How to Get an NPN in Canada: A Step-by-Step Guide for Manufacturers

Why You Need an NPN

If you want to sell a natural health product (NHP) in Canada — vitamins, minerals, herbal remedies, probiotics, or traditional medicines — you must have a Natural Product Number (NPN) issued by Health Canada. It's not optional. It's the law under the Natural Health Products Regulations (NHPR).

An NHP must have the required product licence before it is marketed for sale in Canada. Retailers and marketplaces may reject products that do not have the required authorization.

What Is an NPN?

An NPN is an eight-digit number that Health Canada assigns to a natural health product after reviewing its safety, efficacy, and quality. It tells consumers and retailers that the product has been assessed and meets Canadian standards.

Think of it as a product licence — similar to a DIN (Drug Identification Number) for pharmaceuticals, but specifically for natural health products.

The 5 Steps to Getting Your NPN

Step 1: Identify the Correct Monograph

Health Canada publishes monographs that describe accepted ingredients, conditions of use, risk information, and evidence pathways. The current official monograph and ingredient databases should be checked for each application.

Monograph fit, proposed conditions of use, and the evidence package influence the application pathway. A formula should be assessed as a whole before a class or timeline is assumed.

Practical point: Incorrect monograph matching is a common source of avoidable deficiencies. Check the current NNHPD monograph and ingredient databases against the complete formula and proposed conditions of use.

Step 2: Prepare Your Product Licence Application (PLA)

The PLA is the core submission to Health Canada. It includes:

Product name (brand name + proper name)
Medicinal ingredients with exact quantities per dosage unit
Non-medicinal ingredients (excipients, capsule materials, preservatives)
Recommended dosage (must fall within monograph ranges)
Route of administration (oral, topical, etc.)
Recommended use or purpose (the health claim — must match monograph language)
Risk information (contraindications, warnings, adverse reactions)
Specifications for each medicinal ingredient (identity, purity, potency)

Step 3: Create Your Product Facts Table

Health Canada's amended NHP labelling rules include standardized Product Facts Table requirements for applicable products and a transition period ending in June 2028. Current guidance should be checked before artwork is finalized. The table includes:

Medicinal ingredients with quantity per unit
Non-medicinal ingredients list
Recommended dose
Risk information
Lot number and expiry date

Nostrum can prepare a draft Product Facts Table within an agreed application or label scope, subject to product-specific review and approval.

Step 4: Prepare and Transmit Through the Current Health Canada Channel

Product licence application information is prepared in the current Web ePLA format and transmitted through Health Canada's current ePost Connect process. Site Licence applications use a separate LiquidFiles submission channel. Confirm the current instructions before transmission because channels can change. Pathway and review timing depend on the formulation, claims, evidence, application quality, and Health Canada's review; published service standards are not approval guarantees.

Step 5: Receive Your NPN (or Fix Deficiencies)

If Health Canada accepts the application, it issues a product licence. The product must still satisfy applicable label, site, quality, import, and post-market obligations before and after sale. Health Canada may request clarification or additional evidence during review.

Common Mistakes That Delay NPN Approval

Wrong monograph match — Selecting a monograph that doesn't exactly match your ingredient form or dose
Dosage outside monograph range — Your recommended dose must fall within the monograph's minimum and maximum
Missing risk information — Every contraindication and warning in the monograph must appear on your label
Incomplete specifications — Identity, purity, and potency testing must meet NNHPD standards
Incorrect Product Facts Table format — Must follow the exact template prescribed by Health Canada

How Nostrum Health Helps

Nostrum Health can support a scoped NPN application engagement for manufacturers:

Monograph matching — We identify the correct monograph for every ingredient in your product
PLA drafting — AI-assisted application preparation that follows Health Canada's exact format
Product Facts Table preparation — Drafted from reviewed product and licence information
Submission and follow-up — Support for filing and responses within the agreed scope
Operating-model assessment — We define the licensed sites, quality records, importer, and written responsibilities required for the proposed arrangement

Regulatory services are scoped to the product and evidence. Eligible manufacturers may also apply for our Manufacturer-to-Amazon Partnership, which has no upfront service fee only when the manufacturer provides 500 saleable units DDP Incoterms® 2020 to the Canadian delivery point named in the signed agreement and accepts the payout formula and post-delivery pass-through charges stated there. Review fit and apply →

Key Takeaways

NHPs marketed for sale in Canada generally require an NPN or DIN-HM, as applicable
Application pathway and timing depend on monograph fit, claims, evidence, and Health Canada's review
Incorrect monograph matching is a common source of avoidable application issues
A complete, well-supported application can reduce avoidable deficiencies, but Health Canada controls its review, requests, decisions, and timing
A Canadian operating model can involve an existing Site Licence holder when sites, activities, evidence, and responsibilities are properly defined

Need help with an NPN file? Ask Nostrum Health to scope the assessment, application, and follow-up work.