Publication of List of Manufacturers Suspended from Licensing for the Manufacture of Therapeutic Goods - Cyclopet Pty Ltd and Selborne Biological Services

Overview

The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, aims to regulate the quality and safety of therapeutic goods, including medicines, medical devices, and blood products, within the country. The Act establishes a licensing system for the manufacture of therapeutic goods and empowers the Therapeutic Goods Administration (TGA) to ensure compliance with quality, safety, and efficacy standards. This legislation addresses the problem of ensuring that therapeutic goods available in the market are of acceptable quality and do not pose risks to public health. The policy objective is to protect public health by regulating the manufacturing processes and ensuring that manufacturers meet the necessary standards for the production of therapeutic goods. The Delegate of the Secretary of the Department of Health, Dr Harry Rothenfluh, has published a notice under Section 41(1)(d) of the Therapeutic Goods Act 1989, announcing the suspension of manufacturing licences for certain therapeutic goods. Specifically, the licences of Cyclopet Pty Ltd and Selborne Biological Services (Australia) Pty Ltd have been suspended at the request of the manufacturers. The suspension of Cyclopet Pty Ltd’s licence is effective from 2 July 2015 to 2 April 2016, while the suspension for Selborne Biological Services (Australia) Pty Ltd is from 2 July 2015 to 2 January 2016. This action aims to ensure the quality and safety of therapeutic goods by preventing the distribution of potentially unsafe products during the suspension period.

Scope and Application

The Therapeutic Goods Act 1989 governs the regulation of therapeutic goods in Australia, ensuring that these products are safe, of high quality, and effective for their intended use. This Act applies to entities involved in the manufacturing, importing, supplying, or advertising of therapeutic goods within Australia, including medicines, medical devices, blood, and tissues. The Act extends its reach to all states and territories of Australia, thereby establishing a comprehensive national framework for the oversight of therapeutic goods. The Act's application includes the suspension of licences to manufacture therapeutic goods under specific circumstances, as evidenced by the notice published by the Delegate of the Secretary of the Department of Health. This notice pertains to the suspension of licences held by Cyclopet Pty Ltd and Selborne Biological Services (Australia) Pty Ltd, which are subject to the terms and conditions outlined in the Act. The suspensions are in effect for specified periods and were requested by the manufacturers themselves. The Therapeutic Goods Act may be further extended or restricted through subordinate instruments, such as regulations or guidelines, which provide additional detail and operational clarity to the overarching legislative framework.

Key Provisions

The key operative sections of this publication under the Therapeutic Goods Act 1989 (the "Act") involve the suspension of licences for the manufacture of therapeutic goods. Section 41(1)(d) of the Act allows the Secretary to suspend a licence to manufacture therapeutic goods. In this instance, the Secretary has exercised this power at the request of the manufacturers themselves, as detailed in the notice. Specifically, the licences in question are those held by Cyclopet Pty Ltd, licence number MI-2010-LI-03381-3, and Selborne Biological Services (Australia) Pty Ltd, licence number MI-2010-LI-02443-3. These suspensions are effective from 2 July 2015 to 2 April 2016 for Cyclopet Pty Ltd, and from 2 July 2015 to 2 January 2016 for Selborne Biological Services (Australia) Pty Ltd. The Act imposes certain obligations and requirements on the entities governed by it. Firstly, manufacturers holding a licence must comply with all conditions of their licence, including maintaining adequate quality control and manufacturing practices. They must also ensure that their therapeutic goods are safe and of acceptable quality. Additionally, the Act requires manufacturers to notify the Secretary of any significant changes in their manufacturing processes or facilities. Failure to adhere to these obligations can result in enforcement actions, including suspension or revocation of their licence, as seen in this publication. In terms of offences, penalties, and consequences for breach, the Therapeutic Goods Act 1989 provides for both civil and criminal penalties. For civil penalties, Section 84 allows for fines up to a maximum of $22,200 per offence for individuals and $111,000 per offence for bodies corporate. Criminal penalties under Section 83 include fines up to $555,000 for individuals and $2,775,000 for bodies corporate, as well as potential imprisonment for serious offences. The specific penalties for breaching the Act would depend on the nature and severity of the breach, and would be determined by the court. This publication under Section 41(1)(d) serves to inform the public and relevant stakeholders of the suspension of the licences of Cyclopet Pty Ltd and Selborne Biological Services (Australia) Pty Ltd. The suspensions are a direct result of compliance issues or other concerns that led the manufacturers to request the suspension themselves. It is important for all licence holders to remain vigilant about their obligations and to ensure adherence to the standards set forth by the Therapeutic Goods Act 1989 to avoid similar outcomes.