflows.
CANADALaws