Complementary Medicines, Nutritional & Sports Supplements and Herbal Products

In Australia all of these products are regulated as medicines and must be entered on the Therapeutic Goods Administration's (TGA) Australian Register of Therapeutic Goods (ARTG) before they may be lawfully sold. The labels must be in English and meet Australia’s standard for medicines labelling. All products to be entered on the ARTG must have a Sponsor in Australia.

Formulations

Complementary Medicines, Nutritional & Sports Supplements and Herbal Products may qualify to be registered or listed depending on ingredients and claims.

Listable complementary medicines and supplements are considered low risk. To qualify for listing, all ingredients including excipients must be known and eligible for use in listable medicines in Australia and claims must be limited to medium or general level health claims.

Higher risk products, or those making stronger health claims, are to be registered and must be evaluated by the TGA before entry on the ARTG.

Full formulation details are required to be submitted for assessment, preferably using correct botanical names for the herbal ingredients.

Good Manufacturing Practice

The TGA is very specific in its requirements. All manufacturers, whether in Australia or overseas, must meet pharmaceutical standards of GMP. Australian manufacturers must be licensed by the TGA. Requirements for overseas manufacturers can be found in the TGA's Standard of Overseas Manufacturers. GMP Certification may be accepted for manufacturers in countries with which Australia has a mutual Recognition Agreement. Only the orignal EU, & EFTA countries, Switzerland and Canada, have these agreements with Australia. Manufacturers from newer EU countries, New Zealand and USA must provide extensive documentation and undergo a "desk audit". If acceptable GMP evidence cannot be obtained, and for all other countries, an inspection by Australian auditors will be required. Anyone intending to import these products from overseas should check with us for advice first before entering into any agreements.

Labelling and Claims made for the Products

Labelling must conform to the TGA's general requirements for labelling medicines found in the Therapeutic Goods Order No 69. Products cannot usually be sold in Australia in the same labelling that is used overseas. If the product is an imported product, it can not be approved unless the manufacturer is prepared to provide special labels for Australia.

Sponsors are required to hold scientific evidence to support health claims as outlined in the TGA's “Guidelines for the Levels and Kinds of Evidence to support Claims for Therapeutic Goods".

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