Publication of List of Manufacturers Granted Licence for the Manufacture of Therapeutic Goods – 4 October 2023

Overview

The Therapeutic Goods Act 1989 was enacted to provide for the regulation of therapeutic goods, ensuring their safety, quality, and efficacy, while also addressing the need for transparency in the manufacturing process. This Act was introduced to address the gaps in the regulation of therapeutic goods, ensuring that they meet the necessary standards before being made available to the public. The Act empowers the Therapeutic Goods Administration (TGA), a body within the Department of Health and Aged Care, to grant licences to manufacturers who meet the stringent criteria for producing these goods. The policy objective of the Act is to protect public health by ensuring that therapeutic goods are safe and of high quality, thereby providing assurance to consumers and healthcare providers about the products they use. The publication of the list of manufacturers granted a licence under the Therapeutic Goods Act 1989 is a critical function of the TGA, aimed at maintaining transparency and accountability in the therapeutic goods market. By making this information publicly available, the Act ensures that stakeholders can verify the legitimacy and compliance of manufacturers. This transparency not only helps in upholding the standards set by the Act but also fosters trust in the therapeutic goods supply chain. The issuance of a licence, such as the one granted to Herbal-ID under Licence No. MI-2022-LI-01126-1, signifies that the manufacturer has met the rigorous standards required for the production of therapeutic goods, thereby safeguarding public health and ensuring that the goods are fit for their intended use.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, ensuring that products such as medicines, medical devices, and blood products are safe, of high quality, and effective for their intended use. The Act applies to all entities and individuals involved in the manufacturing, importation, supply, or advertising of therapeutic goods within Australia. This includes pharmaceutical companies, medical device manufacturers, healthcare providers, and any other entities that engage in activities related to therapeutic goods. The Act's jurisdictional reach is national, applying across the Commonwealth of Australia and its territories. While the Act broadly regulates the therapeutic goods industry, there are certain exclusions and exemptions, such as over-the-counter herbal remedies and traditional medicines that meet specific criteria, which may not require the same level of regulatory oversight. The Therapeutic Goods Administration, under the Department of Health and Aged Care, may also extend or restrict the application of the Act through subordinate instruments such as regulations and guidelines, which provide further detail on the implementation and enforcement of the Act.

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 allows the Secretary of the Department of Health and Aged Care, Therapeutic Goods Administration, to grant a licence to manufacturers who meet the specified criteria. In this instance, Section 38 has been invoked to grant a Licence to Manufacture Therapeutic Goods to HERBAL-ID, identified as Unit 4/8 Day Road, East Rockingham, WA, 6168, under Licence No. MI-2022-LI-01126-1. This licence authorises HERBAL-ID to manufacture therapeutic goods, subject to the conditions and requirements set out in the Act. The obligations and requirements imposed on HERBAL-ID, as the licence holder, include compliance with all relevant standards, guidelines, and regulations set by the Therapeutic Goods Administration (TGA). This includes ensuring that all therapeutic goods produced are of a quality suitable for use, are safe, and meet the necessary efficacy standards. HERBAL-ID must maintain proper records of all manufacturing processes, quality control measures, and any adverse events or product defects. Furthermore, HERBAL-ID is obligated to notify the TGA of any changes to their manufacturing processes or premises, and to submit periodic reports as required by the TGA. Failure to comply with the provisions of the Therapeutic Goods Act 1989, or the terms of the licence, can result in various penalties and consequences. Under Section 38AA of the Act, significant breaches of the licence conditions or other sections of the Act may be considered offences. The maximum penalties for these offences can include substantial fines and, in some cases, imprisonment. Additionally, the TGA has the authority to take enforcement actions such as suspending or revoking the licence, which would prevent HERBAL-ID from continuing to manufacture therapeutic goods. Civil and administrative penalties may also apply, depending on the nature and severity of the breach. The precise penalties are determined based on the specific circumstances of each case and the discretion of the relevant authorities.