Publication of List of Manufacturers Revoked from Licensing for the Manufacture of Therapeutic Goods - Phebra Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the importation, supply, and manufacture of therapeutic goods in Australia, ensuring they are safe and of high quality. The Act provides a comprehensive framework for the regulation of therapeutic goods, including medicines, medical devices, and blood and blood components. The Therapeutic Goods Administration (TGA), which operates under the Department of Health, is responsible for enforcing the provisions of the Act. The TGA's primary policy objective is to protect public health by ensuring that therapeutic goods available in Australia are of acceptable quality, safety, and efficacy. This legislative framework addresses the gap in ensuring that only reputable and compliant entities manufacture therapeutic goods in Australia. On 30 January 2014, the Delegate of the Secretary of the Department of Health, Therapeutic Goods Administration, published a notice regarding the revocation of a licence to manufacture therapeutic goods. The notice pertained to the revocation of the licence held by Phebra Pty Ltd, located at 332 Burns Bay Road, Lane Cove, NSW, 2066. The revocation was carried out under Section 41(1)(d) of the Therapeutic Goods Act 1989 at the request of the manufacturer, Phebra Pty Ltd. This action was taken to maintain the integrity and safety of the therapeutic goods market in Australia.

Scope and Application

The Therapeutic Goods Act 1989 applies to a broad range of entities and individuals involved in the manufacture, supply, import, export, and advertising of therapeutic goods within Australia. This encompasses pharmaceutical products, medical devices, and other goods intended for therapeutic use. The Act primarily governs the therapeutic goods industry to ensure that all products available to the public meet safety, quality, and efficacy standards. The Act applies to both individuals and corporate entities, and its scope includes the entire supply chain of therapeutic goods, from manufacturing to distribution and sale. Geographically, the Act has a national reach, as it is a Commonwealth Act, meaning it applies across all states and territories of Australia. While the Act broadly applies to all therapeutic goods, certain exclusions and exemptions may apply, such as for research and development purposes under specific conditions or for goods used in clinical trials. The Act's application can be further refined or extended through subordinate instruments, including regulations and guidelines issued by the Therapeutic Goods Administration (TGA). These instruments help to clarify and detail the requirements and processes mandated by the Act, ensuring consistent and comprehensive regulation of therapeutic goods across the country.

Key Provisions

The Therapeutic Goods Act 1989 (the "Act") outlines the procedures and requirements for the regulation of therapeutic goods in Australia. Section 41(1)(d) of the Act (1) allows the Secretary to revoke a manufacturer’s licence to manufacture therapeutic goods under certain circumstances. In this case, the Secretary has exercised this power by revoking the licence held by Phebra Pty Ltd (Licence No. MI-15122004-LI-000313-1) situated at 332 Burns Bay Road, Lane Cove, NSW, 2066. The revocation was carried out at the request of the manufacturer, as stated in the notice issued on 30 January 2014 by Dr. Harry Rothenfluh, the Delegate of the Secretary for the Office of Manufacturing Quality (2). The revocation of a licence under Section 41(1)(d) imposes specific obligations and requirements on the parties involved. For Phebra Pty Ltd, this revocation means they are no longer authorised to manufacture therapeutic goods. They must cease all manufacturing activities immediately and comply with any additional directives or requirements issued by the Therapeutic Goods Administration (TGA). The revocation also necessitates that Phebra Pty Ltd take steps to ensure that any therapeutic goods produced prior to the revocation are managed in accordance with the Act and any relevant regulations. This includes proper storage, disposal, or reclassification of the goods as necessary. The Act also outlines potential offences, penalties, and consequences for breaches of its provisions. For example, manufacturing therapeutic goods without a valid licence, as required by the Act, constitutes an offence. If Phebra Pty Ltd were to continue manufacturing after the revocation, they could face criminal charges, including fines and imprisonment. The specific penalties depend on the nature and severity of the offence but can include substantial financial penalties and imprisonment terms as prescribed under the Act and other relevant legislation. Furthermore, any ongoing manufacturing activities could result in the seizure of goods and additional administrative actions by the TGA.