Poisons Standard Amendment No. 5 of 2012

Administered by Department of Health, Disability and Ageing

Legislation au F2012L02515 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Subject:           Therapeutic Goods Act 1989

Poisons Standard Amendment No. 5 of 2012

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 January 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 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 small 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 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 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 following substances:

  • fingolimod.  The invitation to comment in relation to this substance was advertised on the TGA website (www.tga.gov.au) from 10 August 2011, and closed on 7 September 2011.  Public submissions were taken into consideration at the October 2011 meeting of the ACMS.  Further public comment was subsequently invited on the delegate’s interim decision on 21 December 2011, with a closing date of 13 January 2012.  The delegate’s final decision in relation to this matter was published on the TGA website on 28 November 2012;
  • cetirizine, ibuprofen, penflufen and tranexamic acid.  The invitation to comment in relation to these substances was advertised on the TGA website from 26 April 2012, and closed on 25 May 2012.  Public submissions were taken into consideration at the June 2012 meetings of the ACCS and/or the ACMS.  Further public comment was subsequently invited on the delegate’s interim decision on 5 September 2012, with a closing date of 19 September 2012.  The delegate’s final decision in relation to this matter was published on the TGA website on 10 October 2012.

In each case, the delegate decided that these decisions should commence from 1 January 2013.

Other amendments set out in this instrument added new substances abiraterone acetate, aminocyclopyrachlor, boceprevir, fidaxomicin, ridaforolimus and telaprevir 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 straightforward, in accordance with the SPF, to not require public consultation.  For some of these previously unscheduled substances, consultation in relation to scheduling was undertaken with the sponsor of the substance.

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) was enacted to establish and maintain a comprehensive system of controls for the quality, safety, efficacy, and timely availability of therapeutic goods in Australia. This Act also provides a framework for the States and Territories to adopt a uniform approach to control the availability and accessibility of poisons, ensuring their safe handling. Administered by the Therapeutic Goods Administration (TGA), the Act authorises the Secretary to the Department of Health and Ageing, or a delegate, to amend the Poisons Standard or prepare a new one. This Standard classifies poisons into various schedules, which dictates the degree of control over their availability to the public. The amendments introduced by the Poisons Standard Amendment No. 5 of 2012, which came into effect on 1 January 2013, aim to refine and update the scheduling of certain substances, including fingolimod, cetirizine, ibuprofen, penflufen, tranexamic acid, abiraterone acetate, aminocyclopyrachlor, boceprevir, fidaxomicin, ridaforolimus, and telaprevir, based on expert advisory committee recommendations and public consultations where appropriate. This legislative instrument is designed to address any gaps in the existing scheduling and classification of substances, thereby enhancing public health and safety.

Scope and Application

The Therapeutic Goods Act 1989 (TG Act) governs the quality, safety, efficacy, and timely availability of therapeutic goods used or exported from Australia, with a focus on poisons management through the Poisons Standard. This Act applies to persons and entities involved in the manufacture, supply, or advertising of therapeutic goods within Australia. It is administered by the Therapeutic Goods Administration (TGA), and its jurisdiction extends across the Commonwealth, with the Poisons Standard being referenced by State and Territory legislation for local regulatory purposes. The Act includes expert advisory committees, the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS), which provide advice on scheduling decisions. The Poisons Standard, which is amended through legislative instruments like the Poisons Standard Amendment No. 5 of 2012, classifies substances into various schedules based on the level of control required for public health and safety. These amendments, which may include changes to existing entries or the addition of new substances, are made by a delegate of the Secretary and are effective from 1 January 2013, unless otherwise specified. Notably, some amendments undergo public consultation, while others are deemed straightforward enough to be made without public input. The Act does not allow for disallowance under the Legislative Instruments Act 2003, nor does it require a human rights compatibility statement under the Human Rights (Parliamentary Scrutiny) Act 2011.

Key Provisions

The main operative sections of the Poisons Standard Amendment No. 5 of 2012, as provided under the Therapeutic Goods Act 1989 (TG Act), involve updates to the scheduling of therapeutic substances in Australia. Section 52D(2) of the TG Act allows the Secretary to the Department of Health and Ageing, or a delegate of the Secretary, to amend the existing Poisons Standard or prepare a new document that includes schedules of substances. These schedules determine the degree of control over the availability and supply of these substances to the public. The amendments, detailed in Schedule 1 of the instrument, include changes to existing entries and the introduction of new substances into the Poisons Standard, which took effect from 1 January 2013. The Act imposes several obligations on parties and entities governed by it, particularly those dealing with scheduled substances. These include compliance with the new scheduling provisions as outlined in the amended Poisons Standard. The amendments affect how substances are classified and the restrictions placed on their supply and advertising. For instance, the Act and the associated regulations prohibit advertising certain prescription and over-the-counter medicines, as well as substances classified in more restrictive schedules. The amendments also introduce potential civil and criminal consequences for non-compliance. For example, unauthorised advertising of substances classified in Schedules 4, 8, 3 (excluding Appendix H), 9, or Appendix C is strictly prohibited. Violators may face penalties, although the exact penalties are not specified in the explanatory statement. Additionally, entities found in breach of these provisions may be subject to regulatory action by the Therapeutic Goods Administration (TGA), which could include fines, enforcement actions, or other administrative penalties. Public consultations were conducted for certain substances, such as fingolimod, cetirizine, ibuprofen, penflufen, and tranexamic acid, where amendments were based on expert committee advice and public feedback. Other substances, such as abiraterone acetate, aminocyclopyrachlor, boceprevir, fidaxomicin, ridaforolimus, and telaprevir, were added to the Poisons Standard without public consultation, as they were deemed straightforward enough to not require it. These amendments are significant as they directly impact the regulation and accessibility of therapeutic goods within Australia, ensuring that substances are appropriately controlled to protect public health and safety.

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