Therapeutic Goods (Poisons Standard—June 2023) Instrument 2023

Administered by Department of Health, Disability and Ageing

Legislation au F2023L00617 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

Therapeutic Goods Act 1989

 

Therapeutic Goods (Poisons Standard—June 2023) Instrument 2023

 

The Therapeutic Goods Act 1989 (“the Act”) provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy, and timely availability of therapeutic goods that are used in, or exported from, Australia. The Act also provides a framework for State and Territory governments to adopt a uniform approach to control the availability and accessibility, and to ensure the safe handling, of medicines and poisons in Australia. The Act is administered by the Therapeutic Goods Administration (“the TGA”) within the Australian Government Department of Health and Aged Care.

 

Part 6-3 of the Act (sections 52AA to 52EC) provides the basis for a uniform system of access controls for goods containing scheduled substances. The scheduling of substances allows restrictions to be placed on their supply to the public, in the interests of public health and safety. The scheduling of substances is aimed at minimising the risks of poisoning from, and the misuse or abuse of, scheduled substances.

 

Subsection 52D(2) of the Act empowers the Secretary to amend the current Poisons Standard or to prepare a document in substitution for the current Poisons Standard. The current Poisons Standard includes Schedules containing the names or descriptions of substances, with certain levels of control applying to each Schedule in accordance with the risk associated with the substances in a Schedule.

 

The Therapeutic Goods (Poisons Standard—June 2023) Instrument 2023 (“the Instrument”) repeals and replaces the Therapeutic Goods (Poisons Standard—February 2023) Instrument 2023 (“the Former Instrument”), which had been in effect since 1 February 2023.

 

The purpose of the Instrument is principally to incorporate a number of changes to existing entries and to include a number of specified substances in the current Poisons Standard for the first time.

 

Background

 

The Poisons Standard reflects decisions of the Secretary or a delegate of the Secretary regarding the classification of medicines and poisons into the different Schedules, signifying the degree of risk and the control recommended to be exercised over their availability to the public. These decisions are published on the TGA website.

 

The Act establishes two expert advisory committees, the Advisory Committee on Medicines Scheduling (“the ACMS”) (section 52B of the Act refers) and the Advisory Committee on Chemicals Scheduling (“the ACCS”) (section 52C of the Act refers), which provide advice and make recommendations to the Secretary on matters relating to medicines and chemicals scheduling decisions.

 

The Scheduling Policy Framework (“the SPF”) provides guidance on whether a decision concerning the scheduling of substances would benefit from being referred to ACMS or ACCS for advice. A copy of the SPF can be found at: www.tga.gov.au/publication/ahmac-scheduling-policy-framework-medicines-and-chemicals.

 

The Schedules to the Poisons Standard are incorporated by reference in State and Territory legislation for regulatory purposes. This enables restrictions to be placed on the supply of scheduled substances to the public, according to the degree of risk associated with the substances and the level of control recommended over their availability, in the interest of public health and safety.

 

Similarly, the Commonwealth utilises the scheduling and classification of substances in the current Poisons Standard for some regulatory and enforcement purposes under the Act. For example, the Act prohibits the publication or broadcasting of advertisements to consumers about prescription medicines containing substances included in Schedule 4 or Schedule 8 to the current Poisons Standard, or over-the-counter medicines containing substances included in Schedule 3 and not included in Appendix H of the current Poisons Standard. The advertising of substances included in Schedule 9 or Schedule 10 to the Poisons Standard is also prohibited.

 

Purpose

 

The Instrument incorporates a number of changes to existing entries in the current Poisons Standard, and includes a number of specified substances in the current Poisons Standard for the first time. A number of these changes were made following the provision of advice from the ACCS or the ACMS, in accordance with the procedures set out in Subdivision 3D.2 of Part 6 of the Therapeutic Goods Regulations 1990 (“the Regulations”) for amending the Poisons Standard when a proposed amendment is referred to an expert advisory committee.

