If you want to sell vitamins, herbal products, probiotics, or any natural health product in Canada, you need a Natural Product Number (NPN) — a licence issued by Health Canada under the Natural Health Products Regulations. Without it, you cannot legally market your product in Canada, regardless of where it was manufactured.

Getting that licence, however, is where many companies run into difficulty. Health Canada’s review process is thorough, and submissions that arrive incomplete or poorly prepared can face months of deficiency cycles — or outright refusal.

At Arora 297 Consultancy, we’ve helped companies secure over 1,000 NHP product licences over 20+ years. This guide walks you through the process, the evidence requirements, and the most common mistakes we see — so you can avoid them.

What Is an NHP Product Licence?

An NHP Product Licence (also called a Product Licence Application or PLA) is the authorization Health Canada issues to allow a natural health product to be sold in Canada. The licence is tied to a specific product formulation, dosage, and label — any changes may require a new application or amendment.

Products requiring a licence include vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines, probiotics, omega-3 and other fatty acids, and sports nutrition products, among others.

The 5 Steps to Getting an NPN in Canada

Step 1 — Determine your product category

Health Canada classifies NHPs by their medicinal ingredients and intended use. The category determines what type of evidence you need — compendial references, traditional use references, or clinical evidence. Getting this wrong is the most common reason for refusal.

Step 2 — Build your evidence package

Your evidence must support every claim on your label — the medicinal ingredient, the dose, the route of administration, and the recommended use. Health Canada cross-references your evidence against its accepted monographs and compendiums. Gaps in evidence are the leading cause of deficiency notices.

Step 3 — Prepare your bilingual label

All NHP labels must comply with the Natural Health Products Regulations labeling requirements in both English and French. Required elements include the product name, NPN number (once issued), medicinal ingredients with quantities, non-medicinal ingredients, recommended use, dose, cautions, and manufacturer information. Label issues are the second most common reason for deficiency notices.

Step 4 — Submit your Product Licence Application

Applications are submitted electronically through Health Canada’s Natural Health Products Online System (NHPOLS). Health Canada has 60 days to review Class I and II applications and 210 days for Class III. However, these timelines only begin once Health Canada accepts the submission as complete — an incomplete application is rejected before the clock even starts.

Step 5 — Respond to deficiency notices

If Health Canada identifies gaps in your evidence or labeling, they issue a deficiency notice. You typically have 75 days to respond. Each deficiency cycle adds months to your timeline — which is why submitting a complete, well-prepared application from the start is so important.

The Most Common Reasons NHP Applications Are Refused

• Evidence doesn’t match the product category or intended use
• Recommended dose isn’t supported by cited references
• French label is non-compliant or missing required elements
• Non-medicinal ingredients not accepted by Health Canada
• Site licence not in place before submission
• Product misclassified as NHP when it should be a drug

Do You Also Need a Site Licence?

If you manufacture, package, label, or import NHPs in Canada, you also need a Site Licence from Health Canada. The site licence requires demonstrated GMP (Good Manufacturing Practice) compliance. It must be in place before you can sell your product — not just before you apply. Many companies overlook this and face delays as a result.

How Long Does the NHP Licence Process Take?

With a complete, well-prepared submission, Class I and II applications take approximately 60–90 days. Class III applications can take 6–12 months. Deficiency cycles add 3–6 months per round, which is why preparation matters enormously.

Our first-submission approach means most of our clients receive their NPN within the standard review window — without the back-and-forth that can add a year or more to the process.

How Arora 297 Can Help

We’ve filed over 1,000 NHP product licence applications for companies across Canada and the United States. Our 98% audit success rate reflects a simple philosophy: we submit when we’re confident, not just when we’re ready.

Every engagement is led by senior regulatory experts who know Health Canada’s framework in detail. We handle product classification, evidence review, site licence applications, bilingual label compliance, and all Health Canada correspondence — so you can focus on your product.

Book a Free NHP Regulatory Assessment

If you’re planning to sell a natural health product in Canada, the best first step is understanding exactly what your product needs. We offer a free 30-minute regulatory assessment — no obligation — to walk you through the pathway, timelines, and what to expect.

Contact us at arora297consultancy.com or call +1-519-498-5957.