Supply of Goods by CSL Limited

Overview

The Therapeutic Goods Act 1989 was enacted by the Parliament of Australia to regulate the supply of therapeutic goods within the country, addressing the need for a comprehensive framework to ensure the safety, quality, and efficacy of such goods. This Act provides the legal foundation for the regulation of medicines, medical devices, and other therapeutic goods, aiming to protect public health by controlling the importation, supply, and advertising of these goods. In particular, the Act facilitates the establishment of a national system for the regulation of therapeutic goods, ensuring that they meet the necessary standards before being made available to the public. This specific notice, issued on 15 July 2013 by Chris Rolls, a delegate of the Secretary of the Department of Health and Ageing, grants consent for CSL Limited to supply certain lots of an oral inactivated cholera vaccine, DUKORAL, with labels that do not fully comply with certain labelling requirements set out in Therapeutic Goods Order No 69. The consent is granted under sections 14 and 14A of the Therapeutic Goods Act 1989 and is subject to specific conditions, including that the exemption applies only to the specified lots and that all other labelling requirements must be met. This measure is intended to facilitate the supply of the vaccine while ensuring that the public's health is safeguarded through the enforcement of other regulatory standards.

Scope and Application

The Therapeutic Goods Act 1989, as referenced in the gazette notice, applies to entities involved in the supply of therapeutic goods in Australia, including pharmaceutical companies such as CSL Limited. In this particular case, the Act facilitates an exemption for specific lots of an oral inactivated cholera vaccine, DUKORAL, allowing them to be supplied with labels that do not comply with certain labelling requirements set out in Therapeutic Goods Order No 69. This exemption is narrowly tailored to the specified lots mentioned and mandates adherence to all other labelling requirements. The exemption is granted by a delegate of the Secretary of the Department of Health and Ageing, subject to specific conditions, including that the exemption is limited to these particular lots and that all other regulatory requirements are met. This notice underscores the Act's role in regulating the supply of therapeutic goods while allowing for flexibility in certain circumstances to ensure public health and safety.

Key Provisions

The key operative sections of this notice are sections 14, 14A, and 15 of the Therapeutic Goods Act 1989 (the Act). Section 14 allows the Secretary of the Department of Health and Ageing to give consent for the supply of therapeutic goods under certain conditions. Section 14A provides the authority for the Secretary to delegate this power to another person, which in this case is Chris Rolls. Section 15 sets out the conditions under which this consent can be given, as seen in the notice. The notice specifies that CSL Limited is granted consent to supply certain lots of the oral inactivated cholera vaccine, DUKORAL, with labels that do not comply with the requirements of paragraph 3(2)(h) of Therapeutic Goods Order No 69, but only for these specified lots, and all other label requirements must still be adhered to. The obligations and requirements imposed by this notice on CSL Limited and the Department of Health and Ageing include ensuring that the specified lots of the oral inactivated cholera vaccine are supplied in accordance with the conditions outlined in the notice. CSL Limited must adhere to all other parts of Therapeutic Goods Order No 69, ensuring that all other labelling requirements are met. Additionally, the supply of this product must comply with the standard conditions for the supply of goods registered in the Australian Register of Therapeutic Goods. The delegate, Chris Rolls, must ensure that the consent provided is strictly adhered to the terms and conditions outlined, and that any breaches are promptly addressed. Failure to comply with the conditions of the consent may lead to legal consequences. The Therapeutic Goods Act 1989 provides for various offences and penalties for breaches. Depending on the nature and severity of the breach, it may be classified as an offence under the Act, leading to criminal penalties. The maximum penalties for offences under the Act can include fines and imprisonment. Additionally, any supply of therapeutic goods that does not comply with the Act or the conditions of consent may result in civil consequences, such as product recalls, fines, or other corrective actions. The notice itself does not specify the exact penalties but refers to the broader legal framework under which such penalties are determined.