If you’re preparing to sell natural health products in Canada, understanding the Natural Product Number (NPN) is critical. This number represents regulatory approval from Health Canada and is a legal requirement for marketing natural health products (NHPs) in the country.
Whether you’re launching a vitamin, herbal supplement, or probiotic, the process of this plays a central role in your product’s success. In this article, we break down what the NPN is, why it matters, and how your company can obtain one efficiently.
What Is an NPN?
An NPN, or Natural Product Number, is an eight-digit license number issued by Health Canada. It confirms that a product has been reviewed and authorized for sale based on its safety, efficacy, and quality. Once granted, the NPN must appear on the product’s label.
Displaying an NPN signals that your product meets Canada’s federal regulatory standards. This is especially important to consumers, retailers, and online marketplaces, all of whom rely on the NPN as a sign of compliance and legitimacy.
Which Products Require an NPN?
In this we required for a wide range of natural health products sold in Canada. These include:
- Vitamins and minerals, herbal remedies
- Homeopathic medicines, probiotics and amino acids
- Traditional and culturally based medicines & Other naturally derived products intended to maintain or improve health
If your product falls into any of these categories, it cannot be legally sold, imported, or advertised in Canada without an NPN.
Why the NPN Matters
The NPN is more than just a formality. Without it, your product is not legally authorized for sale. It may be stopped at the border, removed from shelves, or rejected by online platforms and retail partners. More importantly, it serves as proof to consumers that your product has undergone a scientific and regulatory review process.
For brand owners, the NPN also improves market access, establishes credibility with buyers, and protects against legal risks. Securing one should be a priority before any commercial activity begins.
How to Get an NPN
To obtain an NPN, you must submit a product license application to Health Canada. The application includes details on your product’s ingredients, formulation, recommended use, dose, and method of administration. You will also need to submit evidence to support the product’s safety and efficacy this can come from Health Canada monographs, published studies, or clinical data.
The review process also requires proposed label text, marketing claims, and manufacturing site details. Once Health Canada reviews and approves the file, an issued and your product is added to the Licensed Natural Health Products Database.
How Long Does It Take?
Approval timelines vary depending on how closely your product aligns with existing Health Canada monographs.
Products that follow an existing monograph exactly can be submitted as a Class I application, which may be approved in as little as 10 to 30 days. Class II and Class III submissions, which involve more complex evidence or novel claims, typically take between 60 and 180 days.
What If You Don’t Have Clinical Studies?
Many NPNs are approved without new clinical trials. If your product’s ingredients and claims are supported by Health Canada monographs or published literature, a dossier can often be built around that existing evidence. However, if you’re using novel ingredients or making innovative claims, additional safety and efficacy data may be required.
Do You Need a Canadian Presence?
A Canadian mailing address is not required, but international applicants must appoint a Canadian representative or importer to fulfill regulatory obligations and facilitate communication with Health Canada.
Common Pitfalls That Delay Approval
Delays in NPN approval are often caused by incomplete applications, unsubstantiated health claims, or inaccurate ingredient disclosures. Misalignment with regulatory monographs or gaps in evidence are also common issues. Working with a regulatory expert helps you avoid these errors, respond to Health Canada inquiries, and stay on track for timely approval.
Frequently Asked Questions
Is an NPN required for products sold on Amazon Canada?
Yes. Amazon requires all supplements and natural health products listed on its Canadian platform to have a valid NPN.
Can you sell a product while the NPN is pending?
No. Products cannot be legally imported, advertised, or sold in Canada without an issued NPN.
Is the NPN valid indefinitely?
Yes, but you must maintain compliance. Any change to the formulation, claims, or manufacturing process may require re-evaluation.
What’s the difference between an NPN and a DIN?
An NPN applies to natural health products, while a Drug Identification Number (DIN) is required for pharmaceutical drugs and over-the-counter medications.
How Quality Smart Solutions Can Help
Navigating Health Canada’s NPN process requires detailed regulatory knowledge and scientific accuracy. At Quality Smart Solutions, we help businesses move through the process with confidence and speed. Our services include:
- Product eligibility assessment, Application preparation and submission
- Label and claims compliance review, Health Canada communication and response handling
- Ongoing regulatory consulting for formulation and strategy
Whether you’re launching your first product or scaling a portfolio, we simplify the NPN process so you can focus on growth.
Final Thoughts
Its is not just a regulatory checkbox it’s a critical asset for product credibility, legal compliance, and long-term market success. Obtaining one can feel complex, but with the right support, it becomes a strategic advantage.
Contact us today to get expert support on your NPN application, or explore our NHP Licensing Services to get started.
