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

Overview

The Therapeutic Goods Act 1989, enacted by the Commonwealth of Australia's Parliament, was introduced to ensure that therapeutic goods available in Australia are of acceptable quality and meet safety and efficacy standards. This legislation established a regulatory framework to control the importation, supply, and advertising of therapeutic goods, aiming to protect public health by ensuring that these products are safe, of high quality, and perform as claimed. In particular, the Act was designed to address the gap in regulation concerning the oversight of therapeutic goods to maintain and enhance the health of the Australian population. In the context of the 2015 Gazette notice, a delegate of the Secretary of the Department of Health granted consent under sections 14 and 14A of the Act for the importation and supply of a specific kit for the preparation of technetium (99m Tc) sestamibi injection, which did not conform to certain labelling requirements. The consent was issued to Mallinckrodt Australia Pty Ltd, subject to conditions ensuring that the approved labels remained unchanged and that a referral system was in place for any queries or complaints. This action underscores the Act's policy objective of balancing regulatory compliance with the need to facilitate access to necessary medical treatments.

Scope and Application

The Therapeutic Goods Act 1989 applies to a wide range of therapeutic goods, including medicines, medical devices, blood and blood components, tissues, and therapeutic goods used in clinical trials. The Act is administered by the Therapeutic Goods Administration (TGA), a department within the Australian Government’s Department of Health. It applies to persons and entities involved in the importation, manufacture, supply, and advertising of therapeutic goods within Australia. This includes pharmaceutical companies, healthcare providers, and retailers. The Act’s jurisdiction covers the entire Commonwealth of Australia, ensuring a consistent regulatory framework across the nation. Exclusions from the Act include certain goods such as food, cosmetics, and most devices not used for medical purposes, as well as some research activities that fall under other regulatory schemes. The Act also allows for the creation of specific regulations and standards through subordinate instruments, which can extend or clarify its provisions, ensuring it remains adaptable to new developments in therapeutic goods and their regulation.

Key Provisions

The Therapeutic Goods Act 1989, specifically sections 14 and 14A, outlines the process through which the Department of Health can consent to the importation and supply of therapeutic goods that do not fully comply with the Act's requirements. In this particular instance, on 2 September 2015, a delegate of the Secretary of the Department of Health granted a consent application made by Mallinckrodt Australia Pty Ltd. This consent allowed for the importation and supply of a kit for the preparation of technetium (99m Tc) (Technescan Sestamibi) sestamibi injection, registered under AUST R 170503, which did not conform to the labelling requirements stipulated in paragraph 3(2)(l) of Therapeutic Goods Order No. 69. More specifically, the labels did not include the name and address of the previous sponsor. This consent was effective for a period of 12 months, from 14 September 2015 to 13 September 2016, and was subject to certain conditions to ensure the safe and effective use of the therapeutic goods. Under the Therapeutic Goods Act 1989, entities such as Mallinckrodt Australia Pty Ltd must ensure that the therapeutic goods they wish to import and supply meet the stipulated requirements of the Act and its associated orders. However, in exceptional circumstances, such as the one outlined in this consent, the Act provides a mechanism for the Department of Health to allow the importation and supply of goods that do not fully comply with certain regulatory requirements. This consent process is intended to facilitate access to therapeutic goods that are otherwise beneficial, while ensuring that any potential risks are mitigated through the imposition of specific conditions. The obligations imposed on the parties under this consent include ensuring that the labels in use are those that were approved and provided with the application letter. Furthermore, Mallinckrodt (the outgoing sponsor) must have arrangements in place to refer any queries or complaints concerning the products to Landauer (the incoming sponsor). The Act mandates that these obligations are adhered to in order to maintain the integrity and safety of the therapeutic goods supplied in the Australian market. Failure to comply with the conditions set out in the consent granted under sections 14 and 14A of the Therapeutic Goods Act 1989 can result in significant consequences. The Act provides for both civil and criminal penalties for breaches. Civil penalties can include fines, with the maximum penalty for contravening the Act potentially reaching up to $1,650,000 for corporations and $330,000 for individuals, depending on the severity and nature of the breach. Additionally, criminal penalties may apply, including imprisonment for up to five years for individuals found guilty of serious offences under the Act. These penalties underscore the importance of compliance with the conditions set out in the consent and the broader regulatory requirements of the Act.