Poisons Standard Amendment No. 5 of 2011

Administered by Department of Health, Disability and Ageing

Legislation au F2011L02530 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Subject:           Therapeutic Goods Act 1989

 

Poisons Standard Amendment No.5 of 2011

 

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 and Ageing, 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 for 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.  Part 6-3 of the TG Act also provides for the constitution of those committees and other administrative arrangements in relation to the carrying out of their functions in accordance with the regulations.

 

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 purpose of this instrument is to amend the Poisons Standard 2011.  The amendments to the Poisons Standard 2011 set out in Schedule 1 of this instrument consist of decisions made by a delegate of the Secretary.  These amendments commence on 1 January 2012.

 

The Schedules contained in the Poisons Standard are referred to under State and Territory legislation for regulatory purposes.  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 Appendix C of the Poisons Standard is also prohibited.

 

The amendments to the Poisons Standard 2011 that are set out in this instrument consist of changes to existing entries and changes to include specified substances in the Poisons Standard for the first time.

 

A number of these changes were made following the provision of advice from the ACMS and the ACCS.  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 advisory committee for advice.  A copy of the SPF is available from www.tga.gov.au/industry/scheduling-spf.htm.

 

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

 

  • 5-aminolevulinic acid, laureth carboxylic acids and sodium lauryl sulfate.  The invitation to comment in relation to these substances was advertised on the TGA website (www.tga.gov.au) from 29 September 2010, and closed on 29 October 2010.  Public submissions were taken into consideration at the December 2010 joint meeting of the ACMS and the ACCS.  Further public comment was subsequently invited on the delegate’s interim decisions on 16 February 2011, with a closing date of 2 March 2011.  The delegate’s final decisions in relation to these matters were published on the TGA website on 23 March 2011.  The delegate decided that these decisions should be implemented from 1 January 2012;

 

  • cefquinome, derquantel, diethylhexyl phthalate and metofluthrin.  The invitation to comment in relation to these substances was advertised on the TGA website from 15 December 2010, and closed on 19 January 2011.  Public submissions were taken into consideration at the February 2011 meeting of the ACCS.  Further public comment was subsequently invited on the delegate’s interim decisions on 27 April 2011, with a closing date of 11 May 2011.  The delegate’s final decisions in relation to these matters were published on the TGA website on 1 June 2011.  The delegate decided that these decisions should be implemented from 1 January 2012; and

 

  • mesotrione, naphthalene (including camphor), nicotine, pyroxasulfone and saflufenacil.  The invitation to comment in relation to these substances was advertised on the TGA website from 13 April 2011, and closed on 13 May 2011.  Public submissions were taken into consideration at the June 2011 meetings of the ACMS and the ACCS.  Further public comment was subsequently invited on the delegate’s interim decisions on 24 August 2011, with a closing date of 7 September 2011.  The delegate’s final decisions in relation to these matters were published on the TGA website on 28 September 2011.  The delegate decided that these decisions should be implemented from 1 January 2012.

 

The other amendments set out in this instrument added the new substances cabazitaxel, catumaxomab, flazasulfuron and ipilimumab to the Poisons Standard for the first time.  These decisions were delegate-only decisions that were not open to public consultation, as they were considered to be sufficiently straight forward, in accordance with the guidelines in the SPF, as to not require public consultation.  For some of these previously unscheduled substances, consultation in relation to scheduling was undertaken with the sponsor of the substances.

 

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).

 

Overview

The Therapeutic Goods Act 1989 (TG Act) was enacted to ensure the quality, safety, efficacy and timely availability of therapeutic goods used or exported from Australia. It provides a framework for controlling the availability and accessibility of poisons, with the aim of minimising the risks of poisoning and misuse. The Therapeutic Goods Administration (TGA) is responsible for administering the TG Act, and the Poisons Standard, which classifies substances into schedules signifying the degree of control over their availability, is a key instrument in this process. The Therapeutic Goods Administration (TGA) has the authority to amend the Poisons Standard or prepare a new one under subsection 52D(2) of the TG Act. This is achieved through the advice and recommendations of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS). The Poisons Standard Amendment No. 5 of 2011 was introduced to update the Poisons Standard, incorporating new substances and revising existing entries, following advice from these committees and public consultations. The amendments to the Poisons Standard aim to enhance the regulation of therapeutic goods, ensuring they meet the safety and efficacy standards required by the TG Act. These amendments are integral to the Commonwealth's and the States and Territories' regulatory and enforcement frameworks for therapeutic goods.

Scope and Application

The Therapeutic Goods Act 1989 (TG Act) serves as the regulatory framework for controlling the quality, safety, efficacy, and timely availability of therapeutic goods used or exported from Australia, overseen by the Therapeutic Goods Administration (TGA). This Act also establishes a uniform system for the control of poisons across the states and territories, aimed at ensuring safe handling and accessibility. Under the TG Act, the Poisons Standard, which classifies substances into various schedules based on the level of control needed, is subject to amendment by a delegate of the Secretary. This instrument amends the Poisons Standard, affecting substances such as 5-aminolevulinic acid and cefquinome, among others, by altering their classifications or including them for the first time. These amendments are made following advice from expert committees and public consultation, and they take effect from 1 January 2012. The scheduling of substances under this instrument is integral to both state and federal regulatory frameworks, guiding enforcement actions under the TG Act and related legislation.

Key Provisions

The main operative sections of the Poisons Standard Amendment No.5 of 2011 (the Amendment) pertain to the changes made to the Poisons Standard 2011, which classifies substances into schedules based on the degree of control recommended over their availability to the public. These changes include the reclassification of some substances and the introduction of new substances into the Poisons Standard. Specifically, section 3 of the Amendment outlines the changes made to the Poisons Standard by amending Schedule 1 of the instrument. These amendments, which took effect from 1 January 2012, involved various substances being added to or reclassified within the Poisons Standard schedules. The amendment also specifies that certain decisions were made by a delegate of the Secretary, while others were made following advice from the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS), and after considering public submissions. The Amendment imposes certain obligations and requirements on the parties and entities it governs. For instance, it requires that the Poisons Standard be referenced under State and Territory legislation for regulatory purposes. The Commonwealth also uses the scheduling and classification of substances in the Poisons Standard for regulatory and enforcement purposes under the Therapeutic Goods Act 1989 (TG Act). Additionally, the Amendment mandates that the scheduling decisions be made in accordance with the Scheduling Policy Framework (SPF), which provides guidance to assist delegates in making decisions on whether a matter would benefit from being referred to an advisory committee for advice. Public consultation was a part of the process for certain substances, requiring the Therapeutic Goods Administration (TGA) to advertise the proposals on its website and consider public submissions before making final decisions. The Amendment includes provisions for offences, penalties, and civil or criminal consequences for breaches of the Poisons Standard. Under the TG Act, there are prohibitions on advertising certain substances to consumers, with specific penalties for violations. For example, advertising prescription medicines in Schedule 4 or 8, or over-the-counter medicines in Schedule 3 that are not included in Appendix H, is prohibited. Similarly, advertising substances in Schedule 9 or Appendix C is also prohibited. The TG Act provides for the imposition of fines and imprisonment for breaches related to the advertising of scheduled substances, although the specific penalties are not detailed in the Amendment. Furthermore, any breaches of the Poisons Standard that contravene the TG Act may result in civil or criminal actions, depending on the nature and severity of the breach.

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