If you plan to sell a natural health product in Canada, you’ve probably asked what an NPN is and why it’s important. A Natural Product Number (NPN) is an eight-digit identifier issued by Health Canada that confirms a product has been assessed and approved for safety, efficacy, and quality. The NPN is product-specific and must appear on the packaging of a product for sale.
Without an NPN, your product cannot be legally sold in Canada. Even if it’s available internationally, you still need Health Canada’s approval to enter the Canadian market. Without it, you risk enforcement actions, limited distribution opportunities, and a lack of trust from both retailers and consumers.
Keep reading to learn how the NPN process works and why it’s essential for compliance and consumer trust. Want a quick visual overview first? Check out our infographic below.
What is an NPN
An NPN is a licensing number assigned by Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD). It ensures that your product meets strict quality standards and is safe for public use and consumption.
You’ll find the NPN printed on the product label or carton of every authorized natural health product sold in Canada. In this context, NPNs can appear in products like vitamins, minerals, herbs, and other natural health products.
Why businesses need an NPN
Canada has one of the most regulated markets for natural health products in the world. An NPN shows that your product has gone through a proper and extensive review process for safety and efficacy. This helps protect consumers and builds credibility with retailers and distributors.
Selling without an NPN is highly risky and could have major implications. You could face enforcement actions, product recalls, or penalties. If you want to successfully enter the Canadian market, securing an NPN is a must.
What products require the number
If your product is marketed with health claims and contains naturally derived ingredients, you probably need an NPN. This includes:
- Multivitamins and minerals
- Probiotics and enzymes
- Herbals
- Amino acids and essential fatty acids
- Traditional medicines
You can find full details on what qualifies as a natural health product on Health Canada’s official website.
How to get an NPN in Canada
To receive an NPN, you must submit a product licence application to Health Canada. The application may include:
- Product formulation
- Evidence supporting the safety and efficacy of the product
- Proposed health claims and recommended use
- Manufacturing and quality control processes
- Product label information
Depending on your product’s complexity, the review process can range from 60 days to several months. This makes planning ahead critical for a successful launch.
FAQs About NPNs in Canada
Do all natural health products need an NPN in Canada?
Yes. If your product is marketed with health claims and fits the definition of a natural health product, it must have an NPN issued by Health Canada before it can be sold legally.
How long does it take to get an NPN from Health Canada?
It depends on the product and application class. Most submissions take between 60 and 210 days. Delays are common if the application is incomplete or the product is more complex.
What happens if I sell a product without an NPN?
Selling without an NPN is illegal in Canada. You could face enforcement actions such as product seizures, warning letters, or fines. It also damages your credibility with retailers and consumers.
Can I use an FDA or international product approval instead of an NPN?
No. Even if your product is licensed in another country, you still need a Canadian-specific NPN issued by Health Canada to sell it in Canada.
What if my ingredient isn’t listed in the NHPID?
You can submit an NHPID Issue Form with supporting safety and efficacy data to request its addition. Alternatively, for proprietary ingredients, submitting a Master File (MF) may be required.
Need help with your application?
Many companies struggle with delays and rejections because of incomplete applications or missing documentation. Working with a regulatory expert ensures your submission meets all of Health Canada’s requirements and moves through the system faster.
At Quality Smart Solutions, we help businesses navigate every step of the NPN process. Whether you need full application support or advice on specific sections, we’ve got the expertise to guide you through.
Explore our full NPN application services to see how we can support your compliance goals. Ready to move forward? Fill out the form below to book a free consultation with one of our experts, or contact us directly to get in touch.