The Natural Health Product Regulations came into force on January 1, 2004. Since then, NHPs have been subject to Health Canada's Natural Health Product Regulations and must have a product licence to be sold on the Canadian market. An 8-digit NPN (Natural Product Number) on the NHP label signifies Health Canada's approval.
The Natural and Non-prescription Health Products Directorate (NNHPD) is the regulating authority for natural health products sold in Canada. All natural health products (NHPs) sold in Canada must comply with the Natural Health Product Regulations, governed under the Food and Drugs Act.
All natural health products (NHPs) must have a product licence to be legally sold in Canada. Additionally, Canadian sites that manufacture, package, label and import such products must have a site licence demonstrating GMP compliance.
To obtain a product licence, the applicant must submit a product licence application to Health Canada providing detailed information about the product, such as its medicinal ingredients, dose, and recommended use, as well as adequate safety and efficacy evidence to substantiate the product’s health claims. Once Health Canada completes assessment of the product licence application and determines that the product meets safety, effectiveness and quality requirements, it issues a product licence along with an eight-digit Natural Product Number (NPN) which must appear on the product label.
Additionally, all NHPs must meet specific labelling and packaging requirements.
What can our consulting services do for you?
- Provide a full assessment of your product to determine if the product meets the definition of a natural health product
- Determine the appropriate regulatory strategy to prepare the product licence application for submission to Health Canada
- Prepare the entire product licence application package and submit to Health Canada
- Conduct scientific literature searches to obtain high quality evidence to support the safety and efficacy of your product
- Review and summarize clinical evidence and scientific data
- Act as your regulatory authority liaison during product review, and respond to any information requests from Health Canada should they arise during review
- Prepare product label text and review marketing materials for regulatory compliance
- Manage post-approval product changes
The following products are examples of NHPs which require approval from Health Canada prior to market entry:
- Vitamins and minerals
- Herbal remedies
- Homeopathic medicines
- Traditional medicines like Traditional Chinese and Ayurvedic (East Indian) medicines
- Amino Acids and Essential Fatty Acids
- Topical acne therapy products (ingredient-dependent)
- Sunscreens (ingredient-dependent)
- Medicated skin care products (ingredient-dependent)
- Anti-dandruff products (ingredient-dependent)
- Antiseptic skin cleansers (ingredient-dependent)