 

New schedule entries

 

The Instrument provides for the inclusion of a number of new substances (i.e. new chemical entities) in the Poisons Standard for the first time, including the following:

  • andexanet alfa, in Schedule 4 to the Poisons Standard;
  • avatrombopag, in Schedule 4 to the Poisons Standard;
  • difelikefalin, in Schedule 4 to the Poisons Standard, and Appendix K (sedation warning);
  • ethalfluralin, in Schedule 7 to the Poisons Standard;
  • ivosidenib, in Schedule 4 to the Poisons Standard;
  • pralsetinib, in Schedule 4 to the Poisons Standard;
  • spiromesifen, in Schedule 5 to the Poisons Standard;
  • tigolaner, in Schedule 5 and 6 to the Poisons Standard (at different concentrations).

 

The Instrument also introduces a new schedule entry for an existing substance:

  • brimonidine, in Schedule 2 to the Poisons Standard; and makes a consequential amendment to the Schedule 4 entry for brimonidine;

 

Amendments to schedule entries

 

The Instrument includes amendments to existing schedule entries for a number of substances, including the following:

  • amendments to the schedule entries for fexofenadine and melatonin;
  • deletion of ivermectin from Appendix D (clause 10) of the Poisons Standard, with no changes to the entries for ivermectin in Schedules 4, 5 or 7.

 

The Instrument also includes minor amendments to the schedule entry for afamelanotide, and consolidates the index entries for phenylphenol and o-phenylphenol, principally to add clarity, remove duplicate index entries, and correct typographical errors. These amendments do not alter the substantive content or effect of those schedule entries.

Incorporation by reference

 

Subsection 52D(4B) of the Act relevantly provides that, despite subsection 14(2) of the Legislation Act 2003 (“the Legislation Act”), an instrument made under paragraph (2)(a) or (b) of section 52D may make provision in relation to a matter by applying, adopting or incorporating any matter contained in an instrument or other writing as in force or existing from time to time.

 

The Instrument incorporates the following documents by reference, in the manner outlined:

 

  • United States Code of Federal Regulations, Title 16, Section 1700.15, Poison prevention packaging standards and Section 1700.20, Testing procedure for special packaging. The intended manner of incorporation is as in force from time to time, as specifically provided for in paragraph (b)(iv) of the definition of child-resistant packaging in section 6 of the Instrument. This document is freely available from the Code of Federal Regulations website (www.ecfr.gov); and

 

  • National Transport Commission, Australian Code for the Transport of Dangerous Goods by Road & Rail. The intended manner of incorporation is as it exists from time to time, as identified in section 10 of the Instrument. This document is freely available from the National Transport Commission website (www.ntc.gov.au).

 

The following documents are also incorporated by reference, with the intended manner of incorporation being as they exist from time to time, as provided in section 10 of the Instrument:

 

  • Australian Standard AS 1928‑2007, Child‑resistant packaging – Requirements and testing procedures for reclosable packages (ISO 8317:2015, MOD);

 

  • International Organization for Standardization Standard ISO 8317:2015, Child‑resistant packaging—Requirements and testing procedures for reclosable packages;

 

  • Australian Standard AS 2216‑1997, Packaging for poisonous substances;

 

  • Australian Standard AS 4710-2001, Packages for chemicals not intended for access or contact with their contents by humans;

 

  • Australian Standard AS 1580-301.1-2005, Paints and related materials – Methods of test – Non-volatile content by mass;

 

  • Australian Standard AS 8124.4-2003, Safety of toys, Part 4: Experimental sets for chemistry and related activities;

 

  • Australian/New Zealand Standard AS/NZS ISO 8124.3:2012, Safety of toys Part 3: Migration of certain elements (ISO 8124-03:2010, MOD);

 

  • Australian Standard AS 1928‑2001, Child‑resistant packages;

 

  • British Standards Institution Standard BS EN ISO 8317:2004, Child‑resistant packaging—Requirements and testing procedures for reclosable packages;

 

  • Canadian Standards Association Standard CSA Z76.1‑06, Reclosable Child‑Resistant Packages;

 

  • Personal Care Products Council of America, International Cosmetic Ingredient Dictionary & Handbook; and

 

  • Agricultural and Veterinary Chemicals Code (Agricultural Active Constituents) Standards 2022, published by the Australian Pesticides and Veterinary Medicines Authority.

