Natural health products (nhp’s) are a subset of drugs in Canada requiring a pre-market licence, which means they carry health claims, cautions and directions for use. These include vitamins, minerals, amino acids, enzymes, probiotics, fatty acids and more.
In Canada, natural health products (nhp’s) are regulated on a country-wide (federal) level by the government body named Health Canada, and specifically within one of their departments called the Non-Prescription and Natural Health Products Directorate (NNHPD).
Canada has one of the best regulatory frameworks in the world for natural health product licensing. Natural health products are considered a subset of drugs within the Food and Drugs Act. The Natural Health Products Regulations (2003) defined a natural health products as virtually any naturally occurring substance (in animals, humans, plants, etc) within a certain list of broad criteria, and excluding other types of products such as tobacco and biologics. For products that are marketed in other countries as “food supplements”, these are most likely going to be classified as nhp’s in Canada. Usually, products in discrete dosage forms (e.g., capsules or tablets) automatically classify a health product as either a drug or nhp.
There are many ingredients which are further restricted, through other legislation or Health Canada policies. In effect, it makes product launches into Canada daunting to the outsider. Our company is the premiere consulting firm of choice for Canada’s top manufacturers, and we have licensed some of the most complex products on the marketplace.
For products made in Canada, the manufacturing facility has to be GMP compliant (with a site licence) and the product has to achieve a product licence – called a Natural Product Number (NPN). All product licences issued by Health Canada are made public through the database called the Licensed Natural Health Products Database (LNHPD). In order to achieve an NPN, documentation must be presented to Health Canada proving efficacy, safety and quality, mostly with peer-reviewed journal articles on the various medicinal ingredients in the product. There are no government application fees at this time. The timeframe for NPN issuance is between 10 days and 6 months depending on product complexity. Legally, an nhp must achieve an NPN before being sold in the Canadian market.
NHP Consulting has submitted over 40,000 NPN applications on behalf of manufacturers, distributors and retailers of natural health products. Contact us to find out why we are Canada’s leading consulting firm for the licensing of natural health products.