Natural Health Products (NHPs): Definition and Canadian Regulatory Overview

What Are Natural Health Products (NHPs)?

Natural Health Products (NHPs) are substances used to maintain or improve health. In Canada, they include a wide range of products such as:

• Vitamins and minerals
• Herbal remedies
• Homeopathic medicines
• Traditional medicines (e.g., Ayurvedic, Traditional Chinese Medicine)
• Probiotics
• Essential fatty acids and amino acids

These products are available without a prescription and are often used to support general wellness, prevent health issues, or address minor conditions.

How Are NHPs Regulated in Canada?

NHPs are regulated by Health Canada under the Natural Health Products Regulations, which fall under the Food and Drugs Act. The goal is to ensure that products sold to Canadians are safe, effective, and high quality.

Key Regulatory Requirements:

Product Licensing

Before being sold, all NHPs must be approved by Health Canada and issued a Natural Product Number (NPN) or DIN-HM for homeopathic medicines.

Site Licensing

Companies that manufacture, package, label, or import NHPs must hold a valid Site Licence and comply with Good Manufacturing Practices (GMP) to ensure product quality and safety.

Labelling Compliance

All NHPs sold in Canada must comply with specific labelling requirements. These include mandatory information such as:

• Product name and dosage form
• Medicinal and non-medicinal ingredients
• Recommended use or purpose
• Directions for use and cautions
• Product license (NPN or DIN-HM)
• Name and address of the license holder
• Lot number and expiry date

Ongoing Oversight

Health Canada requires companies to report any serious adverse reactions, maintain records, and allow inspections to ensure ongoing compliance.

Need help with NHP compliance in Canada?

Our regulatory experts can guide you through product licensing, label reviews, and site licensing to ensure your NHPs meet Health Canada’s requirements.