Site Licence for Natural Health Products in Canada: Everything You Need to Know

What Is a Site Licence?

A Site Licence is Health Canada's authorization for specified NHP activities and sites under the Natural Health Products Regulations. The current issued licence, annex, foreign-site evidence, and operating records control the applicable scope; a public holder listing alone does not prove every activity or arrangement.

Think of it this way: the NPN is the product licence (what you're selling). The Site Licence is the facility licence (where it's made, stored, or imported through).

Who Needs a Site Licence?

You need one if you:

Manufacture NHPs in Canada (compounding, encapsulating, tableting)
Package NHPs through the packaging activities and sites identified in the applicable licence scope
Label NHPs (applying any label to a finished product)
Import NHPs into Canada for sale

You do NOT need one if you only:

Retail NHPs (sell them as-is to consumers)
Broker NHPs (facilitate transactions without touching product)

The Foreign Manufacturer Problem

If you're a US or international manufacturer, you cannot import NHPs directly into Canada without a Canadian Site Licence holder. Your options are:

Set up a Canadian subsidiary and obtain your own Site Licence
Use a Canadian distributor/importer who already holds one

Nostrum Health can assess whether an appropriately licensed Canadian operating arrangement can be supported for the proposed products, sites, and activities.

Site Licence Requirements

Good Manufacturing Practices (GMP)

Health Canada's GMP requirements for NHPs include:

Sanitation — Written sanitation program, pest control, clean facilities
Equipment — Properly maintained, calibrated, and validated equipment
Personnel — Trained staff with defined roles and responsibilities
Quality Assurance — A QAP who reviews and releases every batch
Documentation — Written SOPs for every process, batch records, deviation reports
Complaint handling — Documented process for receiving, investigating, and resolving complaints
Recall procedures — Written recall protocol in case of safety issues

Quality Assurance Person (QAP)

Every Site Licence holder must designate a QAP — someone who:

Reviews and approves each batch before release to market
Has the training, experience, and technical knowledge appropriate to the assigned activities and products
Can halt distribution of any batch that doesn't meet specifications
Maintains oversight of all quality-related activities

The QAP is a legal requirement. No QAP = no Site Licence.

Timing and Cost

Health Canada publishes service standards for site licence application review, but a service standard is not an approval guarantee. Preparation and review timing depend on application completeness, activities, sites, GMP evidence, deficiencies, and regulator workload.

Government fee policy and private readiness costs can change. Confirm the current official fee policy and obtain project-specific quotes for quality documentation, facilities, testing, personnel, and professional support before budgeting.

Some brands work with a Canadian Site Licence holder rather than building every regulated activity in-house. The correct arrangement depends on the activities, sites, products, quality system, and written responsibilities involved.

Using Licensed Sites in a Defined Operating Model

A brand may coordinate regulated Canadian activities through appropriately licensed sites and qualified parties. That does not remove the brand's obligation to use compliant products, records, labels, claims, and supply-chain arrangements.

Nostrum Health can assess a proposed Canadian operating model and define which responsibilities can be supported within an agreed scope. Depending on the product and arrangement, that work may include:

Site Licence and foreign-site pathway assessment
Quality documentation and QAP release coordination
Canadian import, storage, and record-keeping planning
Bilingual label and NPN readiness review
Commercial launch planning after regulatory dependencies are satisfied

How Nostrum Health Can Help

We connect regulatory assessment with quality, import, operational, and commercial planning. Scope and commercial terms are confirmed only after reviewing the products, manufacturing sites, documentation, and intended Canadian activities.

Discuss your Canadian market-entry plan →

Key Takeaways

A Site Licence is required for any facility that manufactures, packages, labels, or imports NHPs in Canada
Foreign manufacturers must use a Canadian Site Licence holder to import
Timing and cost depend on the proposed activities, sites, evidence, readiness work, and Health Canada's current process
A compliant model can involve appropriately licensed Canadian and foreign sites with clearly assigned responsibilities
Product licensing, site licensing, quality release, importation, and commercial launch should be assessed together

Planning a Canadian launch? Discuss the regulatory and operating model with Nostrum Health.