Supply of quetiapine (as fumarate) (seroquel XR) modified release tablet 50 mg in blister pack by AstraZeneca

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the supply of therapeutic goods in Australia, ensuring that such goods meet required standards for quality, efficacy, and safety. The Act provides the legal framework within which the Therapeutic Goods Administration (TGA) operates, overseeing activities such as the registration, evaluation, and monitoring of therapeutic goods. The 1989 Act was introduced to address the need for a cohesive and effective regulatory system governing therapeutic goods to protect public health. The Parliament of Australia enacted the Act to establish a robust regulatory environment, with the policy objective of safeguarding the health and safety of Australians by ensuring that therapeutic goods available in the market are of an acceptable standard. The Act allows the TGA to take necessary actions, including granting specific consents for the supply of therapeutic goods that do not fully comply with certain regulatory standards, provided that such actions do not compromise public safety.

Scope and Application

The Therapeutic Goods Act 1989 governs the regulation of therapeutic goods in Australia, encompassing a broad range of products including medicines, medical devices, and blood and blood components. This Act applies to any person or entity involved in the supply, importation, or manufacture of therapeutic goods within Australia. The application of the Act is comprehensive, covering the entire supply chain and ensuring that therapeutic goods meet safety, quality, and efficacy standards. The Act applies nationally, covering all states and territories within the Commonwealth of Australia. The Act's scope includes the regulation of the manufacture, supply, importation, and exportation of therapeutic goods, as well as the advertising and representation of these goods. The Therapeutic Goods Administration (TGA), under the auspices of the Department of Health, enforces the Act and related regulations, including Therapeutic Goods Orders (TGOs), which provide further detail on specific aspects of the regulation. The consent given for the supply of quetiapine (as fumarate) modified release tablets in the specified batches, despite their non-compliance with certain labelling requirements, demonstrates the TGA's ability to conditionally approve the supply of therapeutic goods that do not fully conform to regulations, subject to specific conditions that mitigate any potential risks.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) provides a framework for regulating therapeutic goods, including medicines, in Australia. Under section 14 and 14A of the Act, the Secretary of the Department of Health has the authority to give consent for the supply of therapeutic goods that do not fully conform with the standards set out in Therapeutic Goods Orders (TGO). In this particular case, the Secretary's delegate has given consent for the supply of quetiapine (as fumarate) (seroquel XR) modified release tablets 50 mg in blister packs (Aust R 138917) by AstraZeneca, subject to specific conditions (section 15(1)). The consent is limited to certain batches of the product, namely batch 60009807 (3150 packs), batch 60010214 (5074 packs), and batch 60010402 (7810 packs), as specified in the conditions attached to the consent. These batches do not conform to paragraph 3(2)(n) of TGO 69 because the label for the product contains an incorrect registration number. Despite this non-compliance, the consent stipulates that the carton labels currently in use (Aust R number 153883) should be used, and all other aspects of the label must comply with TGO 69. The obligations imposed by the Act on the parties involved include ensuring that the supplied therapeutic goods meet the standards set out in the TGO, except where consent has been granted under section 14 or 14A. In this case, AstraZeneca must ensure that the specified batches of quetiapine comply with all aspects of TGO 69 except for the registration number on the label. The Therapeutic Goods Administration (TGA) must also monitor compliance with the conditions of the consent to ensure that the supplied goods meet the necessary standards. Failure to comply with the conditions of the consent or with the requirements of the Act and the TGO can result in various consequences. Under section 21 of the Act, a person who contravenes the Act, a regulation, or an order can be subject to enforcement actions. Civil penalties can be imposed for breaches of the Act or the regulations, with the maximum penalty depending on the nature and seriousness of the offence. In more severe cases, criminal penalties, including fines and imprisonment, can be imposed. The specific penalties are detailed in the Act and can vary widely based on the circumstances of the breach.