Consent given pursuant to Sections 14 and 14A to the importation and supply of the therapeutic goods specified - Bayer Australia Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to regulate therapeutic goods in Australia, establishing a framework for the control of the quality, safety, efficacy, and timely availability of these goods. The Act was introduced to address the need for a comprehensive legislative structure governing therapeutic products, including medicines, medical devices, and other health-related items. The enacting body for this legislation was the Parliament of Australia, with the policy objective being to protect public health by ensuring that therapeutic goods meet necessary standards. In specific instances, such as the consent provided for the importation and supply of ALK-SELTZER LEMON-LIME FLAVOUR aspirin 324mg effervescent tablet strip (new formula) by Bayer Australia Ltd, the Act allows for certain exceptions to standard requirements to facilitate the availability of therapeutic goods that otherwise may not meet specific regulatory standards, provided that such consent is granted by the appropriate authority. This approach aims to balance regulatory compliance with public health needs.

Scope and Application

The Therapeutic Goods Act 1989 applies to therapeutic goods, including medicines, medical devices, and related substances, within the Commonwealth of Australia. This Act provides a regulatory framework for the control and oversight of therapeutic goods, ensuring their safety, quality, and efficacy. The Act applies to various entities such as manufacturers, importers, suppliers, and distributors of therapeutic goods, as well as individuals involved in the research, testing, or advertising of these products. The scope of the Act extends to the entire Australian jurisdiction, encompassing all states and territories, thereby establishing a uniform regulatory standard across the country. Notably, the Therapeutic Goods Order No. 78, which specifies the standards for tablets and capsules, plays a crucial role in enforcing the requirements outlined in the Act. While the Act broadly governs the therapeutic goods industry, certain exclusions and exemptions may apply, often defined through subordinate instruments that provide further clarity and specific implementation guidelines. The Act's regulatory framework is designed to protect public health by ensuring that therapeutic goods meet specified standards, thus maintaining a high level of safety and quality throughout the supply chain.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) provides a framework for regulating therapeutic goods in Australia. Section 14 and 14A of the Act allow the delegate of the Secretary of the Department of Health to give consent for the importation and supply of therapeutic goods that do not conform with the requirements of Therapeutic Goods Orders (TGOs). In this case, the delegate has given consent for Bayer Australia Ltd to import and supply a new formula of ALK-SELTZER LEMON-LIME FLAVOUR aspirin 324mg effervescent tablets that do not meet the specifications outlined in the Therapeutic Goods Order No. 78 – Standard for Tablets and Capsules (section 14 and 14A (1)). Specifically, the effervescent tablets exceed the allowable limit for free salicylic acid and have wider limits for the content of the active ingredient, aspirin, at expiry. The obligations imposed by this consent on Bayer Australia Ltd include adhering to the terms and conditions specified in the consent. They must ensure that the product is labelled accurately to inform consumers of its non-compliance with the TGOs and that it is imported and supplied only within the specified timeframe, from 16 January 2015 until 2 December 2017. Bayer Australia Ltd must also maintain records and documentation to demonstrate compliance with the consent conditions, which may be subject to inspection by the Therapeutic Goods Administration (TGA). Failure to comply with the terms of the consent may result in various consequences. Under the Act, non-compliance with consent conditions is an offence (section 32DA(2)). Offenders may face criminal penalties, including fines of up to $1,650 for individuals and $8,250 for bodies corporate, as stipulated in section 32DA(4) of the Act. Additionally, the TGA has the authority to take enforcement actions, such as seizing non-compliant goods, issuing infringement notices, or pursuing legal action to prevent further breaches. Civil penalties may also apply, and the maximum fines can escalate based on the severity and recurrence of the offence. These provisions underscore the importance of adhering to the regulatory requirements governing therapeutic goods in Australia.