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10 July 2019
On 23 May 2018 Health Canada published its Overview of the Reporting Adverse Reactions to Marketed Health Products – Guidance Document for Industry:
This guidance document provides market authorization holders (MAHs) with assistance on how to comply with the Food and Drugs Act, the Food and Drug Regulations and the Natural Health Products Regulations with respect to reporting adverse reactions (ARs) to marketed health products.
Marketed health products include:
These adverse reactions are to be reported to the Canada vigilance programme of the Marketed Health Products Directorate of Health Canada.
For further information on this topic please contact Brandon Heard at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (firstname.lastname@example.org). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
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