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