Legislation

This Order constitutes an optional medical device standard for therapeutic vaping devices and therapeutic vaping device accessories.

To read the full text, visit the Federal Register of Legislation.

These Rules specify circumstances in which a health practitioner is authorised to supply specified medical devices which are not included in the Australian Register of Therapeutic Goods (ARTG), under the TGA's Special Access Scheme category C pathway.

To read the full text, visit the Federal Register of Legislation.

To read the full text, visit the Federal Register of Legislation.

This Specification specifies kinds of medical devices that cannot be approved for marketing in Australia if they are intended to be used exclusively for one or more specified purposes.

This Determination specifies the information that must accompany an application to include a medical device in the Australian Register of Therapeutic Goods (ARTG).

This Instrument amends the Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020 to specify certain articles and components for use in the manufacture of therapeutic vaping devices or their accessories that are medical devices for the purposes of the Therapeutic Goods Act 1989.

This Instrument specifies certain classes of articles that are considered medical devices for the purposes of the Therapeutic Goods Act 1989.

This Specification facilitates the publication of aggregated and de-identified statistical information in relation to medicinal cannabis products under the authorised prescriber (AP), special access scheme category A (SAS A) and special access scheme category B (SAS B) pathways.

This Specification facilitates the publication of information about medicinal cannabis products that have been the subject of the authorised prescriber (AP) scheme or the Special Access Scheme (SAS) B.

This Specification sets out the required advisory statements for specified non-prescription medicines, including over the counter and registered complementary medicines.

This Specification facilitates the open publication of certain kinds of therapeutic goods information relating to ingredients of medicines and components of biologicals in the Australian Register of Therapeutic Goods (ARTG).

These Rules authorise specified classes of health practitioners to supply specified therapeutic goods in certain circumstances, under the TGA's Special Access Scheme category C pathway.

This Determination sets out the list of reportable medicines which forms the Medicines Watch List under s 30EJ(1) of the Therapeutic Goods Act 1989.

These Rules amend the Therapeutic Goods (Medicines—Authorised Supply) Rules 2022 to include the authorised supply of certain therapeutic vaping goods by specified health practitioners under certain conditions, and update references to the Special Access Scheme (SAS) Guidelines.

This Therapeutic Goods Order constitutes a standard for medicines in relation to serialisation and the use of data matrix codes.

To read the full text, visit the Federal Register of Legislation.

This Specification facilitates the release of therapeutic goods information relating to the importation or exportation of therapeutic goods that are mercury to specified government bodies, to support Australia’s international obligations under the Minamata Convention on Mercury.

This Therapeutic Goods Order determines various publications which constitute standards for medicine manufactured in Australia, or imported into Australia, for export only.

This Therapeutic Goods Order constitutes a standard relating to the kinds of information required to be included on the label of prescription and other related medicines.

This Therapeutic Goods Order constitutes a standard relating to the kinds of information required to be included on the label of non-prescription medicines.

This Therapeutic Goods Order constitutes a standard in relation to therapeutic goods that are haematopoietic progenitor cells derived from cord blood.

This Therapeutic Goods Order constitutes a standard for child-resistant packaging for specified kinds of medicines.

This Determination specifies the information that must accompany an application to register an over the counter medicine on the Australian Register of Therapeutic Goods (ARTG).