Reporting adverse reactions to marketed health products - Guidance document for industry (French, HTML)

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Publisher-reported update

2024-04-04

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, but excluding blood and blood components and cells, tissues and organs.

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