Poisons Standard Amendment No. 4 of 2012

Administered by Department of Health, Disability and Ageing

Legislation au F2012L02202 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

Subject:           Therapeutic Goods Act 1989

Poisons Standard Amendment No. 4 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 22 November 2012.

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 two editorial amendments to correct errors that were inadvertently made to the Poisons Standard by Poisons Standard Amendment No. 3 of 2012, in relation to the scheduling of loratadine.

The amendments in Poisons Standard Amendment No. 3 of 2012 (which was registered on the Federal Register of Legislative Instruments on 16 August 2012, and commenced on 1 September 2012) were intended to reflect a scheduling decision which was published on the TGA’s website (www.tga.gov.au) on 30 May 2012.

That decision exempted from scheduling solid dose oral preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when in a primary pack containing 5 dosage units or less and labelled with a recommended daily dose not exceeding 10 mg of loratadine.

Due to a drafting error, the amendment in Poisons Standard Amendment No. 3 of 2012 did not include wording clarifying that loratadine in all preparations for oral use was to be captured in Schedule 2.

As such, the relevant entry inadvertently captured liquid oral preparations in Schedule 4 and only exempted from scheduling solid dose preparations (tablets) for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when in a primary pack containing 5 dosage units or less and labelled with a recommended daily dose not exceeding 10 mg of loratadine.

This instrument therefore amends the relevant entries in the Poisons Standard 2012 regarding loratadine to make it clear that all preparations for oral use are to be classified as Schedule 2, including liquid preparations, with divided preparations for the treatment of seasonal rhinitis in adults and children 12 years of age and over when in a primary pack containing 5 dosage units or less and labelled with a recommended daily dose not exceeding 10mg of loratadine to be exempt from scheduling.

The decision to amend the Poisons Standard in the manner set out in this instrument was a delegate-only decision.  This decision was not considered to require referral to a scheduling advisory committee as it related to an editorial amendment to correct an error.  It was also considered to be important to address the inadvertent up-scheduling to Schedule 4 of liquid oral loratadine preparations as soon as possible following the matter coming to the regulator’s attention.

Sponsors of affected products, and relevant State and Territory authorities, were contacted as soon as the error was identified, to explain the situation.

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 a comprehensive regulatory framework for the quality, safety, efficacy, and timely availability of therapeutic goods used or exported from Australia. This Act provides the basis for a uniform system of controls, administered by the Therapeutic Goods Administration (TGA), to manage the availability and safe handling of poisons across the nation. The Poisons Standard, which categorises substances into schedules based on the level of control required for public health and safety, is integral to this regulatory framework. The Act also mandates the establishment of advisory committees, the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS), to advise on scheduling matters. The Poisons Standard Amendment No. 4 of 2012, enacted by a delegate of the Secretary to the Department of Health and Ageing, aims to correct errors made in the previous amendment concerning the scheduling of loratadine, ensuring that all oral preparations are appropriately classified and that specific exemptions for certain preparations are correctly applied. This amendment addresses a legislative gap identified in the previous Poisons Standard Amendment No. 3 of 2012, which inadvertently classified liquid oral loratadine preparations under Schedule 4 instead of Schedule 2. By rectifying this error, the 2012 Amendment ensures that the intended regulatory control over loratadine preparations is accurately reflected, thereby maintaining the integrity of the scheduling system and protecting public health. This corrective action was deemed urgent to prevent potential misuse or adverse effects due to incorrect scheduling. The amendments, which are not subject to disallowance or requiring a human rights compatibility statement, were promptly communicated to sponsors and relevant authorities to facilitate immediate compliance.

Scope and Application

The Therapeutic Goods Act 1989, through its Poisons Standard, regulates the availability and accessibility of therapeutic goods in Australia, ensuring they are safe and of high quality. The Act applies to therapeutic goods used within Australia or exported from the country, encompassing a broad range of products and substances. The Poisons Standard, which is a legislative instrument under the TG Act, classifies substances into various schedules based on the level of control required to manage their risks to public health. This classification is integral to the regulation of substances, enabling the imposition of appropriate restrictions on their supply to the public. The Act extends its reach across the Commonwealth, with States and Territories aligning their regulatory approaches to align with the Poisons Standard. The scheduling decisions are made by the Secretary to the Department of Health and Ageing or their delegates, often informed by recommendations from the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling. The amendments to the Poisons Standard, as detailed in the Poisons Standard Amendment No. 4 of 2012, address specific errors in previous amendments concerning the scheduling of loratadine, ensuring that all oral preparations of this substance are correctly classified, thus maintaining the integrity and effectiveness of the regulatory framework.

Key Provisions

The main operative sections of the Therapeutic Goods Act 1989 (TG Act) (section 52D(2)) allow the Secretary to the Department of Health and Ageing, or a delegate of the Secretary, to amend the Poisons Standard, or to prepare a new Poisons Standard that includes schedules containing the names or descriptions of substances. The Act also establishes expert advisory committees (sections 52B and 52C) that provide advice on medicines and chemicals scheduling decisions. The Poisons Standard itself, which consists of decisions regarding the classification of poisons into nine different Schedules, is referenced under State and Territory legislation for regulatory purposes. The Act imposes obligations on the parties or entities it governs to ensure that therapeutic goods used or exported from Australia meet quality, safety, efficacy, and timely availability standards. It also requires a uniform approach to controlling the availability and accessibility of poisons in Australia, and ensuring their safe handling. The Poisons Standard sets out access controls for goods containing scheduled substances to minimise the risks of poisoning, misuse, or abuse. The Act prohibits the publication of advertisements about certain prescription and over-the-counter medicines, and substances included in Schedule 9 or Appendix C of the Poisons Standard. The Act includes provisions for offences, penalties, and civil or criminal consequences for breaches. For example, the Act and associated regulations prohibit the publication of advertisements for prescription medicines included in Schedule 4 or 8, and over-the-counter medicines in Schedule 3 that are not included in Appendix H. Advertising substances included in Schedule 9 or Appendix C is also prohibited. Breaches of these advertising provisions may result in fines of up to $111,100 for individuals and $555,500 for bodies corporate, as well as potential criminal penalties. This particular legislation, the Poisons Standard Amendment No. 4 of 2012, amends the Poisons Standard 2012 to correct errors made in a previous amendment (Poisons Standard Amendment No. 3 of 2012) that inadvertently classified liquid oral loratadine preparations in Schedule 4. This amendment was made by a delegate of the Secretary and was not considered to require referral to a scheduling advisory committee, as it related to an editorial amendment to correct an error. The amendments to the Poisons Standard regarding loratadine aim to ensure that all preparations for oral use are classified as Schedule 2, with divided preparations for the treatment of seasonal rhinitis in adults and children 12 years of age and over, when in a primary pack containing 5 dosage units or less and labelled with a recommended daily dose not exceeding 10 mg of loratadine, to be exempt from scheduling.

Legal classification tags

Area of Law
Medical Law
Regulatory Standards
Instrument
Statutory Instrument
Concepts
Definitions & Interpretation
Regulatory Standards
Enforcement Powers
Reporting & Disclosure Obligations

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.