product categories

NATURAL HEALTH
PRODUCTS

What is a Natural Health Product?

The NHP definition has two components: function and substance. The function component refers to the natural health product definition capturing those substances that are manufactured, sold or represented for use in:

  1. the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
  2. restoring or correcting organic functions in humans;
  3. modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.

The substance component refers to the medicinal ingredient in a natural health product.

Under the Natural Health Products Regulations, which came into effect on January 1, 2004, natural health products (NHPs) are defined as:

  • Vitamins and minerals
  • Herbal remedies
  • Homeopathic medicines
  • Traditional medicines such as traditional Chinese medicines
  • Probiotics
  • Other products like amino acids and essential fatty acids

How are they regulated in Canada ?

All the natural health products (NHPs) marketed in Canada fall under Food and Drugs Act. The Natural Health Products Regulations require individuals to obtain a product licence before they can sell a natural health product (NHP) in Canada. To obtain a product licence, individuals must submit a product licence application to the Natural Health Products Directorate (NHPD). The application must include sufficient data to allow NHPD to evaluate the safety, quality and efficacy of the NHP when used according to the recommended conditions of use. Drug-natural health product combinations are always regulated as drugs.

Who is affected by this regulation?

  • Manufacturers
  • Packers
  • Labellers
  • Importers
  • Distributors

And if I don’t comply with this regulation ?

Health Canada may at any time inspect a site, and suspend or cancel a product or site licence when there are reasonable grounds to believe that it is necessary to do so to prevent injury to the health of a purchaser or consumer of a natural health product. Moreover, Health Canada shall suspend the marketing or importation authorization of a natural health product, and to require the manufacturer/distributor to recall the product.

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