Canada regulates natural health products (NHPs) as drugs, rather than foods. This includes products such as supplements, aromatherapy products, hand sanitizers, traditional medicines, and homeopathic products. Because they are regulated in many similar ways to over-the-counter drugs, these products undergo a rigorous review by Health Canada including ingredients, claims, cautions, warnings, dosages, and dosage forms.
If the manufacturer is in Canada, it is the manufacturer that registers the product. If the product is imported, it is the importer who must register the product, and the importer is legally responsible for the products they sell.
NHPs are permitted to make claims that are not permitted for food; Health Canada has determined that any oral liquid that is consumed less than 90 mL per serving may qualify as an NHP. This means that “wellness beverages” cannot be registered as an NHPs and ingredients and claims for such beverages are limited to those for food. Health Canada considers social media sites and websites as extensions of the label, so any claims made there must also meet food regulations.
Health Canada does not currently charge fees for reviewing and registering NHPs, but this is likely to change in the next few years. The proposed fees are significant and could range from $2000 per product to over $20,000 per product. Health Canada is currently triaging applications to push products that are to be made in Canada or sold in Canada within a few months of registration to the front of the review line.
We can help you navigate the application process which is complex and requires a lot of detailed information about the product and the medicinal ingredients used in the product. Contact us to learn more.
Any Canadian manufacturer or importer of natural health products (NHPs) requires a site license issued by Health Canada. Sites are required to have a full written Good Manufacturing Practices (GMP) program that shows the products are made consistently and safely, and are stored safely before being sold to retailers.
We help businesses with both writing and training for GMP programs and site license applications, depending on their needs.
Health Canada does not currently charge an annual fee for a site license, but Health Canada has proposed fees that may start at $11,000 per year, depending on the kind of activity being licensed.
