Consent pursuant to Sections 14 and 14A to the importation and supply of the therapeutic goods specified by AFT Pharma Australia Pty Ltd

Overview

The Therapeutic Goods Act 1989, enacted by the Commonwealth Parliament, serves as the primary legislative framework governing the regulation of therapeutic goods in Australia. This Act was introduced to address the need for a comprehensive regulatory system to ensure the safety, quality, and efficacy of therapeutic goods available to consumers. The Therapeutic Goods Administration (TGA), an agency within the Department of Health, administers this Act to uphold its policy objective of protecting public health by regulating therapeutic goods. On 30 July 2015, a delegate of the Secretary of the Department of Health granted a consent under sections 14 and 14A of the Act to AFT Pharma Australia Pty Ltd, allowing the importation and supply of a specific batch of Levetiracetam oral solution that did not fully comply with certain labelling requirements. This consent was issued to address a specific instance where the carton label failed to declare the presence and content of maltitol in the product, and it was applicable only to Batch 150073 of the product, while maintaining the approved labels for the product.

Scope and Application

The Therapeutic Goods Act 1989 applies to a broad range of therapeutic goods, including medicines, medical devices, blood, and tissues, within the Commonwealth of Australia. This legislation encompasses both natural and synthetic products, ensuring that they meet safety, quality, and efficacy standards before being supplied within Australia. The Act applies to persons and entities involved in the manufacture, importation, supply, and advertising of therapeutic goods, thereby ensuring that all goods entering the Australian market comply with stringent regulatory standards. Additionally, the Act extends its reach to conduct and transactions associated with therapeutic goods, ensuring a comprehensive regulatory framework. The geographic jurisdiction of the Act is national, governing the therapeutic goods market across the entirety of Australia, including states, territories, and the Commonwealth. While the Therapeutic Goods Act 1989 covers a wide array of therapeutic goods, there are specific exclusions and exemptions provided under the Act and its subordinate instruments. For instance, certain goods such as complementary medicines and therapeutic goods used for personal or domestic purposes may be subject to different or lesser regulatory requirements. The application of the Act can be extended or restricted through subordinate instruments such as therapeutic goods orders, which provide further detail and specificity in relation to particular types of therapeutic goods. These orders often outline the specific requirements that goods must meet to comply with the Act, thereby ensuring a consistent and effective regulatory environment.

Key Provisions

Under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act), the Secretary of the Department of Health has the authority to consent to the importation and supply of therapeutic goods that do not fully comply with certain regulatory requirements. In this specific case, the delegate of the Secretary has consented to the importation and supply of Levetiracetam (LEVETIRACETAM-AFT) oral solution 100 mg/mL in bottle [AUST R 218279], specifically Batch 150073, which does not conform to the labelling requirements stipulated in paragraph 3(2)(d)(iii) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. This non-compliance relates to the carton label not declaring the presence and content of the ingredient maltitol in the product. This consent is effective from 30 July 2015 and is limited to the specified batch of the product. The Act imposes several obligations and requirements on the parties involved in the importation and supply of therapeutic goods. Firstly, the Act requires that all therapeutic goods meet the standards and criteria outlined in the Therapeutic Goods Orders, which include detailed labelling requirements. Section 14 of the Act allows the Secretary to consent to non-compliance if certain conditions are met, ensuring that public health and safety are not compromised. In this case, the consent is conditional upon the continued use of the currently approved labels for the product. This ensures that consumers and healthcare professionals have the necessary information to make informed decisions about the use of the product. The Therapeutic Goods Act 1989 also provides for various offences, penalties, and civil/criminal consequences for breaches of its provisions. While the consent granted under sections 14 and 14A does not automatically result in penalties, any failure to adhere to the conditions of the consent or any other non-compliance with the Act could lead to enforcement actions. Under the Act, serious or repeated breaches can result in substantial penalties. For example, Section 83 of the Act outlines penalties for supplying therapeutic goods that do not comply with the Act or the regulations, with maximum fines for corporations reaching up to $2,100,000 and individuals facing maximum fines of $210,000, as well as potential imprisonment terms. Additionally, civil penalties can be imposed for misleading or deceptive conduct related to therapeutic goods, with the maximum penalty for corporations being six times the value of the benefit obtained through the conduct. In summary, the Therapeutic Goods Act 1989 provides a framework for regulating the importation and supply of therapeutic goods in Australia, with specific provisions in sections 14 and 14A allowing for consent to be granted in cases of non-compliance under certain conditions. The obligations under the Act include adhering to the labelling requirements and any conditions imposed by the Secretary. Failure to comply with the Act can result in significant penalties, highlighting the importance of adhering to the regulatory standards to ensure public health and safety.