Natural Health Products in Canada, Part 2: The (Proposed) Cost Recovery Fees You Must Budget For

[Update Sept 20 2025: Recovery fees are to be pushed back after much industry opposition. No set date as to when they’re back on the table so it doesn’t mean industry is cleared from regulatory costs. Read on to get a sense of Health Canada was originally looking for.]

This is Part 2 of a three-part series on bringing Natural Health Products (NHPs) to Canada. Part 1 covered licensing; Part 2 details costs; Part 3 will compare the Canadian framework to the U.S. (strategy, speed, and risk).

Historically, Health Canada did not charge application fees for NHP product licences (NPNs), site licences(manufacture/import), or annual right-to-sell fees. That is changing. As part of a cost-recovery model, Health Canada has tabled significant fees tied to assessment and ongoing compliance. Brands should plan for these costs now—even if small-business reductions apply initially—because pricing models and margins must remain viable after any temporary relief expires.

Key takeaway

Budget for three fee streams: (1) product licensing (NPN) by class, (2) site licensing for manufacturers/importers, and (3) an annual right-to-sell per SKU. Expect additional fees for amendments. While small-business relief exists, responsible planning prices to the full (unreduced) fee schedule.

The three major fee buckets

1) Product licensing (NPN assessment)

Application fees scale with dossier complexity:

• Class 1 / Class 2 (attesting to monographs or near-monograph alignment): from ~$7,200.

• Class 3 (outside monographs/novel combinations, doses, or claims): up to ~$58,000 for a “novel” application.

Post-licensing changes (e.g., dosage adjustments, formula optimizations, certain flavor/format changes) may trigger additional review: ~$7,200–$23,000 per change, depending on scope.

2) Site licensing (manufacture / import)

Annual fees to hold or renew a site licence:

• Manufacturer/packer/tester: ~$23,000/year

• Importer: ~$20,000/year

• Amendments (e.g., add a warehouse or an additional contracted site): ~$5,000 each.

These site-licence obligations sit alongside the product licence and cover GMP, documentation, audits, and quality systems.

3) Annual right-to-sell

An annual per-SKU fee of approximately $542. Manage portfolio size and SKU proliferation with this recurring cost in mind.

Small-business relief (and why not to rely on it for pricing)

Health Canada’s small-business concept has included companies with ≤100 employees or $30,000–$5M (CAD) in annual revenue. Typical relief discussed:

• First NHP submission: 100% fee remitted (one time)

• Subsequent pre-market evaluations: ~50% reduction

• Annual right-to-sell and site-licence fees: ~25% reduction

Planning guidance: Price to the full fee schedule, not the discounted one. Relief can change, phase out, or become ineligible as the business scales; margins must withstand the true steady-state cost base.

Timeline expectations and risk

Published performance standards (e.g., 60–90 days for Class 1/2, ~180 days for Class 3) have been characterized as internal targets, not binding service guarantees. Even with high fees, there is no obligation to meet target timelines. Portfolio plans should include buffer time and cash-flow coverage for extended reviews and iterative information requests.

What this means for brands

Budgeting & pricing

• Build a pro forma P&L with: full NPN fees by class, site-licence fees (including importer obligations if manufacturing abroad), right-to-sell per SKU, and likely amendment fees over the first 12–24 months.

• Model Class 3 scenarios realistically (evidence generation, longer timelines, more queries).

• Avoid relying on temporary small-business reductions; treat them as upside, not baseline.

Portfolio discipline

• Minimize SKU creep; each additional SKU adds right-to-sell cost, dossier maintenance, and future amendment exposure.

• Where differentiation is not critical, consider Class 1/2 routes using monographs to control costs and time. Reserve Class 3 for products with a strong strategic need for uniqueness.

Supply-chain structure

• If importing, remember the importer must hold a site licence and is accountable for foreign GMP equivalence. Factor this into partner selection and agreements.

• Expect site amendments over time (new 3PLs, labs, or co-packers) and budget accordingly.

Change control & lifecycle

• Plan for post-licensing change fees when optimizing formulas, claims, or formats.

• Stabilize formulas early; each iterative tweak can become a cost event.

Quick FAQ

Do these fees replace testing or GMP obligations?
No. They are in addition to all quality, testing, and stability requirements—and any third-party lab costs.

If a product sells in the U.S., why is Canada so expensive?
Canada’s NHPs are treated as drug-like: pre-market licensing, full disclosure, and dossier evidence. U.S. dietary supplements follow a different model; simply re-labeling does not bypass Canadian review or fees.

Will a Class 1/2 approach always be cheaper?
Generally yes, but only if the product can fully or largely attest to monographs. The trade-off is less differentiation(claims/doses aligned with many competitors).

Can fees be avoided by outsourcing everything?
No. Whether you manufacture domestically or import, the site-licence and product-licence obligations—and associated fees—still apply somewhere in your chain (and the Canadian importer is on the hook when product is foreign-made).

What’s next in this series

• Part 1: Licensing (NPN classes, evidence, stability, site-licence basics).

• Part 3: Canada vs. U.S.—speed, cost, claims latitude, and how to choose the right path for your brand.

Next steps

1) Book a Regulatory Readiness Consultation

Get a concrete plan that aligns claims strategy with Class 1/2/3 pathways, maps site-licence needs (manufacture vs. import), and builds a fee-aware roadmap (including amendment and lifecycle planning).
→ Book a Consultation

2) Enroll in SSET (Signature Supplement Startup Essentials Training)

Modules covering finding and vetting manufacturers, claim substantiation, specs/testing, stability protocols, label compliance, and supplier/site qualification. While scooped for US, the principles and strategies all apply to Canada.
→ Enroll in SSET and pair it with a consult.

3) Established brands

Already in market or expanding from the U.S.? Engage targeted support: portfolio NPN review, Class 3 upgrades, importer/site-licence strategy, stability remediation, and retailer/Amazon readiness.
→ Contact us to scope support

About Blue Ocean Regulatory

Blue Ocean Regulatory helps supplement and health-product brands enter, scale, and defend their markets with smart, pragmatic compliance. Services include NPN submissions and FDA-compliant claims strategy, site-licence/importer submissions,, stability and specifications design, label/pack compliance, and retailer/Amazon audit preparation. The focus: translate regulation into clear plans, lean documentation, and fewer surprises so teams can launch with confidence and grow sustainably.