Poisons Standard Amendment No. 2 of 2014

Administered by Department of Health, Disability and Ageing

Legislation au F2014L00566 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

Subject:           Therapeutic Goods Act 1989

 

Poisons Standard Amendment No. 2 of 2014

 

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 purpose of this instrument is to amend the Poisons Standard 2013. The amendments to the Poisons Standard 2013 set out in Schedule 1 of this instrument consist of decisions made by a delegate of the Secretary. These amendments commence on 1 June 2014.

 

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 Appendix C of the Poisons Standard is also prohibited.

 

The amendments to the Poisons Standard 2013 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 ACMS and 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 http://www.tga.gov.au/industry/scheduling-spf.htm.

 

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

 

  • Esomeprazole and macrogols - the invitation to comment in relation to these substances was advertised on the TGA website (www.tga.gov.au) from 29 August 2013, and closed on 26 September 2013; and

 

  • Aminopyralid, phosphonium, tributyloctyl-,chloride (1:1), pyridine, 2-chloro-6- (trichloromethyl), sulfites, benzidine-based azo dyes, 2-amino-5-ethylphenol, 2-butanone, oxime (also known as methyl ethyl ketone oxime), diethylene glycol monobutyl ether, tetrahydrofuran, 2-nitrotoluene, furfural (also known as 2-furancarboxaldehyde), methanol, pentanoic acid, 3-methyl-2-oxo-, ethyl ester, mercaptoacetic acid,1,3-cyclohexadiene-1-carboxylic acid, 4,6,6-trimethyl-, ethyl ester, 3,7-dimethyl-2,6-octadienal isomers (citral, geranial and neral), zinc lactate, triethanolamine, trisiloxane, 1,1,1,3,5,5,5-heptamethyl-3-[(trimethylsilyl)oxy], interpretation, ethanol, 2-(dimethylamino)- (also known as deanol) and salicylic acid - the invitation to comment in relation to these substances was advertised on the TGA website (www.tga.gov.au) from 17 October 2013, and closed on 14 November 2013.

 

Public submissions in relation to these substances were taken into consideration at the meetings of the ACCS, the ACMS and a joint meeting of the ACMS and the ACCS, in November 2013. Further public comment was subsequently invited on the delegate’s interim decisions on 27 February 2014, with a closing date of 13 March 2014. The delegate’s final decisions in relation to these matters were published on the TGA website on 14 April 2014.

 

The delegate decided that these decisions should be implemented from 1 June 2014.

 

Other amendments set out in this instrument added a number of new substances to the Poisons Standard for the first time, including collagenase clostridium histolyticum, empagliflozin, febuxostat, normal human immunoglobulin, serelaxin, simeprevir, sofosbuvir, umeclidinium, afoxolaner and fluensulfone.

 

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 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, enacted by the Parliament of Australia, aims to establish and maintain a system of controls for the quality, safety, efficacy, and timely availability of therapeutic goods used or exported from Australia. This Act also provides a framework for states and territories to adopt a uniform approach to control the availability, accessibility, and safe handling of poisons within Australia. The Therapeutic Goods Administration is responsible for administering this Act. One of the key provisions of the Act is the Poisons Standard, which classifies substances into different schedules based on the degree of control recommended to be exercised over their availability to the public. The Poisons Standard Amendment No. 2 of 2014, enacted by a delegate of the Secretary to the Department of Health, amends the Poisons Standard 2013 to include new substances and update existing entries, following recommendations from the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling and considering public submissions. The purpose of this amendment is to ensure the safe handling and restricted supply of scheduled substances in accordance with the degree of risk associated with them, thereby protecting public health and safety. These amendments, which took into account expert advice and public consultation where applicable, commenced on 1 June 2014. This amendment also aligns with the Scheduling Policy Framework, which guides decision-making on whether to refer matters to expert advisory committees for advice.

