Publication of List of Manufacturers Suspended From Licensing for the Manufacture of Therapeutic Goods – 15 October 2024

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the quality, safety, and efficacy of therapeutic goods in Australia, ensuring that such products are not harmful to consumers. This Act addresses the need to control and standardise the manufacture, supply, and distribution of therapeutic goods, including medicines, medical devices, and blood products. The Therapeutic Goods Administration (TGA), an agency of the Department of Health and Aged Care, administers this Act. The policy objective of the Act is to protect public health by ensuring that therapeutic goods are of an acceptable quality and are not harmful to consumers, while also facilitating access to therapeutic goods that meet necessary standards. The Act provides a framework for regulating the entire lifecycle of therapeutic goods, from development through to post-market surveillance. On 15 October 2024, Katherine Clark, acting as a delegate of the Secretary of the Department of Health and Aged Care and the Therapeutic Goods Administration, published details concerning the suspension of manufacturing licenses for certain therapeutic goods. Specifically, the licence held by AEGROS LIMITED was suspended from 26 August 2024 to 31 March 2025, and the licence held by LITTLE GREEN PHARMA LTD was suspended from 1 October 2024 to 1 April 2025, both at the request of the manufacturers. This action was taken under Section 41 of the Therapeutic Goods Act 1989, reflecting the TGA's commitment to maintaining high standards for the safety and quality of therapeutic goods available in the Australian market.

Scope and Application

The Therapeutic Goods Act 1989 applies to a broad range of entities and individuals involved in the manufacture, supply, and advertising of therapeutic goods in Australia. This includes companies, manufacturers, importers, and suppliers of therapeutic goods, as well as entities and individuals who provide services related to therapeutic goods. The Act covers a wide range of therapeutic goods, including medicines, medical devices, blood, and tissues, and it is applicable across the Commonwealth, including all states and territories. The Act sets out the regulatory framework for the approval, manufacture, supply, importation, and advertising of therapeutic goods in Australia, and it provides for the establishment of standards and guidelines to ensure the safety, quality, and efficacy of these goods. The Act also provides for the suspension or cancellation of licences for the manufacture of therapeutic goods in cases of non-compliance or where it is in the public interest to do so. In terms of geographic and jurisdictional reach, the Therapeutic Goods Act 1989 applies throughout the Commonwealth of Australia, including all states and territories. The Act also applies to therapeutic goods imported into Australia, regardless of where they were manufactured. The Act may be extended or restricted through subordinate instruments, such as regulations or guidelines, which provide further detail on specific aspects of the Act or establish additional requirements for certain types of therapeutic goods. There are no stated exclusions or exemptions from the Act, although certain activities may be subject to different regulatory frameworks depending on the type of therapeutic good involved.

Key Provisions

Under Section 41(1)(d) of the Therapeutic Goods Act 1989, the Secretary of the Department of Health and Aged Care, Therapeutic Goods Administration, has the authority to suspend a licence to manufacture therapeutic goods. This power is exercised through a written notice, as evidenced by the publication of the suspension of the licences held by AEGROS LIMITED and LITTLE GREEN PHARMA LTD. The suspension of these licences, MI-19042005-LI-000513-1 for AEGROS LIMITED and MI-2019-LI-12964-1 for LITTLE GREEN PHARMA LTD, is effective from specified dates: 26 August 2024 to 31 March 2025 for AEGROS LIMITED, and 1 October 2024 to 1 April 2025 for LITTLE GREEN PHARMA LTD. These suspensions were made at the request of the manufacturers themselves, indicating a voluntary compliance measure. The obligations imposed on the parties whose licences are suspended include refraining from manufacturing any therapeutic goods during the suspension period. Both AEGROS LIMITED and LITTLE GREEN PHARMA LTD must adhere to the terms of their respective suspension notices, ensuring they do not engage in any manufacturing activities that could contravene the Act. This requirement is crucial to maintaining the integrity of the therapeutic goods supply chain and protecting public health. Failure to comply with the suspension of the licence can result in severe consequences. Under the Therapeutic Goods Act 1989, breaches of the suspension terms can lead to criminal charges and penalties. The Act allows for enforcement actions, including fines and potential imprisonment, to deter non-compliance. The maximum penalties for manufacturing therapeutic goods without a valid licence can be significant, reflecting the seriousness of ensuring that only safe and effective products are available to the public. This regulatory framework is essential to uphold the standards of quality and safety in the therapeutic goods market.