Overview

The Therapeutic Goods Act 1989, enacted by the Commonwealth Parliament, aims to regulate the supply of therapeutic goods in Australia to ensure they are safe and of high quality. This Act provides the framework for the Therapeutic Goods Administration (TGA) to monitor and control the importation, supply, and advertising of therapeutic goods. The 1989 Act was introduced to address the need for a cohesive and effective regulatory system to protect public health by ensuring that therapeutic goods available in Australia meet required safety, quality, and efficacy standards. The legislative consent given on 14 April 2014, under sections 14 and 14A, allows for the supply and importation of specific therapeutic goods, in this case, Elevit with Iodine, despite not fully conforming to certain clauses of the applicable standards, subject to specific conditions that ensure the therapeutic goods' safety and quality standards are upheld.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods, which include medicines, medical devices, blood, and tissues in Australia. This Act applies to the entities and individuals involved in the supply, importation, and manufacture of these goods within the Commonwealth jurisdiction. The Act sets out the standards and requirements that these goods must meet to ensure they are safe and of high quality. The Act also extends its application through subordinate instruments, such as regulations and standards, which provide more detailed guidance on specific aspects of therapeutic goods regulation. In this particular case, the Act provides consent for the supply and importation of specific batches of a therapeutic good, "Elevit with Iodine," under certain conditions and for a limited period. The consent granted under sections 14 and 14A of the Act is subject to specific conditions and limitations, ensuring that the therapeutic goods meet the necessary safety and quality standards.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) includes specific provisions that allow the Secretary of the Department of Health to give consent for the supply and importation of certain therapeutic goods. Section 14 permits the Secretary to consent to the supply and importation of specified therapeutic goods or classes of goods, while Section 14A allows for this consent to be given without the goods conforming to certain clauses of the applicable standards (Sections 14(1) and 14A(1)). In this instance, the consent granted under sections 14 and 14A pertains to the supply and importation of Elevit with Iodine, with specific batch numbers, by Bayer Australia Ltd. This consent is provided for the period ending 31 July 2014 (Section 15(1)). Under the Act, the obligations imposed on the parties governed by these sections include ensuring that the therapeutic goods meet the requirements set out in the consent, such as the specified Australian Register of Therapeutic Goods number (ARTG No.) and compliance with the terms and conditions outlined in the consent. In the case of Elevit with Iodine, Bayer Australia Ltd must ensure that the content of each active ingredient complies with the limits stated in Table 1, such as calcium, phosphorus, iodine, copper, iron, magnesium, zinc, folic acid, ascorbic acid, nicotinamide, dl-alpha tocopheryl acetate, cholecalciferol, pyridoxine hydrochloride, calcium pantothenate, riboflavine, thiamine nitrate, cyanocobalamin, biotin, and others. The consent given under section 14A specifically allows for deviations from certain clauses of the applicable standard, TGO 78, but only within the specified limits and conditions (Sections 14(1) and 14A(1)). Failure to comply with the conditions set out in the consent or the applicable standards could result in civil or criminal consequences. Under the Act, an offence is created for contravening the terms of the consent or the applicable standards (Section 23D(1)). The maximum penalties for contravening these provisions include fines and/or imprisonment. For example, for a corporation, the maximum penalty for a single offence under Section 23D(1) is $2,100,000 or three times the value of the benefit obtained, whichever is the greater, along with a daily penalty of $210,000 for each day the offence continues (Section 23D(3)). Individual officers of the corporation could also face penalties under Section 23D(2), including fines of up to $210,000 and/or imprisonment for up to five years. The specific penalties depend on the nature and severity of the breach and may be subject to additional provisions in other sections of the Act.