On December 6, 2013, the Government of Canada introduced the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) Amendments to the Food and Drugs Act (Bill C-17). On November 5, 2014 it received Royal Assent.
The Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) introduces amendments to the Food and Drugs Act that will improve Health Canada’s ability to collect post-market safety information, and take appropriate action when a serious risk to health is identified. These amendments will improve better protection of patient health and safety and increase consumer confidence in therapeutic products on the market.
Key amendments to the Food and Drugs Act include:
- Power to require information, tests or studies
- Power to require a label change/package modification
- Power to recall unsafe therapeutic products
- Ability to disclose information in certain circumstances
- Tougher measures for those that do not comply
- Mandatory reporting of serious adverse drug reactions and medical device incidents by healthcare institutions
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