Description

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.

Resources

Name	Format	Description	Link
Reporting adverse reactions to marketed health products - Guidance document for industry	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/reporting-adverse-reactions-marketed-health-products-guidance-industry/guidance-document.html
Reporting adverse reactions to marketed health products - Guidance document for industry	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/rapports-publications/medeffet-canada/declaration-effets-indesirables-produits-sante-commercialises-orientation-industrie/document-dorientation.html

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