If you’re considering purchasing a natural health product that you hope will allow you to do business in Canada, there are some key steps to take before committing to this Canadian market. Natural health products (NHP), as defined as “any substance or device, natural or synthetic, including foods and beverages, presented as having preventive or curative properties through promoting wellbeing or managing disease”, comprise a significant part of the healthcare market in Canada and with over 15,000 licensed NHP currently on the market,
What is a Natural Health Product (NHP)?
There are five regulations under Canada’s Natural and Non-prescription Tradeable Health Products regulations that address health claim authorization in Canada. These regulations obligate producers and distributors to prove compliance with claims to the Health Product Regulatory Authority (HPRA) before adding a regulated health claim to any natural health product, such as dietary supplements.
Types of natural health products
A natural health product license is a type of health care protection plan. It allows business owners to sell, manufacture or import natural health products to Canadians. Successful applicants must conduct research, undertake quality control measures, be able to provide evidence of the safety and efficacy of their product’s ingredients, and ensure that consumers know all about the importance of natural health management.
Who can apply for a licence?
Those seeking a natural health product licence in Canada must fulfil certain requirements. As the product category changes, so do the requirements. For example, when natural health products came into the market, it was required that applicants hold a degree in natural science to be eligible for a licence. With new developments in technology and scientific understanding of the world’s herbs and supplements, licensing requirements have shifted towards technical expertise and scientific knowledge instead.
Types of data to submit to get a licence
Before applying for a course, look into course providers. You most likely need a standard health care category license, with an occupational health care category license, or both. There are three ways to obtain a licence. The first is by presenting documentation from your country’s regulatory authority, which includes details of their country-specific training requirements to show that you have met the national competency standard for health care professionals. The other two ways are through the Canadian College of Naturopathy and Integrative Medicine or through the Canadian Society of Yoga Therapy.
How to find your product’s fit with qualifications for an NHP
There are three qualifications your product must meet in order to sell to health care professionals or for sale that requires an NHP site license.
These qualifications are:
(1) the product does not interfere with, harm, or induce to avoid medication;
(2) laboratory says the action is natural and has been used as a food ingredient for at least one year before being submitted as a finished product; and
(3) Health Canada has not assessed the use of the action as per Section 18 as it would be within their criterion.
What are the costs of getting an NHP licence?
The costs of getting a natural health product licence for Canada can be quite large. The initial cost is $460 and includes everything such as the application fee, the fingerprinting and background check, an inspection visit to your facility, and your application taking 1-2 months to process. If you want an expedited review of your application $10,000 would get you 1 day’s processing time at 55 degrees Celsius and 2 stops overall in Montreal and Vancouver.
What types of things should I know about natural health products before applying?
The natural health product license is a notification for the consumption of dietary supplements, cosmetics, natural health products, herbal drugs, and essential oils. Depending on the type of natural health product you are considering you will need to create certain materials for your marketing materials. For instance, if you are thinking about entering the cosmetic market or marketing a natural health supplement, you will need to provide thousands of dollars worth of marketing materials before your application can be assessed by Health Canada.
Is selling or marketing my product allowed without an NHP licence?
The answer to this question has far-reaching implications for the product you’re selling, given that selling certain types of natural health products without an NHP (Natural Health Product) licence in Canada is illegal. The restrictions outlined in the law narrow down what options are available for sellers, including off-label use of your product. If you want to sell your natural health products without licensing, there exist some alternatives to marketing/selling your products under these conditions.