Publication of List of Manufacturers Granted Licence for the Manufacture of Therapeutic Goods – 21 August 2024

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the provision of therapeutic goods in Australia, aiming to ensure their quality, safety, and efficacy. This legislation fills a critical gap by establishing a comprehensive regulatory framework for the approval, manufacture, and distribution of therapeutic goods, including medicines, medical devices, and blood products. The Act was introduced by the Commonwealth Parliament to address the need for stringent oversight and quality control in the therapeutic goods sector. The policy objective behind the Act is to protect public health by ensuring that only therapeutic goods meeting the required standards are available for use in Australia. On 21 August 2024, the Therapeutic Goods Administration, as a delegate of the Secretary of the Department of Health and Aged Care, published a list of manufacturers granted a licence to manufacture therapeutic goods under Section 38 of the Therapeutic Goods Act 1989. This publication identifies specific companies, including COREGAS PTY LTD, DHL SUPPLY CHAIN (AUSTRALIA) PTY LIMITED, MAHPHARMA PTY LTD, CYCLOWEST HOLDINGS PTY LTD, and ANGRON PTY LTD, that have been granted licences to manufacture therapeutic goods. The publication serves to inform the public and stakeholders about the entities authorised to produce therapeutic goods, ensuring compliance with the regulatory standards set by the Act.

Scope and Application

The Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration (TGA) under the Department of Health and Aged Care, governs the regulation of therapeutic goods in Australia. This Act applies to entities and individuals involved in the manufacture, supply, and importation of therapeutic goods, ensuring that these goods meet safety, quality, and efficacy standards. The scope of the Act includes all therapeutic goods, which encompass medicines, medical devices, blood and blood components, tissues, and in vitro diagnostic goods. The Act applies nationally across Australia, covering all states and territories, thereby establishing a uniform regulatory framework for therapeutic goods. Specific entities, such as manufacturers, importers, and suppliers, are required to comply with the provisions of the Act, which includes obtaining necessary licences and adhering to manufacturing and quality standards. The Act does not, however, apply to certain goods that are exempt, such as listed low-risk medical devices and certain non-therapeutic goods. The application and enforcement of the Act may be extended or modified through subordinate instruments, such as regulations and guidelines, issued by the TGA.

Key Provisions

The Therapeutic Goods Act 1989, under Section 38, empowers the Secretary to grant a Licence to Manufacture Therapeutic Goods to eligible entities. This recent publication (Section 1) lists specific companies that have been granted such licences. The listed companies include COREGAS PTY LTD with Licence No. MI-2021-LI-03524-1, DHL SUPPLY CHAIN (AUSTRALIA) PTY LIMITED with Licence No. MI-2023-LI-12749-1, MAHPHARMA PTY LTD with Licence No. MI-2023-LI-09891-1, CYCLOWEST HOLDINGS PTY LTD with Licence No. MI-2022-LI-15970-1, and ANGRON PTY LTD with Licence No. MI-2023-LI-12445-1. Each licence is tied to a specific address, which is noted in the publication. Entities granted a Licence to Manufacture Therapeutic Goods are subject to certain obligations under the Therapeutic Goods Act 1989. These obligations include adhering to stringent quality control standards, maintaining detailed records of manufacturing processes, and ensuring that all therapeutic goods produced meet the required safety and efficacy standards. Additionally, the licence holders must comply with any additional requirements stipulated by the Therapeutic Goods Administration, such as regular inspections and reporting. Failure to meet these obligations can lead to the suspension or revocation of the licence. The Therapeutic Goods Act 1989 also outlines specific offences and penalties for breaches of the legislation. Any entity found to be manufacturing therapeutic goods without a valid licence, or in violation of the conditions of their licence, can face substantial penalties. These penalties may include fines, imprisonment, or both, depending on the severity of the breach. For example, knowingly manufacturing substandard therapeutic goods could result in a maximum penalty of up to five years imprisonment and/or substantial fines. Additionally, civil actions for compensation may be pursued against entities that cause harm due to non-compliance. In summary, the Therapeutic Goods Act 1989, through its Section 38, mandates that only entities with valid licences can manufacture therapeutic goods in Australia. The Act imposes rigorous quality and compliance requirements on these entities, with serious consequences for non-compliance. These consequences include fines, imprisonment, and civil liabilities, ensuring that the therapeutic goods supplied to the Australian market are of the highest quality and safety standards.