Supply of INTANZA influenza vaccine split virion inactivated 9 microgram/strain/0.1mL suspension for injection pre-filled syringe by Sanofi-Aventis Australia Pty Ltd

Overview

The Therapeutic Goods Act 1989 (the Act) was enacted to regulate the supply of therapeutic goods in Australia, ensuring that they are safe and of high quality. The Act addresses the gap in regulation by providing a framework for the approval, advertising, and monitoring of therapeutic goods, including medicines, medical devices, and blood products. This legislation was enacted by the Commonwealth Parliament, with the primary policy objective of protecting public health by ensuring that therapeutic goods available in Australia meet necessary safety, quality, and efficacy standards. On 9 May 2013, a delegate of the Secretary of the Department of Health and Ageing granted specific consents under sections 14 and 14A of the Act, allowing Sanofi-Aventis Australia Pty Ltd to supply the INTANZA influenza vaccine under certain conditions, despite it not fully conforming to the labelling requirements of Therapeutic Goods Order No. 69. This consent was subject to conditions, including the repackaging of the syringe trays in Australian cartons with Australian Product Information.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, encompassing a broad range of products including medicines, medical devices, blood and blood components, tissues, and vaccines. This Act applies to entities and persons involved in the research, development, manufacture, supply, import, export, advertising, and sponsorship of therapeutic goods. It extends to all states and territories within Australia, establishing a national framework for the oversight of therapeutic goods. The Act’s application is facilitated and detailed through various Therapeutic Goods Orders (TGOs) and other subordinate instruments, which provide specific regulations and standards that must be adhered to. Notably, section 14 and section 14A of the Act allow for certain exemptions and consents that can modify the application of the Act’s requirements, such as those granted in the context of specific therapeutic goods under particular conditions. In the instance provided, Sanofi-Aventis Australia Pty Ltd received consent for the supply of a specific batch of INTANZA influenza vaccine under conditions that deviate from the labelling requirements set out in TGO 69, highlighting the Act’s flexibility to accommodate specific circumstances while maintaining overall regulatory standards.

Key Provisions

The main operative sections of the Therapeutic Goods Act 1989 relevant to this notice are sections 14 and 14A, which pertain to the approval and conditions of therapeutic goods supply. In this instance, section 14 allows the Secretary to consent to the supply of a therapeutic good that does not conform to certain regulations, while section 14A outlines the conditions under which such consent can be granted. The Act also includes section 15(1), which imposes specific conditions on the consent provided by the Secretary's delegate. Under the Therapeutic Goods Act 1989, the obligations and requirements imposed on the parties governed by this legislation include obtaining consent from the Secretary of the Department of Health and Ageing for the supply of therapeutic goods that do not conform to certain regulatory requirements. In this particular case, Sanofi-Aventis Australia Pty Ltd has been granted consent to supply the INTANZA influenza vaccine, but this consent is subject to specific conditions. These conditions require that the tamper-evident syringe trays must be repackaged in an Australian carton and that the Australian Product Information (PI) must accompany the product. Additionally, this exemption is limited to a specific batch of the vaccine, Intanza Batch K8103-3, with an expiry date of 31 December 2013. Failure to comply with the conditions set forth in the Therapeutic Goods Act 1989 may result in various consequences. Section 14A of the Act outlines the specific conditions attached to the consent granted by the Secretary’s delegate, and non-compliance with these conditions could lead to the revocation of the consent. Additionally, the Act imposes obligations on manufacturers and suppliers to ensure that their products meet all regulatory standards unless otherwise explicitly exempted. Breaches of these obligations could lead to administrative actions, fines, or other legal repercussions. The Act does not specify exact penalties for breaches, but they can include civil penalties or criminal charges, depending on the severity and intent behind the breach. Given the specific nature of this exemption and the limited scope to a particular batch of the vaccine, the implications of non-compliance are significant. The therapeutic goods in question are medical products, and any deviation from the specified conditions could potentially compromise patient safety or the integrity of the product. Therefore, the obligations and conditions set out in the Act are designed to ensure that any deviation from standard regulatory requirements is carefully controlled and monitored.