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?