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

Overview

The Therapeutic Goods Act 1989 (the Act) was enacted to regulate the supply of therapeutic goods in Australia, ensuring that such goods are of an acceptable quality and their use does not pose unacceptable health risks. This Act addresses the need for a cohesive regulatory framework governing the importation, supply, and quality of therapeutic goods, thereby protecting public health. The Therapeutic Goods Administration (TGA), a part of the Department of Health, is the enacting body responsible for administering the Act and ensuring compliance with its provisions. The policy objective of the Act is to safeguard the health and safety of the Australian population by providing a systematic approach to the regulation of therapeutic goods. On 29 July 2015, a delegate of the Secretary of the Department of Health granted consent for the importation and supply of certain ketorolac trometamol products that did not conform to specific labelling requirements, illustrating the Act’s flexibility in addressing unique circumstances while maintaining its core objective of public health protection.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, encompassing a wide range of products including medicines, medical devices, blood, and tissues. The Act applies to all entities involved in the supply, import, and advertising of therapeutic goods within Australia, as well as to individuals such as health professionals who administer these goods. Its jurisdiction covers the entire Commonwealth of Australia, ensuring a uniform regulatory framework across all states and territories. While the Act broadly covers therapeutic goods, it excludes certain items such as food, cosmetic products, and goods used in conjunction with tattooing or body piercing, which are regulated under separate legislation. The Act also includes provisions for subordinate instruments that may extend or further specify the application of its provisions, such as therapeutic goods regulations and orders, which can introduce additional conditions or exemptions not explicitly covered in the principal Act. The Act thus provides a comprehensive legal structure for the oversight and management of therapeutic goods in Australia.

Key Provisions

Under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act), a delegate of the Secretary of the Department of Health has granted consent to Atnahs Pharma Australia Pty Ltd for the importation and supply of certain ketorolac trometamol (TORADOL) injections and tablets. The consent specifically allows for the use of labels that do not comply with the requirements of paragraph 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines (TGO 69). These labels include the name and contact details of the previous sponsor, Roche Products Pty Ltd, rather than those of the current sponsor, Atnahs Pharma Australia Pty Ltd. The consent is effective from 29 July 2015 until 31 March 2016. The Act imposes certain obligations on the parties involved in this consent. Atnahs Pharma Australia Pty Ltd must ensure that the labels used for the ketorolac trometamol products include the previously approved labels for Roche Products Pty Ltd. Additionally, there must be arrangements in place to promptly refer any queries or complaints concerning the products to Atnahs Pharma Australia Pty Ltd. This ensures that any concerns or issues with the products are addressed in a timely and effective manner. Failure to comply with the conditions of the consent, or any other provisions of the Therapeutic Goods Act 1989, may result in legal consequences. While specific offences, penalties, or civil/criminal consequences are not detailed in the provided text, breaches of the Act can generally lead to enforcement actions by the Therapeutic Goods Administration. These actions may include fines, product recalls, or other regulatory measures. The maximum penalties for breaches of the Therapeutic Goods Act 1989 can vary depending on the nature and severity of the offence, with potential penalties including substantial fines for both individuals and corporations, as well as imprisonment in serious cases. It is essential for Atnahs Pharma Australia Pty Ltd to adhere strictly to the terms of the consent and the requirements of the Act to avoid any legal repercussions.