Consent given pursuant to sections 14 and 14A for the importation and supply of the therapeutic goods specified - AstraZeneca Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to provide for the regulation of therapeutic goods, including medicines, medical devices, and blood and blood components, to ensure their quality, safety, and efficacy. The Act was introduced to address the need for a comprehensive legislative framework to regulate the importation, supply, and advertising of therapeutic goods in Australia, thereby protecting public health. Enacted by the Commonwealth Parliament, the policy objective of the Act is to ensure that therapeutic goods available in Australia meet acceptable standards of quality, safety, and efficacy, and that information about these goods is accurate and accessible to consumers and healthcare professionals. In the case of the Therapeutic Goods Act 1989, the delegate of the Secretary of the Department of Health has granted specific consent for the importation and supply of certain medicinal products that do not fully comply with labelling requirements, subject to particular conditions being met to safeguard public health.

Scope and Application

The Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration, provides the framework for regulating therapeutic goods in Australia. This Act applies to a broad range of therapeutic goods including medicines, medical devices, blood and blood components, tissues, and cosmetics. The legislation applies to entities such as manufacturers, importers, sponsors, and suppliers of therapeutic goods, as well as individuals involved in the advertising, supply, and distribution of these goods. The scope of the Act is national, ensuring consistent regulation across the Commonwealth of Australia, including states and territories. Certain products and activities may be exempt or subject to specific conditions, such as in the case of the consent granted for the importation and supply of saxagliptin products by AstraZeneca, which was permitted despite non-compliance with specific labelling requirements, subject to certain conditions. The application and enforcement of the Act can be further detailed through Therapeutic Goods Orders and other subordinate instruments, which provide specific regulations and standards for various therapeutic goods.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) provides a regulatory framework for the control of therapeutic goods in Australia. Under sections 14 and 14A of the Act, the Secretary of the Department of Health can give consent to the importation and supply of therapeutic goods that do not conform to certain requirements. In this instance, the Secretary's delegate granted AstraZeneca Pty Ltd consent to import and supply saxagliptin (as hydrochloride) in combination with metformin hydrochloride modified release, under specific conditions. The consent pertains to three different formulations: KOMBIGLYZE XR 2.5/1000, KOMBIGLYZE XR 5/1000, and KOMBIGLYZE XR 5/500, which have batch numbers listed in the notice. The Act imposes several obligations on the parties involved in the importation and supply of these therapeutic goods. Firstly, AstraZeneca must ensure that the labels for the products currently supplied reflect the previous sponsor's details along with the current sponsor's information, which serves as the distributor. Secondly, AstraZeneca must have arrangements in place to redirect all correspondence related to the products to the current sponsor. These obligations are intended to maintain transparency and ensure that consumers and healthcare professionals can access accurate information about the therapeutic goods. Non-compliance with the terms of the consent or the Act itself may result in legal consequences. While the Therapeutic Goods Act does not explicitly state penalties for breaches in this context, general provisions within the Act provide for civil and criminal penalties for non-compliance. Under section 95 of the Act, civil penalties can include fines of up to $22,200 for individuals and $111,000 for corporations, while criminal penalties can include fines of up to $555,000 for individuals and $2,775,000 for corporations, along with potential imprisonment terms. These penalties underscore the importance of adhering to the terms of the consent and the broader requirements of the Act.