Department of the Environment

About us | Contact us | Publications

Header imagesHeader imagesHeader images

Publications archive - Biodiversity

Disclaimer

Key departmental publications, e.g. annual reports, budget papers and program guidelines are available in our online archive.

Much of the material listed on these archived web pages has been superseded, or served a particular purpose at a particular time. It may contain references to activities or policies that have no current application. Many archived documents may link to web pages that have moved or no longer exist, or may refer to other documents that are no longer available.

Healthy people - healthy wildlife

Proceedings of the second Australian Symposium on traditional medicine and wildlife conservation
Melbourne Australia, March 1999


Import Controls on Traditional Medicine under the Therapeutic Goods Act 1989 and Associated Labelling Issues

Dr Fiona Cumming
Director
Office of Complementary Medicines
Therapeutic Goods Administration

The Therapeutic Goods Act

Amendments have been made to the Therapeutic Goods Act 1989 to implement reforms to the regulation of complementary medicines. These reforms are of direct relevance to traditional medicines, which are regulated as complementary medicines within the therapeutic goods regulatory system.

The use of complementary medicines in Australia and throughout the world is on the increase. It is currently estimated that more than 60% of Australians use complementary medicines at least once per year, and current trends show that this figure will probably rise. These complementary medicines include vitamins, minerals, herbal, naturopathic and/or homoeopathic preparations.

In view of increasing use and acceptance of complementary medicines and following discussions with industry and other key stakeholders, the Government determined that it was a matter of priority to review the existing regulations. Key considerations for the review included:

The review has resulted in the amendments to legislation mentioned earlier in this paper, and in a range of administrative and educational reforms. Implementation of these reforms will provide a ‘one stop regulatory shop’ for the complementary medicines industry, that is, the Office of Complementary Medicines within the Therapeutic Goods Administration (TGA). Integral to the functioning of the Office of Complementary Medicines will be the Complementary Medicines Evaluation Committee (CMEC). This statutory committee with membership focusing on scientific and regulatory expertise and clinical experience will provide high level advice to the Office of Complementary Medicines with regard to the evaluation of substances and products for use in Australia and for the substantiation of claims.

Another cornerstone of the reform package was the establishment of an industry/government Complementary Healthcare Consultative Forum (CHCF). The purpose of this forum is to promote government and industry dialogue on complementary healthcare policy, trade, research and related issues.

The overall aim of the Therapeutic Goods Act 1989 (the Act) is to ensure the quality, safety and efficacy of therapeutic goods available to the Australian public so that consumers can be confident in the medicines available to them. It is also important that medicines are made available in a timely manner.

There are several pieces of legislation that affect the regulation of medicines, including traditional medicines. The Therapeutic Goods Administration regulates medicines, but if the medicine is of human, plant or animal origin for import the Australian Quarantine Inspection Service (AQIS) also has jurisdiction. If the medicine includes protected species, environmental protection legislation plays a part and if the medicine comes from overseas, then Customs legislation comes into effect. Additionally, the Therapeutic Goods Administration recognises and supports Australia as a signatory to the Convention of International Trade in Endangered Species of Wild Fauna and Flora (CITES).

When it comes to enforcing laws for the importation and exportation of medicines, it is Customs which has jurisdiction through the Customs (Prohibited Imports) Regulations and the Customs (Prohibited Exports) Regulations. The TGA administers two schedules of the Customs (Prohibited Imports) Regulations:

Schedule 8 (goods the importation of which is prohibited if permission is not granted under regulation 5H), and

The TGA advises Customs as to the items which should be listed in the Schedules and issues import and export permits and licences, and Customs enforces these Schedules.

When it comes to the Therapeutic Goods Act 1989 the following sections relate specifically to the importation of therapeutic goods:

The definition of 'therapeutic goods' is broad and includes goods that are made to appear to be for therapeutic use, unless the goods are foods as described in the Therapeutic Goods Act 1989.

Some goods are exempted from Registration or Listing in the ARTG under Section 18 of the Act and Regulation 12 (1) and 12 (1a). These goods are listed in Schedules 5 and 5a to the regulations, respectively. It is possible that this exemption could apply to certain traditional medicines.

For example, under provisions of Schedule 5 of the Act 'personal imports' and also starting materials used in the manufacture of therapeutic goods, may be exempt from the requirement to be included in the ARTG before they may be lawfully imported, manufactured, supplied or exported.

Subsections 19 (5-9) of the Act and Regulation 12B provide a way for certain medical practitioners to supply certain therapeutic goods to specified recipients under the authorised user approval (AUA) schemes. Goods used solely for experimental purposes in humans, that is for clinical trials, need not be included in the ARTG if special approval is granted for these for import, export or supply in Australia, under Subsection 19 (1)(b) of the Act.

The Special Access Scheme (SAS) allows individual patients to obtain access to medicines not approved for general supply via a medical practitioner under particular circumstances. Arrangements under the SAS vary according to the health status of the individual patient.

This paper has set out a summary of major pieces of legislation which apply to medicines and which may therefore apply to traditional medicines and also has described in some detail the provisions within the Therapeutic Goods Act 1989 which may relate specifically to traditional medicines if they are imported. The Therapeutic Goods Act 1989 includes provisions that allow the TGA to declare medicines to be Prohibited Imports under the Customs Act where the medicines are imported into Australia without first being included in the ARTG when they are required to be. This allows the powers of Customs to come into play, which can include searching, seizing, destroying or deporting of therapeutic goods.