On May 23, 2018, Health Canada published Overview of the Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry. “This guidance document provides market authorization holders (MAHs) with assistance on how to comply with the Food and Drugs Act, the Food and Drug Regulations and the Natural Health Products Regulations with respect to reporting adverse reactions (ARs) to marketed health products”, including: pharmaceutical drugs, biologics, radiopharmaceutical drugs and natural health products. These ARs are to be reported to the Canada Vigilance Program of the Marketed Health Products Directorate (MHPD) of Health Canada.
