Australian regulatory guidelines for complementary medicines (ARGCM)
Version 6.0, October 2016
Regulation of complementary medicines in Australia
Australian Register of Therapeutic Goods (ARTG)
Unless exempt (refer to exempt goods) any therapeutic product for which indications are made must be entered on the Australian Register of Therapeutic Goods (ARTG) before it can be legally imported, exported, manufactured or supplied for use in Australia.
- an initial application fee
- an annual charge to maintain the inclusion of their product on the ARTG.
Registered and listed complementary medicines
Within the regulatory framework, complementary medicines are either registered or listed on the ARTG (refer to Medicines and TGA classifications) based on their ingredients and the indications made for the medicine.
Regulatory requirements and guidance for complementary medicines
In Australia, the Therapeutic Goods Act 1989 (the Act) is administered by the TGA and provides a uniform national framework for import, export, manufacture and supply of therapeutic goods. The Act is supported by the Therapeutic Goods Regulations 1990 and various Therapeutic Goods Orders (TGOs) and determinations, which provide details relevant to the various provisions in the Act.
All therapeutic goods must conform with applicable standards before they can be entered on the ARTG. The standards recognised under the Act are those made by the Minister under section 10 of the Act (TGOs) and the default standards. It should be noted that any matter specified in an order under section 10 of the Act has precedence over requirements of the default standards.
- Medicines Advisory Statements Specification 2016
- The Permissible Ingredients Determination
- Compositional guidelines: Where there is no default standard available for a substance permitted for use in listed medicines, a TGA compositional guideline links formal descriptions and specifications with the Australian approved ingredient name.
- The European Medicines Agency (EMA) website provides information about medicine evaluation, including scientific guidelines on the evaluation of herbal medicines.
- The Evidence guidelines: Guidelines on the evidence required to support indications for listed complementary medicines assist sponsors to determine the appropriate evidence to support therapeutic indications made in relation to listable medicines.
- Australian Clinical Trials provides information for sponsors developing clinical trials for a medicine or a new complementary medicine substance.
Other legislation and requirements applicable to complementary medicines
Sponsors should be aware of other applicable Australian legislation and requirements, such as:
- Environment Protection and Biodiversity Conservation Act 1999
- Food Standards Australia New Zealand Act 1991
- Customs Act 1901 and the Customs (Prohibited Imports) Regulations 1956
- Industrial Chemicals (Notification and Assessment) Act 1989 and the National Industrial Chemicals Notification and Assessment Scheme
- Gene Technology Act 2000 and the Gene Technology Regulations 2001
- Competition and Consumer Act 2010 and the Australian Consumer Law
- National Measurement Act 1960
- Australian Dangerous Goods Code
- Agricultural and Veterinary Chemicals Code Act 1994.
In addition, sponsors should be aware of the requirements applicable under other Australian State and Territory legislation such as those concerning:
- weights and measures
- deceptive packaging
- state/territory therapeutic goods legislation
- state/territory drugs and poisons scheduling
- genetically modified organisms or genetically modified products.
Consent to supply goods that are not compliant with prescribed standards
A sponsor can apply under sections 14 and 14A of the Act, to request consent to supply goods that do not comply with a prescribed standard or aspects of a prescribed standard.
Please refer to Consent to import, supply or export therapeutic goods that do not comply with standards - information for industry on the TGA website.
Application for consent to import, supply or export goods that do not comply with standards - section 14/14A available on the TGA website. Such requests incur an application fee.