EXPLANATORY STATEMENT
Subject: THERAPEUTIC GOODS ORDER NUMBER 54A
AMENDMENT TO THE STANDARD FOR DISINFECTANTS AND STERILANTS
(section 10, Therapeutic Goods Act 1989)
The Therapeutic Goods Act 1989 (the Act), which was enacted on 17 January 1990, regulates the establishment and maintenance of a national system of controls relating to the quality, safety and efficacy of therapeutic goods which are used in humans. The Act came into effect on 15 February 1991.
Section 10 of the Act empowers the Minister, or an Officer of the Commonwealth with the appropriate delegation, by Order published in the Commonwealth of Australia Gazette to determine, as required, standards for therapeutic goods.
Part 2 of the Act, in sections 10-15, contains provisions dealing with the standards which may be applied to therapeutic goods. This Part covers matters such as the determination of standards (s. 10), date of effect of standards (s.11), special standards (s.14) and consent being subject to conditions etc…. in certain circumstances (s.15).
Section 10(1) of the Act states that “The Minister may, by order published in the Commonwealth of Australia Gazette, determine that matters specified in the order specify a standard for therapeutic goods or a class of therapeutic goods identified in the order (whether or not those goods are the subject of a monograph in the British Pharmacopoeia or the British Pharmacopoeia (Veterinary)”.
The Therapeutic Goods Committee (TGC), which is the committee that advises the Minister on matters relating to standards for therapeutic goods agreed at their 19 April 1996 meeting, that the document entitled Standard for Disinfectants and Sterilants should be adopted as a Therapeutic Goods Order (TGO). This Order was signed by the delegate of the Minister on 25 October 1996.
The present Order, “No. 54A – Amendment to the standard for disinfectants and sterilants”, was made on 26 March 1997 to effect changes recommended by the Senate Standing Committee for Regulations and Ordinances in their letter of 28 November 1996 from the Committee Chairman (Bill O’Chee) to the Minister for Health and Family Services (Michael Wooldridge). This Order removes the technical legislative flaws present in TGO No.54 namely:
that documents not referenced in the parent Act, were described as however, “published from time to time”; and
that a discretion conferred upon the Secretary in TGO 54 would not have been subject to merits review.
TGO No.54A also includes two minor clarifications that were subsequently requested by industry and gives the start date for the labelling provisions.
Overview
The Therapeutic Goods Act 1989 was enacted by the Commonwealth Parliament to establish a national regulatory framework governing the quality, safety, and efficacy of therapeutic goods used in humans. The Act came into effect on 15 February 1991, providing a legislative foundation for the oversight of therapeutic goods. Section 10 of the Act grants the Minister or a delegated officer the authority to establish standards for therapeutic goods through orders published in the Commonwealth of Australia Gazette. This legislative instrument, Therapeutic Goods Order No. 54A, amends the standard for disinfectants and sterilants to rectify technical flaws identified in the previous Order, No. 54, and includes minor clarifications requested by industry. The objective of these amendments is to ensure that the standards for disinfectants and sterilants are legally sound and effectively meet the regulatory requirements set out in the Therapeutic Goods Act.
Scope and Application
The Therapeutic Goods Order Number 54A, which amends the standard for disinfectants and sterilants, applies to all therapeutic goods classified as disinfectants and sterilants within the Commonwealth of Australia. This encompasses individuals, entities, and industries that manufacture, supply, or distribute these goods. The order is an extension of the Therapeutic Goods Act 1989, which establishes a national system for controlling the quality, safety, and efficacy of therapeutic goods used in humans. The Order is designed to ensure that disinfectants and sterilants meet specific standards to safeguard public health. The scope of the Order is national, as it pertains to the entire Commonwealth, thereby ensuring uniformity across all states and territories. However, the Act allows for further specification and regulation of these standards through subordinate instruments, thus extending its application. There are no stated exclusions or exemptions in this particular Order, meaning all disinfectants and sterilants must comply with the specified standards.
Key Provisions
The primary operative sections of the Therapeutic Goods Order No. 54A, which amends the standard for disinfectants and sterilants, include section 10 of the Therapeutic Goods Act 1989 (the Act), which allows the Minister to determine standards for therapeutic goods through Orders published in the Commonwealth of Australia Gazette. This Order, No. 54A, specifically addresses and rectifies technical flaws identified in the previous Order No. 54, ensuring that all referenced documents are properly cited and that any discretion conferred upon the Secretary is subject to merits review. Additionally, it incorporates minor clarifications requested by the industry and provides a start date for the labelling provisions.
The Order imposes several obligations on the parties and entities it governs. Firstly, it requires that all disinfectants and sterilants meet the newly specified standards as outlined in the Order. This includes compliance with the labelling requirements, which detail how these products must be marked to inform users of their therapeutic qualities and any necessary warnings or instructions. Entities must also ensure that any discretion given to the Secretary under the Order is exercised fairly and in accordance with the Act. Furthermore, the Order necessitates that all relevant documentation and references are correctly cited, which aids in transparency and accountability.
In terms of consequences for non-compliance, the Therapeutic Goods Act 1989 provides for both civil and criminal penalties. Section 34 of the Act states that any person who contravenes an Order under section 10 is liable to a penalty, which can be significant depending on the severity of the breach. For example, under section 33 of the Act, an individual may face a fine of up to $330,000 for each offence if the breach is deemed serious, while corporations may face even higher penalties. Additionally, persistent or serious breaches can lead to criminal charges, resulting in potential imprisonment, further emphasizing the importance of adhering to the standards set out in the Order.