North America
Tags: Canada, Life ScienceBy Timothy M. Squire, Fasken Martineau DuMoulin
On June 18, 2016, the Federal Department of Health published a Notice of Intent to amend the Food and Drug Regulations and the Medical Devices Regulations to implement key authorities under Vanessa’s Law (the “Notice of Intent”).
Vanessa’s Law received royal assent on November 6, 2014, and amended the Food and Drugs Act (the “Act”) by substantially increasing Health Canada’s pre and post-market authority over industry stakeholders and radically changing the consequences for violating the Act and its regulations. Vanessa’s Law introduced the most significant amendments to the Act in 50 years, and represents a new chapter in Canadian drug and medical device regulatory enforcement … (read full article in PDF below)
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