Supply of the product Saxagliptin (as hydrochloride) by AstraZeneca Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted by the Commonwealth Parliament to provide a legislative framework for the regulation of therapeutic goods in Australia, addressing the need for a unified system to ensure the safety, quality, and efficacy of therapeutic goods. The Act established the Therapeutic Goods Administration (TGA) within the Department of Health to oversee the regulation of therapeutic goods, including medicines, medical devices, and blood and blood components. The policy objective of the Act is to protect public health by ensuring that therapeutic goods available in Australia meet acceptable standards of quality, safety, and efficacy. In 2014, the delegate of the Secretary of the Department of Health provided consent for the supply of the product saxagliptin (as hydrochloride) (KOMBIGLYZE XR) by AstraZeneca Pty Ltd, under certain conditions to address non-compliance with labelling requirements specified in Therapeutic Goods Order No. 69. This consent ensures that the product can be supplied while corrective measures are implemented to update the labelling information.

Scope and Application

The Therapeutic Goods Act 1989 governs the regulation of therapeutic goods in Australia, including medicines, medical devices, blood, and tissues. This legislation applies to entities involved in the manufacturing, importation, supply, and advertising of therapeutic goods, ensuring that these goods meet safety, quality, and efficacy standards. The Act applies across the Commonwealth of Australia, impacting businesses and individuals within the therapeutic goods industry, regardless of state or territory boundaries. Notably, the Act extends its application through various regulations and orders, such as the Therapeutic Goods (Advertising) Determination 2010 and the Therapeutic Goods (Registration) Regulations 1990, which provide further detail on specific aspects of therapeutic goods regulation. Exemptions and exclusions are provided for certain goods under particular circumstances, such as for goods used in research and testing or for personal use. In this instance, the Therapeutic Goods Administration has granted a specific consent under sections 14 and 14A of the Act for the supply of a pharmaceutical product, saxagliptin (as hydrochloride) combined with metformin hydrochloride, manufactured by AstraZeneca Pty Ltd. The consent addresses a non-conformance with the labelling requirements specified in Therapeutic Goods Order No. 69. This consent is conditional, requiring that the current labels be used with the previous sponsor’s details alongside the current sponsor’s information and ensuring all correspondence is redirected to the current sponsor. This arrangement is temporary, valid for 12 months, and no other changes to the product have been authorised.

Key Provisions

The Therapeutic Goods Act 1989, specifically under sections 14 and 14A, governs the supply of therapeutic goods in Australia. These sections allow the Secretary of the Department of Health to give consent for the supply of certain products that do not meet all regulatory requirements but are considered acceptable under specific conditions. In this instance, the Secretary’s delegate has given consent for the supply of saxagliptin (as hydrochloride) in various formulations under the brand name KOMBIGLYZE XR by AstraZeneca Pty Ltd. However, the consent is subject to certain conditions because the product labels do not conform to the requirements set out in Therapeutic Goods Order No. 69 (TGO 69), which pertains to the general requirements for labels for medicines. The consent provided by the Secretary’s delegate imposes several obligations on the parties involved. Firstly, AstraZeneca Pty Ltd must ensure that the carton labels for KOMBIGLYZE XR tablets include both the previous and current sponsor details until a label update can be implemented. Additionally, AstraZeneca must redirect all correspondence related to the product to their current sponsor details, ensuring that all communications are properly managed and directed. It is also crucial that no other changes are made to the product during this period, maintaining the product’s integrity and consistency as per the regulatory standards. Failure to comply with the conditions set by the Secretary’s delegate can lead to serious consequences. Under the Therapeutic Goods Act 1989, non-compliance with the specified conditions of consent could result in enforcement actions, which may include fines or other civil or criminal penalties. The Act does not specify the exact penalties in this instance, but generally, violations can attract significant fines and legal repercussions, potentially impacting the company’s reputation and market operations. Ensuring adherence to the regulatory conditions is therefore crucial for avoiding these potential negative outcomes.