Scope and Application

The Therapeutic Goods Act 1989, as amended by the Poisons Standard Amendment No. 2 of 2014, governs the control and regulation of therapeutic goods within Australia. This legislation applies to the quality, safety, efficacy, and timely availability of therapeutic goods used in or exported from Australia, and establishes a uniform system of controls to manage the availability and accessibility of poisons across the country. The Therapeutic Goods Administration (TGA) administers this Act and is responsible for the implementation of the Poisons Standard, which includes the classification of substances into nine different schedules indicating the level of control required over their public availability to mitigate health and safety risks. The Act applies to various substances and entities involved in the manufacture, supply, and distribution of therapeutic goods, including medicines and chemicals. The jurisdictional reach of this legislation is national, as it pertains to the entire Commonwealth of Australia. The Poisons Standard Amendment No. 2 of 2014 includes amendments to the existing Poisons Standard, made by a delegate of the Secretary to the Department of Health. These amendments consist of changes to existing entries and the inclusion of new substances within the Poisons Standard. The amendments apply to substances such as esomeprazole, macrogols, and several other chemicals, with some of these decisions being made following advice from the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling. The amendment instrument also includes substances added to the Poisons Standard for the first time, such as collagenase clostridium histolyticum, empagliflozin, and others. The amendment instrument, being a legislative instrument under the Legislative Instruments Act 2003, is not subject to disallowance, and therefore, a statement of compatibility with human rights is not required. The amendments set out in this instrument commence on 1 June 2014.

Key Provisions

The Therapeutic Goods Act 1989 (TG Act) and the Poisons Standard Amendment No. 2 of 2014 provide a regulatory framework for the control and management of therapeutic goods, including poisons, in Australia. Section 52D(2) of the TG Act allows the Secretary to the Department of Health, or a delegate, to amend the Poisons Standard or prepare a new one, which classifies substances into different Schedules based on the level of control recommended over their availability to the public (section 52D(2)). Part 6-3 of the TG Act establishes a uniform system of access controls for goods containing scheduled substances, aiming to minimise the risks of poisoning and misuse (section 6-3). The Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) provide expert advice and recommendations on scheduling decisions (sections 52B and 52C). The Poisons Standard, which includes nine Schedules, is referenced in State and Territory legislation to enforce restrictions on the supply of scheduled substances (section 52D). The amendments to the Poisons Standard 2013, effective from 1 June 2014, involve changes to existing entries and the addition of new substances, such as collagenase clostridium histolyticum and empagliflozin, to the Standard for the first time (Schedule 1). These amendments are based on advice from the ACMS, ACCS, and public consultations where applicable. The Poisons Standard Amendment No. 2 of 2014 imposes obligations on entities to comply with the new classifications and restrictions on the supply of scheduled substances. This includes ensuring that advertising of certain substances, such as prescription medicines in Schedule 4 or 8, and over-the-counter medicines in Schedule 3 but not in Appendix H, is prohibited (section 52D). Entities must also adhere to the new classifications for substances like aminopyralid and pyridine, which have been added to the Standard for the first time. Public consultations were held for substances like esomeprazole and macrogols, with submissions considered by the relevant advisory committees. For substances like collagenase clostridium histolyticum, which were added without public consultation, entities must still comply with the new classifications and restrictions. Failure to comply with the provisions of the Poisons Standard and the TG Act can result in civil or criminal penalties. The TG Act prohibits the publication of advertisements for scheduled substances in certain categories and imposes penalties for non-compliance. The exact penalties are not specified in the explanatory statement, but generally, breaches of the TG Act can result in fines and, in some cases, imprisonment. The amendments to the Poisons Standard 2013 aim to enhance public health and safety by ensuring appropriate controls are in place for the supply of scheduled substances. Non-compliance with these new classifications and restrictions can lead to regulatory action under the TG Act, including fines and other enforcement measures. The legislative instrument is not subject to disallowance under the Legislative Instruments Act 2003 (section 42) and does not require a statement of compatibility with human rights under the Human Rights (Parliamentary Scrutiny) Act 2011.

Legal classification tags

Area of Law
Administrative Law
Regulatory Standards
Environmental Law
Instrument
Regulation
Concepts
Definitions & Interpretation
Enforcement Powers
Reporting & Disclosure Obligations
Consultation Requirements

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.