Publication of List of Manufacturers Granted Licence for the Manufacture of Therapeutic Goods – 9 April 2025

Overview

The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, was introduced to regulate the safety, quality, and efficacy of therapeutic goods available in the Australian market. The Act established a comprehensive framework for the approval, monitoring, and oversight of therapeutic goods, including medicines, medical devices, and blood products. One of its key objectives is to ensure that therapeutic goods available to consumers meet necessary standards for safety and effectiveness. This Act empowers the Therapeutic Goods Administration (TGA) to grant licenses to manufacturers, thereby allowing the TGA to maintain stringent control over the manufacturing processes and the distribution of therapeutic goods. The TGA, acting under the authority of the Act, ensures that manufacturers comply with good manufacturing practices, thereby safeguarding public health. On 9 April 2025, the Department of Health and Aged Care, through the Therapeutic Goods Administration, published details of licences granted to several manufacturers of therapeutic goods, including Johnson & Johnson Pacific Pty Ltd, Food and Pharma Australia Pty Ltd, St Vincent’s Institute of Medical Research t/a National Serology Reference Laboratory Australia, and Trisnbell Pty Ltd trading as TNB Pharmaceuticals. This publication is part of the ongoing regulatory process to maintain the integrity and safety of the therapeutic goods supply chain in Australia. The policy objective of these regulations is to ensure that only products that meet the required standards for quality, safety, and efficacy are available to consumers, thereby protecting public health.

Scope and Application

The Therapeutic Goods Act 1989 provides a comprehensive framework for the regulation of therapeutic goods in Australia, ensuring that these products are safe, of high quality, and effective. The Act applies to any entity or individual involved in the manufacture, importation, supply, or advertising of therapeutic goods within Australia, which include medicines, medical devices, blood, and tissues. The legislation extends to the entire Commonwealth, thereby governing therapeutic goods across all states and territories. However, certain activities, such as the regulation of blood and tissues, are subject to specific state and territory laws, and the Act acknowledges these jurisdictional nuances. The Act also specifies exclusions; for instance, therapeutic goods used solely for personal, non-commercial purposes are exempt from the licensing requirements. The scope of the Act is further refined through subordinate instruments that provide detailed guidelines on compliance and enforcement. These regulations ensure that the primary Act’s objectives are met effectively, maintaining the high standards expected in the therapeutic goods industry.

Key Provisions

The Therapeutic Goods Act 1989 outlines the requirements and processes for the licensing of therapeutic goods manufacturers (s. 38). According to this Act, the Secretary of the Department of Health and Aged Care, Therapeutic Goods Administration has the authority to grant licences to companies for the manufacture of therapeutic goods. The published list includes four companies that have been granted such licences: JOHNSON & JOHNSON PACIFIC PTY LTD, FOOD AND PHARMA AUSTRALIA PTY LTD, ST VINCENT’S INSTITUTE OF MEDICAL RESEARCH trading as NATIONAL SEROLOGY REFERENCE LABORATORY AUSTRALIA, and TRISNBELL PTY LTD trading as TNB PHARMACEUTICALS. Each of these companies has been issued a specific licence number, and their locations have been documented in the notice. The obligations imposed on the licence holders are significant, as they must adhere to the standards and requirements set forth by the Therapeutic Goods Administration. These obligations include maintaining appropriate manufacturing practices, ensuring product quality, and complying with all relevant regulations regarding the production and distribution of therapeutic goods. The companies must also keep detailed records of their manufacturing processes and be subject to regular inspections by the Therapeutic Goods Administration to ensure ongoing compliance. Failure to meet these obligations can lead to serious consequences. Under the Therapeutic Goods Act 1989, breaches of licensing conditions can result in the revocation of the licence, which would prevent the company from continuing to manufacture therapeutic goods. Additionally, the Act allows for the imposition of fines and other penalties for non-compliance. For instance, Section 120 of the Act provides for substantial financial penalties for offences related to the manufacture of therapeutic goods, with the maximum penalty often reflecting the severity of the breach. Civil or criminal proceedings may also be initiated against individuals or companies that fail to comply with the Act, further underscoring the importance of adhering to the stipulated requirements.