Supply of Palifermin 6.25 mg powder for injection vial by Invida Australia Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the supply and use of therapeutic goods in Australia, aiming to ensure that such products are safe, of acceptable quality, and properly represented. The Act was introduced to address the need for a cohesive framework governing the therapeutic goods market, ensuring consumer protection and public health are upheld. The Therapeutic Goods Act 1989 is administered by the Australian Parliament, with the overarching policy objective being to safeguard the health and safety of the Australian public by regulating the quality, efficacy, and safety of therapeutic goods available in the market. In this context, on July 20, 2012, the delegate of the Secretary of the Department of Health and Ageing provided consent for the supply of the product palifermin (KEPIVANCE) 6.25 mg powder for injection vial by Invida Australia Pty Ltd. The consent was granted subject to specific conditions due to the product not conforming with the Therapeutic Goods Order 69, primarily concerning the use of UK-approved labels instead of Australian approved labels. The consent includes restrictions on the supply of the product in UK-approved packaging, the addition of a sticker with Australian sponsor details and ARTG number, the provision of an Australian Product Information document, and a consent period of two years from the date of issuance.

Scope and Application

The Therapeutic Goods Act 1989 applies to a broad range of entities and persons involved in the regulation, manufacturing, and supply of therapeutic goods within Australia. This includes pharmaceutical companies, medical device manufacturers, and individuals or organisations involved in the distribution and sale of these goods. The Act regulates the quality, safety, efficacy, and proper labelling of therapeutic goods, ensuring they meet the standards set by the Therapeutic Goods Administration (TGA). The geographic reach of the Act is national, as it applies across Australia, encompassing all states and territories. Certain therapeutic goods may be exempt from some provisions of the Act, such as those listed in Schedule 4 or approved under specific orders like Therapeutic Goods Order 69. In this particular instance, the Act extends its application through the issuance of a notice under Section 14A, allowing for the supply of a non-conforming product under specified conditions. The consent granted under this section is subject to strict conditions, including the use of UK-approved packaging with Australian sponsor details and the provision of an Australian Product Information document. This consent is also time-bound, valid for a period of two years from the date of issuance.

Key Provisions

The Therapeutic Goods Act 1989, specifically under sections 14 and 14A, outlines the requirements for the supply of therapeutic goods that do not conform to the standards set out in Therapeutic Goods Orders. In this instance, the Secretary's delegate has provided consent (section 14(1)) for the supply of the product palifermin (KEPIVANCE) by Invida Australia Pty Ltd, despite the product not meeting the requirements of Therapeutic Goods Order 69. This consent is explicitly conditional, as outlined in section 15(1) of the Act. The conditions imposed on this consent include restricting the supply to the product in UK-approved packaging, as documented in correspondence from the company dated April 13, 2012. Additionally, an Australian sponsor sticker detailing the sponsor’s information and ARTG number must be affixed to the packaging. Each carton supplied must also include an Australian Product Information document. This consent is granted for a limited period of two years from the date of consent, July 20, 2012. Entities governed by these provisions are required to ensure compliance with the stipulated conditions to maintain the validity of the consent. This involves adhering to packaging specifications, ensuring the presence of required documentation, and potentially modifying supply practices to align with Australian regulatory standards. Failure to meet these conditions may result in non-compliance with the Therapeutic Goods Act, leading to potential enforcement actions. The Therapeutic Goods Act includes provisions for both civil and criminal penalties for non-compliance. Offences under this Act can result in substantial fines and, in severe cases, imprisonment. The specific maximum penalties vary depending on the nature and severity of the breach, but they are designed to ensure strict adherence to therapeutic goods regulations to protect public health and safety. It is crucial for parties involved in the supply of therapeutic goods to be fully aware of and comply with these legislative requirements to avoid facing these serious consequences.