Publication of List of Manufacturers Granted Licence for the Manufacture of Therapeutic Goods – 9 July 2024

Overview

The Therapeutic Goods Act 1989, enacted by the Commonwealth Parliament, was introduced to regulate the supply of therapeutic goods in Australia. The Act provides a framework for ensuring that therapeutic goods available to consumers meet acceptable standards of quality, safety, and efficacy. The Act aims to protect public health by regulating the manufacturing, importation, advertising, and supply of therapeutic goods. The Therapeutic Goods Administration (TGA), a part of the Department of Health and Aged Care, is responsible for administering the Act. The policy objective of the Act is to ensure that therapeutic goods are safe, of high quality, and that their benefits outweigh any risks associated with their use. The TGA exercises its powers under the Act to license manufacturers, ensuring compliance with the rigorous standards set to safeguard public health.

Scope and Application

The Therapeutic Goods Act 1989, as applied through the Gazetted notice by the Therapeutic Goods Administration, pertains to the regulation and licensing of entities involved in the manufacture of therapeutic goods in Australia. This Act applies to specific entities that have been granted a Licence to Manufacture Therapeutic Goods, as detailed in the published list. The entities include companies such as CBE Pure Solutions, Artisan Laboratories Pty Ltd, CSL Innovation Pty Ltd, Finishing Services Pty Ltd, Jinqi Wellbeing Pty Ltd, EIR Health Pty Ltd, Toll Transport Pty Ltd, Sandoz Pty Ltd, and Specialised Therapeutics Australia Pty Ltd, each identified by their respective licence numbers and physical addresses across various states including Victoria, Queensland, and New South Wales. The scope of the Act ensures that these manufacturers comply with the regulatory requirements set forth to maintain the quality and safety of therapeutic goods available in the Australian market. The Act's jurisdiction extends nationally, covering all entities involved in the manufacture of therapeutic goods within the Commonwealth of Australia. Any exclusions, exemptions, or thresholds are not explicitly stated in this particular Gazette notice but are typically defined in the broader provisions of the Therapeutic Goods Act 1989 and its subsidiary legislation.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) provides for the regulation of therapeutic goods in Australia. Under Section 38 of the Act, the Secretary has the authority to grant licences to entities that wish to manufacture therapeutic goods. The recent publication of the list of manufacturers granted licence by the Therapeutic Goods Administration (TGA) includes several companies, each identified by a unique licence number and their respective locations (Section 38(1)). These companies include CBE PURE SOLUTIONS, Artisan Laboratories Pty Ltd, CSL Innovation Pty Ltd, Finishing Services Pty Ltd, Jinqi Wellbeing Pty Ltd, EIR Health Pty Ltd, Toll Transport Pty Ltd, Sandoz Pty Ltd, and Specialised Therapeutics Australia Pty Ltd. Each licence holder is authorised to manufacture therapeutic goods within the scope permitted by their specific licence. The obligations imposed on these licence holders include adherence to the standards and guidelines set forth by the TGA. These obligations are detailed in the conditions of their respective licences. Each licensee must ensure that their manufacturing processes comply with the Therapeutic Goods (Manufacturing Licence Standards) Order 2018, which sets out the quality and safety standards for the manufacture of therapeutic goods (Section 10(1)(a)). This includes maintaining appropriate facilities, equipment, and personnel qualifications, as well as ensuring that all products meet the required standards before distribution. Additionally, the licence holders must comply with all relevant labelling requirements, including accurate and clear labelling of all therapeutic goods produced (Section 10(1)(b)). Failure to comply with the provisions of the Act or the conditions of the licence may result in enforcement actions. The Act provides for both civil and criminal penalties for breaches. For example, if a licensee fails to comply with the manufacturing standards, they may be subject to a civil penalty of up to $2,200,000 for a corporation or $440,000 for an individual (Section 96(1)(a)). In cases of serious or repeated breaches, the TGA may also seek a court order to suspend or cancel the licence (Section 106). Furthermore, criminal offences under the Act may result in fines of up to $1,100,000 for a corporation or $220,000 for an individual, and in some cases, imprisonment for up to five years (Section 92). These penalties underscore the importance of strict adherence to the regulatory requirements set out by the TGA.