Legislation

This Act amends the Therapeutic Goods Act 1989 to improve regulation of therapeutic goods in Australia, enhancing safety and access.

This legislation aims to streamline and improve the regulation of therapeutic goods in Australia by updating parts of the Therapeutic Goods Act 1989.

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

The Act amends the Therapeutic Goods Act 1989 to improve regulation of therapeutic goods in Australia, enhancing safety and efficacy standards.

This Act removed the Health Minister's approval requirement for RU486 (abortion medication), transferring decision-making authority to the Therapeutic Goods Administration.

This Instrument makes various amendments to the Therapeutic Goods Advertising Code.

This Instrument amends the Therapeutic Goods Advertising Code to add a reference to the Therapeutic Goods (Restricted Representations—HHD Group Pty Limited) (AZ) Permission 2021.

This Specification facilitates the release of specified therapeutic goods information relating to adverse events following immunisation to specified persons or bodies.

This Declaration amends the Therapeutic Goods (Articles that are Not Medical Devices) Declaration 2023 to specify certain other therapeutic goods that are not medical devices for the purposes of the Therapeutic Goods Act 1989.

This Determination specifies a number of articles that are not medical devices for the purposes of the Therapeutic Goods Act 1989.

The legislation amends the rules for the authorised supply of unapproved therapeutic goods in Australia under the TGA's Special Access Scheme category C pathway.

This Determination specifies the information that must accompany an application to include a therapeutic good that is a biological in the Australian Register of Therapeutic Goods (ARTG).

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

This Determination sets out standard conditions for the inclusion of biologicals in the Australian Register of Therapeutic Goods (ARTG).

This Instrument specifies whether certain things are or are not biologicals for the purposes of the Therapeutic Goods Act 1989.

This Specification facilitates the public release of specified therapeutic goods information relating to breast implants.

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

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

This Specification facilitates the release of specified therapeutic goods information relating to clinical trials to specified persons or bodies.

This Specification provides what information must accompany an application to register complementary medicines on the Australian Register of Therapeutic Goods (ARTG).

This Determination specifies what information must accompany applications to list complementary medicines on the Australian Register of Therapeutic Goods (ARTG).

This Order constitutes an optional conformity assessment standard for specified quality management systems relating to the manufacture of medical devices.

This Order clarifies whether specified goods or classes of goods are therapeutic goods according to the terms of the definition of 'therapeutic goods' in the Therapeutic Goods Act 1989.

This Determination excludes specified hand sanitisers from the operation of the Therapeutic Goods Act 1989.

This legislation amends the list of goods excluded from regulation under Australia's therapeutic goods framework.