Bills Digest No. 150 2000-01
Therapeutic Goods (Charges) Amendment Bill 2001
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
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
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ISSN 1328-8091
© Commonwealth of Australia 2000
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Published by the Department of the Parliamentary Library, 2000.
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