Bills Digest No. 105 2001-02
Therapeutic Goods (Charges) Amendment Bill
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
Contact Officer & Copyright Details
Therapeutic Goods (Charges) Amendment
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.
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 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
The 2001 Bill was discussed in Bills
Digest No. 150 of 2000-01. See also Bills
Digest No 149 of 2000-01.
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
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.
© 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
Published by the Department of the Parliamentary Library,
Back to top