Publication of List of Manufacturers with Revoked Suspension from Licensing for the Manufacture of Therapeutic Goods – 9 April 2025

Overview

The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, addresses the regulation of therapeutic goods to ensure public health and safety. This Act establishes a framework for the approval, regulation, and monitoring of therapeutic goods, including medicines, medical devices, and biological products. It was introduced to address the need for a cohesive and rigorous regulatory system to safeguard consumers from the risks associated with substandard or unsafe therapeutic goods. The Act provides the Therapeutic Goods Administration (TGA) with the authority to grant licenses, monitor compliance, and take enforcement actions, including suspension and revocation of licenses, to maintain high standards in the therapeutic goods market. This legislative framework aims to ensure that therapeutic goods available in Australia meet quality, safety, and efficacy requirements. On 9 April 2025, Katherine Clark, as a delegate of the Secretary of the Department of Health and Aged Care and the Therapeutic Goods Administration, published a notice concerning the revocation of suspension of a licence held by Australia Biotechnology Manufacturing Pty Ltd. The licence, MI-2022-LI-08268-1, pertains to the manufacturing of therapeutic goods at their facility located at 25-27 Pacific Drive, Keysborough, VIC, 3173. The revocation of the suspension, effective from 20 February 2025, was carried out at the request of the manufacturer. This action signifies the TGA's commitment to maintaining stringent oversight over the manufacturing processes of therapeutic goods, ensuring that only compliant entities are permitted to operate within the Australian market.

Scope and Application

The Therapeutic Goods Act 1989 applies to individuals and entities involved in the manufacturing, supply, and importation of therapeutic goods in Australia, encompassing a broad range of products including medicines, medical devices, and blood products. This Act applies to all states and territories within Australia and regulates the quality, safety, and efficacy of therapeutic goods to protect public health. The revocation of suspension of a manufacturing licence, as specified in the Act, pertains to companies that have previously had their manufacturing licences suspended and now meet the criteria for reinstatement. The geographic scope of this Act is national, ensuring uniform standards and practices across all jurisdictions. The revocation of a suspension under Section 41(5) of the Act highlights the legislative framework that allows for the reinstatement of a manufacturer's licence following compliance with relevant health and safety standards. The revocation, in this case, applies to Australia Biotechnology Manufacturing Pty Ltd, with the licence number MI-2022-LI-08268-1, located at 25-27 Pacific Drive, Keysborough, VIC, 3173. This specific revocation took effect from 20 February 2025, as announced by Katherine Clark, the Delegate of the Secretary of the Department of Health and Aged Care, Therapeutic Goods Administration, under the authority granted by Section 41 of the Act.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) includes a provision under Section 41(5) which allows the Secretary to revoke the suspension of a licence to manufacture therapeutic goods. In this instance, the Secretary, represented by Katherine Clark, has exercised this power and revoked the suspension of the licence held by Australia Biotechnology Manufacturing Pty Ltd (ABMP), licence number MI-2022-LI-08268-1, located at 25-27 Pacific Drive, Keysborough, VIC, 3173. This revocation was carried out following a request from the manufacturer and took effect from 20 February 2025. This revocation means that ABMP can resume its operations under the previously issued licence, which had been temporarily suspended. The Act imposes several obligations on ABMP as a licence holder. These include ensuring compliance with the quality and safety standards set forth in the Therapeutic Goods Regulations 1990. ABMP must also maintain records of their manufacturing processes, including any adverse events, and report these to the Therapeutic Goods Administration (TGA) as required. Furthermore, ABMP is responsible for ensuring that all therapeutic goods manufactured meet the standards specified in the Australian Register of Therapeutic Goods (ARTG). The TGA retains the right to inspect the manufacturing facilities and processes at any time to ensure compliance with the Act and the regulations. Failure to comply with the requirements of the Therapeutic Goods Act 1989 can result in several consequences. If ABMP fails to meet the quality and safety standards, or if it does not maintain proper records or report as required, the TGA may take enforcement actions. These can include the issuance of a caution or warning, the imposition of fines, or even the suspension or revocation of the licence. Under Section 86 of the Act, an individual found guilty of an offence can be subject to a fine of up to $210,000 for a corporation. In more severe cases, criminal charges may be laid, which could result in imprisonment for up to five years. The specific penalties depend on the nature and severity of the breach, and the discretion of the court.