Therapeutic Goods Order No. 67A - Amendment to Therapeutic Goods Order No. 67 - Standard for Dental Materials (29/07/2002)

Overview

The Therapeutic Goods (Standard Dental Materials) Order 2002 is an amendment to the Therapeutic Goods Order No. 67, known as the "Standard for Dental Materials" (TGO 67). Enacted by the Commonwealth of Australia in 2002, this legislative instrument amends the standards for dental materials to align with the updated international standards. This was achieved under the authority of the Therapeutic Goods Act 1989, with the Minister for Health and Ageing delegating the task to Terry Slater. The order removes outdated references to older International Organization for Standardization (ISO) standards and incorporates more recent standards to ensure that the therapeutic goods used in Australia meet current safety and quality requirements. The policy objective behind this amendment is to maintain and enhance the safety and efficacy of dental materials available to consumers in Australia, ensuring they are up-to-date with global best practices.

Scope and Application

The Therapeutic Goods Order No. 67A amends the Therapeutic Goods Order No. 67, specifically addressing the standards for dental materials, and applies to entities involved in the manufacture, supply, or use of dental materials within the Commonwealth of Australia. This legislative instrument is applicable to any person or entity involved in activities relating to the therapeutic goods industry, particularly those producing, supplying, or using dental materials. It seeks to ensure that these materials meet specific standards to guarantee safety and efficacy, thereby regulating the conduct and transactions involved in the distribution and use of such therapeutic goods. The Order is a refinement of the Therapeutic Goods Act 1989, which operates on a national level, affecting the entire country uniformly. The amendment replaces outdated standards with newer, more stringent ones, ensuring that all involved parties comply with the most current regulatory requirements. No specific exclusions or exemptions are noted within this legislative instrument, and its application is expected to be comprehensive across the therapeutic goods sector in Australia. The amendments are set to take effect twelve months after the gazette of this Order, providing a transition period for entities to adapt to the new standards.

Key Provisions

The Therapeutic Goods Order No. 67A amends the existing Therapeutic Goods Order No. 67, which pertains to the standard for dental materials. The primary operative sections of this legislative instrument involve the deletion of references to the previous standard "ISO 4049:1988" and its associated dental resin-based filling materials (Sections 1(a) and 1(b)), and the introduction of a new reference to the updated standard "ISO Standard 4049:2000" along with the reclassification of materials to "polymer-based filling, restoration and luting materials" (Sections 1(c) and 1(d)). These changes reflect an update to the technological and material standards for dental applications. The amended Order imposes obligations on parties and entities governed by TGO 67 to adhere to the new standards specified in the ISO 4049:2000. This includes ensuring that any dental materials classified under the new category of "polymer-based filling, restoration and luting materials" comply with the updated technical specifications and quality requirements outlined in the 2000 version of the ISO standard. This obligation ensures that all materials used in dental practice meet the latest safety and efficacy standards, which are critical for patient health and treatment outcomes. There are no specific offences, penalties, or consequences outlined within the legislative instrument itself for non-compliance with the new standards. However, non-compliance with the Therapeutic Goods Act 1989 or any associated orders can result in civil or criminal penalties. Under the Act, offences may lead to fines and, in severe cases, imprisonment. For example, under Section 20 of the Act, the maximum penalty for a corporation found guilty of an offence can be up to $1,100,000. Additionally, individuals who are officers of the corporation and are involved in the offence can face personal fines of up to $220,000 and imprisonment for up to five years. These potential consequences underscore the importance of adhering to the regulatory standards set forth in the amended Order.