Publication of List of Manufacturers Granted Licence for the Manufacture of Therapeutic Goods – 11 February 2025

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the supply of therapeutic goods in Australia, ensuring that these products are safe, of high quality, and that they perform as claimed. This legislation was introduced to address the need for stringent controls over the manufacturing, importation, advertising, and supply of therapeutic goods to protect public health. The Act is administered by the Therapeutic Goods Administration (TGA), which is part of the Department of Health and Aged Care. The primary policy objective of the Act is to safeguard the health and safety of Australians by ensuring that therapeutic goods available in the market meet the necessary standards of quality, safety, and efficacy. This is achieved through the licensing of manufacturers and other entities involved in the supply chain, thereby maintaining the integrity of the therapeutic goods market. The 11 February 2025 publication by Katherine Clark, Delegate of the Secretary, Therapeutic Goods Administration, highlights the recent grants of manufacturing licences to various entities, including MODERNA MANUFACTURING AUSTRALIA PTY LTD, AUSPHEX PTY LTD, SYMBIO LABORATORIES PTY LTD, and AUSTRALIAN RED CROSS LIFEBLOOD. This announcement is a practical application of the legislative framework established by the Therapeutic Goods Act 1989, ensuring that these companies are authorised to manufacture therapeutic goods under the oversight of the TGA. By publishing these details, the Department of Health and Aged Care reinforces its commitment to transparency and accountability in the regulation of therapeutic goods.

Scope and Application

The Therapeutic Goods Act 1989 applies to entities engaged in the manufacture, supply, and distribution of therapeutic goods within Australia. This legislation ensures that such goods meet quality, safety, and efficacy standards. The Act specifically pertains to companies and individuals who are licensed to manufacture these goods, with the Licence to Manufacture Therapeutic Goods serving as a critical regulatory instrument. This list includes entities such as MODERNA Manufacturing Australia Pty Ltd, AUSPHEX Pty Ltd, SYMBIO Laboratories Pty Ltd, and Australian Red Cross Lifeblood, all of which have been granted specific licences to manufacture therapeutic goods. The Act covers all therapeutic goods, which include a wide range of products such as medicines, medical devices, blood and blood components, and in vitro diagnostic goods. The geographic reach of the Act is national, applying across all states and territories of Australia. However, the Act does provide for certain exclusions, such as goods that are considered exempt under the regulations, and may also incorporate subordinate instruments to further define and refine the scope of its application. These subordinate instruments can specify additional conditions or requirements for the manufacture and distribution of therapeutic goods, thereby extending or restricting the application of the primary Act.

Key Provisions

The Therapeutic Goods Act 1989, particularly Section 38, facilitates the granting of a licence to entities for the manufacture of therapeutic goods in Australia. This section allows the Secretary of the Department of Health and Aged Care to issue a licence to specific companies, as detailed in the Gazette publication. The listed companies include MODERNA MANUFACTURING AUSTRALIA PTY LTD (Licence No. MI-2024-LI-03818-1), AUSPHEX PTY LTD (Licence No. MI-2022-LI-07402-1), SYMBIO LABORATORIES PTY LTD (Licence No. MI-2022-LI-15450-1), and AUSTRALIAN RED CROSS LIFEBLOOD – an operating division of the Australian Red Cross Society (Licence No. MI-2024-LI-05736-1). These licences are crucial as they authorise these companies to manufacture therapeutic goods within Australia, adhering to the standards and regulations set forth by the Therapeutic Goods Administration. The Act imposes several obligations on the licensed manufacturers. Primarily, these companies must comply with stringent quality and safety standards to ensure that the therapeutic goods they produce are safe and effective for their intended use. This includes maintaining proper records of their manufacturing processes, ensuring that facilities and equipment meet regulatory standards, and adhering to Good Manufacturing Practice (GMP) guidelines. Additionally, they are required to report any adverse events or quality issues related to the therapeutic goods they produce to the Therapeutic Goods Administration. Regular inspections and audits may also be conducted by the TGA to ensure ongoing compliance with the Act. Failure to comply with the obligations set out in the Therapeutic Goods Act 1989 can lead to serious consequences. The Act provides for both civil and criminal penalties for breaches. Civil penalties can include fines up to a significant amount, depending on the severity and frequency of the offence. For instance, knowingly supplying therapeutic goods that do not comply with the standards could result in a fine of up to $1.1 million for a corporation. In more severe cases, criminal offences may be charged, leading to imprisonment for individuals involved in the breach. The maximum penalties are set out in the various sections of the Act, ensuring that there are clear repercussions for non-compliance.