Canadian Regulation NPN

Canadian Regulation NPN


Canadian Regulation NPN

The Natural Health Products Regulations were created after many consultations with Canadian consumers, academics, healthcare 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, 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.

Canadian regulation NPN (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. They do not apply to health care practitioners who compound products on an individual basis for their patients, or to retailers of NHPs.

Canadian regualtion NPN: 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.

You can search for licensed natural health products using Health Canada’s Licensed Natural Health Products Database. See How do I know if a product has been licensed? For more information.

Canadian Regulation NPN:

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, pharmacopeias and traditional resources. The type and amount of supporting evidence required depending on the proposed health claim of the product and its overall risks.

Canadian regualtion NPN: Labelling

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
  • the quantity of product in the bottle
  • a 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

More information on labeling and packaging requirements for natural health products is available in the Labelling Guidance Document.

Candian Regulation NPN: 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.

Canadian Regulation NPN: 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
  • a 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 businesses. More information on Good Manufacturing Practices for NHPs is available in the Good Manufacturing Practices Guidance Document. (2017 08 15)

Canadian Regualtion NPN: About Natural Health Products

Using natural health products can be a good way to maintain or improve your health. But just because a product is “natural” doesn’t mean it is safe for you to use.

This section will tell you more about:

Canadian Regulation NPN: What are natural health products?

Natural health products (NHPs) are naturally occurring substances that are used to restore or maintain good health. They are often made from plants, but can also be made from animals, microorganisms and marine sources. They come in a wide variety of forms like tablets, capsules, tinctures, solutions, creams, ointments and drops.

Natural health products, often called “complementary” or “alternative” medicines, include:

  • vitamins and minerals
  • herbal remedies
  • homeopathic medicines
  • traditional medicines like traditional Chinese and Ayurvedic (East Indian) medicines
  • probiotics
  • other products like amino acids and essential fatty acids

Many everyday consumer products, like certain toothpastes, antiperspirants, shampoos, facial products and mouthwashes are also classified as natural health products in Canada.

Fast fact: 71% of Canadians have used natural health products like vitamins and minerals, herbal products, and homeopathic medicines.

NHPs are used and marketed for a number of health reasons, like the prevention or treatment of an illness or condition, the reduction of health risks, or the maintenance of good health. They must be safe to be used as over-the-counter products. Products needing a prescription are regulated as drugs.

Are there risks to using natural health products?

While natural health products are generally safe and have fewer side effects than medications, they are not risk free. Risks include:

  • manufacturing problems (like contamination, incorrect ingredients or dosage)
  • unproven claims, which can lead people to use the wrong products for serious conditions or to delay proper treatment
  • not enough information for people to make an informed choice (like incorrect instructions or no warnings that a product may not be suitable for certain groups)
  • interaction with prescription drugs or other natural health products
  • unwanted side effects, like allergic reactions

Fast fact: 12% of Canadians who use natural health products report that they have experienced unwanted side effects (adverse reactions).

Health Canada responded to Canadians’ concerns about these risks by creating the Natural Health Products Regulations in 2004. See What is Health Canada doing to protect me? for more.

How can I use natural health products safely?

Take these steps to minimize your risk:

  • Talk to a health care professional like a doctor, pharmacist or naturopath before choosing a product. This is especially important for children, pregnant or breast-feeding women, seniors, and people with serious medical conditions.
  • To prevent interactions, make sure your health care provider knows what other drugs and natural health products you are using.
  • Use approved products. Look for NPN / DIN-HM numbers that identify licensed products.
  • Be skeptical of health-related claims that seem too good to be true. Don’t rely on ads: do your own research and talk to your health care provider.
  • Read and follow all instructions on the product label.
  • Report unwanted side effects (adverse reactions) to your health care provider and Health Canada.

How do I know if a product has been authorized?

To be licensed in Canada, natural health products must be safe, effective, of high quality and carry detailed label information to let people make safe and informed choices.

You can identify products that have been licensed for sale in Canada by looking for the eight-digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) on the label.

A NPN or DIN-HM means that the product has been authorized for sale in Canada and is safe and effective when used according the instructions on the label.

You can search for licensed natural health products using Health Canada’s Licensed Natural Health Products Database.