Since the original announcement of cost recovery for Natural Health Products (NHPs), although there has been a significant reduction in the proposed fees for businesses, proposed fees still remain which would still have a major impact on your Canadian business.
There are proposed fees for each product license application and amendment, with Class 3 applications having the highest fees. Each NPN (Natural Product Number) would also be subject to an annual “right-to-sell” fee. In addition, there are proposed fees for site license applications, amendments and renewals, with the cost dependent on activities (manufacturing, labelling, importing).
Health Canada is now suggesting that these fees be phased-in over a 7-year approach, starting in December 2025.
What can you do to reduce the financial burden?
Certain product types such as traditional & homeopathic medicines, capsules, tablets, and tinctures would be considered a non-food format and, depending on the ingredients and claims, would likely need to be licensed as an NHP prior to sale in Canada. Following an initial review of the formula and product claims to confirm alignment with the NHP Regulations, our team would suggest applying for your NPN as soon as possible, to avoid the upcoming application fees. Doing it right the first time will also help avoid fees to amend your license in the future.
Other edible product types such as bars, powdered drink mixes, beverages, and gummies could be considered as food-format and may have another pathway into the Canadian market. The Supplemented Food regulations allow for certain supplemental ingredients such as vitamins, minerals, amino acids and caffeine to be added to certain food-format product types. Our team would suggest reviewing your formulation against these regulations and the relevant upper limits for supplemental ingredients, to see if this pathway could work. Supplemented foods have no pre-market review by Health Canada and therefore no associated application fees for market access.
Other topical product types such as lotions and creams may be considered as cosmetic products, again depending on the ingredients used and claims made on the label. Cosmetic products must be notified to Health Canada prior to sale, but there is low processing time and no application fees associated with this process, presenting a second “work-around” for the proposed NHP cost recovery framework.
Where do you start?
As a business owner, it’s important to understand your options and the relevant timelines and costs associated with marketing health products in Canada for 2025 and beyond. Our team at SNI will often suggest a Classification review to start the process. Our team will review your product format, ingredients and claims, and then outline the potential pathway(s) (such as NHP, Cosmetic, Food) and the impact of choosing one pathway over another.
Reach out to our team today to get a quote to review your product, and for recommendations on best pathway to market!
Contact us at [email protected] for all your industry inquiries.