 

However, these documents are not publicly available for free. Rather, they can, by prior written arrangement where possible and without charge, be viewed by members of the public at the TGA office in Fairbairn, ACT. While these documents are not available for free, it is anticipated that the persons most affected by their adoption in the current Poisons Standard would likely be in possession of these documents. As important benchmarks for the safety of therapeutic goods and other consumer goods, it would be infeasible from a regulatory perspective to not adopt such benchmarks on the basis that the publications are not available for free.

 

Consultation

 

Proposed amendments referred to an expert advisory committee

 

Public comment was invited in relation to the proposed amendments that were referred to the November 2022 meetings of the ACMS and the ACCS. In particular, invitation to comment on the proposed inclusion of new entries for ethofluralin and tigolaner, and the amendments in relation to brimonidine, fexofenadine, ivermectin and melatonin, was published on the TGA website on 1 September 2022, with a closing date of 29 October 2022. A further invitation to comment on these proposals was published on 3 February 2023, with a closing date of 3 March 2023. Notification of the final decisions made in relation to these substances was published on the TGA website on 3 May 2023.

 

Delegate-only decisions

 

The decisions to include andexanet alfa, avatrombopag, difelikefalin, ivosidenib, pralsetinib, and spiromesifen in the Poisons Standard were made as delegate-only decisions, in accordance with the SPF, and were considered sufficiently straightforward as to not require public consultation. The decisions are made pursuant to Subdivision 3D.3 of Part 6 of the Regulations. Notification of these decisions was published on the TGA website on 3 May 2023.

 

The minor amendments with respect to afamelanotide, phenylphenol and o-phenylphenol were considered sufficiently minor as not to require public consultation.

 

The Instrument is a legislative instrument for the purposes of the Legislation Act. However, section 42 of the Legislation Act relating to disallowance does not apply (subsection 52D(4A) of the Act refers). As the Instrument is not disallowable, subsection 9(1) of the Human Rights (Parliamentary Scrutiny) Act 2011 does not require that the Instrument be accompanied by a statement of compatibility with the human rights recognised under that Act.

 

In providing that disallowance does not apply to an instrument made under paragraphs 52D(2)(a) or (b) of the Act, subsection 52D(4A) of the Act appropriately recognises that instruments made under these paragraphs form part of an intergovernmental scheme, which should not be subject to unilateral disallowance by the Commonwealth Parliament, consistent with section 44 of the Legislation Act. Under this scheme, the current Poisons Standard principally provides a set of recommendations to the States and Territories as to the appropriate level of controls that should apply to medicines and poisons.

 

The States and Territories regulate such substances by electing to apply the current Poisons Standard as a law within their own jurisdiction. In this way, the current Poisons Standard does not have direct application in its own right. If the current Poisons Standard was to be subject to disallowance, this would impact the current uniform system of restrictions in Australia relating to the supply of scheduled substances, and would lead to confusion and different approaches across different States and Territories with respect to their handling, storage, possession and supply of scheduled substances.

 

Further, as inclusion of new medicines in the current Poisons Standard is often a consequence of the granting of marketing approval of new medicines under the Act, it is likely that disallowance would also lead to delays for Australian patients in accessing new and effective treatments.

 

The Instrument commences on 1 June 2023.

Overview

The Therapeutic Goods Act 1989 was enacted to establish and maintain a national system of controls for the quality, safety, efficacy, and timely availability of therapeutic goods used in or exported from Australia. This legislation provides a framework for State and Territory governments to adopt a uniform approach to control the availability and accessibility, and to ensure the safe handling, of medicines and poisons within Australia. The Act is administered by the Therapeutic Goods Administration (TGA) within the Australian Government Department of Health and Aged Care. The Act's Part 6-3, in particular, establishes a uniform system of access controls for goods containing scheduled substances, aiming to minimise the risks of poisoning and misuse or abuse through the scheduling of substances. The Therapeutic Goods (Poisons Standard—June 2023) Instrument 2023 updates and replaces the previous Instrument from February 2023, incorporating changes to existing entries and adding new substances to the Poisons Standard for the first time. These changes were primarily made based on advice from the relevant expert advisory committees, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling, and follow procedures outlined in the Therapeutic Goods Regulations 1990. The Instrument also incorporates several other standards and benchmarks for packaging and transport of dangerous goods, although these documents are not freely available to the public.

