Publication of List of Manufacturers Granted Licence for the Manufacture of Therapeutic Goods – 8 March 2023

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the supply of therapeutic goods in Australia, ensuring these products are safe, of high quality, and effective for their intended use. The Act was introduced to address the need for a comprehensive framework governing the manufacturing, importation, advertising, and distribution of therapeutic goods. This legislation provides the basis for the Therapeutic Goods Administration (TGA) to administer the Act and enforce compliance with its provisions. The policy objective of the Act is to protect public health by ensuring that therapeutic goods available in Australia meet acceptable standards of quality, safety, and efficacy. The Act empowers the TGA to issue licenses to manufacturers, thereby maintaining oversight and accountability within the therapeutic goods industry. On 8 March 2023, Katherine Clark, acting as a delegate of the Secretary of the Department of Health and Aged Care, published details of licenses granted to two manufacturers under Section 38 of the Therapeutic Goods Act 1989. The manufacturers, VEGANIC SKN and LAVIDA NUTRACEUTICALS PTY LTD, have been granted licences to manufacture therapeutic goods, subject to compliance with the Act’s stringent requirements. This publication serves to notify the public and relevant stakeholders of the approved entities, thereby ensuring transparency and adherence to the regulatory standards set forth by the TGA.

Scope and Application

The Therapeutic Goods Act 1989 applies to persons or entities engaged in the manufacturing, supply, or advertising of therapeutic goods in Australia. This encompasses a broad range of products, including medicines, medical devices, and other health-related items, thereby affecting various industries such as pharmaceuticals, biotechnology, and health services. The Act is administered by the Therapeutic Goods Administration (TGA), which operates under the Department of Health and Aged Care. The jurisdictional reach of this Act is nationwide, extending to all states and territories within the Commonwealth of Australia, ensuring a uniform regulatory framework across the country. The Act grants specific licences to manufacturers, such as those recently granted to VEGANIC SKN and LAVIDA NUTRACEUTICALS PTY LTD, which are required to meet certain standards to legally produce and distribute therapeutic goods. Subordinate instruments, such as regulations and guidelines, may further define the scope and application of the Act, providing detailed specifications and compliance requirements. Notably, certain exclusions and exemptions may apply, particularly for research purposes or specific low-risk products, but these are clearly delineated within the legislative text and related documents.

Key Provisions

The Therapeutic Goods Act 1989 outlines various provisions for the regulation of therapeutic goods in Australia. Section 38 of the Act provides the authority for the Secretary of the Department of Health and Aged Care, through the Therapeutic Goods Administration, to grant licences to entities for the manufacture of therapeutic goods. In the case of VEGANICSKN and LAVIDANUTRACEUTICALS PTY LTD, Section 38 has been exercised to grant licences for the manufacture of such goods. These licences are identified by unique licence numbers, MI-2022-LI-08123-1 for VEGANICSKN and MI-2021-LI-09708-1 for LAVIDANUTRACEUTICALS PTY LTD, and specify the locations where the manufacturing activities are permitted to occur. Entities that have been granted a licence under Section 38 of the Therapeutic Goods Act 1989 are subject to a range of obligations and requirements. These obligations typically include adhering to Good Manufacturing Practice standards, ensuring that the therapeutic goods they produce meet safety, quality, and efficacy standards, and complying with any conditions stipulated in their licence. The entities must maintain records and documentation as required by the Therapeutic Goods Administration, and they are responsible for reporting any changes in their manufacturing operations or facilities to the relevant authorities. Furthermore, they must ensure that all therapeutic goods produced are properly labelled and packaged, and that any adverse events associated with their products are reported in accordance with the Act. Failure to comply with the requirements and obligations set out in the Therapeutic Goods Act 1989 can result in significant legal consequences. The Act provides for both civil and criminal penalties for breaches. For instance, under Section 32HA, the maximum penalty for manufacturing therapeutic goods in contravention of a licence condition can be a substantial fine or imprisonment. Specifically, the penalty can be up to 12 months imprisonment and/or a fine of up to $126,000 for an individual, and for a body corporate, the fine can escalate to up to $630,000. Additionally, the Therapeutic Goods Administration has the authority to take enforcement actions such as cancelling a licence, issuing public warnings, or initiating legal proceedings against non-compliant entities. These measures are intended to uphold the safety and quality of therapeutic goods available in the Australian market.