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 Parliament, was introduced to regulate the importation, supply, and manufacturing of therapeutic goods in Australia, addressing a need for consistent standards and safety in the medical product market. In 2015, a delegate of the Secretary of the Department of Health, acting under the authority of sections 14 and 14A of the Act, provided specific consent for Mallinckrodt Australia Pty Ltd to import and supply the OCTREOSCAN injection composite pack with a needle that did not fully comply with certain labelling requirements. This consent was granted to facilitate the transition of sponsorship without compromising product safety or efficacy, reflecting the policy objective of ensuring that therapeutic goods meet the necessary quality and safety standards while allowing for practical adjustments in business operations.

Scope and Application

The Therapeutic Goods Act 1989 applies to a wide range of therapeutic goods, including medicines, medical devices, and blood and blood components, ensuring they are of acceptable quality, safety, and efficacy. The Act is applicable to persons and entities involved in the manufacture, importation, supply, and advertising of therapeutic goods in Australia, with its jurisdiction extending across the Commonwealth. The Act includes provisions for the regulation of therapeutic goods through various orders and standards that specify requirements for quality, safety, efficacy, and labelling among other things. Notably, the Act also delineates exclusions and exemptions for certain products such as blood donated for personal use or for use by a close relative. The scope of the Act can be further extended or refined through subordinate instruments such as regulations and orders, allowing for more detailed specifications and adaptations to technological and scientific advancements. In the specific case of the Therapeutic Goods Order No. 69, which pertains to labelling requirements for medicines, an exception was made for Mallinckrodt Australia Pty Ltd, allowing them to import and supply OCTREOSCAN injection composite packs with labels that do not include the previous sponsor's details, subject to certain conditions and for a limited period.

Key Provisions

Sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) address the consent for the importation and supply of therapeutic goods that do not fully comply with certain legislative requirements. In this case, the delegate of the Secretary of the Department of Health has consented to the importation and supply of an injection composite pack with needle (OCTREOSCAN) [AUST R 55928] by Mallinckrodt Australia Pty Ltd. This consent allows the product to be imported and supplied despite not conforming with paragraph 3(2)(l) of Therapeutic Goods Order No. 69, which pertains to the general requirements for labels for medicines. Specifically, the labels do not include the name and address of the previous sponsor, which is a requirement under this paragraph. This consent is effective from 14 September 2015 to 13 September 2016. The Therapeutic Goods Act 1989 imposes several obligations and requirements on the parties involved. Firstly, the sponsor of the therapeutic goods, in this case, Mallinckrodt Australia Pty Ltd, must ensure that the labels for the products adhere to the specified standards unless otherwise consented by the Secretary. However, given the consent, certain deviations are permissible for the specified period. Secondly, there must be arrangements in place for handling queries or complaints regarding the products. In this scenario, any such issues must be referred to Landauer, the incoming sponsor. Thirdly, no other changes to the product or its distribution are permitted beyond what is outlined in the consent. The Therapeutic Goods Act 1989 also specifies the potential consequences for non-compliance. While this particular consent provides an exception, any breach of the general labelling requirements outside of the consented period could result in severe penalties. Under the Act, an individual or entity found guilty of contravening the labelling requirements could face substantial fines and even imprisonment. The specific penalties can vary based on the severity of the offence, the intent behind the contravention, and other relevant factors. The Act ensures that therapeutic goods meet certain safety and quality standards to protect public health.