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

Guidance Document for Source Establishments - Reporting Adverse Reactions to Human Cells, Tissues and Organs 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 2021-06-01 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetyguidance documentsource establishmentsreporting adverse reactionssafetyhuman cellstissuesorgans Guidance Document for Source Establishments - Reporting Adverse Reactions to Human Cells, Tissues and OrgansHTML 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 OrgansHTML 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

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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