COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
PUBLICATION OF CANCELLATION OF ENTRIES FOR KINDS OF MEDICAL DEVICES FROM THE AUSTRALIAN REGISTER OF THERAPEUTIC GOODS SECTION 41GP OF THE THERAPEUTIC GOODS ACT 1989
I, Jane Cook, delegate of the Secretary to the Department of Health for the purposes of section 41GP of the Therapeutic Goods Act 1989 (the Act), hereby publish particulars of the cancellation of the following entry of a kind of medical device from the Australian Register of Therapeutic Goods (the ARTG) under paragraph 41GN(1)(b) of the Act:
ARTG entry of kind of medical device: Syringe, hypodermic, metered-delivery
ARTG number: 140670
Sponsor: Livingstone International Pty Ltd
Date effective: 3 February 2014
Reasons: As the sponsor did not provide information to substantiate compliance with the essential principles, the sponsor failed to comply with a condition to which the inclusion of the kind of device in the ARTG was subject under s.41FN (3)(a).
(Signed by)
Dr Jane Cook
Delegate of the Secretary to the Department of Health
28 January 2014
Overview
The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, aims to regulate therapeutic goods to ensure public health and safety. This Act was introduced to address the need for a comprehensive regulatory framework governing the quality, safety, and efficacy of therapeutic goods, including medicines, medical devices, and other health-related products. One of the key provisions of the Act is the ability to cancel entries for kinds of medical devices from the Australian Register of Therapeutic Goods (ARTG) when certain conditions are not met. This legislative mechanism allows the Therapeutic Goods Administration to maintain the integrity and reliability of the ARTG by removing devices that do not comply with necessary standards and requirements.
In the context of the cancellation of an entry for a hypodermic syringe with metered-delivery from the ARTG, the Act enables the Administration to enforce compliance with essential principles. This particular cancellation was due to the sponsor, Livingstone International Pty Ltd, failing to provide information to substantiate compliance with these essential principles, thereby breaching a condition of inclusion in the ARTG. This action underscores the importance of the Therapeutic Goods Administration's role in safeguarding public health by ensuring that only therapeutic goods meeting specified standards are available for use in Australia.
Scope and Application
The Therapeutic Goods Act 1989, as applied in this specific case, pertains to the regulation and administration of therapeutic goods in Australia, including medical devices. The Act applies to entities, specifically sponsors who are responsible for registering therapeutic goods, including medical devices, in the Australian Register of Therapeutic Goods (ARTG). The Act's scope includes all medical devices, such as the hypodermic syringe mentioned in the gazette, which falls under the category of metered-delivery devices. The Act operates nationally across Australia, extending its jurisdiction to all entities involved in the manufacture, supply, and advertising of therapeutic goods within the country. The Act includes provisions for exclusions, exemptions, or thresholds, which may be detailed in subordinate instruments or regulations. In this instance, the cancellation of the ARTG entry for the specified medical device is pursuant to section 41GP of the Act, which allows for the removal of entries that fail to meet the necessary compliance standards, such as failing to provide adequate information to substantiate compliance with the essential principles as outlined in section 41FN(3)(a). The delegate of the Secretary to the Department of Health, Dr. Jane Cook, exercises the authority granted under the Act to publish such cancellations, ensuring the safety and efficacy of therapeutic goods available to the public.
Key Provisions
The main operative sections of the Therapeutic Goods Act 1989, in this context, pertain to the cancellation of entries for kinds of medical devices from the Australian Register of Therapeutic Goods (ARTG). Specifically, section 41GP authorises the delegate of the Secretary to the Department of Health to publish particulars of the cancellation of entries (41GP). The cancellation in this case involves the removal of a specific entry from the ARTG due to non-compliance with the conditions set forth in section 41FN(3)(a). This section of the Act requires sponsors to provide information that substantiates the compliance of the medical device with the essential principles, which are guidelines for ensuring the safety and efficacy of therapeutic goods.
The obligations imposed by the Act on the parties, specifically the sponsor of the medical device in question, include providing adequate information to demonstrate compliance with the essential principles. In this instance, Livingstone International Pty Ltd, the sponsor of the hypodermic syringe with metered-delivery, failed to provide the necessary information to substantiate compliance with these essential principles. This failure to meet the conditions set by the Act led to the cancellation of the device’s entry in the ARTG.
In terms of consequences for non-compliance, the Act does not explicitly outline specific offences, penalties, or consequences for the cancellation of entries in this context. However, the cancellation of an entry from the ARTG signifies a significant regulatory action against the sponsor for failing to meet the legislative requirements. The primary consequence is the removal of the medical device from the ARTG, which effectively means that the device can no longer be legally marketed or supplied in Australia. This action underscores the importance of adhering to the essential principles and the obligations placed on sponsors to ensure the safety and efficacy of therapeutic goods.