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Therapeutic goods determinations

20 August 2021

If you intend to rely on any legislation referred to on this website, you should access copies of the official versions. These instruments are amended from time to time and may, on occasions, be replaced or new instruments made.


Blood and tissues

Complementary medicines

Excluded goods


Medical devices

Medicine shortages

  • Therapeutic Goods (Reportable Medicines) Determination 2018
    Identifies those medicines (other than medicines which contain substances included in Schedule 4 or 8 to the current Poisons Standard) that must comply with the mandatory reporting requirements relating to medicines shortages and permanent discontinuations
  • Therapeutic Goods (Medicines Watch List) Determination 2018
    Identifies key reportable medicines for which a shortage or a decision by the sponsor of a reportable medicine to permanently discontinue the product will be of critical impact for the purposes of the reporting requirements for medicines shortages and permanent discontinuations

Medicines watch list

OTC medicines

Overseas regulators

Permissible indications

Permissible ingredients

Reportable medicines

Specified foreign countries and jurisdictions under subregulation 16DA(3)

Specified foreign countries under section 19A(3)

  • Therapeutic Goods (Foreign Countries) Determination 2016
    Specifies the foreign countries in which registration or approval for general marketing of specified therapeutic goods in at least one of those countries is a prerequisite for the purposes of subparagraph 19A(1)(b)(i) of the Therapeutic Goods Act 1989