The Canadian system of pre-market licensing for natural health products (dietary supplements) tends to be surrounded by a cloud of mystery for groups looking to sell their products in Canada. The two types of licenses required before sale are distinct in what they cover, and the licenses may be owned by different parties, which results in further bewilderment for many candidates.
The submission of a product license application to Health Canada will cover the actual product, what is in it and how it is used. Both Canadian and non-Canadian companies may apply for a product license applications for a natural health product and receive a Natural Product Number (NPN).
However for the second type of license, a natural health product site license, only Canadian companies are eligible to apply. The site license process is in place so that Health Canada can ensure that a Canadian company rather than a foreign company oversee and attest to GMP compliance, as required by Part 3 of the Natural Health Product Regulations.
The Canadian applicant will complete the necessary documentation to demonstrate GMP compliance at all facilities involved in their supply chain including the Canadian facility that is importing the products, the non-Canadian facility that manufactures the products, and any additional location involved in packaging and labelling the products. Each location listed on the license is required to provide the Canadian applicant with their GMP evidence for the site license application. There is often multiple buildings listed on a single site license application.
Having a clear understanding of the distinction between the two types of natural health product licenses and who is permitted by Health Canada to apply for them may help reduce the time to market and increase the chance of success during the application stage.