Importing Supplements Into Canada: The Complete Guide for Manufacturers

Why Manufacturers Consider Canada

Canada can be an attractive expansion market for established natural health product manufacturers, but market demand does not remove the need for product licensing, compliant labels, a lawful site and import arrangement, and channel-specific commercial diligence.

The Regulatory Framework

Natural Health Products Regulations (NHPR)

All natural health products in Canada are regulated under the NHPR, administered by the Natural and Non-Prescription Health Products Directorate (NNHPD) within Health Canada. This is separate from:

Foods and supplemented foods — subject to distinct food requirements and classification rules
Natural health products — subject to the Food and Drugs Act and the Natural Health Products Regulations

Key distinction: In the US, supplements are regulated under DSHEA as a subset of food. In Canada, they have their own regulatory category with stricter requirements.

What Counts as an NHP?

Vitamins and minerals (above certain doses)
Herbal remedies
Homeopathic medicines
Traditional medicines (Chinese, Ayurvedic)
Probiotics
Amino acids and essential fatty acids
Products in dosage forms that meet the applicable NHP classification rules; Nostrum's current commercial product scope is limited to tablets and capsules

Classification depends on the ingredients, dose, route, format, representation, and intended use. Confirm classification before selecting a licensing pathway.

Requirements for Importing NHPs into Canada

1. Product Licence (NPN or DIN-HM)

Every NHP sold in Canada must have a product licence — either an NPN (Natural Product Number) or a DIN-HM (for homeopathic medicines). This is obtained by filing a Product Licence Application (PLA) with Health Canada.

The NPN must appear on the product label. No NPN = no legal sale.

2. Site Licence

Anyone who manufactures, packages, labels, or imports NHPs in Canada must operate through sites and activities authorized by an applicable Site Licence issued by Health Canada. The licence-holder record, current issued licence and annex, foreign-site evidence, and written operating responsibilities must be reconciled for the proposed arrangement.

Important: If you're a foreign manufacturer, you need a Canadian importer with a Site Licence. You cannot import directly without one.

Defining the Canadian importer, licensed sites, quality evidence, and written responsibilities is a common source of preventable readiness gaps. Options include:

Get your own Site Licence — Requires a Canadian facility, QAP, and GMP documentation
Use an appropriately licensed Canadian arrangement — Define the importer, licensed sites, quality evidence, and written responsibilities before shipment

3. Bilingual Labelling

All NHP labels in Canada must be in both English and French. This includes:

Product name
Medicinal and non-medicinal ingredients
Dosage instructions
Risk information (warnings, contraindications, adverse reactions)
Product Facts Table (transitioning by 2028)
Lot number and expiry date

4. Quality Assurance

Imported NHPs must meet Canadian quality specifications:

Identity testing — Prove each ingredient is what you say it is
Purity testing — Confirm absence of contaminants (heavy metals, microbials, pesticides)
Potency testing — Verify active ingredients meet label claims

5. Product Facts Table

By 2028, all NHPs in Canada are expected to display a standardized Product Facts Table that includes medicinal ingredients, non-medicinal ingredients, recommended dose, risk information, and lot number/expiry date.

The Import Process Step by Step

Obtain your NPN (or have an agent do it for you)
Confirm the licensed operating arrangement for the importer and sites involved
Prepare bilingual labels with Product Facts Table
Arrange customs brokerage — NHPs require proper HS codes and Health Canada documentation at the border
Ship according to the approved operating model — Use the importer and applicable licensed sites identified for the shipment
Quality release — The responsible qualified quality party reviews and releases each batch where required before sale
List on marketplace — Get your product in front of Canadian retailers and distributors

Common Pitfalls

Licensing gap — A missing or unsuitable site and import arrangement can delay or prevent lawful importation
Incorrect tariff classification — Classification should be confirmed with the responsible customs professionals for the shipment
Missing bilingual labels — French is mandatory, even for online-only sales
Unrealistic dosage claims — Health Canada strictly enforces monograph dose ranges
Skipping QAP release — Every single batch must be signed off before it reaches consumers

How Nostrum Health Can Support a Scoped Engagement

Nostrum performs or coordinates only the work included in the written scope. Client, manufacturer, laboratory, customs, warehouse, carrier, marketplace, and other third-party responsibilities remain explicit:

NPN application — We match your ingredients to monographs and draft your PLA
Licensed operating-model review — We assess the importer, sites, evidence, records, and responsibilities required for the agreed arrangement
Bilingual labelling — We prepare draft English/French label content for product-specific review and approval
Quality release — The responsible qualified quality party performs release where included and supported by the applicable evidence and operating model
Warehousing & 3PL coordination — We can coordinate an assessed Canadian provider where included
Channel planning — We can scope Amazon and other agreed channel work without guaranteeing acceptance or sales

Each import arrangement depends on complete product, site, quality, label, and shipment evidence. Eligible partnership applicants can request no upfront service fee by providing 500 saleable units DDP Incoterms® 2020 to the Canadian delivery point named in the signed agreement; the payout formula and any post-delivery pass-through charges are stated in that agreement. Apply for a fit review →

Considering Canada? Apply for a fit review so the product, evidence, importer, sites, quality responsibilities, shipment plan, and channel scope can be assessed before commitments are made.