Poisons Standard Amendment No. 2 of 2010

Administered by Department of Health, Disability and Ageing

Legislation au F2010L03274 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

 Subject: Therapeutic Goods Act 1989

 

Poisons Standard Amendment No.2 of 2010

 

 

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 (medicines and chemicals) in Australia.  The Therapeutic Goods Administration (the TGA) is responsible for administering the TG Act and associated Regulations under the 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 or prepare a document (a new Poisons Standard) that includes schedules containing the names or descriptions of substances, in substitution for the current Poisons Standard.  This authority had previously been provided to an independent statutory committee established under the TG Act, the National Drugs and Poisons Schedule Committee (NDPSC), which no longer exists due to the implementation of amendments to the TG Act that commenced on 1 July 2010.

 

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 interest 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 also establishes two expert advisory committees, the Advisory Committee on Medicines Scheduling (section 52B) and the Advisory Committee on Chemicals Scheduling (section 52C).  These statutory committees provide advice and make recommendations to the Secretary (or a delegate of the Secretary) on matters relating to medicines and chemicals scheduling decisions and in relation to any other matters referred to them by the Secretary.  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 2010.  The amendments to the Poisons Standard 2010 set out in Schedule 1 of this instrument consist of decisions made by a delegate of the Secretary.  These amendments commence on 1 January 2011. 

 

The statutory procedures set out under the TG Act and the Therapeutic Goods Regulations 1990 (the Regulations) allow the delegate of the Secretary to consider applications under section 52EAA of the TG Act to amend the current Poisons Standard, or to initiate an amendment or the making of a new document to substitute the current Poisons Standard on the Secretary’s (or a delegate of the Secretary) own initiative (see subsection 52D(3) of the TG Act).  Regulation 42ZCZU of the Regulations allows the Secretary, or her delegate, to make a final scheduling decision in response to an application under section 52EAA to amend the current Poisons Standard, if the decision aligns with the proposal in the application and without referring the matter for consideration by an expert advisory committee.

 

The decisions set out in this instrument were in regard to a number of new substances that have not been previously included in the Poisons Standard, as well as a number of editorial and/or errata amendments, which the delegate of the Secretary decided did not require referral to an expert advisory committee. 

 

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).

 

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.

 

A regulatory impact statement does not accompany this instrument as the amendments to the
Poisons Standard set out in this instrument are regarded as having minimal regulatory impact in general and are necessary public health measures to allow consumers appropriate and safe access to the substances contained in the amendments. 

 

These amendments did not involve public consultation as most of the amendments relate to substances that have never been entered in the Australian Register of Therapeutic Goods for the purposes of registration under the Act and have never been listed in the Poisons Standard.  For the medicines set out in this instrument, consultation was only undertaken with the sole sponsor of the medicine and expert advisory committees as they relate to the registration of the medicine.

 

 Medicines containing these new substances have never been supplied to the general public in Australia and have been classified as high risk medicines used for the treatment of serious conditions.  They are therefore required to be registered under the Act.  For these medicines to be lawfully supplied in Australia, they have to undergo a stringent process for registration that requires the evaluation of the medicine against the criteria set in subsection 25(1).  In general, the registration criteria are science based and input from the public is not necessary for their evaluation. 

 

Although registered medicines containing these substances can be lawfully supplied in Australia, the States and Territories have responsibility for controls over the access to these high risk medicines.  These controls include that these medicines can only be prescribed by a registered medical practitioner or other authorised prescribers when included in Schedule 4 or 8 of the Poisons Standard.  It is therefore required that these new high risk medicines be included in the Poisons Standard prior to commencing supply.  This arrangement is consistent with the approach recommended in the Galbally Report, that is that the registration of medicines be better integrated with the scheduling of substances contained in these medicines.   This arrangement  is consistent with procedural requirements set out under the Regulations.

