Description

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.

Resources

Name	Format	Description	Link
Clarification of section 4.3 (Regulatory Authority Sources) of the 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/notice.html
Clarification of section 4.3 (Regulatory Authority Sources) of the 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/announce.html

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