We can assist you with all of your regulatory requirements for Complementary Medicines, Foods or Cosmetics.

COMPLEMENTARY & LISTED MEDICINES

The Therapeutics Goods Act 1989 (The Act) requires that all therapeutic goods that are imported or manufactured for supply in Australia be included in the Australian Register of Therapeutic Goods (ARTG).

In Australia, Complementary Medicines, such as herbal, vitamin, mineral and nutritional supplements, as well as sunscreens are classified as therapeutic goods and are included under listed medicines on the ARTG.

COSMETIC REGULATION

Cosmetic products in Australia must comply with the NICNAS Cosmetics Guidelines set out by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) and be labelled in accordance with the Trade Practices – Consumer Product Information Standards.

A cosmetic product is considered a Therapeutic Good if a therapeutic claim is made, further requiring the product to be listed or registered on the Australian Register of Therapeutic Goods (ARTG).

FOOD STANDARDS

All food products that are manufactured or imported and sold in Australia and New Zealand must comply with the standards set by Food Standards Australia New Zealand (FSANZ).

Advanced Wellness Regulatory Solutions’ professional team of consultants can review your product and advise you on whether it is a therapeutic good or a food, ensuring compliance with the relevant codes.

NZ HEALTH PRODUCTS

In New Zealand complementary medicines are currently regulated under the Dietary Supplements Regulations 1985, which fall under the Food Act 1981. Dietary Supplements are presently regulated by Medsafe and therapeutic and marketing claims must comply with the guidelines set out by the Therapeutic Advertising Pre-vetting Services (TAPPS).