Publication of List of Manufacturers Suspended from Licensing for the Manufacture of Therapeutic Goods – 11 February 2025

Overview

The Therapeutic Goods Act 1989, enacted by the Commonwealth Parliament, was introduced to regulate the supply and importation of therapeutic goods in Australia, ensuring they are safe, of high quality, and effective. The Act addresses issues related to the quality and safety of therapeutic goods by governing their manufacture, importation, and supply, ensuring that they meet necessary standards. This legislation empowers the Therapeutic Goods Administration (TGA) to take action, such as suspending manufacturing licenses, when required to protect public health. In this context, the TGA has the authority under Section 41(1)(d) of the Act to suspend a licence if there are concerns about the quality or safety of the therapeutic goods being produced. The policy objective of this suspension is to safeguard public health by preventing potentially unsafe therapeutic goods from entering the market. On 11 February 2025, Katherine Clark, acting as a delegate of the Secretary of the Department of Health and Aged Care and the Therapeutic Goods Administration, published a notice regarding the suspension of a manufacturing licence. Specifically, the licence held by Golden Health Pty Ltd, located at 542 Somerville Road, Sunshine West, VIC, 3020, with the licence number MI-2015-LI-01228-1, was suspended from 31 October 2024 to 28 February 2025 at the request of the manufacturer. This action was taken to ensure that the therapeutic goods produced by the company do not pose a risk to public health during the specified period.

Scope and Application

The Therapeutic Goods Act 1989 applies to entities and individuals engaged in the manufacture, importation, supply, or sponsorship of therapeutic goods within Australia. This encompasses a broad range of products, including medicines, medical devices, blood, and tissues, ensuring that these goods meet specific safety, quality, and efficacy standards. The Act applies nationally, with jurisdiction over therapeutic goods across the Commonwealth, states, and territories of Australia. The Therapeutic Goods Administration (TGA), operating under the Department of Health and Aged Care, is the regulatory authority responsible for enforcing compliance with the Act. The Act includes provisions for issuing, suspending, or cancelling licences for manufacturing therapeutic goods, as demonstrated in the recent suspension of GOLDEN HEALTH PTY LTD’s licence. The Act does not specify exclusions or exemptions but operates through subordinate instruments, such as the Therapeutic Goods Regulations 1990, which provide further detail on compliance requirements and enforcement mechanisms.

Key Provisions

The Therapeutic Goods Act 1989, through Section 41, empowers the Secretary of the Department of Health and Aged Care, Therapeutic Goods Administration to suspend a licence for the manufacture of therapeutic goods. Specifically, Section 41(1)(d) allows the Secretary to suspend a licence on the request of the manufacturer, as evidenced by the notice published on 11 February 2025. In this instance, the licence held by Golden Health Pty Ltd, located at 542 Somerville Road, Sunshine West, VIC, 3020, Licence No. MI-2015-LI-01228-1, has been suspended from 31 October 2024 to 28 February 2025. This suspension halts the manufacturer's ability to produce therapeutic goods during the specified period. The obligations under the Therapeutic Goods Act 1989 require manufacturers like Golden Health Pty Ltd to adhere to stringent quality and safety standards. When a licence is suspended, the manufacturer must cease all activities related to the manufacture of therapeutic goods within the stipulated timeframe. This ensures that any potential risks associated with the manufacturing process are mitigated during the suspension period. The manufacturer must also ensure that any ongoing or planned manufacturing activities are halted to comply with the Act's provisions. Failure to comply with the suspension order can result in significant consequences. Under the Therapeutic Goods Act 1989, continued manufacturing during the suspension period can be considered an offence. The Act provides for both civil and criminal penalties for non-compliance. Civil penalties may include fines, while criminal penalties could result in imprisonment. The exact penalties are not specified in the notice but are detailed in the relevant sections of the Act. Adhering to the suspension is crucial to avoid these legal repercussions.