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 was enacted to regulate the quality, efficacy, and safety of therapeutic goods, such as medicines, medical devices, and blood products, available in Australia. This Act addresses the need for a comprehensive legislative framework to ensure that therapeutic goods meet established standards and are safe for use by consumers. The Therapeutic Goods Administration (TGA), under the auspices of the Commonwealth of Australia's Department of Health, is the body responsible for administering and enforcing this Act. One of the policy objectives of the Act is to facilitate the appropriate use of therapeutic goods by allowing exceptions under certain conditions, such as the importation and supply of goods that do not fully conform with labelling requirements, provided that such exceptions do not compromise the safety and efficacy of the goods. The consent granted under sections 14 and 14A of the Act to Mallinckrodt Australia Pty Ltd for the importation and supply of Technetium (99mTc) (TECHNESCAN HDP) oxidronate powder for injection vials, despite non-compliance with certain labelling requirements, exemplifies this objective.

Scope and Application

The Therapeutic Goods Act 1989 applies to a wide range of therapeutic goods within Australia, including medicines, medical devices, blood and blood components, tissues, and complementary medicines. This Act regulates the importation, supply, and manufacture of these goods to ensure that they meet specific quality, safety, and efficacy standards. The Act applies to entities and individuals involved in any aspect of the therapeutic goods supply chain, including manufacturers, importers, sponsors, and suppliers. It has jurisdiction over the entire Commonwealth of Australia, with oversight by the Therapeutic Goods Administration, a department within the Australian Government's Department of Health. While the Act provides for broad coverage, certain exclusions and exemptions apply, such as for therapeutic goods used for personal or domestic purposes, or for research purposes under specified conditions. Additionally, the Act can extend or restrict its application through various subordinate instruments, including therapeutic goods orders, which provide detailed requirements for different types of therapeutic goods. In the particular case of the notice issued on 2 September 2015, the consent granted under sections 14 and 14A of the Act pertains to the temporary non-conformance of specific labels for a Technetium (99mTc) kit, subject to certain conditions aimed at maintaining consumer safety and effective communication regarding the product.

Key Provisions

The Therapeutic Goods Act 1989 contains specific provisions for the regulation of therapeutic goods in Australia. Under sections 14 and 14A, a delegate of the Secretary of the Department of Health can consent to certain activities that would otherwise be prohibited or restricted. In this instance, the delegate has consented to the importation and supply of a specific kit, namely the kit for preparation of Technetium (99mTc) (TECHNESCAN HDP) oxidronate powder for injection vial (AUST R 75500), by Mallinckrodt Australia Pty Ltd. This consent is for a period of 12 months, from 14 September 2015 to 13 September 2016. The consent issued under sections 14 and 14A of the Therapeutic Goods Act 1989 requires that the labels for the product do not conform with the requirements of paragraph 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. This means that the labels for the kit will not include the name and address of the previous sponsor. The consent is contingent upon several conditions being met. Firstly, the labels to which this consent applies must be those currently approved and provided with the application letter. Secondly, there must be arrangements in place with Mallinckrodt (the outgoing sponsor) for the referral of any queries or complaints concerning the products to Landauer (the incoming sponsor). Thirdly, no other changes have been made to the product or its labelling. The Therapeutic Goods Act 1989 imposes several obligations on the parties involved in the importation and supply of therapeutic goods. The Act requires that any therapeutic goods imported or supplied in Australia must comply with the relevant regulations and standards. In this case, the consent issued under sections 14 and 14A of the Act requires that Mallinckrodt Australia Pty Ltd adhere to the conditions outlined above. The Act also requires that any therapeutic goods be labelled in accordance with the Therapeutic Goods Order No. 69 – General requirements for labels for medicines. Failure to comply with these obligations may result in legal action being taken against the party responsible. The Therapeutic Goods Act 1989 also contains provisions for offences, penalties, and civil/criminal consequences for breach of its provisions. The Act provides for a range of penalties for offences, including fines and imprisonment. For example, section 29 of the Act provides for a maximum penalty of $22,000 for individuals and $110,000 for bodies corporate for supplying therapeutic goods that are not of the quality or standard required by the Act. Similarly, section 30 of the Act provides for a maximum penalty of $1,100 for individuals and $55,000 for bodies corporate for providing false or misleading information about a therapeutic good. The Act also provides for civil penalties, such as pecuniary penalties and injunctions, for breaches of its provisions.