Reporting adverse reactions to marketed health products - Guidance document for industry

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, but excluding blood and blood components and cells, tissues and organs. 2024-04-04 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyOverviewguidance-documentreporting adverse reactionsMarketed Health ProductsIndustrymarket authorization holders 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

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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