If you intend to rely on any legislation referred to on this website, you should access copies of the official versions. These instruments are amended from time to time and may, on occasions, be replaced or new instruments made.
Biologicals
- Therapeutic Goods (Biologicals - Specified Things) Instrument 2021
This instrument specifies things that are (where those things also satisfy paragraph 32A(1)(b) of the Therapeutic Goods Act 1989), and things that are not, biologicals for section 32A of the Therapeutic Goods Act 1989. - Therapeutic Goods (Biologicals - Information that Must Accompany Application for Inclusion in Register) Determination July 2018
Sets out the kind of information that must accompany an application for the inclusion of a biological in the Australian Register of Therapeutic Goods, and the form in which that information must be provided - Therapeutic Goods (Biologicals - Conditions of Inclusion in Register) Determination 2018
Sets out standard conditions applying to the inclusion of biologicals in the Australian Register of Therapeutic Goods
Blood and tissues
- Therapeutic Goods (Excluded Goods) Determination 2018
Specifies goods that are excluded for the purposes of the Therapeutic Goods Act 1989, principally human cells and tissue products in certain circumstances
Complementary medicines
- Therapeutic Goods (Complementary Medicines - Information that Must Accompany Application for Registration) Determination 2018
Sets out the kind of information which must accompany an application for the registration of a complementary medicine, and the form in which the application must be submitted - Therapeutic Goods (Complementary Medicines - Information that Must Accompany Application for Section 26AE Listing) Determination 2018
Sets out the kind of information which must accompany an application for the listing of a complementary medicine under section 26AE of the Therapeutic Goods Act 1989 and the form in which the application must be submitted
Conditions of listing
- Therapeutic Goods (Listed Medicines - Conditions of Listing) Determination 2022
Sets out the standard conditions that will automatically apply to the listing of certain medicines that are listed in the Australian Register of Therapeutic Goods (ARTG) under section 26A or 26AE of the Therapeutic Goods Act 1989.
Excluded goods
Manufacturing
- Manufacturing principles & guidelines
These instruments determine principles to be observed in the manufacture of therapeutic goods for use in humans
Medical devices
- Therapeutic Goods (Transition to EU Medical Devices Regulation - Stakeholder Testing) (Information) Specification 2022
This instrument specifies the therapeutic goods information, which relates to the transition of certain medical devices to the new EU medical devices regulation, that may be released to specified persons and bodies for the purpose of obtaining feedback in relation to the usefulness, suitability and presentation of the information. - Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Amendment (Singapore) Determination 2022
This instrument amends the Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Determination 2018 to specify that an extract from, or copy of, an entry in the Singapore Register of Health Products may accompany an application for inclusion for certain kinds of medical device in the Australian Register of Therapeutic Goods. - Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Amendment (European Union - Consequential Amendments) Determination 2022
This instrument amends the Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Determination 2018 to extend the period of time in which an application for inclusion of Class 2 and Class 3 IVD medical devices may be supported with an ISO 13485 certificate. - Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Amendment (COVID-19 Measures - Class 1 IVD Medical Devices) Determination 2020
This instrument amends the Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Determination 2018 to specify that a declaration of conformity must accompany an application for inclusion in relation to Class 1 in vitro diagnostic (IVD) medical devices. - Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Amendment (COVID-19 Measures - Class I Medical Devices) Determination 2020
This instrument amends the Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Determination 2018 to specify that a declaration of conformity must accompany an application for inclusion in relation to certain Class I medical devices and Class I system or procedure packs. - Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Determination 2018
Determines the kind and form of information that must accompany an application for a kind of medical device to be included in the Australian Register of Therapeutic Goods - Therapeutic Goods (Overseas Regulators) Determination 2018
Specifies the specific entities that are determined to be an overseas regulator for the purposes of subsection 41BIB(1) of the Act
Medicine shortages
- Therapeutic Goods (Reportable Medicines) Determination 2018
Identifies those medicines (other than medicines which contain substances included in Schedule 4 or 8 to the current Poisons Standard) that must comply with the mandatory reporting requirements relating to medicines shortages and permanent discontinuations - Therapeutic Goods (Medicines Watch List) Determination 2018
Identifies key reportable medicines for which a shortage or a decision by the sponsor of a reportable medicine to permanently discontinue the product will be of critical impact for the purposes of the reporting requirements for medicines shortages and permanent discontinuations
Medicines watch list
- Therapeutic Goods (Medicines Watch List) Determination 2018
The medicines set out in Schedule 1, being reportable medicines, are determined for the purposes of subsections 30EF(2) and 30EG(2) of the Act.
OTC medicines
- Therapeutic Goods (OTC Medicines - Information that Must Accompany Application for Registration) Determination 2018
Sets out the kind of information which must accompany an application for the registration of an over-the-counter (OTC) medicine, and the form in which the application must be submitted
Overseas regulators
- Therapeutic Goods (Overseas Regulators) Amendment (Singapore) Determination 2022
This instrument amends the Therapeutic Goods (Overseas Regulators) Determination 2018 to determine the Health Sciences Authority of Singapore to be an overseas regulator for the purposes of section 41BIB of the Therapeutic Goods Act 1989. - Therapeutic Goods (Overseas Regulators) Determination 2018
Determines certain bodies to be overseas regulators for the purposes of section 41BIB of the Therapeutic Goods Act 1989.
Permissible indications
- Therapeutic Goods (Permissible Indications) Determination (No. 1) 2021
Specifies the indications that are permitted for use in a medicine listed in the Australian Register of Therapeutic Goods under sections 26A or 26AE of the Therapeutic Goods Act 1989 and any requirements associated with their use in such medicines
Permissible ingredients
- Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2023
Specifies those ingredients that may be contained in a medicine that is listed in the Australian Register of Therapeutic Goods under section 26A or 26AE of the Therapeutic Goods Act 1989, and requirements in relation to the inclusion of those ingredients in such medicines. - Therapeutic Goods (Permissible Ingredients - Information hat must Accompany Application for Variation) Determination
Prescription medicines
- Therapeutic Goods (Prescription Medicines - Kind of Information that Must Accompany Application for Registration) Determination 2022
This instrument determines, for the purposes of subparagraph 23B(2)(d)(i) of the Therapeutic Goods Act 1989, the kind of information that must accompany an application for the registration of certain prescription and other medicines. - Therapeutic Goods (Prescription Medicines - Information Accompanying Applications for Registration) Determination 2021
This instrument determines, for the purposes of subparagraph 23B(2)(d)(ii) of the Therapeutic Goods Act 1989, the form for information in an application dossier that accompanies an application for the registration of certain prescription and other medicines.
Pharmacopoeias
- See pharmacopoeias for Therapeutic goods (exempting monographs) determinations
Reportable medicines
- Therapeutic Goods (Reportable Medicines) Determination 2018
The medicines set out in Schedule 1, being medicines that are registered goods, are determined to be reportable medicines for the purposes of subparagraph 30EH(1)(b)(ii) of the Act.
Specified foreign countries and jurisdictions under subregulation 16DA(3)
- Therapeutic Goods (Foreign Countries and Foreign Jurisdictions) Determination 2019
Specifies the foreign countries and jurisdictions determined for the purpose of regulation 16DA of the Therapeutic Goods Act 1989
Specified foreign countries under section 19A(3)
- Therapeutic Goods (Foreign Countries) Determination 2016
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
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