Legislation

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.

The TGO 100 Order sets forth the minimum microbiological quality standards that therapeutic goods must meet.

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).

This Determination sets out overseas bodies which are overseas regulators of medical devices for the purposes of the Therapeutic Goods Act 1989.

This Determination sets out the list of permitted therapeutic claims (indications) which may be made in relation to medicines that are listed on the Australian Register of Therapeutic Goods (ARTG) under sections 26A, or 26AE, of the Therapeutic Goods Act 1989 (these are listed, and listed assessed medicines).

This Determination sets out a list of ingredients which have been assessed or otherwise considered to be safe for use in medicines that are listed in the Australian Register of Therapeutic Goods (ARTG) (including assessed listed medicines), and associated requirements to be followed when using particular ingredients in such medicines.

This Determination specifies the kind of information that must accompany an application for a recommendation by the Secretary that the Minister vary a section 26BB determination made under the Therapeutic Goods Act 1989.

This Determination specifies the approved format for an application dossier accompanying an application for registration of a prescription medicine on the Australian Register of Therapeutic Goods (ARTG).

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

This Specification facilitates the release of specified therapeutic goods information relating to prescription medicines to Therapeutic Guidelines Ltd (TGL) to facilitate the publication of specified information in the journal Australian Prescriber.

This Specification facilitates the publication of specified therapeutic goods information relating to applications for the registration of prescription medicines in the Australian Register of Therapeutic Goods (ARTG).