Natural Health Products in Canada
Natural Health Products (NHP) are naturally-occurring substances and include:
- Vitamins and minerals
- Herbal remedies
- Homeopathic medicines
- Traditional medicines such as traditional Chinese medicine
- Other products such as amino acids and fatty acids.
All NHP’s sold in Canada are subject to Natural Health Products Regulations. These regulations address consumer concerns about safety and availability.
To be legally sold in Canada, all NHP must have a product license. To obtain a license, applicants must provide detailed information about the product to Health Canada, including medicinal ingredients, source, dose, potency, non-medical ingredients and recommended uses(s). Once Health Canada has assessed a product and decided it is safe, effective and of high quality, it issues a product license along with an 8-digit Natural Products Number (NPN) which must appear on the label.
Canadian sites which manufacture, package, label and import these products must have a site license. To obtain a license, sites must:
- Maintain proper distribution records
- Have proper procedures for product recalls
- Have proper procedures for handling, storage and delivery of their products
- Demonstrate that they meet Good Manufacturing Practices (GMP) requirements.
Evidence Requirements for Safefy and Efficacy
The safety and efficacy of NHP’s and their health claims must be supported by proper evidence so that consumers and Health Canada know the products are indeed safe and effective. Evidence may include clinical trials data or references to published studies, journals, pharmacopoeias and traditional resources. The type and amount of supporting evidence required depends on the proposed health claim of the product and associated potential risks.
All NHP must meet labeling requirements to help consumers make safe and informed purchasing decisions. Information required includes:
- Product name
- Product license number
- Quantity of product in the bottle
- Complete list of all medicinal and non-medicinal ingredients
- Recommended use or dose
- Cautionary statements (if needed)
- Special storage conditions (if needed).
Good Manufacturing Practices
Good Manufacturing Practices (GMP) ensure proper standards and practices for the testing, manufacturing, storage, handling and distribution of the product are met. This includes:
- Product specifications
- Sanitary program
- Quality assurance
- Sterile products
- Lot or batch samples
- Recall reporting