Legislation

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

This Instrument authorises the public release of specified therapeutic goods information that has been reported to the TGA and is recorded in the Database of Adverse Event Notifications (DAEN).

This Instrument authorises the release of specified therapeutic goods information relating to medicine shortages and availability data either to a specified person, body or authority or to the public.

This legislation specifies information requirements for therapeutic vaping products and devices in Australia for regulatory and safety purposes.

This Specification specifies therapeutic goods information that may be released by the Secretary in relation to compliance reviews of listed medicines.

This Determination sets out conditions for listing specified listed medicines on the Australian Register of Therapeutic Goods (ARTG).

This legislation updates the requirements for the manufacturing of therapeutic goods in Australia to ensure compliance with minimum benchmarks and to ensure the safety and quality of therapeutic goods manufactured in Australia.

This Determination sets out the principles to be observed in the manufacture of therapeutic goods.

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

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

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.

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

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 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 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.