Frequently Asked Questions - Natural Health Products Regulations
This document is an unofficial summary of the Regulations. It is not intended to substitute for, supersede or limit the requirements under the applicable legislation. In case of any discrepancy between this summary and the legislation, the legislation will prevail.
What is the purpose of this regulation?
The Natural Health Products Regulations are intended to help provide Canadians with access to natural health products that are safe, effective and of high quality.
Natural health products (NHPs) are defined in the Natural Health Products Regulations and include vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines such as Traditional Chinese Medicines, probiotics, and other products like amino acids and essential fatty acids.
What are the key elements of this regulation?
The regulations set out requirements for the manufacture, packaging, labelling, storage, importation, distribution and sale of natural health products in Canada, as well as clinical trials involving human subjects.
The main components of the regulations are: definitions, product licensing, adverse reaction reporting, site licensing, good manufacturing practices, clinical trials involving human subjects, and labelling/packaging.
How does this regulation affect Canadian businesses?
These regulations place requirements on persons who sell NHPs, namely manufacturers, distributors, importers, packagers and labellers. 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 Licence
A product licence applicant must declare specific information about the NHP they intend to sell, for example, the quantity of the medicinal ingredient(s) it contains, the standards it meets, the recommended use or purpose for which the NHP is intended to be sold, and the supporting data on safety and efficacy. The type and amount of supporting evidence required depends on the proposed health claim of the product and its overall risks.
A product licence applicant is also required to attest that the product is manufactured, packaged, labelled, distributed and imported in accordance with good manufacturing practices.
The regulations also require product licence holders to monitor all adverse reactions related to their product. License holders must report serious adverse reactions to Health Canada.
Site Licence
A site licence is required for importers, manufacturers, packagers and labellers of NHPs. To get a licence, companies 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.
When did the Natural health Product Regulations come into force?
The Natural Health Products Regulations came into force on January 1, 2004 under the Food and Drugs Act.
Where can I get more information on the Natural Health Products Regulations?
For more information please visit Health Canada's Natural Health Product website.
For more information
To learn about upcoming or ongoing consultations on proposed federal regulations, visit the Canada Gazette and Consulting with Canadians websites.
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