Supply of the product Filgrastim (rbe) by Hospira Pty Ltd

Overview

The Therapeutic Goods Act 1989 (TGA Act) was enacted to regulate the supply and advertising of therapeutic goods in Australia, ensuring they are of acceptable quality and safe for consumers. The Act was introduced to address the gap in the regulation of therapeutic goods, which were previously managed under various state and federal laws. This consolidation aimed to streamline the regulatory process and enhance public health protection. The TGA Act is administered by the Therapeutic Goods Administration (TGA), a department within the Australian Government's Department of Health, with the primary policy objective of ensuring that therapeutic goods available in Australia meet safety, quality, and efficacy standards. The 2013 consent granted by the delegate of the Secretary for the supply of the product filgrastim, despite non-compliance with certain labelling standards, demonstrates the TGA's role in balancing regulatory compliance with public health needs.

Scope and Application

The Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration (TGA) under the Commonwealth of Australia's Department of Health, governs the regulation of therapeutic goods within Australia. This legislation applies to a wide range of entities, including manufacturers, importers, and suppliers of therapeutic goods, which include medicines, medical devices, blood, and tissues. The Act encompasses the regulation of the entire lifecycle of therapeutic goods, from their development and clinical trials to their manufacture, supply, advertising, and post-market surveillance. The Act applies nationally across Australia, ensuring a consistent regulatory framework is upheld across all states and territories. Notably, the Act does not apply to therapeutic goods used for personal or domestic purposes, nor to goods used in research or clinical trials exempt under certain conditions. Additionally, the scope of the Act can be extended through subordinate instruments, such as therapeutic goods orders (TGOs) and therapeutic goods regulations (TGRs), which provide detailed specifications and requirements for the regulation of particular classes of therapeutic goods.

Key Provisions

The Therapeutic Goods Act 1989, as amended, contains various provisions that govern the regulation of therapeutic goods in Australia. Section 14 of the Act allows the Secretary of the Department of Health to give consent for certain therapeutic goods to be supplied, despite not fully meeting the requirements of Therapeutic Goods Orders (TGOs). In this instance, section 14A permits the supply of filgrastim (rbe) (NIVESTIM) 480 microgram/0.5 mL injection solution prefilled syringes that do not conform with specific paragraphs of TGO 69. This consent is contingent upon compliance with certain conditions as stipulated in section 15 of the Act. The Act imposes several obligations on the parties involved in the supply of therapeutic goods. Firstly, the Company, Hospira Pty Ltd, must ensure that the repackaging of the UK sourced syringes is conducted at the registered secondary packaging site in Croatia. This repackaging must include adding the blister label to the packed plaster trays placed in the currently registered Australian carton and ensuring that the product, apart from the syringe label, is identical to the Australian-registered version. Additionally, a "Dear Health Care Professional" letter must be supplied to pharmacists and wholesalers to inform them of the consent conditions and any pertinent information. Failure to comply with the conditions specified in the consent may lead to various consequences under the Act. While the specific penalties for breach are not detailed in the text, non-compliance with the Therapeutic Goods Act 1989 and the TGOs can lead to civil or criminal penalties. These may include fines, imprisonment, or both, depending on the severity of the breach. The exact penalties are determined by the courts and are influenced by factors such as the intent behind the breach and the potential harm caused.