As of January 1, 2004, the natural health products regulations came into force and apply to all natural health products, NHPs. The regulations set out the requirements for the importation of NHPs. Sections A.01.040 to A.01.044 of the food and drug regulations that govern importation are incorporated in the regulations.
In accordance with section 100 of the natural health products regulations, the importation of natural health products, NHPs, that are in violation of the regulations or the Food and Drugs Act are prohibited. These products cannot be sold or imported in Canada.
According to section A.01.044 of the food and drugs regulations, a natural health product that is in violation may be imported if relabelling or modifying of the natural health product would be in conformity with the regulations or the Food and Drugs Act to allow for lawful sale in Canada. Importers using this provision must: a) notify the Health Products Food Branch Inspectorate, HPFBI, of the proposed importation; and b) relabel or modify the natural health product as necessary for lawful sale in Canada within three months after the importation or period of time specified by Health Canada.
Also, according to Health Canada’s importation of human use drugs for personal use enforcement directive, individuals may seek drugs for personal use up to three months.
The Natural Health Products Directorate has consulted with the Department of Foreign Affairs and International Trade, DFAIT, and the World Trade Organization, WTO, on technical barriers to trade with NAFTA. In addressing foreign trade issues, domestic and imported NHPs are treated equally to ensure a level playing field under the regulations with respect to product license, site license and good manufacturing practices, GMPs, requirements.
Provisions in international agreements on importation of unauthorized products are consistent with the respective requirements under the General Agreement on Tariffs and Trade, GATT, and NAFTA.