Health Canada recently published two guidance documents, effective 23 May 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 and issue-related summary reports, as well as procedures for the submission of these reports to Health Canada.
For further information on this topic please contact Brandon Heard at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
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