Scope and Application

The Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration (TGA) within the Australian Government Department of Health and Aged Care, sets up a national system of controls for the quality, safety, efficacy, and timely availability of therapeutic goods in Australia. The Act also facilitates a uniform approach for state and territory governments to regulate the availability, accessibility, and safe handling of medicines and poisons. Part 6-3 of the Act, particularly sections 52AA to 52EC, establishes a uniform system for access controls on goods containing scheduled substances, ensuring public health and safety by minimising the risks of poisoning and misuse of these substances. The Act empowers the Secretary to amend or replace the Poisons Standard, which categorises substances based on their risk level and the degree of control needed over their availability to the public. The Therapeutic Goods (Poisons Standard—June 2023) Instrument 2023 amends the Poisons Standard by incorporating changes to existing entries and including new substances for the first time. This Instrument replaces the Therapeutic Goods (Poisons Standard—February 2023) Instrument 2023 and incorporates several new substances into the Poisons Standard, such as andexanet alfa, avatrombopag, difelikefalin, ethalfluralin, ivosidenib, pralsetinib, spiromesifen, and tigolaner, each placed in different schedules based on their risk profiles. Additionally, it includes brimonidine in Schedule 2 and makes amendments to entries for fexofenadine, melatonin, and ivermectin. The Instrument also incorporates various standards and regulations by reference, such as the United States Code of Federal Regulations and the Australian Code for the Transport of Dangerous Goods by Road and Rail, ensuring alignment with international and national safety benchmarks. Notably, this Instrument does not apply to disallowance, preserving the uniform regulatory approach across Australia and avoiding potential delays in patient access to new treatments.

Key Provisions

The Therapeutic Goods (Poisons Standard—June 2023) Instrument 2023 modifies the existing Poisons Standard, which is incorporated by reference into State and Territory legislation for regulating the supply of scheduled substances. The Instrument introduces several new substances into the Poisons Standard, including andexanet alfa, avatrombopag, difelikefalin, ethalfluralin, ivosidenib, pralsetinib, spiromesifen, tigolaner, and brimonidine, each placed into different schedules based on their risk profile and required level of control. Additionally, it makes amendments to existing entries for substances such as fexofenadine, melatonin, and afamelanotide, and removes ivermectin from Appendix D while retaining its entries in other schedules. The Instrument also consolidates and corrects index entries for phenylphenol and o-phenylphenol without altering their substantive content. The changes are based on advice from expert committees and follow a consultation process with the public and relevant stakeholders. The Instrument imposes obligations on the parties involved in the handling, supply, and regulation of therapeutic goods containing scheduled substances. For example, it requires that substances be classified and scheduled in a manner that reflects their risk to public health and safety, and that these classifications be incorporated into State and Territory legislation. The Instrument also mandates the use of specific packaging standards for certain substances to prevent poisoning, particularly among children. Furthermore, it restricts the advertising of certain substances to the public, particularly those that pose a higher risk of misuse or abuse. These obligations are designed to ensure that the supply of therapeutic goods is controlled in a way that protects public health and safety. Failure to comply with the provisions of the Instrument can result in various civil or criminal consequences, depending on the nature and severity of the breach. For example, advertising restricted substances in a manner that contravenes the Poisons Standard could result in fines or other penalties under State and Territory legislation. Similarly, supplying substances without the appropriate level of control, as dictated by their schedule in the Poisons Standard, could also lead to regulatory action, including fines or other sanctions. The specific penalties for breaches of the Poisons Standard vary by jurisdiction, but can include substantial fines and, in some cases, imprisonment for serious offences. The Instrument itself does not specify maximum penalties, as these are typically detailed in the relevant State and Territory legislation that incorporates the Poisons Standard.

Legal classification tags

Area of Law
Medical Law
Environmental Law
Instrument
Regulation
Concepts
Definitions & Interpretation
Reporting & Disclosure Obligations
Licensing & Registration

Interactions

Authorises

All Versions

Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.