American Herbal Products Association (AHPA) > Resources > Regulations > International

International Supplement Regulations

Canada

How are herbal products regulated in Canada?
Herbal products are regulated in Canada by Health Canada through the Natural Health Products Directorate (NHPD). In Canada these products are categorized as Natural Health Products.
What is a Natural Health Product?
Under the Natural Health Products Regulations, which came into effect on January 1, 2004, natural health products (NHPs) 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.

NHPs 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.

I want to sell my herbal products in Canada - How do I do that?
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php#pl

What other information is available about Canada?
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/index-eng.php

What Other Trade Organizations Are Operating On Industry's Behalf In Canada?
Canadian Health Food Association www.chfa.ca
Saskatchewan Herb & Spice Association www.saskherbspice.org

Australia

How are Herbal Products Regulated In Australia?
Medicinal products containing herbs, vitamins, minerals, and nutritional supplements, homoeopathic medicines and certain aromatherapy products are referred to as 'complementary medicines'. These are regulated as medicines under the Therapeutics Goods Act 1989i (the Act). Complementary medicines comprise traditional medicines, including traditional Chinese medicines, Ayurvedic medicines and Australian indigenous medicines

The Department of Health and Aging's Therapeutics Goods Administration (TGA) is the governmental agency responsible for administering the provisions of the Act..

What Is A Complementary Medicine?
For the purpose of regulating complementary medicines, the Act1 and the Therapeutic Goods Regulations 19902 ii (the Regulations) respectively define what is a complementary medicine and designate the types of active ingredients that may be used in such medicines.

A complementary medicine is defined as a therapeutic good consisting wholly or principally of one or more designated active ingredients each of which has a clearly established identity and a traditional use. Traditional use means use of the designated active ingredient that is well documented, or otherwise established, according to the accumulated experience of many traditional healthcare practitioners over an extended period; and accords with well-established procedures of preparation, application and dosage.

Complementary medicines in Australia are not subject to the standards and guidelines of the Codex Alimentarius Commission.

I Want To Sell My Herbal Products In Australia. How Do I Do That?
http://www.tga.gov.au/industry/cm-basics.htm

What Other Information Is Available About Australia?
http://www.tga.gov.au/index.htm

What Other Trade Organizations Are Operating On Industry's Behalf In Australia?
Complimentary Healthcare Council (CHC)

EUROPEAN UNION (EU)

UNITED KINGDOM (UK)


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