Consent given pursuant to sections 14 and 14A for the supply and importation of the Therapeutic Goods specified subject to conditions specified - between 29 July 2014 and 7 March 2015

Overview

The Therapeutic Goods Act 1989, enacted by the Australian Parliament, establishes a framework for regulating therapeutic goods within Australia, aiming to ensure the safety, quality, and efficacy of such goods. The Act was introduced to address the need for a cohesive and comprehensive legislative approach to the regulation of therapeutic goods, including medicines, medical devices, and other health-related products. The Therapeutic Goods Administration, operating under the Department of Health, administers the Act to implement its objectives. On 29 July 2014, the delegate of the Secretary of the Department of Health granted consent to AbbVie Pty Ltd for the importation and supply of specific therapeutic goods under certain conditions. This consent allows for the use of labels that do not conform to the requirements of the Therapeutic Goods Order No. 69, specifically those that bear the previous sponsor’s name instead of the new sponsor’s name, effective until early 2015. The policy objective is to facilitate the transition of product sponsorship while ensuring that therapeutic goods remain subject to rigorous regulatory oversight to protect public health.

Scope and Application

The Therapeutic Goods Act 1989, as amended, governs the regulation of therapeutic goods in Australia, encompassing a wide range of products including medicines, medical devices, and blood products. Section 14 and 14A of the Act pertain to the importation and supply of therapeutic goods, and in this context, the Act applies to entities or individuals seeking to import and supply specific products that do not conform to certain regulatory requirements. In the case of AbbVie Pty Ltd, consent has been granted for the importation and supply of specific batches of therapeutic goods, such as levobupivacaine hydrochloride and isoflurane, which do not comply with labelling requirements but are subject to conditions to ensure that previously approved labels are used and that there is continuous customer contact maintained. The consent issued under the Act is effective for a limited period, until March 7 or March 10, 2015, depending on the product. The Act’s jurisdictional reach is national, applying across the Commonwealth of Australia, and while the Act itself provides the primary legal framework, its application may be further extended or restricted through subordinate instruments such as regulations and orders.

Key Provisions

Sections 14 and 14A of the Therapeutic Goods Act 1989 pertain to the consent given by the Secretary of the Department of Health for the importation and supply of therapeutic goods. Specifically, section 14(1) allows for the Secretary to consent to the supply of therapeutic goods that do not fully comply with the standards set out in the Therapeutic Goods Orders, provided that certain conditions are met. In this instance, section 14A of the Act was invoked to permit the importation and supply of specified products by AbbVie Pty Ltd, despite the products not adhering to the labelling requirements under Therapeutic Goods Order No. 69. The consent is limited to specific products and batches and is valid for a defined period, from July 29, 2014, to March 7, 2015, and March 10, 2015, for certain products. The obligations imposed on the parties governed by this Act include ensuring that the products supplied meet the required standards as closely as possible and adhering to the conditions set by the Secretary. In this case, AbbVie Pty Ltd must use labels previously approved by the Secretary, which bear the details of the previous sponsor, Abbott. Furthermore, they must maintain continuous customer contact as described in the company's letter to the Department of Health. This requirement is critical to ensure that any issues arising from the non-compliant labelling can be promptly addressed and resolved. Failure to comply with the conditions of the consent or any other provision of the Therapeutic Goods Act 1989 can result in significant legal consequences. Under section 25 of the Act, any person who contravenes the Act or the regulations may be subject to a range of penalties. These can include fines, imprisonment, or both, depending on the severity of the offence. For example, section 10(1) of the Act stipulates that a person who contravenes a prohibition or restriction in the Act may be fined up to $1.65 million for a corporation and $330,000 for an individual, or imprisoned for up to five years, or both, for serious offences. For less severe breaches, the fines can be up to $82,500 for a corporation and $16,500 for an individual. The exact penalties depend on the nature and extent of the breach, as well as any previous convictions.