Publication of List of Manufacturers Revoked from Licensing for the Manufacture of Therapeutic Goods – 1 August 2022

Overview

The Therapeutic Goods Act 1989 was enacted to ensure the safety, quality, and efficacy of therapeutic goods available in Australia. This legislation was introduced to address the need for stringent regulation of therapeutic products to protect public health. The Act empowers the Therapeutic Goods Administration (TGA), a body within the Department of Health and Aged Care, to regulate the manufacturing, importation, advertising, and distribution of therapeutic goods. The policy objective of the Act is to maintain and improve the health of Australians by ensuring that therapeutic goods are of acceptable quality and pose no unacceptable risks to health when used as intended. As part of its regulatory functions, the TGA can revoke the licences of manufacturers who no longer meet the necessary standards or have requested the revocation of their licence, as evidenced by the recent publication concerning the revocation of several manufacturing licences.

Scope and Application

The Therapeutic Goods Act 1989 applies to entities involved in the manufacture, supply, and advertising of therapeutic goods within Australia. This Act governs the licensing and regulation of therapeutic goods, which include medicines, medical devices, and blood and blood components. The Act applies to both individuals and corporate entities that engage in the manufacture or distribution of these goods. It imposes obligations on manufacturers to obtain a licence and adhere to quality standards, while also regulating the advertising of therapeutic goods to ensure they are safe and of high quality. The Act's jurisdiction extends across the entire Commonwealth of Australia, including all states and territories, thereby establishing a national regulatory framework for therapeutic goods. There are, however, specific exclusions and exemptions within the Act, such as those relating to certain types of blood products and traditional medicines. The application and enforcement of the Act are further facilitated through subordinate legislation and regulations, which provide additional detail and specificity to the primary Act.

Key Provisions

The Therapeutic Goods Act 1989 (the "Act") contains provisions that govern the manufacture of therapeutic goods in Australia. Section 41(1)(d) of the Act allows the Secretary of the Department of Health and Aged Care, Therapeutic Goods Administration to revoke a licence to manufacture therapeutic goods under certain circumstances. In accordance with this section, the Secretary has revoked the licences of several entities, as detailed in the Gazette (C2022G00706). The revoked licences include those of the South Western Sydney Local Health District trading as Liverpool Hospital (Licence No. MI-2020-LI-03810-1), the Department of Economic Development, Jobs, Transport and Resources (Licence No. MI-2016-LI-09655-1), Functional Foods Global Pty Ltd (Licence No. MI-2016-LI-01860-1), and Active Display Group (Licence No. MI-2020-LI-08352-1). These revocations were made at the request of the respective manufacturers. The Act imposes various obligations and requirements on entities holding a licence to manufacture therapeutic goods. These include ensuring that the manufacture of the goods complies with the standards set out in the Therapeutic Goods Regulations 1990, maintaining records of the manufacturing process, and reporting any adverse events or incidents related to the manufacture of the goods. Licence holders must also ensure that the therapeutic goods they manufacture are of a suitable quality and meet the required safety and efficacy standards. Failure to comply with the requirements of the Act and the Therapeutic Goods Regulations may result in civil or criminal penalties. For example, a person who contravenes a provision of the Act may be subject to a civil penalty of up to $222,200 for a corporation and $44,440 for an individual, as set out in section 42AB of the Act. In addition, a person who is found guilty of an offence under the Act may be subject to criminal penalties, including fines and imprisonment. For example, section 32 of the Act provides for a maximum penalty of $5.5 million for a corporation and $1.1 million for an individual for offences related to the supply of therapeutic goods that are not included in the Australian Register of Therapeutic Goods. In summary, the Therapeutic Goods Act 1989 sets out the requirements for the manufacture of therapeutic goods in Australia, including the obligation to hold a valid licence and comply with the relevant standards and regulations. The Act also provides for the revocation of licences in certain circumstances, as well as civil and criminal penalties for non-compliance. The recent revocation of several licences, as detailed in the Gazette, demonstrates the importance of adhering to the requirements of the Act and maintaining high standards of quality and safety in the manufacture of therapeutic goods.