Publication of List of Manufacturers Revoked from Licensing for the Manufacture of Therapeutic Goods - 28 May 2021

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the quality, efficacy, and safety of therapeutic goods within Australia, addressing the need for stringent oversight and control over the manufacture, supply, and advertising of such goods. This Act provides the legal framework for the Therapeutic Goods Administration (TGA) to ensure that therapeutic goods available in Australia meet necessary standards and are appropriately monitored to protect public health. The policy objective of the Act is to safeguard the health and safety of the Australian public by ensuring that therapeutic goods are of high quality, effective, and safe for use. On 28 May 2021, Katherine Clark, Delegate of the Secretary of the Department of Health, published a notice under section 41 of the Therapeutic Goods Act 1989, revoking the licences of three manufacturers: Integria Healthcare (Ballina) Pty Ltd, GlaxoSmithKline Consumer Healthcare Australia Pty Ltd, and Central Adelaide Local Health Network (operating as SA Pathology). The revocations were made at the request of the respective manufacturers, indicating compliance with the Act’s provisions for voluntary relinquishment of manufacturing licenses. This action reinforces the TGA's commitment to maintaining stringent controls over the therapeutic goods market in Australia, ensuring that manufacturers adhere to the highest standards of quality and safety.

Scope and Application

The Therapeutic Goods Act 1989 governs the regulation of therapeutic goods in Australia, encompassing products such as medicines, medical devices, and blood. The Act applies to entities involved in the manufacturing, importing, advertising, and supplying of therapeutic goods. The scope of the Act includes all therapeutic goods marketed within Australia, ensuring they meet safety, quality, and efficacy standards. The Act applies nationally across the Commonwealth of Australia, with the Therapeutic Goods Administration (TGA) under the Department of Health administering and enforcing its provisions. The Act provides for the licensing of activities related to therapeutic goods, and it includes provisions for the revocation of licenses, as evidenced by the revocation of the licenses of several manufacturers noted in the gazette. The Act also includes various exclusions and exemptions, such as for goods used for personal, non-commercial purposes or for research and development under specific conditions. The application and enforcement of the Act may be extended or specified through subordinate legislation and regulations, which provide additional detail on matters such as licensing requirements, standards, and penalties for non-compliance.

Key Provisions

The key provisions of the Therapeutic Goods Act 1989, as applied in the revocation of certain licences, include Section 41, which allows the Secretary to revoke a licence to manufacture therapeutic goods under specific circumstances. In this instance, Section 41(1)(d) is the operative section, allowing the Secretary to revoke the licences held by the mentioned entities, namely Integria Healthcare (Ballina) Pty Ltd, GlaxoSmithKline Consumer Healthcare Australia Pty Ltd, and Central Adelaide Local Health Network (operating as SA Pathology), at the request of the manufacturers themselves (Section 41(1)(d)). The Act imposes specific obligations on the entities that hold manufacturing licences for therapeutic goods. These entities are required to maintain certain standards of quality and compliance with regulations to ensure the safety and efficacy of the therapeutic goods they produce. This includes adhering to good manufacturing practices, maintaining proper records, and ensuring that their products meet the necessary quality and safety standards. The revocation of the licences indicates a failure to meet these obligations, potentially due to non-compliance or other regulatory issues. Breach of the obligations set out in the Therapeutic Goods Act 1989 can result in severe consequences. The Act provides for both civil and criminal penalties for non-compliance. For example, knowingly supplying therapeutic goods that do not comply with the standards can result in significant fines and imprisonment. The maximum penalties can vary depending on the severity of the breach, but they are intended to be stringent enough to deter non-compliance and ensure that therapeutic goods available in the market meet the required safety and quality standards. Additionally, the revocation of a manufacturing licence, as seen in this case, can have significant implications for the entities involved, potentially impacting their ability to operate in the industry.