Therapeutic Goods Amendment Regulations 2002 (No. 6)

Overview

The Therapeutic Goods (Charges) Amendment Regulations 2002 (No. 6) were enacted to address the need for continuity in the availability of therapeutic goods, specifically for preparedness against potential bioterrorist attacks and public health emergencies. This legislation amends the Therapeutic Goods Regulations 1990 to ensure that certain therapeutic goods, which were previously exempted from registration and listing requirements, can be stockpiled for future use under the authority of the Therapeutic Goods Act 1989. The Act aims to establish and maintain a system of controls for the quality, safety, efficacy, and timely availability of therapeutic goods used or exported from Australia. The Therapeutic Goods Administration is responsible for administering the Act. The Regulations, issued under the authority of the Parliamentary Secretary to the Minister for Health and Ageing, make technical amendments to maintain the exemption of specific goods from registration or listing requirements, aligning with the policy objective of safeguarding public health in the event of an emergency.

Scope and Application

The Therapeutic Goods (Charges) Amendment Regulations 2002 (No. 6) aim to make technical amendments to the Therapeutic Goods Regulations 1990, facilitating the continued availability of specific therapeutic goods for stockpiling in anticipation of potential threats to public health, such as bioterrorist attacks. The Act applies to therapeutic goods that are used in Australia or exported from Australia, with the Therapeutic Goods Administration responsible for administering the Act. The Regulations, under section 63 of the Therapeutic Goods Act 1989, amend the Principal Regulations to ensure that certain therapeutic goods can be stockpiled without the need for registration or listing, provided they are exempted under section 18A of the Act, which pertains to national interests in stockpiling for public health preparedness or responding to actual public health emergencies. The amendments ensure the continuation of exemptions for specific therapeutic goods such as Combopen and Atropen Autoinjectors, and specified smallpox vaccines, from 1 January 2003, aligning with the intended exemptions under section 18A of the Act. The Regulations also remove outdated exemptions, ensuring that the framework remains relevant and effective in addressing contemporary public health needs.

Key Provisions

The Therapeutic Goods (Charges) Amendment Regulations 2002 (No. 6) (the Regulations) are technical amendments to the Therapeutic Goods Regulations 1990 (Principal Regulations) (F2002B00352). These amendments aim to ensure the continued availability of certain therapeutic goods for stockpiling in preparation for potential threats to public health, such as bioterrorist attacks, by aligning the Principal Regulations with the Therapeutic Goods Act 1989 (the Act). The key provisions of these Regulations include amendments to Schedule 5A, which lists therapeutic goods exempted from registration and listing requirements. The amendments are designed to reflect changes in the national preparedness strategy and to ensure compliance with the Act. Under the Regulations, specific therapeutic goods that are currently listed in Schedule 5A of the Principal Regulations will continue to be exempt from the requirement to be registered or listed in the Australian Register of Therapeutic Goods, provided they meet certain conditions. For example, Regulation 3 amends Items 9 and 10 of Schedule 5A to clarify that the exemption ceases on 31 December 2002 unless an exemption under section 18A of the Act takes effect immediately thereafter. This amendment ensures that the exemption for these goods will continue if they are deemed necessary for stockpiling or responding to a public health emergency. The Regulations impose specific obligations on the parties or entities they govern. Sponsors of therapeutic goods, such as manufacturers or importers, must ensure that the goods they stock for emergency preparedness comply with the conditions set out in Schedule 5A and any applicable exemptions under section 18A of the Act. This includes ensuring that the goods are stored appropriately and that they meet the quality, safety, and efficacy standards set by the Therapeutic Goods Administration (TGA). Additionally, the TGA is responsible for monitoring compliance with these Regulations and the Act, and for taking appropriate action if a breach is detected. Failure to comply with the Therapeutic Goods (Charges) Amendment Regulations 2002 (No. 6) or the Therapeutic Goods Act 1989 can result in significant legal consequences. The Act provides for both civil and criminal penalties for breaches, depending on the severity of the offence. For instance, a person who imports, manufactures, or supplies therapeutic goods that are not registered or listed, or that are exempted but do not meet the conditions of the exemption, may face fines of up to $220,000 for an individual and $1,100,000 for a body corporate. In more serious cases, such as those involving wilful or reckless conduct, the penalties can be even higher. Additionally, the TGA can take enforcement actions such as seizing non-compliant goods or issuing infringement notices for minor breaches.