Guidance Document for Source Establishments - Reporting Adverse Reactions to Human Cells, Tissues and Organs

Description

This guidance document provides source establishments with assistance on how to comply with adverse reaction reporting obligations under the Food and Drugs Act and the Safety of Human Cells, Tissues and Organs for Transplantation Regulations

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Guidance Document for Source Establishments - Reporting Adverse Reactions to Human Cells, Tissues and Organs HTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/reporting-adverse-reactions-human-cells-tissues-organs.html#toc0
Guidance Document for Source Establishments - Reporting Adverse Reactions to Human Cells, Tissues and Organs HTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/declaration-effets-indesirables-cellules-tissus-organes-humains.html#toc0

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