A Comment on Canada’s New Natural Health Product Regulations

Published in Journal of Biolaw & Business, vol. 7, no. 3.

Canada’s Natural Health Product Regulations came into force on January 1, 2004. The extent to which these new regulations will alter Canada’s health regulatory and patent law regime remains to be seen. However, as outlined in this article, regulatory pathway, data protection, patent register and pricing review are a few of the issues that may need to be freshly considered by manufacturers seeking to market medicinal products in Canada.

Canada’s framework for the regulation of food and drugs underwent significant change recently, with the introduction, on January 1, 2004, of the Natural Health Product Regulations. These regulations, which were promulgated under Canada’s Food and Drugs Act, introduce to Canadian law the concept of natural health products (NHPs), which have the potential to encompass a wide array of products, including some not typically associated with legislation of this nature.