Consent given pursuant to sections 14 and 14A to the importation and supply of the therapeutic goods specified by Global Medical Solutions Australia

Overview

The Therapeutic Goods Act 1989, enacted by the Commonwealth of Australia’s Parliament, was introduced to regulate therapeutic goods to ensure they are safe, of high quality and effective, and to protect public health by controlling their advertising, supply, and importation. One of the key objectives of the Act is to provide for the regulation of therapeutic goods, including medicines, in a way that balances consumer protection with the availability of therapeutic goods. In this context, the Therapeutic Goods Administration, under the Act, may consent to certain exceptions for the supply of therapeutic goods that do not fully comply with the regulatory standards to facilitate access to potentially beneficial treatments under controlled conditions. This approach helps address the gap where strict adherence to regulatory standards might impede the availability of therapeutic goods that could offer significant health benefits. The Therapeutic Goods Administration, a part of the Department of Health, granted a consent under sections 14 and 14A of the Therapeutic Goods Act 1989 for the importation and supply of a specific batch of HEPATOLITE kits by Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific. This consent allows for the use of these kits, which do not meet the full labelling requirements stipulated in the Therapeutic Goods Order No. 69, to ensure continued access to this therapeutic good while mitigating any potential risks through specific conditions, including the provision of a modified package insert and over-sticker labelling to clearly communicate the appropriate storage conditions.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods within Australia, which encompasses a wide range of products, including medicines, medical devices, blood, tissues, and therapeutic appliances. This Act applies to persons and entities involved in the supply, importation, and advertising of therapeutic goods. It extends across the Commonwealth, and its regulations and orders are binding throughout Australia. The Act provides for various exemptions and thresholds, depending on the type of therapeutic goods and the specific provisions of related orders. The Therapeutic Goods Order No. 69, which pertains to labelling requirements for medicines, includes detailed provisions about what must be included on labels to ensure consumer safety and product efficacy. However, in this particular case, the Act permits deviations from the labelling requirements for the specified product under certain conditions, such as the consent provided for the import and supply of HEPATOLITE kits for a limited period and specific batch numbers. This consent is subject to conditions that ensure the safety and efficacy of the product, such as the provision of a 'Dear Healthcare Provider' letter and an Australian package insert. The application of the Act can be further refined or extended through subordinate instruments, which can introduce additional conditions or exemptions as necessary.

Key Provisions

Sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) allow for the consent of the Secretary of the Department of Health for certain activities that would otherwise be non-compliant with the Act or the Therapeutic Goods Regulations. In this instance, section 14 consents to the importation and supply of the HEPATOLITE kit for production of Technetium (99mTc) disofenin powder for injection multidose vial [AUST R 19146], which does not conform to the requirements of paragraph 3(2)(j) of the Therapeutic Goods Order No. 69, specifically regarding the description of storage conditions on the label. This consent is given on the application of Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific. Section 14A specifies the terms and conditions under which the consent is granted. The Therapeutic Goods Act 1989 imposes several obligations on the parties involved. Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific must ensure that the product imported and supplied meets the conditions specified in the consent. This includes sending a ‘Dear Healthcare Provider’ letter to inform healthcare providers about the differences between the Australian and US versions of the product, ensuring the Australian package insert is provided and highlighting the correct Australian storage conditions. Additionally, the carton labels for the product, originally intended for the US market, must be over-stickered with the Australian sponsor's details and the AUST R number to ensure compliance with Australian standards. Failure to adhere to the conditions specified in the consent may result in legal consequences. While specific offences and penalties are not outlined in the consent notice, breaches of the Therapeutic Goods Act 1989 can lead to substantial penalties. For example, supplying non-compliant therapeutic goods can attract penalties under section 28A, which can include fines of up to $222,200 for individuals and significantly higher amounts for corporations, along with potential imprisonment terms. Furthermore, ongoing non-compliance may result in further enforcement actions by the Therapeutic Goods Administration, including product recalls and further legal proceedings. In summary, sections 14 and 14A of the Therapeutic Goods Act 1989 provide a mechanism for the Secretary of the Department of Health to grant consent for the importation and supply of therapeutic goods that do not fully comply with regulatory requirements, subject to specific conditions. Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific must adhere to these conditions to avoid potential civil and criminal penalties associated with non-compliance with the Act.