Guidance document on reporting adverse reactions to marketed health products

On 23 May 2018 Health Canada published its 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.

Marketed health products include:

• pharmaceutical drugs;
• biologics;
• radiopharmaceutical drugs; and
• natural health products.

These adverse reactions are to be reported to the Canada vigilance programme of the Marketed Health Products Directorate of Health Canada.

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