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 be registrable or listable
depending on ingredients and claims.
Listable complementary medicines and
supplements are considered low risk and 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 required 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,
Switzerlandand Canada, have these agreements with Australia. Manufacturers from
newer EU countries, New Zealand and the USA must provide extensive
documentation and undergo a "desk audit". If acceptable GMP evidence
can not be obtained, and for all other countries, an inspection by Australian
auditors willbe 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, unless the manufacturer is prepared to provide special labels for
Australia, the products cannot be approved.
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".
Sports
Supplements Sold as Foods
Protein based powders without
therapeutic claims can be sold as foods provided composition and labelling is
in accordance with Australia’s Food Standards. Products in capsule and tablet
form with specific dosages, generally cannot be sold as foods, and must be
entered on the ARTG as complementary medicines before supply in Australia.
Check with us for early advice when considering any proposal to import “Sports
Supplements” from overseas.
Getting
Started….
To get started, ADVANTAGEMPC needs a
list of the formulations. You can use our Formulations Form to provide details
of the product. Please complete and email or fax us the ADVANTAGE MPC Formulations
Form and complete the Free Online Consultation Form.
