NHP Licensing (Canada) – Secure Your NPN the Right Way

In Canada, dietary supplements don’t exist as a regulatory category. Instead, they fall under Natural Health Products (NHPs) — a unique framework governed by Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD).

Before you can legally sell an NHP in Canada, your product must be licensed and assigned a Natural Product Number (NPN). This is not optional. Without an NPN, your product cannot be marketed, imported, or sold in Canada.

At Blue Ocean Regulatory, we help supplement and functional food brands navigate the NHP licensing process from start to finish. We prepare and submit applications, resolve regulatory questions, and ensure your labels and claims align with Canadian requirements.

Why NHP Licensing Is Different

Unlike the U.S., where dietary supplements can go to market without pre-approval, Canada requires pre-market approval for every NHP. That means:

  • Each formula needs its own NPN application.

  • Health Canada must approve your ingredients, claims, and label before launch.

  • Supporting evidence (monographs, published studies, traditional use references) must be provided for each medicinal ingredient.

This makes the Canadian market both highly regulated and highly trusted — but also challenging for brands not familiar with the system.

What Our NHP Licensing Service Covers

We manage the entire licensing process so you don’t get lost in the paperwork.

1. Formula & Evidence Review

  • Assessment of all medicinal and non-medicinal ingredients.

  • Review against existing NNHPD monographs and ingredient databases.

  • Identification of gaps where additional evidence or reformulation may be required.

  • Alignment of dosage forms and daily limits with Health Canada requirements.

  • Review and compile safety and efficacy studies (when applicable).

2. Application Preparation & Submission

  • Preparation of the NHP application through the Natural and Non-prescription Health Products Online Solution (NNHPD portal).

  • Compilation of evidence packages (scientific studies, pharmacopoeias, traditional references).

  • Drafting of proposed health claims supported by evidence.

  • Submission to Health Canada via their electronic portal.

3. Labeling & Claims Alignment

  • Review and adaptation of labels to Canadian requirements.

  • Ensuring bilingual (English/French) formatting.

  • Mandatory caution and risk statements (e.g., pregnancy warnings, interactions).

  • Alignment of claims with Health Canada’s monographs and approved wording.

4. Regulatory Correspondence & Resolution

  • Responding to Health Canada requests for clarification or additional evidence.

  • Negotiating acceptable claim wording with reviewers.

  • Providing updates on status and timelines.

Challenges Brands Typically Underestimate

The NHP licensing process often takes brands by surprise because it looks deceptively straightforward. Here are the most common blind spots we help fix:

  • Timelines: While some monograph-based products can be approved in weeks, most applications take months or years. Brands often underestimate lead times and miss retailer launch windows.

  • Evidence Gaps: Not all ingredients have NNHPD monographs. For novel or higher-dose ingredients, brands must provide clinical studies or authoritative references — which can delay approval.

  • Dosage & Claim Restrictions: Health Canada imposes strict daily limits and approved claims. A formula that works in the U.S. may need adjustment to be compliant in Canada.

  • Bilingual Labels: Every NHP sold in Canada must have fully bilingual English/French labeling. Many U.S. brands forget this requirement and face costly relabeling.

  • Non-Medicinal Ingredients: Even excipients must be on Health Canada’s approved list. Using an unlisted sweetener, coloring agent, or capsule material can trigger delays.

  • Site Licensing: If you manufacture, package, or label NHPs in Canada, your facility needs a site license. Many brands don’t realize this until late in the process.

  • Post-Licensing Obligations: Brands must maintain records, report adverse events, and update formulations with Health Canada — not just secure the NPN and move on.

Why Brands Work With Blue Ocean Regulatory

We’ve guided brands of all sizes — from startups launching their first Canadian NHP to established companies expanding their portfolios — through the licensing process.

What sets us apart is our ability to anticipate obstacles before they derail your launch. We factor in the client’s supply chain into the application process, the evidence Health Canada expects, and how to adapt U.S. supplements and foods for Canadian compliance without losing brand identity.

Our expertise has been recognized by NutraIngredients USA, we’ve been invited to guest speak at Council for Responsible Nutrition events, and featured on The Nutracast Podcast — trusted by industry leaders to simplify complex regulatory frameworks.

Next Steps

If you plan to sell supplements or functional foods in Canada, don’t wait until the last minute to start the licensing process. Health Canada approval takes time, and retailers will not list your product without a valid NPN.

Book an NHP Licensing Consultation with Blue Ocean Regulatory today. We’ll guide you through the evidence, submission, and labeling process, anticipate challenges, and secure your NPN so you can launch into the Canadian market with confidence.