Publication of List of Manufacturers Granted Licence for the Manufacture of Therapeutic Goods – 09 July 2025

Overview

The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, was introduced to address the need for regulation and oversight of therapeutic goods in order to ensure public health and safety. The Act established the Therapeutic Goods Administration (TGA) under the Department of Health, Disability and Ageing, which is responsible for regulating the supply, manufacture, and advertising of therapeutic goods. The primary policy objective of the Act is to protect the public from unsafe and ineffective therapeutic goods, thereby ensuring that therapeutic goods available in Australia meet necessary quality, safety, and efficacy standards. The Act provides the legal framework for the TGA to issue licences to entities involved in the manufacture and supply of therapeutic goods, ensuring that only compliant and quality-assured products reach the market.

Scope and Application

The Therapeutic Goods Act 1989 applies to any person or entity involved in the manufacture, supply, or importation of therapeutic goods in Australia. This includes pharmaceutical products, medical devices, blood and blood components, and therapeutic appliances, amongst others. The Act governs the regulation of these goods to ensure their safety, quality, and efficacy. It applies across the Commonwealth and extends to all states and territories within Australia, establishing a unified regulatory framework for therapeutic goods. While the Act broadly covers a wide range of therapeutic goods, there are specific exclusions and exemptions, such as certain low-risk products, which are detailed in the Act or associated regulations. The application of the Act can be further extended or restricted through subordinate legislation, such as regulations and guidelines, which provide additional detail on compliance requirements and enforcement mechanisms.

Key Provisions

The Therapeutic Goods Act 1989, specifically Section 38, mandates the publication of a list of manufacturers granted a licence for the manufacture of therapeutic goods (Section 38). In this context, the Therapeutic Goods Administration (TGA) has granted licences to several companies, including MAGELLANS LABORATORIES PTY LTD, PIA PHARMA PTY LTD, TASMANIAN PHARMACEUTICALS PTY LTD, SW TRANSLINK PACKAGING PTY LTD, SEQIRUS PTY LTD, MCDONNELL DOUGLAS HOLDING PTY LTD, and EXERGY PTY LTD. Each of these companies has been assigned a unique licence number and is permitted to manufacture therapeutic goods in accordance with the terms and conditions of their respective licences. The obligations imposed on these licensed manufacturers include adherence to strict quality standards and regulatory requirements. These obligations encompass maintaining adequate facilities and equipment, ensuring that the manufacturing processes meet all relevant guidelines, and having appropriate personnel with the necessary qualifications and training. Additionally, manufacturers are required to implement and maintain a quality management system that ensures the safety, efficacy, and quality of the therapeutic goods they produce. They must also keep detailed records of their manufacturing processes and activities, which must be made available to the TGA upon request. Failure to comply with the obligations and requirements set forth in the Therapeutic Goods Act 1989 can result in significant consequences. Section 26 of the Act outlines various offences that can be committed, such as manufacturing therapeutic goods without a valid licence or failing to comply with the conditions of a licence. Offences under this Act can result in both civil and criminal penalties. For example, individuals and companies found guilty of manufacturing therapeutic goods without a valid licence may face fines of up to $220,000 for individuals and $1,100,000 for companies. Furthermore, imprisonment terms can be imposed, with individuals potentially facing up to five years in prison and companies up to seven years. These penalties reflect the seriousness of non-compliance and the importance of adhering to the regulatory framework designed to protect public health.