Clarification of section 4.3 (Regulatory Authority Sources) of the Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry

Clarification of section 4.3 (Regulatory Authority Sources) of the Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry The intent of this notice is to clarify Health Canada’s expectations with respect to the re-reporting of cases identified from the Canada Vigilance (CV) Online Database by Market Authorization Holders (MAHs). In particular, this clarifies section 4.3 of the May 2018 update to the Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry. 2024-03-30 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyClarification of section-4.3Regulatory Authority SourcesReporting Adverse ReactionsMarketed Health ProductsGuidance-Document for Industry Clarification of section 4.3 (Regulatory Authority Sources) of the Reporting Adverse Reactions to Marketed Health Products - Guidance Document for IndustryHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/reporting-adverse-reactions-marketed-health-products-guidance-industry/notice.html Clarification of section 4.3 (Regulatory Authority Sources) of the Reporting Adverse Reactions to Marketed Health Products - Guidance Document for IndustryHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/rapports-publications/medeffet-canada/declaration-effets-indesirables-produits-sante-commercialises-orientation-industrie/announce.html

The intent of this notice is to clarify Health Canada’s expectations with respect to the re-reporting of cases identified from the Canada Vigilance (CV) Online Database by Market Authorization Holders (MAHs). In particular, this clarifies section 4.3 of the May 2018 update to the Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry.

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