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

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HTML

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Publisher-reported update

2024-03-30

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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