NATURAL HEALTH PRODUCTS IN CANADA
Natural Health Products ( NHP ) are naturally occurring substances and include:
All NHP’s sold in Canada are subject to the Natural Health Products Regulations. These regulations address consumers concerns about availability and safety.
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.
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
All NHP must meet labeling requirements to help consumers make safe and informed choices.
Information required includes:
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: