Natural Health Product Regulation

Canadians can be proud that our country is a global leader in the regulations of natural health products (NHPs). Our rigorous and advanced regulatory system protects our health and safety while ensuring we have access to innovative, safe, effective and high quality NHPs that 79 per cent of Canadians rely on.

All NHPs sold in Canada are subject to the Natural Health Products Regulations, which came into effect on January 1, 2004. These regulations were created after consultations with Canadian consumers, academics, health care practitioners and industry stakeholders. They address Canadians' concerns about NHP availability and safety, as well as the 53 recommendations made by the House of Commons Standing Committee on Health in 1998.

But recently, Health Canada launched a proposal called the Consulting Canadians on the Regulation of Self-Care Products in Canada, which proposes changes that could significantly alter the way natural health products are regulated, and impact many of products you use on a daily basis. Learn more about this proposal and help us stop it by clicking the button below. 

The pre-approval system

The Canadian approach to regulation is often referred to as a “pre-approval” system which means that all NHPs must be approved by Health Canada before they are allowed to be legally sold in Canada. 

Other countries have alternative methods for regulating NHPs. For example, the United States regulates NHPs (known as “dietary supplements”) as food products and uses an approach referred to as “post market reporting.” This means that NHPs can be marketed and sold in the U.S. without government review or approval and manufacturers are expected to report any adverse effects. 

The Natural Product Number (NPN) and Homeopathic Medicine Drug Identification Number (DIN-HM)

 

 

The Natural Product Number (NPN) is an eight-digit number located on the product label. Found on all NHPs legally licensed for sale in Canada, this number means that the product has been assessed by Health Canada and deemed to be safe, effective and of high quality. Best of all, all the information attached to this number is completely traceable through Health Canada’s Licensed Natural Health Products Database.

A Homeopathic Medicine Number (DIN-HM) is an eight-digit number that must be displayed on the label of any homeopathic product that has been approved for sale in Canada. Homeopathic Medicines are a unique class of natural health products, but undergo similar licensing and approval processes through Health Canada.

Licensing

In order to sell an NHP in Canada, a company must have a product and site licence.

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

In order to receive a product licence, the company must complete a Product Licence Application. This detailed document about the product must include: medicinal ingredients, source material, dose, potency, non-medicinal ingredients and recommended use(s).

All Canadian manufacturers, packagers, labellers, and importers of NHPs must have site licenses. These licenses require manufacturers to maintain proper distribution records and have proper procedures for product recalls and for the handling, storage and delivery of their products.

Manufacturers must also meet Good Manufacturing Practice (GMP) requirements, including: proper standards and practices for the testing, manufacturing, storage, handling and distribution of natural health products. More information on Good Manufacturing Practices for NHPs is available in the Good Manufacturing Practices Guidance Document.

All of this information, and more, is available on Health Canada’s website here.

Want to learn more about the benefits of NHPs and how to use them to support your naturally healthy lifestyle? Explore our blog and Lifestyle Tips pages, and consider signing up for our newsletter. To find a CHFA Member natural health store near you, click here.

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