COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 15 April 2015, the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”), on the application of Janssen-Cilag Pty Ltd, gave consent to the importation and supply of
- IMBRUVICA 140 mg ibrutinib capsules
that do not conform with the requirements of the paragraph 3(2)(l) and 3(2)(n) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines, in that the labels lack the registration number and the name and address of the Australian sponsor.
The consent is effective from the date of this letter until 31 July 2015.
Overview
The Therapeutic Goods Act 1989 was enacted to regulate the supply of therapeutic goods in Australia, ensuring their quality, safety, and efficacy. This Act, administered by the Therapeutic Goods Administration (TGA) under the Department of Health, was introduced to address the need for comprehensive oversight and regulation of therapeutic goods to protect public health. The Act empowers the TGA to control the importation, supply, and advertising of therapeutic goods, thereby ensuring that such goods meet the necessary standards and are appropriately labelled. On 15 April 2015, the delegate of the Secretary of the Department of Health granted a specific consent under sections 14 and 14A of the Act for the importation and supply of IMBRUVICA 140 mg ibrutinib capsules, manufactured by Janssen-Cilag Pty Ltd, despite the product labels not fully conforming to certain labelling requirements as stipulated in the Therapeutic Goods Order No. 69. This consent was issued to address a temporary supply issue, allowing the therapeutic product to be made available while maintaining the overarching goal of protecting public health through the regulation of therapeutic goods.
Scope and Application
The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, including their import, supply, and advertisement. This Act encompasses a broad range of therapeutic goods, such as medicines, medical devices, blood, and tissues, and applies to both individuals and entities involved in the production, supply, or advertising of these goods. The jurisdictional reach of the Act is national, extending across the Commonwealth of Australia, including its states and territories. The Act provides a framework for ensuring that therapeutic goods available in Australia are of acceptable quality and are not harmful to health. Under this Act, the Therapeutic Goods Administration (TGA) has the authority to issue various types of consents and approvals, such as those for importing non-compliant goods, as exemplified in the notice regarding the IMBRUVICA 140 mg ibrutinib capsules. Notably, the consent granted in this instance allows for the temporary import and supply of capsules that do not meet certain labelling requirements, highlighting the Act's flexibility in addressing specific situations while maintaining overall regulatory standards. The Act can extend or restrict its application through subordinate instruments, which provide further detail on specific requirements and exemptions.
Key Provisions
The Therapeutic Goods Act 1989, specifically sections 14 and 14A, provide a mechanism through which the Secretary of the Department of Health can give consent for the importation and supply of therapeutic goods that do not conform to certain regulatory requirements. In this instance, section 14(1) allows for the Secretary to provide such consent if they are satisfied that the therapeutic goods are satisfactory for supply. The Secretary’s decision, as outlined in section 14A, was made on 15 April 2015 regarding the importation and supply of IMBRUVICA 140 mg ibrutinib capsules by Janssen-Cilag Pty Ltd. The consent granted allows these capsules, which lack the registration number and the name and address of the Australian sponsor on their labels, to be imported and supplied until 31 July 2015.
Under this Act, the Secretary’s consent imposes specific obligations on Janssen-Cilag Pty Ltd. They must ensure that the therapeutic goods, in this case IMBRUVICA 140 mg ibrutinib capsules, meet the required standards for safety, efficacy, and quality, despite the non-conformance with certain labelling requirements. The company is also required to adhere to all other provisions of the Act and related regulations. This includes maintaining records and providing information as required by the Therapeutic Goods Administration.
Failure to comply with the provisions of the Therapeutic Goods Act 1989, including supplying therapeutic goods that do not meet the specified requirements, can result in significant legal consequences. The Act includes various offences and penalties for non-compliance. For example, under section 33DA, supplying therapeutic goods that are not permitted by the Act can result in fines and imprisonment. The maximum penalties for these offences can be substantial, reflecting the seriousness of supplying non-compliant therapeutic goods. Specifically, section 33DA(1) states that a person can be fined up to $222,222 or imprisoned for up to 12 months, or both, for each offence of supplying therapeutic goods that do not comply with the Act. These penalties underscore the importance of adhering to the regulatory requirements set out in the Act.