Publication of List of Manufacturers Granted Licence for the Manufacture of Therapeutic Goods

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the supply of therapeutic goods in Australia, addressing issues related to the safety, quality, and efficacy of these products. The Act was introduced to fill a critical gap in ensuring that therapeutic goods available to consumers met necessary health and safety standards. The Parliament of Australia enacted this legislation to provide a comprehensive legal framework governing the regulation of therapeutic goods, including medicines, medical devices, and other related products. The overarching policy objective of the Act is to protect public health by ensuring that therapeutic goods are of acceptable quality, perform as claimed, and do not pose undue risks to consumers. On 26 April 2018, the Therapeutic Goods Administration, as part of the Department of Health, published a notice regarding the grant of manufacturing licences to specific entities. This notice is a manifestation of the ongoing commitment to enforce the provisions of the Therapeutic Goods Act 1989 by ensuring that manufacturers comply with the regulatory requirements. The publication includes details of licences granted to Antaria Ltd and Functional Foods Global Pty Ltd, affirming the Administration’s role in overseeing and regulating the therapeutic goods manufacturing sector.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, which includes a wide range of products such as medicines, medical devices, blood, and tissues. The Act applies to entities that manufacture, supply, or advertise therapeutic goods, ensuring that these goods meet safety, quality, and efficacy standards. The Act extends its reach across the Commonwealth, thereby affecting manufacturers and suppliers operating within Australia's jurisdiction, irrespective of state or territory boundaries. Specific entities that fall under the purview of this legislation include corporations, individuals, and other legal entities involved in the production or distribution of therapeutic goods. The Act also encompasses the regulation of conduct and transactions related to these goods, ensuring compliance with prescribed standards and requirements. There are certain exclusions and exemptions provided under the Act, such as for goods used for personal or domestic purposes, or those classified under specific categories that are exempt from certain regulatory requirements. The application of the Act can be further extended or restricted through subordinate instruments, which may provide additional details or clarifications on the implementation and enforcement of the legislative provisions.

Key Provisions

The Therapeutic Goods Act 1989 (the "Act") is the primary legislation governing the regulation of therapeutic goods in Australia. Under section 38 of the Act, the Secretary can grant a licence to a manufacturer to manufacture therapeutic goods. This licence ensures that the manufacturer meets the necessary standards for the production of these goods. Specifically, section 38(1) of the Act allows the Secretary to issue a licence if the manufacturer is deemed to have the appropriate facilities, systems, and processes in place to ensure the quality and safety of the therapeutic goods they produce. For the entities granted a licence, such as Antaria Ltd (Licence No. MI-2017-LI-14233-1) and Functional Foods Global Pty Ltd (Licence No. MI-2016-LI-01860-1), the Act imposes several obligations. These entities must maintain their manufacturing facilities in a manner that complies with the standards set out in the Therapeutic Goods Regulations 1990. They must also ensure that their manufacturing processes are controlled to ensure that the therapeutic goods produced meet the required quality and safety standards. Additionally, they are required to keep records of their manufacturing activities and make these records available to the Therapeutic Goods Administration (TGA) upon request. Failure to comply with the requirements of the Act or the associated regulations can result in various consequences. Under section 24 of the Act, a person who contravenes certain provisions can be subject to both criminal and civil penalties. Criminal penalties can include fines of up to $222,000 for individuals and $1,110,000 for bodies corporate, depending on the seriousness of the offence. In addition to criminal penalties, section 25 of the Act allows for the imposition of civil penalties, which can include fines of up to $1,110,000 for serious breaches. Furthermore, the TGA has the authority to take action to suspend or cancel a licence if it is found that the licence holder is not complying with the Act or the regulations. This can have significant implications for the ability of the manufacturer to continue to produce therapeutic goods.