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