COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On November 5 2014, the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”), by application of Merck Sharp & Dohme Australia Pty Ltd, gave consent to supply
betamethasone (DIPROSONE) 0.47mg/mL (as dipropionate) lotion bottle [AUST R 18829] that does not conform with clause 3(1)(b)(ii)of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the letter height for parts of the bottle label is less than the minimum requirement of 1.5 mm.
The consent is effective from November 5, 2014.
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The bottle labels to which this consent applies are those supplied with the application, in which the text height for Directions for Use and Sponsor details is 1.3 mm, instead of the required minimum of 1.5 mm.
- The bottles are supplied in their registered cartons, which have text heights compliant with the requirements of TGO 69.
Overview
The Therapeutic Goods Act 1989 was enacted to provide a legal framework for regulating therapeutic goods in Australia, ensuring their quality, safety, and efficacy. This Act was introduced to address the need for comprehensive regulation of therapeutic goods, including medicines, medical devices, and blood and blood components. Enacted by the Parliament of Australia, the Act aims to protect public health by controlling the supply, advertising, and clinical trials of therapeutic goods. In specific instances where non-compliance with certain standards poses minimal risk to public health, the Act allows for the granting of consent to supply goods that do not fully meet regulatory requirements, subject to specified conditions to mitigate any potential risks. The consent given in this instance allows for the supply of betamethasone lotion under certain conditions, despite the non-compliance with label text height requirements, reflecting the Act's balanced approach to regulatory oversight and public health protection.
Scope and Application
The Therapeutic Goods Act 1989 applies to therapeutic goods, including medicines, medical devices, blood, and tissues, within the Commonwealth of Australia. It establishes the framework for the regulation of these goods, ensuring that they meet safety, quality, and efficacy standards. The Act applies to all entities involved in the supply of therapeutic goods, including manufacturers, importers, sponsors, and distributors. It covers various industries, such as pharmaceuticals, biotechnology, and medical device manufacturing, and regulates their conduct and transactions related to therapeutic goods. The Act's jurisdictional reach is national, with the Therapeutic Goods Administration (TGA) as the regulatory body overseeing compliance across all states and territories of Australia. Under the Act, certain exclusions and exemptions apply, particularly for low-risk goods and for research and clinical trial purposes. The application of the Act can be extended or restricted through subordinate instruments, such as therapeutic goods orders, which provide specific requirements and guidelines for different types of goods and activities.
In this particular instance, the Act was applied to consent for the supply of betamethasone lotion by Merck Sharp & Dohme Australia Pty Ltd, where a deviation from the label height requirement was allowed under specific conditions. This case demonstrates how the Act provides flexibility in its application to ensure public health and safety while accommodating legitimate business needs.
Key Provisions
The main operative sections of this legislation (sections 14 and 14A) pertain to the consent process for the supply of therapeutic goods that do not conform with the requirements set out in the Therapeutic Goods Orders. In this instance, Merck Sharp & Dohme Australia Pty Ltd applied for consent to supply a specific formulation of betamethasone lotion, which does not meet the minimum letter height requirements for its bottle labels as stipulated in TGO 69. This consent allows the company to supply the non-compliant product under certain conditions, which are outlined in the Act.
The obligations and requirements imposed on the parties by this Act include adherence to the Therapeutic Goods Orders, specifically the general requirements for labels for medicines (TGO 69). While the bottle labels of the betamethasone lotion supplied by Merck Sharp & Dohme do not meet the specified letter height of 1.5 mm, the cartons in which the bottles are supplied must comply with the requirements of TGO 69. This ensures that the cartons, which are visible and readable to consumers, meet the necessary standards for legibility and safety.
Any breaches of the Therapeutic Goods Act 1989 or the Therapeutic Goods Regulations 1990 may result in civil or criminal penalties. Under section 33 of the Act, an individual or entity found guilty of an offence may be subject to penalties, including fines of up to $1,215,000 for corporations and $243,000 for individuals, depending on the severity of the breach. Additionally, section 35 of the Act allows for criminal prosecution of individuals responsible for the breach, which may result in imprisonment for up to five years. These penalties serve as a deterrent to non-compliance and ensure the safety and quality of therapeutic goods supplied in Australia.