Licensing

View our Health Canada License.

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
  • probiotics
  • other products such as amino acids and fatty acids

All NHP’s sold in Canada are subject to the Natural Health Products Regulations. These regulations address consumers concerns about availability and safety.

PRODUCT LICENSING:

To be legally sold in Canada all NHP must have a Product License. To get a license, applicants must give 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.

SITE LICENSE:

Canadian sites which manufacture, package, label and import these products must have a Site License. To get a license, sites must maintain proper distribution records, have proper procedures for product recalls and for handling, storage and delivery of their products, and demonstrate that they meet Good Manufacturing Practices ( GMP ) requirements.

EVIDENCE REQUIREMENTS FOR SAFETY 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 its overall risks

LABELLING:

All NHP must meet labeling requirements to help consumers make safe and informed choices.

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
  • any cautionary statements
  • any special storage conditions

GOOD MANUFACTURING PRACTICES:

Good Manufacturing Practices ( GMP) make sure proper standards and practices for the testing, manufacturing, storage, handling and distribution are met. This includes:

  • product specifications
  • premises
  • equipment
  • personnel
  • sanitary program
  • operations
  • quality assurance
  • stability
  • records
  • sterile products
  • lot or batch samples
  • recall reporting