Health Canada has released a guidance document, "Amendments to the Food and Drugs Act: Guide to New Authorities (power to require and disclose information, power to order a label change and power to order a recall)" (the Guide), to assist with implementing new Food and Drugs Act provisions that came into force under Bill C-17, Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law).
What You Need to Know
- The Vanessa’s Law amendments are intended to assist Health Canada in identifying, preventing and taking action when therapeutic products present a "serious risk" to the public. Specifically, the amendments strengthen Health Canada’s powers in relation to:
- requiring a person to provide information to help determine whether a product presents a risk;
- disclosing confidential business information in Health Canada’s possession, without the consent of the person to whose business the information relates;
- ordering a label or package change; and
- issuing a product recall.
- The Guide defines a set of principles that Health Canada will follow when a situation in which it is appropriate to exercise these powers is identified, and discusses applicable thresholds and considerations, as well as the scope of each particular power. It provides insight into Health Canada’s position on matters like procedural fairness (i.e., what constitutes "sufficient notice" of an intention to issue an order against an affected party), the content of an order and the meaning of "serious risk" of injury.
- Health Canada is soliciting feedback on the Guide until June 8, 2015.
For more information on the applicability of the Guide to your business or to discuss the consultation process, please contact the authors.
To discuss these issues, please contact the author(s).
This publication is a general discussion of certain legal and related developments and should not be relied upon as legal advice. If you require legal advice, we would be pleased to discuss the issues in this publication with you, in the context of your particular circumstances.
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