Health Canada’s Natural Health Product Regulations have been in place for over one decade, and there have been some significant improvements to the application process over the past few years. Notwithstanding some upgrades there remain a handful of items that continue to be problematic for those groups who are new to the regulations for selling natural health products (NHPs) and dietary supplements in Canada.
Here’s our list of top ten things you need to know before submitting your license applications:
- Food vs Drug: In Canada, NHPs (or dietary supplements) are not considered food products. Instead they fall under the Natural Health Product Regulations of the Food and Drugs Act.
- Product Claims: All natural health products must contain at least one health claim. Each claim is reviewed by Health Canada before licensing.
- Claim Support: The product claims will require supporting evidence, even if others in the category have used the identical claims on their products.
- Product Formulation: The full formulation must be provided to Health Canada with product applications. This includes all inactive ingredients such as fillers, flavour ingredients or proprietary blends.
- Two Licenses are Required: Product licenses and site licenses are different but both are required before NHPs are sold in Canada. While product license holders may be Canadian or non-Canadian, the holder of a site license may only be a Canadian facility with a Canadian address.
- Foreign Facilities: Foreign buildings that manufacture or package NHPs must be recognized as compliant with Good Manufacturing Practices (GMP) in order to take part in the supply chain for natural health products whose final destination is Canada.
- Importers: Importers are required to follow GMP, even if they do not manufacture any products. Importers are responsible for overseeing GMP compliance of all participating groups of the supply chain, by way of a quality technical agreement.
- Product Release: Importer must also ensure that product release procedures are performed for each lot of NHP sold in Canada, according to written finished product specifications.
- Qualified Staff: You must have qualified personnel at each facility involved (within and outside of Canada) to ensure proper product release procedures occur for all lots of NHP.
- Lot Number & Expiry Date: Similar to drug products, natural products must be labelled with a lot number and expiry date. The license holder must therefore ensure that sufficient stability data is provided by the manufacturer to support the product’s shelf-life from date of manufacture.