Publication of List of Manufacturers Granted Licence for the Manufacture of Therapeutic Goods – 23 September 2025

Overview

The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, addresses the need for stringent regulation and quality control of therapeutic goods, which include medicines, medical devices, blood, and tissues. The Act was introduced to fill a critical gap in ensuring that therapeutic goods available in the Australian market are safe, of high quality, and effective for their intended use. The policy objective behind this legislation is to protect public health by regulating the manufacture, supply, and advertising of therapeutic goods. The Therapeutic Goods Administration (TGA), operating under the auspices of the Department of Health, Disability and Ageing, plays a pivotal role in enforcing the Act. This administration ensures that the manufacturers listed in the gazette, such as Probiotec Multipack Pty Ltd, Cannexx Pty Ltd, Australian Tissue Donation Network, and Centre for Digestive Diseases Pty Ltd, comply with the necessary standards and obtain appropriate licences before manufacturing therapeutic goods. By publicising the list of licenced manufacturers, the TGA aims to enhance transparency and maintain the integrity of the therapeutic goods market in Australia.

Scope and Application

The Therapeutic Goods Act 1989 applies to entities and individuals involved in the manufacture, supply, importation, and advertisement of therapeutic goods within Australia. These therapeutic goods encompass a broad range of products including medicines, medical devices, blood, and tissues. The Act mandates that any person or entity seeking to manufacture or supply these goods must obtain the appropriate licences or approvals from the Therapeutic Goods Administration (TGA), an agency under the Commonwealth of Australia. The geographic reach of the Act is national, ensuring that all therapeutic goods within Australia must comply with the regulations set forth. Notably, the Act excludes certain goods from its purview, such as food supplements, cosmetics, and certain devices which fall under different regulatory frameworks. Additionally, the Act allows for the creation of subordinate instruments to further define the scope and application of the legislation, thereby extending or restricting its application as necessary to accommodate new scientific advancements or public health considerations.

Key Provisions

The Therapeutic Goods Act 1989, through Section 38, empowers the Secretary of the Department of Health, Disability and Ageing, Therapeutic Goods Administration, to grant licences to entities for the manufacture of therapeutic goods. The published list, effective as of 23 September 2025, includes several companies granted such licences. These include PROBIOTEC MULTIPACK PTY LTD with licence number MI-2023-LI-08741-1, CANNEXX PTY LTD with licence number MI-2024-LI-09135-1, AUSTRALIAN TISSUE DONATION NETWORK with licence number MI-2022-LI-06074-1, and CENTRE FOR DIGESTIVE DISEASES PTY LTD with licence number MI-2021-LI-04554-1. Each of these entities is authorised to manufacture therapeutic goods as per the conditions specified in their respective licences. Entities granted manufacturing licences under Section 38 of the Therapeutic Goods Act 1989 are subject to specific obligations and requirements. These include adherence to Good Manufacturing Practice (GMP) standards, maintaining records of manufacturing processes, ensuring the quality and safety of the therapeutic goods they produce, and complying with any additional conditions set by the Therapeutic Goods Administration. Failure to meet these obligations can result in the suspension or revocation of the manufacturing licence. Breaches of the Therapeutic Goods Act 1989 can lead to both civil and criminal consequences. For instance, manufacturing therapeutic goods without a valid licence is a criminal offence. The maximum penalty for such an offence can include fines up to $1.65 million for a corporation and imprisonment for up to 10 years for an individual. Additionally, civil penalties, including fines, can be imposed for non-compliance with the requirements of the Act or the terms of the licence. The exact penalties depend on the nature and severity of the breach, with the Therapeutic Goods Administration having the authority to enforce these sanctions. The Therapeutic Goods Act 1989 provides a framework for the regulation of therapeutic goods in Australia, ensuring that the manufacturing processes meet the necessary quality and safety standards. The publication of the list of licensed manufacturers serves as an official record of the entities authorised to produce therapeutic goods. Compliance with the Act is crucial for maintaining public health and safety, and the specified penalties underscore the seriousness with which breaches of the Act are treated.