Therapeutic Goods (Charges) Amendment Bill 2002


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Bills Digest No. 105  2001-02
Therapeutic Goods (Charges) Amendment Bill 2002

WARNING:
This Digest was prepared for debate. It reflects the legislation as introduced and does not canvass subsequent amendments. This Digest does not have any official legal status. Other sources should be consulted to determine the subsequent official status of the Bill.

CONTENTS

Passage History
Purpose
Background
Main Provisions
Contact Officer & Copyright Details


Passage History

Therapeutic Goods (Charges) Amendment Bill 2002

Date Introduced: 14 February 2002

House: House of Representatives

Portfolio: Health and Ageing

Commencement: When Schedule 1 of the Therapeutic Goods Amendment (Medical Devices) Act 2002 commences.

Purpose

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.

Background

The Therapeutic Goods (Charges) Amendment Bill 2002 (the 2002 Bill) is identical to the Therapeutic Goods (Charges) Amendment Bill 2001 (the 2001 Bill). The 2001 Bill lapsed at the time Parliament was prorogued prior to the recent Federal election.

The 2001 Bill was discussed in Bills Digest No. 150 of 2000-01. See also Bills Digest No 149 of 2000-01.

Main provisions

Bills Digest No 150 of 2000-01 explains the relevant provisions. The provisions (and numbering) of the 2002 Bill are identical to those of the 2001 Bill.

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).

Contact Officer and Copyright Details

Natasha Cica
12 March 2002
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.

IRS staff are available to discuss the paper's contents with Senators and Members and their staff but not with members of the public.

ISSN 1328-8091
© Commonwealth of Australia 2002

Except to the extent of the uses permitted under the Copyright Act 1968, no part of this publication may be reproduced or transmitted in any form or by any means, including information storage and retrieval systems, without the prior written consent of the Parliamentary Library, other than by Members of the Australian Parliament in the course of their official duties.

Published by the Department of the Parliamentary Library, 2002.

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