Natural Health Product Regulation in Canada

All Physicians Research Products are Licensed with Health Canada

Natural Health Product Regulation in Canada

All natural health products (NHPs) sold in Canada are subject to the Natural Health Products Regulations, which came into force on January 1, 2004. The Regulations help give Canadians access to a wide range of natural health products that are safe, effective and of high quality. The Natural Health Products Regulations were created after many consultations with Canadian consumers, academics, health care practitioners and industry stakeholders. They address Canadians' concerns about NHP availability and safety, as well as the House of Commons Standing Committee on Health's 53 recommendations on the regulation of natural health products (NHPs) in Canada.

To be legally sold in Canada, all natural health products must have a product license represented by an NPN (Natural Product Number), and the Canadian sites that manufacture, package, label and import these products must have site licenses. To get product and site licenses, specific labeling and packaging requirements must be met, good manufacturing practices must be followed, and proper safety and efficacy evidence must be provided.

Licensing Requirements

The licensing requirements of the Natural Health Products Regulations apply to any person or company that manufactures, packages, labels and/or imports NHPs for commercial sale in Canada.

Product Licensing

All natural health products must have a product license before they can be sold in Canada. To get a license, applicants must give detailed information about the product to Health Canada, including: medicinal ingredients, source, dose, potency, non-medicinal ingredients and recommended use(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 eight-digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM), which must appear on the label. This number lets you know that the product has been reviewed and approved by Health Canada.

Evidence Requirements for Safety and Efficacy

The safety and efficacy of NHPs 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 trial 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 its overall risks.

All NHPs must meet specific labeling requirements, to help you make safe and informed choices about the NHPs you choose to use. Information required on NHP labels includes: product name product license number quantity of product in the bottle complete list of medicinal and non-medicinal ingredients recommended use (including purpose or health claim, route of administration and dose) any cautionary statements, warnings, contra-indications and possible adverse reactions associated with the product any special storage conditions.

Site Licensing

All Canadian manufacturers, packagers, labelers, and importers of natural health products must have site licenses. To get a license, sites must maintain proper distribution records, have proper procedures for product recalls and for the handling, storage and delivery of their products, and demonstrate that they meet good manufacturing practice requirements.

Good Manufacturing Practices

Good Manufacturing Practices make sure proper standards and practices for the testing, manufacture, storage, handling and distribution of natural health products are met. Good Manufacturing Practices for NHPs cover: product specifications premises equipment personnel sanitation program operations quality assurance stability records sterile products lot or batch samples recall reporting Good Manufacturing Practices are meant to ensure safe and high quality products while giving manufacturers, packagers, labelers, importers and distributors the flexibility to implement quality systems appropriate for their product lines and businesses.

FROM: Health Canada's NHPD (Natural Health Products Directorate)