Consent given pursuant to sections 14 and 14A for the supply and importation of the Therapeutic Goods specified subject to conditions specified - between 28 October 2011 and 6 February 2012

Overview

The Therapeutic Goods Act 1989 (the Act) was enacted to address the need for regulation of therapeutic goods, including medicines, medical devices, and blood and blood components in Australia. This Act provides a framework for the regulation of therapeutic goods to ensure their quality, safety, and efficacy. The Act was enacted by the Commonwealth Parliament and its primary policy objective is to protect public health by ensuring that therapeutic goods available in Australia meet acceptable standards of quality, safety, and efficacy. Between 28 October 2011 and 6 February 2012, the delegate of the Secretary of the Department of Health and Ageing granted consent under sections 14 and 14A of the Act, allowing certain therapeutic goods to be supplied, imported, or exported with specific conditions and deviations from the applicable standards, ensuring that the goods still meet overall safety and quality requirements.

Scope and Application

The Therapeutic Goods Act 1989, as outlined in the specified sections and related notices, applies to the regulation of therapeutic goods within Australia. This Act governs the supply, importation, and exportation of therapeutic goods, ensuring they meet the necessary standards for safety, efficacy, and quality. The Act applies to various entities including pharmaceutical companies, health practitioners, and retailers involved in the distribution and sale of therapeutic goods. It encompasses a broad range of therapeutic goods such as medicines, medical devices, and complementary medicines, thereby regulating their manufacture, advertisement, and use. The legislation extends to both Commonwealth and state jurisdictions, ensuring a unified regulatory framework across Australia. While the Act provides for broad coverage, certain exclusions and exemptions may apply, particularly to goods that fall under specific exemptions outlined in subordinate instruments, which may further detail application and enforcement. The Therapeutic Goods Administration (TGA) can issue consents under the Act, subject to specific conditions, allowing for certain deviations from standard requirements to be made on a case-by-case basis.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) governs the regulation of therapeutic goods in Australia, including the supply, importation, and exportation of these goods. Section 14 and 14A of the Act allow the Secretary of the Department of Health and Ageing to give consent for the supply, importation, or exportation of therapeutic goods under certain conditions. This consent enables the supply or importation of specified goods with the Australian Register of Therapeutic Goods number (ARTG No.), without conforming to certain clauses of the applicable standard (Section 14(1)(a) and 14A(1)(a)). Consent is subject to conditions specified in the relevant columns of the Table, and it can be granted for a specific period or until further notice (Section 15(1)). The Act imposes various obligations and requirements on the parties or entities it governs. Sponsors of therapeutic goods must ensure that their products meet the necessary standards and conditions set forth by the Secretary. For instance, Health World Limited is allowed to supply Ethic Nutrients Immune Defence with a label that does not include specific label statements required by the Required Advisory Statements for Medicine Labels in relation to products containing vitamin A intended for use by adults, provided certain conditions are met (Column 6). Similarly, Sanofi-Aventis Healthcare Pty Ltd is permitted to supply Golden Glow Men’s One a day Multivitamin with a label that does not include specific Required Advisory Statements for Medicine Labels, but must include an abridged version of another statement (Column 6). These conditions ensure that consumers receive accurate and relevant information about the products they use. Failure to comply with the conditions set out in the consent under the Therapeutic Goods Act 1989 may result in civil or criminal consequences. Although the specific penalties are not detailed in the extract, breaches of the Act may result in fines, imprisonment, or both, depending on the severity of the offence. The Act also provides for the possibility of court-ordered penalties and the cancellation of ARTG entries for non-compliance. It is essential for sponsors and other parties governed by the Act to adhere to the conditions and requirements set forth to avoid potential legal repercussions.