Notice to industry: Clarification of section 4.3 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 regarding the reporting of cases identified from the Canada Vigilance (CV) Adverse Reaction (AR) Online Database by MAHs. In particular, this notice replaces section 4.3 of the Reporting Adverse Reactions to Marketed Health Products – Guidance Document for Industry (2018) and the Notice to Industry (2020).