International Comparative Guides | 01 April 2019

By Sylvie Rodrigue Ad. E. and Grant Worden

In Canada, the sale of pharmaceuticals and medical devices is regulated by Health Canada under the Food and Drug Act and Regulations and related legislation (Canadian Food Inspection Agency Act, SC 1997 c.6; Consumer Packaging and Labelling Act, RSC 1985, c. C-38; Consumer Packaging and Labelling Regulations, C.R.C., c. 417; Natural Health Products Regulations, SOR/2003-196; Cosmetic Regulations, C.R.C., c. 869; Medical Devices Regulations, SOR/98-282). Product liability is governed by common law principles in all provinces except Québec, where it is governed by civil law, under the Civil Code of Québec, and in certain circumstances the Québec Consumer Protection Act. Product liability claims are typically framed as actions in tort in common law provinces or extra-contractual liability in Québec, though they may also be framed as claims in contract. Typical tort/extra-contractual liability-based claims include negligent design, negligent manufacture, and breach of a duty to warn. Breach of warranty is the most common claim based in contract.

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