Health Canada · NHP licensing
Your NPN application, prepared by people who have filed 200+ of them
You cannot legally sell a natural health product in Canada without a Natural Product Number. We prepare and file the whole application. Product licence, evidence package, bilingual label, Site Licence coordination, all handled. You get to plan a real launch date instead of guessing one.
No retainer. We tell you the class and the timeline before you sign anything.
NPN applications worked on
Class I & II first-time approval
Years of NHP regulatory work
What an NPN actually is, and why most first-time founders learn the hard way
Health Canada classifies most supplements, vitamins, probiotics, herbal products, and homeopathics as Natural Health Products. Every NHP sold in Canada needs a Natural Product Number printed on the label. No exceptions. Not for DTC. Not for cross-border shipments from the US. Not for small brands hoping to fly under the radar. If your product reaches a Canadian customer's doorstep without an NPN on the bottle, you are not in compliance.
Most first-time founders find this out the wrong way. They spend six months on a formula, place the first production order, and launch a Shopify store. Then the application sitting in front of them turns out to need ingredient-level safety data, monograph alignment for every claim, a bilingual label that meets the Natural Health Products Regulations, and a Site Licence holder for whoever handles the product in Canada. The paperwork is not impossible. It is just a different job than running a brand.
That is the part we do. We have worked on more than 200 NPN applications through our team and our partner network, and we prepare the dossier so it is complete before Health Canada sees it. Applications that are complete on submission move through the system. Applications that are not get clarification requests, which is where most timelines fall apart.
What we file for you
Six pieces, all prepared and reviewed before submission. You see the package before Health Canada does.
Product Licence Application
Form-fill, ingredient by ingredient. Medicinal ingredients, quantities, claims, recommended use, and cautionary statements drafted to match Health Canada's expectations.
Evidence package
Safety and efficacy data for every medicinal ingredient. We pull from Health Canada monographs where possible and source supplementary evidence where the monograph route does not cover your formula.
Finished product specifications
Identity, purity, potency, and shelf life. Stability data and the testing protocols that back it up, formatted the way reviewers want to see them.
Bilingual label review
English and French label copy that meets the NHP labelling guide. Recommended use, NPN placeholder, dosage, warnings, all checked against the rules so the label does not become the bottleneck.
Site Licence coordination
We line up a Canadian Site Licence holder for importing or packaging if you do not have one. Required for any NHP that touches the Canadian supply chain.
Clarification request handling
If Health Canada writes back asking for more data, we draft the response. It is part of the engagement, not a separate line item.
Class I, II, or III: what your product is decides everything
The class your formula falls into sets the evidence burden and the timeline. We tell you which one on the discovery call, not after we have started.
Monograph submissions
Your medicinal ingredients are listed in a Health Canada compendial monograph and your claims line up with what the monograph allows. Lowest evidence burden, fastest path. Most multi-vitamins, single-ingredient herbals, and standard probiotic blends sit here.
Monographed with variations
Your ingredients are monographed, but you are proposing a non-standard dose, a non-standard combination, or claims that go slightly past what the monograph supports. Health Canada wants the variance justified, so the dossier is bigger.
Outside the monograph system
Novel ingredients, novel combinations, or claims that need a full safety and efficacy review from scratch. Biotech-adjacent products and clinically-positioned formulas land here. Full evidence package, sometimes an expert opinion.
How we run an NPN in five steps
Discovery call
Thirty minutes. You tell us what the product is supposed to do, who it's for, and what claims you want on the bottle. We push back where the evidence doesn't support the claim — better to find that out now than after we've written the dossier.
Week 1Formulation
We build the formula from scratch. Ingredient selection, dose levels, format (capsule, tablet, powder, softgel), and excipients. Every choice gets weighed against the NPN class it will be filed under, so the formula and the application path move together instead of fighting each other later.
Weeks 1–3Literature review
We pull the efficacy and safety evidence for every medicinal ingredient — monograph references for the easy ones, peer-reviewed studies for anything outside the monograph system. If a study doesn't actually support the claim being made, we say so and adjust before filing. This is the step that decides whether Health Canada accepts the application or sends it back.
Weeks 2–4Filing
Submission through the Natural Health Products Online Solution. You get the file reference number and confirmation that the Health Canada clock has started.
Week 4Clarification handling
Health Canada sends questions, we draft responses. We do not charge extra for this. Answering clarifications is part of the work that gets you to issued.
Until approvalWhy brands choose this service
Predictable approval timeline
We hold every submission until the file is complete, then file it. That is why every Class I and Class II NPN we have filed has been approved on first review. The number is not a marketing claim. It is what happens when applications go in fully prepared. Class III novel-ingredient work is a different conversation, and we tell you upfront where your formula sits.
Complete document preparation
You are not handed a checklist and asked to fill in safety data on your own. We pull monograph entries, write the evidence summaries, draft the label in both official languages, and coordinate the Site Licence on your behalf.
Realistic timelines and class triage
If your product is Class II or III, we tell you on the discovery call. Not after we have already started billing. You get an honest read on what your launch date can actually look like.
Brands we have launched in Canada
“We came in with a rough idea for a mushroom supplement and zero experience with Health Canada. LumaNutra got our NPN approved on the first try and had us selling on Shopify in under 3 months. Honestly, the regulatory piece alone would have taken us a year on our own.”
Sarah C.
Vitality Botanics
3 months · Concept to Shelf“I run a wellness brand, not a supply chain. LumaNutra handled the formulation, got our NPN, designed the packaging, and built our Shopify store. I didn't have to manage any of that. We were selling within 12 weeks of our first call.”
Jennifer W.
Pure North Wellness
12 weeks · Time to Market“We needed to launch in both Canada and the US simultaneously. LumaNutra handled the NPN and FDA registration in parallel and designed one label that worked for both markets. That alone saved us months of back and forth with consultants.”
Priya S.
Elevate Naturals
2 markets · Simultaneous LaunchCommon questions
How long does it take to get an NPN approved?
Class I applications (products using pre-approved monograph ingredients and claims) typically clear in 60 to 90 days. Class II and III applications (novel combinations or ingredients outside the monograph system) can run 6 to 12 months or more depending on the evidence package required.
Do I need an NPN to sell supplements online in Canada?
Yes. Every natural health product sold in Canada needs a valid NPN. That includes online sales and products imported from the USA. There are no exceptions for DTC, small brands, or cross-border e-commerce.
What happens if my NPN application is rejected?
Health Canada typically sends a clarification request first, asking for additional safety data, evidence, or specification updates. Outright rejections are rare when the application is structured properly. Every Class I and Class II NPN we have filed has been approved on first review. We work through clarification requests as part of the service at no additional charge.
Can you file an NPN for a product manufactured in the USA?
Yes. The NPN licenses the finished product for sale in Canada, regardless of where it was manufactured. You will also need a Canadian Site Licence holder to handle importing or packaging for the Canadian market. We coordinate both.
Book a 30-minute review of your NPN path
We will look at your formula, name the class you are likely in, and walk you through a realistic timeline. No homework before the call. If your project is not a fit, we will tell you that too.