Publication of List of Manufacturers Suspended from Licensing for the Manufacture of Therapeutic Goods – 09 July 2025

Overview

The Therapeutic Goods Act 1989, enacted by the Commonwealth of Australia's Parliament, addresses the regulation of therapeutic goods within the country, aiming to ensure the safety, quality, and efficacy of these products. The Act provides a comprehensive framework to manage the manufacture, importation, supply, and advertising of therapeutic goods. It is overseen by the Therapeutic Goods Administration, which operates under the Department of Health, Disability and Ageing. One of the key objectives of this legislation is to protect public health by ensuring that only therapeutic goods that meet certain standards are available for use. In response to Section 41 of the Act, the Delegate of the Secretary, Neville Baker, has published a notice detailing the suspension of licences for certain manufacturers. This action reflects the administration's commitment to upholding the standards and ensuring the integrity of therapeutic goods. Specifically, the licences of Royal Adelaide Hospital Radiopharmacy, Gold Coast Laboratories Pty Ltd, and Veolia Environmental Services (Australia) Pty Ltd have been suspended at the request of the manufacturers themselves, with the suspensions taking effect from June 2025 to June 2026. This measure underscores the importance of maintaining high standards in the manufacture of therapeutic goods to safeguard public health.

Scope and Application

The Therapeutic Goods Act 1989 applies to a broad range of persons and entities involved in the manufacture, supply, advertising, and promotion of therapeutic goods within Australia. This includes pharmaceutical products, medical devices, and other therapeutic items, and applies to all manufacturers, importers, and suppliers of these goods. The Act governs the regulation of these goods to ensure they meet safety, quality, and efficacy standards, and it extends across the Commonwealth of Australia, applying uniformly to all states and territories. The scope of the Act is further defined through subordinate instruments, such as regulations and guidelines, which provide detailed rules and standards for compliance. Notably, certain therapeutic goods may be exempt from some provisions of the Act if they are classified as low-risk or if they are intended for personal use rather than commercial supply. Additionally, certain thresholds may apply, such as the need for a manufacturing licence only for goods produced in quantities exceeding specified limits. This gazetted notice under Section 41 of the Act provides a specific example of its application, detailing the suspension of manufacturing licences for certain entities at the request of the manufacturers themselves, thereby illustrating the Act's role in maintaining regulatory oversight and public safety within the therapeutic goods sector.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) governs the regulation of therapeutic goods in Australia, including the suspension of manufacturing licences. Section 41(1)(d) of the Act allows the Secretary of the Department of Health, Disability and Ageing, Therapeutic Goods Administration, to suspend a licence to manufacture therapeutic goods. This suspension can occur at the request of the manufacturer or under the authority of the Secretary. In this case, the licence of Royal Adelaide Hospital Radiopharmacy, Gold Coast Laboratories Pty Ltd, and Veolia Environmental Services (Australia) Pty Ltd has been suspended by notice in writing, at the request of the manufacturers. The licence of Royal Adelaide Hospital Radiopharmacy, with the licence number MI-12112004-LI-000163-1, has been suspended from 26 June 2025 to 1 July 2026. Similarly, the licence of Gold Coast Laboratories Pty Ltd, with the licence number MI-21012005-LI-000387-1, has been suspended from 26 June 2025 to 30 June 2026. Lastly, the licence of Veolia Environmental Services (Australia) Pty Ltd, with the licence number MI-28072005-LI-000720-1, has been suspended from 27 June 2025 to 29 June 2026. The obligations and requirements imposed by the Act on the parties involved include adherence to the regulatory standards for the manufacture of therapeutic goods. The manufacturers must ensure compliance with the Act and its regulations to maintain their licences. In this case, the manufacturers have requested the suspension of their licences, likely to address compliance issues, improve manufacturing practices, or undergo necessary audits and inspections. By voluntarily suspending their licences, the manufacturers acknowledge the importance of adhering to the regulatory standards set forth by the Therapeutic Goods Administration. Breach of the Therapeutic Goods Act 1989 can result in severe consequences, both civil and criminal. Under the Act, the Therapeutic Goods Administration has the authority to take action against entities that fail to comply with the regulatory requirements. Civil penalties may include fines, with the maximum penalty varying depending on the offence. Criminal penalties may include imprisonment, with the maximum penalty also depending on the severity of the offence. Additionally, the Act allows for the seizure and prohibition of sale of non-compliant therapeutic goods, further emphasising the importance of adherence to the regulatory standards. In this case, while the manufacturers have voluntarily suspended their licences, any future breaches of the Act could result in the aforementioned penalties.