Bringing a Natural Health Product (NHP) to Canada: Licensing 101 (Part 1 of 3)
Natural Health Products (NHPs) are regulated in Canada under a framework overseen by Health Canada’s Non-prescription and Natural Health Products Directorate (NNHPD). Unlike U.S. dietary supplements, Canadian NHPs are treated as a subset of drugs, which means pre-market approval and ongoing compliance are required.
This article (Part 1 of 3) focuses on licensing activities—what it takes to obtain a product licence (NPN) and the associated site licences. Part 2 will cover costs, and Part 3 will compare the Canadian path to the U.S. FDA approach and discuss strategy.
Key takeaway
To sell an NHP in Canada, a company must obtain an NPN and ensure the manufacturing or importing sites hold valid site licences. Success hinges on five pillars: (1) ingredient eligibility, (2) a fully disclosed formula with appropriate human evidence for safety and efficacy, (3) a risk-based specification and testing plan, (4) fit-for-purpose labeling aligned to Canada’s monographs where possible, and (5) stability data supporting the expiry date—backed by clear post-licensing change control.
Why Canada feels different
Regulatory status: NHPs are regulated as drug-like products, not foods or supplements.
Pre-market control: Products must receive an NPN before sale, and labels must display it.
Disclosure: Proprietary blends aren’t permitted; full formula disclosure (actives and quantities) is required on the label and in the application.
NPN: what Health Canada reviews
1) Ingredient eligibility
Ingredients must be permitted for NHP use. NNHPD maintains an ingredient database.
If an ingredient is not listed, applicants can submit a dossier to support its inclusion (typically human datademonstrating safe use at the proposed dose, plus identity/quality information). Acceptance adds the ingredient to the database, but does not equal product approval.
2) Full formula (no proprietary blends)
The complete quantitative formula must be revealed in the application and on label.
Each active ingredient’s role, dose, and form (e.g., extract ratio/standardization) must be clear.
3) Safety and efficacy evidence
Applicants submit full-text scientific articles (not abstracts) to justify safety, dosage, and claims.
NNHPD evaluates study design quality (randomization, controls, blinding), population, dose form, and relevance to the proposed product.
Expect rounds of clarification: Health Canada may request claim refinements, dosing changes, new warnings, or additional data. Each response window is time-bound (often 30–60 days).
4) Specifications and testing plan
Include finished-product specifications up front: identity, purity, strength/assay, composition, microbiologicallimits, contaminants (e.g., heavy metals, pesticides where relevant), allergens, and packaging integrity.
State methods, units, and pass/fail limits appropriate to the dosage form (capsule, powder, liquid, etc.).
5) Label content and packaging
Submit complete label text for review: health claims, directions for use, contraindications, cautions/warnings, expiry date format, tamper-evident features, lot coding, and bilingual requirements.
Health Canada assesses the net impression of labeling alongside the evidence.
Fast-track vs. bespoke: Class 1, 2, and 3 applications
Health Canada publishes monographs—pre-cleared ingredient and product categories with permitted doses, claims, and risk statements. These define application “classes”:
Class 1: Product fully attests to a single monograph (or combination monographs where allowed). Administrative review predominates; decisions can be relatively quick when aligned.
Class 2: Product partially aligns with monographs (e.g., different non-medicinals, slight variance). Limited scientific review augments the administrative check.
Class 3: Non-monograph or outside monograph limits (novel actives, new doses/claims, or unique combinations). Requires full evidence review and may involve multiple information requests—longer timelines.
Trade-off: Class 1/2 speed comes with less differentiation (similar claims/doses to competitors). Class 3 offers stronger uniqueness but demands more time, evidence, and cost.
Post-licensing obligations
Securing the NPN is the start—not the finish.
Formula changes: Any change to actives, doses, standardizations, dosage form, or route may require notification or a formal amendment. Some changes invalidate the NPN and trigger a new application.
Label updates: Adding claims, altering directions, modifying warnings, or changing origin statements typically require review.
Manufacturer changes: Switching manufacturers, packagers, or testing labs touches the site licence landscape (see below) and may require updates.
Change control discipline: Track, assess, and document changes; classify whether they are notification, amendment, or new application triggers.
Stability data and expiry dating
The expiry date printed on pack must be substantiated with stability data.
Expect a protocol (real-time and/or accelerated) with defined time points (e.g., 0, 3, 6, 9, 12, 18, 24 months) covering assay of actives, micro, organoleptics, and pack integrity under appropriate conditions.
Budgets should reflect full panel testing at each time point; costs scale with number of actives and method complexity.
Out-of-spec events require investigation, potential reformulation/overage strategy, label updates, or shelf-life reduction.
Site licences: manufacturer and importer responsibilities
Beyond the product licence (NPN), Health Canada requires site licences for relevant parties:
Canadian manufacturers/packagers/labs: Must hold a site licence demonstrating GMP: SOPs, quality system, sanitation, training, calibration, recalls, deviations/CAPA, documentation, and validation where appropriate.
Importers: If product is made outside Canada, the importer must hold a site licence and is accountable for ensuring the foreign site(s) meet equivalent GMP. Importers submit evidence packages (SOPs, certifications, audit reports) to support the licence.
Accountability: When issues arise (e.g., test failures, stability gaps), Health Canada looks first to the importerinside Canada for records, testing, and corrective action.
Typical application package at a glance
Forms: Product licence application + attestations (Class 1/2) or full evidence table (Class 3).
Evidence: Full-text human studies, safety summaries, dose rationale, risk statements aligned to monographs or justified otherwise.
Quality: Finished-product specifications (methods, limits), CM/pack/lab details, batch release plan.
Labels: English/French text, claims, warnings, lot/expiry, tamper-evidence, storage, DIN-format formatting where applicable for NHPs.
Stability: Protocol (or existing data) supporting the proposed shelf life.
Sites: Site licence evidence (or commitments) for Canadian manufacturer/packer/lab and/or importer.
Quick FAQ
Can a proprietary blend be used to conceal exact amounts?
No. Canada requires full disclosure of active ingredient quantities on label and in the dossier.
Are animal or in-vitro studies enough for claims?
Not typically. Health Canada prioritizes human data relevant to the product’s dose, form, and population.
How fast is a Class 1 application?
When perfectly aligned to monographs and administratively clean, Class 1 can move significantly faster than Class 3—but timelines depend on Health Canada workload and completeness.
Is U.S. cGMP certification enough for a foreign CM?
Helpful but not sufficient by itself. The Canadian importer must evidence that foreign sites meet NNHPD-recognized GMP and maintain ongoing qualification.
What’s next in this series
Part 2: Costs—licensing, stability, evidence development, site licensing, and ongoing compliance.
Part 3: Canada vs. U.S.—pros/cons, speed vs. differentiation, and route-to-market strategy.
Next steps
1) Book a Regulatory Readiness Consultation
Map the optimal Class (1/2/3) path, evidence needs, spec/test plan, label claims, and site-licence footprint (manufacturer vs. importer). Leave with a prioritized action plan and templates.
2) Enroll in SSET (Signature Supplement Startup Essentials Training)
A practical program covering claim substantiation, specifications, stability planning, label compliance, and supplier/site qualification— it’s made for US but principles/strategy all apply to Canada.
→ Enroll in SSET and pair it up with a consult.
3) Established brands
Already selling in Canada or expanding from the U.S.? Engage a targeted compliance uplift: NPN portfolio review, Class 3 claim assessment, site-licence support for importers, stability remediation, and retailer/Amazon readiness.
If Canadian market entry is on the roadmap, building the NPN, site-licence, and stability foundations early will save time, cost, and rework—and create a defensible platform for scale.