 

 

 

Overview

The Therapeutic Goods Act 1989 (TG Act) was enacted to establish a system of controls for the quality, safety, efficacy, and timely availability of therapeutic goods used or exported from Australia. The Act also provides a framework for the States and Territories to regulate the availability and accessibility of poisons (medicines and chemicals) to ensure safe handling. The Poisons Standard Amendment No.2 of 2010 addresses a gap in the regulatory system by updating the Poisons Standard, which classifies substances into different schedules based on the degree of control recommended for their public availability. This amendment was introduced to ensure that newly identified substances are included in the Poisons Standard, thereby integrating medicine registration with scheduling as recommended in the Galbally Report. The amendments were made by a delegate of the Secretary to the Department of Health and Ageing, under the authority granted by the TG Act, and do not require disallowance under the Legislative Instruments Act 2003. The Poisons Standard is a crucial legislative instrument that is referenced in State and Territory legislation for regulatory purposes and by the Commonwealth for enforcement under the TG Act.

Scope and Application

The Therapeutic Goods Act 1989 (TG Act) serves as the legislative framework for ensuring the quality, safety, efficacy, and timely availability of therapeutic goods within Australia, including those intended for export. The Act is administered by the Therapeutic Goods Administration (TGA), which is responsible for regulating the therapeutic goods market to protect public health. 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 through the classification of substances into various schedules based on the degree of control needed over their public availability. The Act authorises the Secretary or a delegate to amend the Poisons Standard, which lists substances classified into nine schedules, thereby setting the controls for their supply. This legislative instrument amends the Poisons Standard 2010 by including new substances and making editorial amendments, which are deemed necessary public health measures and do not require extensive public consultation. The amendments concern substances never previously registered in Australia and are considered high-risk medicines requiring stringent evaluation and registration criteria. While these amendments are primarily administrative, they are integral to ensuring that high-risk medicines are safely integrated into the Australian market under appropriate regulatory controls. The Poisons Standard Amendment No. 2 of 2010 applies to substances newly classified and those requiring editorial adjustments, thereby impacting the regulatory landscape for therapeutic goods in Australia. These amendments are integral to aligning the Poisons Standard with the latest therapeutic advancements and ensuring that the public health protections remain robust. The amendments do not involve significant public consultation, as they primarily concern substances that have not yet been introduced to the market and the changes are considered administrative. The scheduling of these substances is crucial for ensuring they are only available through appropriate medical channels, as regulated by the States and Territories in accordance with the TG Act and associated regulations. The Poisons Standard is pivotal in this regulatory framework, as it is referenced by State and Territory legislation and is considered by the Commonwealth for enforcement purposes under the TG Act. This amendment reflects a streamlined approach to scheduling, consistent with the recommendations of the Galbally Report, integrating medicine registration with substance scheduling to enhance public health safeguards.

Key Provisions

The Therapeutic Goods Act 1989 (TG Act) establishes a regulatory framework for therapeutic goods used or exported from Australia, with the Therapeutic Goods Administration (TGA) overseeing its administration. Under section 52D(2) of the TG Act, the Secretary to the Department of Health and Ageing, or a delegate, can amend the Poisons Standard, a schedule containing substances subject to various levels of control. The Poisons Standard consists of nine Schedules, each with a different degree of control based on the risk posed by the substance. Amendments to the Poisons Standard 2010 include new substances and editorial changes, made by a delegate of the Secretary, and these amendments take effect from 1 January 2011. The TG Act imposes obligations on the parties involved in the regulation of therapeutic goods. The Secretary, or a delegate, is responsible for scheduling substances into appropriate categories based on their potential risks. This involves considering applications under section 52EAA of the TG Act to amend the Poisons Standard and making final decisions in line with the application. Additionally, the Act mandates that new substances be registered before they can be supplied in Australia, particularly for high-risk medicines used for serious conditions. The States and Territories must then control access to these medicines, ensuring they are prescribed by authorised medical practitioners only. Breaching the requirements of the TG Act or the Poisons Standard can lead to various legal consequences. While the specific penalties are not detailed in the provided text, the Act likely incorporates general penalties for non-compliance, which can include fines or imprisonment. The Act ensures that substances, particularly those classified under Schedules 4, 8, 3, and 9, are not advertised to consumers without proper approval. The Act also prohibits the advertisement of substances in Schedule 9 or Appendix C, highlighting the stringent controls in place to protect public health. Failure to comply with these advertising restrictions could result in civil or criminal penalties, underscoring the importance of adherence to the regulatory framework established by the TG Act.

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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.