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Health Canada publishes guidance documents that address reporting of adverse reactions

Authored byBrandon Heard

Health Canada recently published two guidance documents, effective May 23, 2018, that address the reporting of adverse reactions to marketed health products (excluding blood and blood components and cells, tissues and organs). First, Reporting Adverse Reactions to Marketed Health Products provides assistance on reporting adverse reactions to marketed health products including good case management practices. Second, Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products addresses the format and content of annual summary reports (ASRs) and issue-related summary reports (IRSRs), as well as procedures for submission of these reports to Health Canada.