Poisons Standard Amendment No. 1 of 2013

Administered by Department of Health, Disability and Ageing

Legislation au F2013L00527 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Subject:           Therapeutic Goods Act 1989

Poisons Standard Amendment No. 1 of 2013

 

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 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 purpose of this instrument is to amend the Poisons Standard 2012.  The amendments to the Poisons Standard 2012 set out in Schedule 1 of this instrument consist of decisions made by a delegate of the Secretary.  These amendments commence on 1 May 2013.

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 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 the Therapeutic Goods Regulations 1990 (the 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 that are 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 2012 set out in this instrument consist of changes to existing entries, and the inclusion of a number of specified substances in the Poisons Standard for the first time.

A number of these changes were made following the provision of advice from the ACCS and the ACMS, in accordance with the procedures set out in Subdivision 3D.2 of Part 6 of the Regulations 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 advisory committee for advice.  A copy of the SPF is available from http://www.tga.gov.au/industry/scheduling-spf.htm.

Public comment was invited on those matters referred to the ACCS and the ACMS, which related to proposals to amend the Poisons Standard in relation to the substances carbamide peroxide, diclofenac, hydrogen peroxide, ostarine, retigabine, selective androgen receptor modulators (SARM), teriflunomide, thymol and vitamin D.  The invitation to comment in relation to these substances was advertised on the TGA website (www.tga.gov.au) from 14 August 2012, and closed on 12 September 2012.  Public submissions were taken into consideration at the October 2012 meeting of the ACMS.  Further public comment was subsequently invited on the delegate’s interim decisions in relation to those substances on 7 January 2013, with a closing date of 21 January 2013.  The delegate’s final decisions in relation to those substances were published on the TGA website on 13 February 2013.  The delegate decided that the decisions should commence from 1 May 2013.

Other amendments set out in this instrument added a number of new substances to the Poisons Standard for the first time, including for example alogliptin, besifloxacin hydrochloride, canagliflozin, crofelemer, cyantraniliprole, dimethyl fumarate, ivacaftor, micafungin, olodaterol, pasireotide, pasireotide disaspartate, prucalopride, retapamulin, tildipirosin, vilanterol and vilanterol trifenatate.  These decisions were delegate-only decisions that were not open to public consultation, as they were considered (in accordance with the SPF) to be sufficiently straightforward, as not to require public consultation.  For some of these previously unscheduled substances, consultation in relation to scheduling was undertaken with the sponsor of the substance.  The delegate’s final decisions in relation to these matters were published on the TGA website on 13 February 2013 and 6 March 2013.  The delegate decided that these decisions should commence from 1 May 2013.

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.

Overview

The Therapeutic Goods Act 1989 (TG Act) governs the regulation of therapeutic goods in Australia, ensuring their quality, safety, efficacy, and timely availability. The Act provides a framework for the scheduling and control of poisons, enabling the states and territories to adopt a uniform approach to regulating the availability and accessibility of these substances. The Therapeutic Goods Administration (TGA) administers the Act, and it includes provisions for amending the Poisons Standard, which lists substances classified into schedules based on the degree of control recommended for their availability to the public. The Poisons Standard Amendment No. 1 of 2013, enacted by a delegate of the Secretary under the authority of the TG Act, aims to update the Poisons Standard 2012 by including new substances and modifying existing entries. The changes were made following advice from expert committees and public consultations, and the amendments commenced on 1 May 2013. These amendments are integral to maintaining a cohesive regulatory environment that safeguards public health and safety by controlling the distribution and use of potentially hazardous substances.

Scope and Application

The Therapeutic Goods Act 1989 (TG Act) and the accompanying Poisons Standard Amendment No. 1 of 2013 govern the regulation of therapeutic goods, including medicines and poisons, in Australia. This legislation applies to a broad spectrum of entities, including individuals, companies, and other organisations that manufacture, supply, or import therapeutic goods within Australia or for export from Australia. The Act's reach encompasses the entire Commonwealth, ensuring a uniform approach to the control and regulation of substances that may pose risks to public health and safety. The Therapeutic Goods Administration (TGA), as the administering authority, enforces the provisions of the Act and the Poisons Standard, which classifies substances into various schedules based on the level of control required for their availability and supply to the public. The Act allows for amendments to the Poisons Standard through decisions made by a delegate of the Secretary, and these amendments can include changes to existing entries or the introduction of new substances. Public consultations are conducted for significant amendments, although some straightforward decisions may proceed without such consultations. The amendments made by this instrument, which include the scheduling of new substances and modifications to existing entries, are intended to enhance public safety by better controlling the availability and use of potentially harmful substances.

Key Provisions

The main operative sections of the F2013L00527, which amends the Poisons Standard under the Therapeutic Goods Act 1989, include section 52D(2) (subsections 52D(2) and 52D(4A)) which authorises the Secretary to the Department of Health and Ageing, or a delegate of the Secretary, to amend the Poisons Standard or prepare a new one, replacing the current Standard for the Uniform Scheduling of Medicines and Poisons. The amendments made in this instrument are intended to update the Poisons Standard 2012, and include changes to existing entries and the addition of new substances, which were decided by a delegate of the Secretary. These amendments are outlined in Schedule 1 of the instrument and are set to commence on 1 May 2013. The obligations and requirements imposed by the Act on the parties or entities it governs include the establishment of expert advisory committees, namely the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS), which provide advice and recommendations to the Secretary or a delegate regarding scheduling decisions. The Poisons Standard, which classifies substances into various schedules, is referred to under state and territory legislation to enable restrictions on the supply of scheduled substances. The Act also prohibits the publication of advertisements to consumers about certain prescription and over-the-counter medicines, as well as substances included in Schedule 9 or Appendix C of the Poisons Standard. The Therapeutic Goods Administration (TGA) is responsible for administering the Act and ensuring compliance with the requirements of the Poisons Standard. In terms of offences, penalties, or civil/criminal consequences for breach, the Therapeutic Goods Act 1989, along with the Therapeutic Goods Regulations 1990, prohibits the publication of advertisements to consumers about prescription medicines included in Schedule 4 or 8 of the Poisons Standard, as well as over-the-counter medicines that are included in Schedule 3 and not included in Appendix H of the Poisons Standard. Advertising of substances included in Schedule 9 or Appendix C of the Poisons Standard is also prohibited. The maximum penalties for contravening these provisions may vary depending on the specific offence and jurisdiction, but can include fines, imprisonment, or both. Additionally, the Act provides for the establishment of civil penalties for breaches of certain obligations under the Act, which may include fines up to a specified amount. The Poisons Standard is a legislative instrument for the purposes of the Legislative Instruments Act 2003; however, section 42 (disallowance) of the Legislative Instruments Act 2003 does not apply to this instrument (refer to subsection 52D(4A) of the Therapeutic Goods Act 1989). 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 Act and its associated regulations are designed to ensure the safe handling, availability, and accessibility of therapeutic goods in Australia, ultimately protecting public health and safety.

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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.