Australia Health Supplement Regulation

1. Definition & classification

In Australia, health supplements are generally regulated as complementary medicines. According to the Therapeutic Goods Regulations 1990, complementary medicine means therapeutic good wholly or principally consisting of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use. Examples of the ingredients are vitamins, minerals, plant material, nutritional substances, essential oils, microorganisms and animal material.

Australia has a two-tiered system for the regulation of medicines, in which medicines are classified as lower risk medicines that are either listed medicines or assessed listed medicines, and higher risk medicines that are registered in the Australian Register of Therapeutic Goods (ARTG). Most complementary medicines are included in the ARTG as listed medicines.

2. Competent authority

3. Market access requirements

3.1 Listing or registration

All complementary medicines must be included in the ARTG before they can be supplied in Australia, unless specifically exempted. They are either listed, or assessed listed, or registered medicines with the relevant AUST number (AUST L or AUST L(A) or AUST R). The application for registration or listing of an item may require the submission of additional information. Listed medicines are not individually evaluated by the TGA before they are supplied in Australia. Instead, they are automatically included in the ARTG following the completion of an application and certification by the product owners that their product meets specific requirements related to safety, quality, and efficacy. Assessed listed medicines require a pre-market evaluation of efficacy by the TGA, as they can have intermediate indications where listed medicines cannot. In addition, registered products are subject to a comprehensive pre-market evaluation by TGA for safety, quality, and efficacy.

3.2 GMP Certificate

GMP certificate is required for overseas manufacturers of their registered or listed products, unless specifically exempted. However, health supplements are typically not regulated under the same stringent standards by the TGA as medicines in countries with Mutual Recognition Agreements (MRAs) with Australia. If these products are manufactured in the same facility that produces other medicinal products and under the same standards and controls, a complementary medicine declaration may be accepted along with the most recent GMP Certificate issued by their local regulatory authority for medicinal products.

4. Product Compliance

4.1 Product requirements

4.2 Label

Therapeutic goods, including complementary medicines, needs to comply with the labelling and packaging requirements in the Therapeutic goods orders (TGOs). Specifically, complementary medicine businesses should follow Therapeutic Goods Order No. 92 - Standard for Labels of Non-prescription Medicines. In addition, according to the Therapeutic Goods Regulations 1990, all medicines included in the ARTG must display the relevant ARTG number.

TGA Assessed Symbol

Some medicines may have a “TGA assessed” symbol and/or statement on the label. TGA assessed statement means that the evidence for the approved indications has been assessed by the TGA. Different requirements for listed, assessed listed and registered medicines are shown in the table below:

* Global Food Compliance Service

Chemlinked provide various market entry services to help stakeholders better understand exporting requirements, establish business, and secure a competitive place to facilitate trade development.

Covered Countries

China, Thailand, Vietnam, Singapore, Malaysia, Philippines, Indonesia, Japan, South Korea, United States, European Union, Australia, New Zealand, etc.

Our Services

• Food Ingredient Review

• Label Review

• Product Registration

• Regulatory Consultation

• Monitoring, Training and Customized Report

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