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Medicines and TGA classifications
Australia has a two-tiered system for the regulation of medicines, including complementary medicines:
- Higher risk medicines must be registered on the Australian Register of Therapeutic Goods (ARTG), which involves individually evaluating the quality, safety and effectiveness of the product.
- Lower risk medicines containing pre-approved, low-risk ingredients and that make limited claims can be listed on the ARTG.
Within the regulatory framework, medicines are classified as either registered or listed:
Registered medicines are assessed by the TGA for quality, safety and efficacy.
- All prescription medicines are registered.
- Most over-the-counter medicines are registered.
- Some complementary medicines are registered.
Listed medicines are assessed by the TGA for quality and safety but not efficacy.
- Some over-the-counter medicines are listed.
- Most complementary medicines are listed.