Natural Health Products Regulations

Act: Food and Drugs Act, R.S.C. 1985, c. F-27
Regulation: Natural Health Products Regulations, SOR/2003-196; Food and Drug Regulations, C.R.C., c. 870

To Whom Does This Apply?

The Natural Health Products Regulations came into effect on January 1, 2004 and apply to the importation, distribution, storage, manufacturing, packaging, labelling, or sale of natural health products, as well as clinical trials involving human subjects in Canada.

Summary

Under the Regulations, Natural Health Products are defined as:

• 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.

Natural Health Products must be safe for consideration as over-the-counter products, be available for self-care and self-selection and not require a prescription to be sold. Products requiring a prescription continue to be regulated under the Food and Drug Regulations.

In order to market natural health products in Canada, the Regulations first require you to obtain the necessary product and site licences.

• A product licence is obtained by demonstrating that your product is safe, effective, and of high quality.
• A site licence is obtained by demonstrating that the manufacturing, packaging, labelling and importation of your product are done in accordance with good manufacturing practices.

*Note: "non-profit" also known as nonprofit organizations, non profit organizations, not-for-profit organizations, voluntary organizations and volunteer organizations.

DISCLAIMER
Information contained in this section is of a general nature only and is not intended to constitute advice for any specific fact situation. For particular questions, the users are invited to contact their lawyer. For additional information, see contact(s) listed below.

Quebec Contact(s):
See National Contact.

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National Contact(s):
Natural Health Products Directorate
Health Canada
A.L. 3302A, Tower A
Qualicum Building
2936 Baseline Road
Nepean, Ontario  K1A 0K9
Telephone: 613-948-8096
Fax: 613-948-6810
Toll-free (information): 1-888-774-5555
TTY Toll-free (hearing impaired): 1-800-267-1245
E-mail: nhpd_dpsn@hc-sc.gc.ca
Web site: http://www.hc-sc.gc.ca/index_e.html