Natural Health Products Regulations

The Natural Health Products Regulations, made by Her Excellency the Governor General in Council on June 5, 2003, aim to regulate the sale and distribution of natural health products (NHPs) in Canada. The regulations apply to NHPs that are used for the diagnosis, treatment, mitigation, or prevention of a disease, disorder, or abnormal physical state in humans, as well as those used to restore or correct organic functions in humans.

The regulations set out definitions for key terms, including "natural health product," "brand name," and "adverse reaction." They also establish requirements for the sale, manufacture, packaging, labeling, and importation of NHPs, including the need for a product license and compliance with specifications.

Product licenses are required to be issued in respect of all NHPs sold in Canada, and applicants must provide detailed information about the product, including its ingredients, recommended conditions of use, and safety and efficacy data. The regulations also set out procedures for refusing to issue or amend a product license and for handling serious adverse reactions.

The regulations incorporate certain provisions from the Food and Drug Regulations, but with some modifications to account for the unique characteristics of NHPs. The regulations do not apply to substances or combinations of substances that are regulated as drugs under the Food and Drug Act.

Overall, the Natural Health Products Regulations aim to provide a framework for ensuring the safety and efficacy of NHPs in Canada while allowing for their use as complementary therapies.