On April 22, 2016, Health Canada issued a notice (Notice) describing how it is managing safety updates for therapeutic products when a serious health risk is identified under the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law).

Vanessa’s Law received royal assent in 2014 and amended the Food and Drugs Act, providing the Minister of Health with new powers in the event Health Canada identifies a serious health risk related to a therapeutic product.  According to the Notice, when Health Canada identifies a therapeutic product which poses serious health risk, it issues a request for a label change in the form of an Advisement Letter to the sponsor. Upon receiving an Advisement Letter, the sponsor may either comply with the requested label change or may respond to Health Canada by submitting representations that support why a label change is not necessary. Health Canada will review the representations and decide whether to order a label change under section 21.2 of the Food and Drugs Act. The label change will occur through the process of filing of a supplement to the relevant drug submission(s).

E-TIPS® ISSUE

16 05 04

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