Poisons Standard July 2015

Administered by Department of Health, Disability and Ageing

Legislation au F2015L00844 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Subject:           Therapeutic Goods Act 1989

 

Poisons Standard July 2015

 

The Therapeutic Goods Act 1989 (the TG Act) provides for the establishment and maintenance of a system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.  The TG Act also provides for a framework for the States and Territories to adopt a uniform approach to control the availability and accessibility, and to ensure the safe handling, of poisons in Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the TG Act.

 

Subsection 52D(2) of the TG Act authorises the Secretary to the Department of Health, or a delegate of the Secretary, to amend the current Poisons Standard (known as the Standard for the Uniform Scheduling of Medicines and Poisons) or to prepare a document (a new Poisons Standard) that includes schedules containing the names or descriptions of substances, in substitution for the current Poisons Standard.

 

Part 6-3 of the TG Act 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.

 

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

 

The Poisons Standard consists of decisions of the Secretary, or a delegate of the Secretary, regarding the classification of poisons into nine different Schedules signifying the degree of control recommended to be exercised over their availability to the public.

 

The Schedules contained in the Poisons Standard are referred to under 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 them and the degree of control recommended to be exercised over their availability, in the interest of public health and safety.

 

The Commonwealth also takes into account the scheduling and classification of substances in the Poisons Standard for regulatory and enforcement purposes under the TG Act.

 

For example, the TG Act and regulations prohibit the publication of advertisements to consumers about prescription medicines included in Schedule 4 or 8 of the Poisons Standard or over the counter medicines included in Schedule 3 and not included in Appendix H of the Poisons Standard. The advertising of substances included in Schedule 9 or Schedule 10/Appendix C of the Poisons Standard is also prohibited.

 

The purpose of this instrument is to prepare a new Poisons Standard (cited as the Poisons Standard July 2015) in substitution for the previous Poisons Standard.  The previous Poisons Standard that is being substituted is the Poisons Standard June 2015 (which commenced on 1 June 2015).

 

The Poisons Standard July 2015 also incorporates a number of new changes not previously included in the Poisons Standard June 2015.  These amendments involve changes to existing entries.

 

A number of these changes were made following the provision of advice from the ACCS, in accordance with the procedures set out in Subdivision 3D.2 of Part 6 of the Therapeutic Goods Regulations 1990 for amending the Poisons Standard when a proposed amendment is referred to an expert advisory committee. 

 

The Scheduling Policy Framework (SPF) provides guidance to assist delegates in making a decision on whether a matter would benefit from being referred to an expert advisory committee for advice.  A copy of the SPF is available from https://www.tga.gov.au/publication/ahmac-scheduling-policy-framework-medicines-and-chemicals.

 

Public comment was invited on those matters referred to the March and July 2014 ACCS meetings, which related to proposals to amend the Poisons Standard in relation to the following substances:

 

  • 2,4-Diaminophenoxyethanol sulfate - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 30 January  2014, and closed on 20 February 2014;
  • 2-Ethylhexyl 2-ethylhexanoate or hexanoic acid, 2-ethyle-,2-ethylhexyl ester - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 30 January  2014, and closed on 20 February 2014;
  • 4,4-Dimethyl-1-cyclohexene-1-propanal - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 30 January  2014, and closed on 20 February 2014;
  • Phenylenediamines - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 29 May 2014, and closed on 26 June 2014.
  • Rosin - the invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 29 May 2014, and closed on 26 June 2014.

 

Further public comment was subsequently invited on the delegates interim decisions on 27 June 2014 (with a closing date of 11 July 2014), and 14 November 2014 (with a closing date of 28 November 2014).

 

The delegates' final decisions in relation to these matters were published on the TGA website on the 7 August 2014, and 24 December 2014.

 

The Poisons Standard is a legislative instrument for the purposes of the Legislative Instruments Act 2003 (the LIA).  However, section 42 (disallowance) of the LIA does not apply (refer to subsection 52D(4A) of the TG Act).

 

As this 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.

 

The instrument commences on 1 July 2015.

