Therapeutic Goods Act 1989 - Determination under subsection 19A(3) (26/08/1997)

Overview

The Therapeutic Goods Act 1989 was enacted by the Parliament of Australia to regulate the supply of therapeutic goods within Australia. This Act was introduced to address the need for a comprehensive regulatory framework that ensures the safety, quality, and efficacy of therapeutic goods available to the public. One of the mechanisms through which the Act achieves this is by enabling the Secretary to the Department of Health and Family Services to exercise certain powers, including specifying foreign countries for the purposes of assessing and approving the quality and safety of imported therapeutic goods. The policy objective of this legislative instrument is to maintain the integrity of the Australian therapeutic goods market by ensuring that imported goods meet the same rigorous standards as those manufactured domestically. This legislative instrument specifies France as the country for the purposes of exercising powers under subsection 19A(1) of the Act in relation to the Stamaril® Yellow Fever Vaccine manufactured by Pasteur Mérieux Sérums and Vaccins.

Scope and Application

The Therapeutic Goods Act 1989 is a pivotal piece of legislation in Australia that regulates therapeutic goods, including medicines, medical devices, and blood products. Specifically, this legislative instrument pertains to the identification of a foreign country in relation to the regulation of a therapeutic good, in this case, Stamaril® Yellow Fever Vaccine manufactured by Pasteur Mérieux Sérums and Vaccins in France. The determination, made by Andrew Podger, Secretary to the Department of Health and Family Services, specifies France as the country relevant for the purposes of exercising powers under subsection 19A(1) of the Act concerning the vaccine. This Act applies to the entities involved in the manufacturing, importing, and distribution of therapeutic goods in Australia, ensuring that such goods meet required safety, quality, and efficacy standards. The Act's jurisdiction is national, covering the entire Commonwealth of Australia, and it extends to regulating both domestic and foreign therapeutic goods, subject to the powers outlined in the legislation. The determination does not introduce any exclusions, exemptions, or thresholds but rather clarifies the specific geographic scope for the exercise of regulatory powers over the identified therapeutic good.

Key Provisions

The Therapeutic Goods Act 1989, under subsection 19A(3), specifies the process by which a foreign country can be designated for the purposes of exercising powers related to the regulation of therapeutic goods, such as vaccines. In this case, section 19A(3) has been invoked to identify France as the country responsible for the regulation of the Stamaril® Yellow Fever Vaccine, which is manufactured by Pasteur Mérieux Sérums and Vaccins (subsection 19A(1)). This determination is significant because it acknowledges the authority of France in overseeing the quality, safety, and efficacy of the vaccine in question. This legislative instrument places an obligation on the relevant authorities within France to ensure that the Stamaril® Yellow Fever Vaccine meets all necessary standards and requirements for therapeutic goods. This includes conducting assessments, inspections, and maintaining records that demonstrate compliance with applicable regulations. Additionally, it mandates that any changes to the manufacturing process, composition, or distribution of the vaccine must be reported to and approved by the relevant Australian authorities to ensure continued compliance with Australian standards. Failure to adhere to the regulations set out by this determination could result in significant consequences. The Therapeutic Goods Act 1989 outlines various offences and penalties for non-compliance, which can include substantial fines and, in severe cases, imprisonment. The precise penalties depend on the nature and severity of the breach but can reach up to $222,200 for a corporation and $44,440 for an individual, along with potential imprisonment terms. These measures are in place to enforce the safety and efficacy standards of therapeutic goods entering the Australian market.