Category Archives: Regulatory

Canada NHP Market-Entry Series · Part 4 of 6

Businesses entering the Canadian Natural Health Product market need to understand the difference between a product licence and an NHP Site Licence. Both are issued by Health Canada, but they serve different regulatory purposes.

What Is an NPN (Product Licence)?

An NPN is an eight-digit number assigned to a licensed NHP after review of its safety, efficacy and quality. It applies to a specific product and its authorized conditions of use, confirms authorization for sale and must appear on the label. Homeopathic medicines are identified by a DIN-HM instead.

What Is an NHP Site Licence?

An NHP Site Licence authorizes specified manufacturing, packaging, labelling or importing activities. It relates to the licensed business, sites and activities, and requires compliance with applicable Good Manufacturing Practices (GMP).

Domestic businesses engaged solely in distribution or storage generally do not require a site licence for those activities alone. Applicable GMP obligations still need to be addressed, and importers have separate licensing responsibilities.

Key Differences

NPN / Product Licence	NHP Site Licence
Authorizes a specific product for sale	Authorizes specified regulated activities
Focuses on the product and its conditions of use	Focuses on operations, sites and GMP compliance
Identified by an eight-digit NPN (DIN-HM for homeopathic medicines)	Identified by a site licence number
Product-specific	Site- and activity-specific

Does Your Business Need Both?

If your business manufactures, packages, labels or imports NHPs into Canada for sale, the applicable site licensing requirements must be met. The products must also have the appropriate product licences before sale. Working with a third-party importer does not remove the need to confirm product authorization and the responsibilities of each party.

How Can Globyz Biopharma Help?

Globyz Biopharma supports businesses exploring Canadian NHP market entry by helping them understand regulatory expectations, importation pathways and quality compliance requirements.

Whether you are launching a new product or expanding an established brand, contact Globyz or email info@globyz.com to discuss your regulatory and operational needs.

Official Resources

Health Canada: Site licensing guidance

Health Canada: Product licensing overview

Continue the Canada NHP Market-Entry Series

Previous: What Is an NPN in Canada?

Next in this series: How to Import Natural Health Products Into Canada

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Canada NHP Market-Entry Series · Part 3 of 6

A Natural Product Number (NPN) is a unique eight-digit number issued by Health Canada to a Natural Health Product that has been authorized for sale in Canada.

An NPN indicates that Health Canada has assessed the product’s safety, efficacy and quality under its recommended conditions of use. Homeopathic medicines use a separate eight-digit identifier, the DIN-HM.

Why Is an NPN Important?

• Regulatory compliance: NHPs require the applicable product licence before they can legally be sold in Canada.
• Product authorization: an NPN relates to a specific product and its authorized ingredients, dosage, intended use and conditions.
• Consumer confidence: the number helps consumers identify an authorized product.
• Market access: product authorization is a key requirement for Canadian sale and distribution.

How Do Businesses Obtain an NPN?

Businesses submit a product licence application to Health Canada. The application includes medicinal and non-medicinal ingredient information, recommended dosage, health claims and the applicable supporting safety, efficacy and quality information.

After approval, Health Canada issues an NPN that must appear on the product label. Businesses should ensure that marketed claims and directions remain consistent with the product licence.

An NPN Is Not an Importer Licence

A product licence does not replace the site licence required for specified activities such as commercial importation. Product licensing and site licensing address different parts of the market-entry process.

How Can Globyz Biopharma Help?

Globyz Biopharma supports businesses exploring Canadian NHP market entry by helping them understand regulatory expectations, importation pathways and quality compliance requirements.

Whether you are launching a new product or expanding an established brand, contact Globyz or email info@globyz.com to discuss your regulatory and operational needs.

Official Resources

Health Canada: Regulation of natural health products

Health Canada: Site licensing guidance

Continue the Canada NHP Market-Entry Series

Previous: Canadian NHP Labelling Requirements

Next in this series: NPN vs. NHP Site Licence in Canada

Return to the Canadian NHP Market-Entry Guide

Canada NHP Market-Entry Series · Part 2 of 6

Natural Health Products (NHPs) sold in Canada must comply with Health Canada’s labelling requirements under the Natural Health Products Regulations. The label must accurately reflect the product’s authorization and applicable conditions of use.

What Must Appear on an NHP Label?

• Licence identification: the eight-digit Natural Product Number (NPN), or DIN-HM for a homeopathic medicine.
• Product identity and authorized use: the product name and applicable recommended use or purpose.
• Ingredients: medicinal ingredients, their quantities and potency where applicable, and non-medicinal ingredients.
• Directions: recommended dose, frequency, duration where required, route of administration and target population.
• Safety information: applicable cautions, warnings, contraindications and known adverse reactions.
• Traceability: lot number and expiry date.
• Business identification: required product licence holder information and importer identification, where applicable.
• Quantity and storage: net quantity and required storage conditions.
• Languages: mandatory information in English and French, subject to applicable exceptions.

Product Facts Table and Enhanced Labelling

Health Canada’s enhanced labelling framework introduces a standardized Product Facts Table where applicable, along with readability requirements. Transition provisions and exemptions affect when and how these requirements apply. Businesses should check the current guidance and compliance updates before approving artwork.

A label review should consider the product’s licence, package format and applicable transition provisions together. The checklist above is an overview; the detailed requirements depend on the product and label.

How Can Globyz Biopharma Help?

Globyz Biopharma supports businesses exploring Canadian NHP market entry by helping them understand regulatory expectations, importation pathways and quality compliance requirements.

Whether you are launching a new product or expanding an established brand, contact Globyz or email info@globyz.com to discuss your regulatory and operational needs.

Official Resources

Health Canada: Labelling guidance

Health Canada: Labelling requirements compliance update

Continue the Canada NHP Market-Entry Series

Previous: Is My Product an NHP in Canada?

Next in this series: What Is an NPN in Canada?

Return to the Canadian NHP Market-Entry Guide

Canada NHP Market-Entry Series · Part 1 of 6

Are you planning to introduce a natural health product into the Canadian market? Before importing, manufacturing, distributing or selling your product in Canada, it is essential to determine how it is classified under Health Canada’s regulatory framework.

In Canada, Natural Health Products (NHPs) are regulated under the Natural Health Products Regulations, established under the Food and Drugs Act.

Which Products May Qualify as NHPs?

Vitamins, minerals, herbal supplements, probiotics and certain traditional medicines may qualify as NHPs. However, a familiar ingredient or a “natural” description does not determine classification on its own.

What Determines Product Classification?

• Medicinal ingredients and whether they are permitted within the NHP framework.
• Intended use and the health claims made for the product.
• Dosage form, recommended use and target population.
• Overall presentation, including how the product is represented to consumers.

Products presented as foods, cosmetics or other types of drugs may fall under different regulatory requirements. Correct classification is an important first step toward regulatory compliance and successful market entry.

What Comes After Classification?

Once the applicable framework is established, an NHP generally requires a product licence before sale. Licensed products carry an eight-digit NPN, or a DIN-HM in the case of homeopathic medicines. Product classification should guide the licensing, labelling and importation plan.

How Can Globyz Biopharma Help?

Globyz Biopharma supports businesses exploring Canadian NHP market entry by helping them understand regulatory expectations, importation pathways and quality compliance requirements.

Whether you are launching a new product or expanding an established brand, contact Globyz or email info@globyz.com to discuss your regulatory and operational needs.

Official Resources

Health Canada: Product classification and the pre-submission process

Continue the Canada NHP Market-Entry Series

Next in this series: Canadian NHP Labelling Requirements

Return to the Canadian NHP Market-Entry Guide