Consultants to the Pharmaceutical and Healthcare Industries
4 Sharan Place, Forestville  Sydney  NSW  2087  Australia
Enquiries: (61- 2) 9975 6205  Facsimile: (61- 2) 9975 6209  email:eden@zipworld.com.au





AUSTRALIAN PRODUCT REGISTRATION REQUIREMENTS . . .





In Australia goods are either classified as therapeutic, cosmetic or food. Once a therapeutic claim is made or implied, then the goods become therapeutic and subject to the requirements of the Australian Therapeutic Goods Act 1989. This is different from many other countries where nutritional and herbal products can often be marketed as foods, provided limited
(or no) therapeutic claims are made.

All therapeutic goods are subject to the requirements of the Therapeutic Goods Act 1989. The Act is divided into 4 main sections which apply equally to vitamins, herbal products, and some essential oils, along with pharmaceutical products.


The Act Controls . . .
The standard of all ingredients used in manufacture.
Advertising and label claims for products.
Registration of Product(s) on the Australian Register of Therapeutic Goods (ARTG).
The manufacturing and packaging conditions and controls (GMP).

In general the Act is administered by the Therapeutic Goods Administration (TGA), a section of the Commonwealth Department of Health and Aged Care. It is designed to ensure that safety, quality and efficacy are built into all therapeutic substances on the Australian market.

All therapeutic goods marketed in Australia MUST be registered on the Australian Register of Therapeutic Goods (ARTG)(unless prescribed exemptions apply). This is a computer database held at the TGA offices in Canberra.

Full REGISTRATION of products on the ARTG (resulting in an AUSTR number being granted) involves disclosure of formulations, and products specifications, evaluation of labels, stability, bioavailability/bioequivalence, pharmaco-toxicology and clinical support data.

Generally, a lower level of product registration is designated for vitamins, minerals and herbal materials (including some essential oils). This is called LISTING and an AUSTL number is granted to products successfully satisfying the following criteria:

Pharmacopoeial standards for starting materials.

Compliance to GMP manufacturing requirements.
Claims within Advertising Code guidelines.
Formulation approval by TGA.
Products satisfy prescribed TGOs/Aust Standards.
Active ingredients are prescribed in the Regulations.

A LISTING does not specifically require submission of efficacy or stability data, however the TGA reserves the right to call for this data from the sponsor at any time without notice.

The manufacturing and packaging conditions are detailed in the Australian Code of Good Manufacturing Practice for Therapeutic Goods (Medicinal Products) 1990, which is usually referred to as 'GMP'.

Briefly, GMP involves attaining an acceptable standard of premises, personnel, process control and documentation. Compliance is a condition of obtaining and maintaining a TGA licence (or accredited status), and is enforced by regular quality audits from TGA officials.

Fees are charged by the TGA for all services including auditing and product registration.

Eden prepares and lodges TGA applications on behalf of clients.


       COSMETIC PRODUCTS IN AUSTRALIA . . .

 Unlike therapeutic goods, there is no clearly defined  registration system for cosmetic products in Australia at the  present time. The legal requirements for marketing cosmetics  are spread throughout a number of Acts, and a firm  understanding is required to avoid legislative difficulties.
 Eden  assists clients to ensure that their products meet the  legal  requirements for packaging, ingredients, labelling, and  advertising claims.

  GMP in Australia            Home




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