Publication of List of Manufacturers Granted Licence for the Manufacture of Therapeutic Goods - 28 May 2021

Overview

The Therapeutic Goods Act 1989, enacted by the Australian Parliament, was introduced to regulate the provision of therapeutic goods in Australia, aiming to ensure their quality, safety, and efficacy. The Act provides a framework for the regulation of therapeutic goods, including medicines, medical devices, blood, and tissues, by establishing licensing requirements for their manufacture, importation, and distribution. The 2021 Gazette publication from the Department of Health Therapeutic Goods Administration under the Act highlights the grant of a Licence to Manufacture Therapeutic Goods, specifying three companies granted such licences. This ongoing legislative effort underscores the commitment to maintaining stringent controls over therapeutic goods to protect public health. The policy objective of the Therapeutic Goods Act 1989 remains to safeguard the health of Australians by ensuring that therapeutic goods are of acceptable quality, safe, and effective for their intended use.

Scope and Application

The Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration (TGA) under the Commonwealth of Australia’s Department of Health, governs the regulation of therapeutic goods within Australia. This legislation encompasses a broad scope, applying to various entities involved in the manufacturing, supply, and advertising of therapeutic goods. Specifically, the Act applies to individuals and entities engaged in the manufacture, importation, supply, or advertising of therapeutic goods, ensuring that these goods meet safety, quality, and efficacy standards. The Act's jurisdictional reach is national, applying uniformly across all states and territories of Australia. However, the Act does not apply to goods that are exempt under specific sections, such as those used for personal or domestic purposes, or those classified as complementary medicines. The Act may also extend its application through subordinate instruments, such as regulations or guidelines, which provide further detail on the implementation and enforcement of the Act’s provisions. These instruments help to clarify the scope of the legislation and ensure compliance by specifying particular thresholds or additional requirements for different types of therapeutic goods.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) provides the legal framework for the regulation of therapeutic goods in Australia. Section 38 of the Act, referenced in this publication, pertains to the grant of licences for the manufacture of therapeutic goods. The notice issued by Katherine Clark, the Delegate of the Secretary of the Department of Health, Therapeutic Goods Administration, confirms the grant of licences to specific entities: Contract Manufacturing Professionals Pty Ltd (Licence No. MI-2020-LI-06420-1), National Measurement Institute (Licence No. MI-2019-LI-09573-1), and CGS INVESTMENTS PTY LTD trading as CGS Pharma (Licence No. MI-2020-LI-08023-1). This means these companies are legally authorised to manufacture therapeutic goods in Australia, subject to the terms and conditions of their respective licences. The entities granted licences under section 38 of the Act are subject to specific obligations and requirements. These include adherence to good manufacturing practices, maintaining records of all manufacturing processes, and ensuring the quality and safety of the therapeutic goods they produce. The licence holders must also comply with any conditions imposed by the Therapeutic Goods Administration (TGA) as part of the licensing process, such as regular inspections and reporting requirements. Failure to meet these obligations could result in the licence being suspended or revoked, potentially leading to legal and financial repercussions for the entities involved. Under the Therapeutic Goods Act 1989, breaches of the Act can result in both civil and criminal penalties. For instance, section 96 of the Act provides for civil penalties, including fines up to $222,250 for individuals and $1,111,250 for bodies corporate, for various regulatory offences. Criminal offences under the Act, such as knowingly supplying prohibited therapeutic goods, can result in imprisonment for up to five years and/or substantial fines. The specific penalties depend on the nature and severity of the breach, with maximum penalties clearly outlined in the relevant sections of the Act. Compliance with the Act is therefore crucial for all licence holders to avoid these severe consequences.