How can I find out if a medication is approved in Australia?

In Plain English

Unfortunately, the provided documents don't contain a direct list of all approved medications in Australia. However, they do give some clues on where to look.

  • AUST R Numbers: These numbers, like "AUST R 224612" (docid=1), are assigned to therapeutic goods approved by the Therapeutic Goods Administration (TGA). If a product has an AUST R number, it indicates it has been registered and approved for supply in Australia.
  • TGA Website: The National Health Act 1953 mentions that the Secretary must make information publicly available on the Department’s website regarding changes to the pharmaceutical benefits scheme. This suggests the TGA website is a good place to look for information on approved medications.
  • Licence to Manufacture Therapeutic Goods: The Therapeutic Goods Act 1989 allows the Secretary to grant licenses to manufacturers of therapeutic goods. While this doesn't directly list approved medications, it indicates which manufacturers are authorized to produce them in Australia.

Detailed Explanation

The documents provided offer insights into how therapeutic goods are regulated in Australia, but do not contain a comprehensive list of approved medications. Here's a breakdown of the relevant points:

  • AUST R Numbers and the Therapeutic Goods Act 1989: Several documents refer to "AUST R" numbers, which are assigned to therapeutic goods registered by the TGA. These numbers appear in the context of consents given under sections 14 and 14A of the Therapeutic Goods Act 1989 for the supply of goods that don't fully comply with labeling requirements. The presence of an AUST R number suggests the medication is approved, even if there are temporary deviations from labeling standards.
  • Therapeutic Goods Order No. 69 (TGO 69): This order, mentioned in several documents (docid=1, 2, 4, 5, 7, 8), sets out the general requirements for labels for medicines. Consents under sections 14 and 14A are often related to non-compliance with specific paragraphs of TGO 69, indicating the importance of adhering to labeling standards for approved products.
  • Pharmaceutical Benefits Scheme (PBS) and the National Health Act 1953: The National Health Act 1953 discusses the Pharmaceutical Benefits Scheme (PBS) and the processes for approved suppliers to claim payments for supplying pharmaceutical benefits. Section 98AB mentions that the Secretary must make information publicly available on the Department’s website regarding changes to the PBS. This suggests that the Department of Health's website (likely the TGA section) would be a valuable resource for finding information on medications approved for inclusion in the PBS.
  • Schedules and the Therapeutic Goods (Poisons Standard—October 2025) Instrument 2025: The Therapeutic Goods (Poisons Standard—October 2025) Instrument 2025 classifies substances into different schedules based on their potential for harm and the level of control required for their availability. While not a direct list of approved medications, it provides information on the scheduling of various substances, which is relevant to their availability and use in Australia.

In summary, while the provided documents don't offer a single list of approved medications, they highlight the importance of AUST R numbers, adherence to labeling standards (TGO 69), and the role of the TGA and PBS in regulating therapeutic goods in Australia. The TGA website is the most likely place to find an official list of approved medications.