Legislation

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.

The Therapeutic Goods (Charges) Act 1989 regulates the fees associated with the registration and listing of therapeutic goods in Australia.

This instrument specifies classes of therapeutic goods for the purpose of section 23A of the Therapeutic Goods Act 1989.

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.

This legislation amends the settings relating to the exclusion of certain sunscreen products from the application of the Australian therapeutic goods laws.

This Determination amends the Therapeutic Goods (Excluded Goods) Determination 2018 so that vaping devices are no longer excluded goods for the purposes of the Therapeutic Goods Act 1989.

This Determination specifies goods that are excluded from regulation for the purposes of the Therapeutic Goods Act 1989.

This Determination exempts certain statements in monograph 3053 for Live Biotherapeutic Products for Human Use of both the British Pharmacopoeia (BP) and European Pharmacopoeia (EP) for particular therapeutic goods, under subsection 3C(2) of the Therapeutic Goods Act 1989.

This Determination is made under section 3C of the Therapeutic Goods Act 1989. Its purpose is to exempt certain statements found in specific monographs from the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopoeia-National Formulary, from being treated as legal ‘standards’ for particular therapeutic goods in Australia.

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

This Instrument contains guidelines setting out the circumstances in which a licence issued under Part 3-3 of the Therapeutic Goods Act 1989 may cover two or more manufacturing sites.

This Specification facilitates the public release of specified therapeutic goods information relating to exemptions that do or do not apply under the Annual Charges Exemption Scheme.

This Specification facilitates the release of information about the materials used in the production of specified medical devices to specified persons for certain purposes.