 

 

Overview

The Therapeutic Goods Act 1989 (TG Act) is a cornerstone of Australia's regulatory framework for therapeutic goods, ensuring the quality, safety, and efficacy of these products, as well as their timely availability. This legislation addresses the need for a cohesive system to manage the use and export of therapeutic goods within Australia. It also provides a basis for uniform control over the availability and handling of poisons across states and territories, with the Therapeutic Goods Administration (TGA) being the key body responsible for administering the Act. The Act’s objective is to protect public health and safety by regulating the scheduling of substances, thereby controlling their accessibility and mitigating risks such as poisoning and misuse. The Poisons Standard, a part of this Act, classifies substances into various schedules based on the level of control necessary, and these classifications are used to enforce restrictions on supply according to the associated risk levels. The Poisons Standard July 2015 was enacted to replace the previous Poisons Standard June 2015, incorporating new changes and updates following advice from expert committees. This legislative instrument aims to reflect the latest expert recommendations and public consultations, ensuring that the scheduling of substances remains aligned with current public health needs and safety standards. The process involves input from advisory committees, public consultations, and adherence to the Scheduling Policy Framework, ensuring that the decisions made are informed and comprehensive. This approach facilitates a robust system of access controls and regulatory enforcement under the TG Act, thereby continuing to safeguard public health and safety through effective management of therapeutic goods and poisons.

Scope and Application

The Therapeutic Goods Act 1989 (TG Act) serves to regulate the quality, safety, efficacy, and timely availability of therapeutic goods within Australia and those exported from the country. This includes a framework for controlling the availability and accessibility of poisons, ensuring their safe handling. The Therapeutic Goods Administration (TGA) is tasked with administering the TG Act. The Poisons Standard, a legislative instrument, is integral to this Act, categorising substances into various Schedules to dictate the level of control over their public availability. This Standard is referred to in state and territory legislation to enforce restrictions on the supply of scheduled substances, aligning with the degree of risk they pose and the control needed to protect public health and safety. The Poisons Standard July 2015 replaces the previous June 2015 Standard, incorporating new changes and amendments to existing entries, based on advice from expert committees and public consultations. The scheduling of substances under the Poisons Standard is pivotal for regulatory and enforcement actions under the TG Act, including the prohibition of certain advertisements for medicines and chemicals.

Key Provisions

The main sections of the Therapeutic Goods Act 1989 (TG Act) that are relevant to the Poisons Standard July 2015 include Section 52D(2), which authorises the Secretary to the Department of Health, or a delegate of the Secretary, to amend the current Poisons Standard or prepare a new one. Part 6-3 of the TG Act establishes a uniform system of access controls for goods containing scheduled substances, allowing for restrictions on their supply to the public. The Act also establishes expert advisory committees, such as the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS), which provide advice on matters related to the scheduling of medicines and chemicals. The Poisons Standard July 2015 is a document that categorises substances into various schedules, with the level of control over their availability to the public corresponding to the degree of risk associated with them. The Poisons Standard July 2015 imposes obligations and requirements on parties and entities that it governs. For example, the Standard prohibits the publication of advertisements for certain prescription and over-the-counter medicines, as well as substances in Schedule 9 or Schedule 10/Appendix C of the Poisons Standard. The Standard also serves as a reference for State and Territory legislation, enabling the implementation of restrictions on the supply of scheduled substances to the public based on the degree of risk and the degree of control recommended to be exercised over their availability. The Commonwealth takes into account the scheduling and classification of substances in the Poisons Standard for regulatory and enforcement purposes under the TG Act. Breaches of the Poisons Standard July 2015 and the TG Act can result in various offences, penalties, and civil or criminal consequences. For example, the Act and regulations prohibit the advertisement of certain prescription medicines and over-the-counter medicines, and the advertising of substances in Schedule 9 or Schedule 10/Appendix C of the Poisons Standard is also prohibited. Penalties for breaches may include fines and imprisonment, depending on the severity of the offence and the specific provisions of the Act and regulations. The maximum penalties for offences under the TG Act are specified in the relevant sections of the Act and may vary depending on the specific offence and the jurisdiction in which it is committed.

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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.