Therapeutic Goods determinations

Biologicals

• Therapeutic Goods (Biologicals—Specified Things) Instrument 2021

  Legislation

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

• Therapeutic Goods (Biologicals— Information that Must Accompany Application for Inclusion in Register) Determination July 2018

  Legislation

  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).

• Therapeutic Goods (Biologicals—Conditions of Inclusion in Register) Determination 2018

  Legislation

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

Blood and tissues

• Therapeutic Goods (Excluded Goods) Determination 2018

  Legislation

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

Complementary medicines

• Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination 2022

  Legislation

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

• Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Section 26AE Listing) Determination August 2018

  Legislation

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

Conditions of listing

• Therapeutic Goods (Listed Medicines—Conditions of Listing) Determination 2022

  Legislation

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

Excluded goods

• Excluded goods orders, determinations and specifications

  11 November 2022

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  Therapeutic Goods (Excluded Goods) determinations and specifications.

Manufacturing

• Manufacturing principles and guidelines

  5 August 2024

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  Therapeutic Goods (Manufacturing Principles) Determination 2024.

Medical Devices

• Therapeutic Goods (Transition to EU Medical Devices Regulation) (Information) Specification 2022

  Legislation

  This Specification facilitates the public release of therapeutic goods information that has been provided to the TGA by a sponsor in an Online Notification Form that relates to the transition of a medical device from certain European Directives to the new EU medical devices regulation.

• Therapeutic Goods (Medical Devices—Authorised Supply) Rules 2022

  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.

• Therapeutic Goods (Medical Devices—Excluded Purposes) Specification 2022

  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.

• Therapeutic Goods (Medical Devices—Excluded Purposes) Specification 2020

  Legislation

  The Therapeutic Goods (Medical Devices—Excluded Purposes) Specification 2020 outlines the specific categories of therapeutic goods that are excluded from the operation of the Therapeutic Goods Act 1989 (Cth).

• Therapeutic Goods (Medical Devices—Specified Articles) Amendment (Vaping) Instrument 2023

  Legislation

  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.

• Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020

  Legislation

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

• Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018

  Legislation

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

• Therapeutic Goods (Overseas Regulators) Determination 2018

  Legislation

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

Medicine shortages

• Therapeutic Goods (Reportable Medicines) Determination 2025

  Legislation

  This Determination specifies medicines which are reportable medicines for the purposes of the Therapeutic Goods Act 1989.

• Therapeutic Goods (Medicines Watch List) Determination 2018

  Legislation

  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.

• Therapeutic Goods (Foreign Countries) Determination 2016

  Legislation

  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

Medicines watch list

• Therapeutic Goods (Medicines Watch List) Determination 2018

  Legislation

  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.

OTC medicines

• Therapeutic Goods (OTC Medicines—Information that Must Accompany Application for Registration) Determination August 2018

  Legislation

  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).

Overseas regulators

• Therapeutic Goods (Overseas Regulators) Determination 2018

  Legislation

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

Permissible indications

• Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025

  3 April 2025

  Regulatory decision notices

  Listed medicines indications and requirements for their use have been updated in the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025.

Permissible ingredients

• Therapeutic Goods (Permissible Ingredients) Determination

  Legislation

  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.

• Therapeutic Goods (Permissible Ingredients—Information that Must Accompany Application for Variation) Determination 2023

  Legislation

  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.

Prescription medicines

• Therapeutic Goods (Prescription Medicines—Kind of Information that Must Accompany Application for Registration) Determination 2022

  Legislation

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

• Therapeutic Goods (Prescription Medicines—Information Accompanying Applications for Registration) Determination 2021

  Legislation

  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).

Pharmacopoeias

• Therapeutic Goods (Exempt Monographs) Determination 2021

  Legislation

  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.

• Therapeutic Goods (Exempt Monographs) Amendment Determination 2025

  Legislation

  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.

• Pharmacopoeias

  24 August 2022

  Page

  Pharmacopoeias provide standards for pharmaceutical substances and medicinal products.

Reportable medicines

• Therapeutic Goods (Reportable Medicines) Determination 2025

  Legislation

  This Determination specifies medicines which are reportable medicines for the purposes of the Therapeutic Goods Act 1989.

Specified foreign countries and jurisdictions under subregulation 16DA(3)

Specified foreign countries under section 19A(3)

• Therapeutic Goods (Foreign Countries) Determination 2016

  Legislation

  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