NPN and what you need to know.

About Natural Health Product Regulation in Canada

To be legally sold in Canada, all natural health products must have a product licence, and the Canadian sites that manufacture, package, label and import these products must have site licences.

To get product and site licences, specific labelling and packaging requirements must be met, good manufacturing practices must be followed, and proper safety and efficacy evidence must be provided.

Product licensing

All natural health products must have a product licence before they can be sold in Canada. To get a licence, 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 licence 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.

Labelling
All NHPs must meet specific labelling 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 licence 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, labellers, and importers of natural health products must have site licenses. To get a licence, 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, labellers, importers and distributors the flexibility to implement quality systems appropriate for their product lines and businesse

Adverse Reaction Reporting

The Natural Health Products Regulations require product licence holders to monitor all adverse reactions related to their product. License holders must report serious adverse reactions to Health Canada. See Adverse Reaction Reporting for more information.
Canadian consumers should report unwanted side effects (adverse reactions) to their health care provider and to Health Canada directly. See Adverse Reaction Reporting for more information.
Reporting side effects is important because it helps Health Canada identify rare or serious adverse reactions, make changes in product safety information, issue public warnings and advisories, and/or remove unsafe products from the Canadian market.

Clinical Trials

A clinical trial is when natural health products are tested using human subjects. Clinical trials are intended:
  • to discover or verify the product's effects
  • to identify any adverse events that are related to its use
  • to study its absorption, distribution, metabolism and excretion
  • to test its safety or efficacy
The  Natural Health Products Regulations set out requirements for conducting a clinical trial. Meanwhile, the Natural Health Products Directorate outlines the range of evidence that can be submitted in support of the safety and efficacy of a natural health product and the quality of a natural health product, or of a homeopathic medicine.
More information on the clinical trial process for natural health products is available in the Clinical Trials for Natural Health Products Guidance Document.

Related Advisories, Warnings and Recalls

For the most recent advisories, warnings and recalls about food, health and consumer products, see Advisories, Warnings and Recalls.

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