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This Digest was prepared for debate. It reflects the legislation as introduced
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CONTENTS
Passage History
Purpose
Background
Main Provisions
Contact Officer & Copyright Details
Therapeutic Goods (Charges) Amendment Bill 2001
Date Introduced: 29 March 2001
House: House of Representatives
Portfolio: Health and Aged Care
Commencement: When Schedule 1 of the Therapeutic Goods Amendment (Medical Devices) Act 2001 commences
To amend the Therapeutic Goods (Charges) Act 1989 to allow annual charges to be levied in respect of the inclusion of medical devices on the Australian Register of Therapeutic Goods (the Register).
The background to this Bill is explained in detail in the Bills Digest for the Therapeutic Goods Amendment (Medical Devices) Bill 2001.
Currently, under the Therapeutic Goods (Charges) Act 1989, annual charges are payable in respect of the 'listing' or 'registration' of therapeutic goods. If the Therapeutic Goods Amendment (Medical Devices) Bill 2001 is passed, medical devices will be 'included' on the Register rather than 'listed' or 'registered'.
Item 3 of Schedule 1 of the Bill amends the Therapeutic Goods (Charges) Act 1989 so that annual charges will be payable also for medical devices that are 'included' on the Register. Under item 5, this extends to medical devices which are 'included' on the Register pursuant to a corresponding State law.
Charges will be payable even if a particular medical device or class of medical devices is suspended from the Register (item 2).
The regulations may prescribe different charges for different classes of therapeutic goods, including different classes of medical devices (item 7). The exemption from annual charges for low volume manufacturers of therapeutic goods is also extended to medical devices (items 8 and 9).
Katrine Del Villar
7 June 2001
Bills Digest Service
Information and Research Services
This paper has been prepared for general distribution to Senators and Members of the Australian Parliament. While great care is taken to ensure that the paper is accurate and balanced, the paper is written using information publicly available at the time of production. The views expressed are those of the author and should not be attributed to the Information and Research Services (IRS). Advice on legislation or legal policy issues contained in this paper is provided for use in parliamentary debate and for related parliamentary purposes. This paper is not professional legal opinion. Readers are reminded that the paper is not an official parliamentary or Australian government document.
ISSN 1328-8091
© Commonwealth of Australia 2000
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Published by the Department of the Parliamentary Library, 2000.