Consent given pursuant to Sections 14 and 14A for the importation and supply of the therapeutic goods specified - between 29 October 2014 and 30 June 2017

Overview

The Therapeutic Goods Act 1989 was enacted to regulate therapeutic goods in Australia, ensuring that the supply and use of these goods do not pose unacceptable health and safety risks. This Act addresses the gap by providing a comprehensive legislative framework to manage the quality, safety, efficacy, and timely availability of therapeutic goods. The Act is administered by the Parliament of Australia and aims to protect public health by controlling the therapeutic goods market. One of the key policy objectives of the Act is to ensure that therapeutic goods meet certain standards and are only supplied if they do not pose an unacceptable risk to public health. In a recent application under sections 14 and 14A of the Act, the delegate of the Secretary of the Department of Health granted consent for the importation and supply of lignocaine (VERSATIS) 5% w/w dermal patches by bioCSL (Australia) Pty Ltd, despite the product not meeting the labelling requirements. This consent was given under specific conditions to ensure continued oversight and management of any potential health risks associated with the product.

Scope and Application

The Therapeutic Goods Act 1989 applies to all therapeutic goods, including medicines, medical devices, blood and blood components, tissues, and human cells, within the Commonwealth of Australia. This Act regulates the importation, supply, and manufacture of these goods to ensure they meet safety, quality, and efficacy standards. The Act applies to all entities involved in the lifecycle of therapeutic goods, such as sponsors, manufacturers, importers, and suppliers, and covers their conduct and transactions related to these goods. The Act's geographic reach is national, encompassing all states and territories of Australia. While the Act generally applies to all therapeutic goods, certain exclusions and exemptions may apply, such as for goods used for personal, non-commercial purposes or research and development activities approved under specific provisions. The application of the Act can also be extended or restricted through subordinate instruments, such as regulations and orders, which may provide further details on specific aspects of the legislation, including labelling and advertising requirements.

Key Provisions

The Therapeutic Goods Act 1989, specifically under sections 14 and 14A, governs the importation and supply of therapeutic goods within Australia. Section 14 allows the delegate of the Secretary of the Department of Health to grant consent for the importation and supply of therapeutic goods that do not fully comply with certain requirements, provided that such consent is in the public interest. Section 14A provides the framework for imposing conditions on such consent to mitigate any risks associated with the non-compliance. In this instance, on October 29, 2014, the delegate granted consent for bioCSL (Australia) Pty Ltd to import and supply lignocaine (VERSATIS) 5% w/w dermal patch, which does not meet the labelling requirements as stipulated in the Therapeutic Goods Order No. 69. This consent is valid from October 29, 2014, until June 30, 2017. The obligations imposed on bioCSL (Australia) Pty Ltd under this consent are quite specific. Firstly, they must use the labels that were previously approved for the former sponsor, Grunenthal Australia Pty Ltd. Secondly, bioCSL must have arrangements in place to ensure that any queries or complaints regarding the product are promptly referred to them from the former sponsor. This arrangement is crucial to maintain the quality control and oversight of the therapeutic goods in question. Breach of the conditions imposed by the delegate can have significant consequences. While the Therapeutic Goods Act does not specify penalties for non-compliance with consent conditions, any failure to adhere to the outlined obligations could result in the consent being revoked. Such revocation would mean that bioCSL would no longer be authorised to import or supply the specified therapeutic goods. Additionally, any serious or repeated breaches may lead to further regulatory action, including potential criminal charges if the breach constitutes an offence under the Act. The specific consequences would depend on the severity and nature of the non-compliance, but it is clear that adherence to the conditions is mandatory to avoid these repercussions.