Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 [2009]

Type
Government
Portfolio
Health and Ageing
Originating house
Senate
Status
Act
Parliament no
42

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Summary

Amends the Therapeutic Goods Act 1989 to: exempt medical devices from the operation of the Act to enable goods to be stockpiled for use in a health emergency and remove the requirement that such exemptions are disallowable instruments; adjust the test of whether a person is a ‘fit and proper person’ to hold a manufacturing licence or a medical device conformity assessment certificate; adopt the European Pharmacopoeia and United States Pharmacopoeia as additional default standards; enable public access to information held by the Therapeutic Goods Administration; ensure controls over restricted and prohibited representations apply to advertisements in all media; and align penalties with current policy formulations.

Progress

Senate
Introduced and read a first time 03 Dec 2008
Second reading moved 03 Dec 2008
Second reading debate 20 Mar 2009
Second reading agreed to 20 Mar 2009
Committee of the Whole debate 20 Mar 2009
Third reading agreed to 20 Mar 2009
House of Representatives
Introduced and read a first time 12 May 2009
Referred to Main Committee 25 May 2009
Second reading moved 26 May 2009
Second reading debate 26 May 2009
Second reading agreed to 26 May 2009
Reported from Main Committee 27 May 2009
Third reading agreed to 27 May 2009
Text of bill as passed both Houses 27 May 2009
Assent
  • Act no.: 38
  • Year: 2009
17 Jun 2009

Documents and transcripts

Text of bill

Explanatory memoranda

Proposed amendments

Senate

Schedules of amendments

No documents at present

Bills digest

Notes

Helpful information

Text of bill

  • First reading: Text of the bill as introduced into the Parliament
  • Third reading: Prepared if the bill is amended by the house in which it was introduced. This version of the bill is then considered by the second house.
  • As passed by both houses: Final text of bill agreed to by both the House of Representatives and the Senate which is presented to the Governor-General for assent.

Explanatory memoranda

  • Explanatory memorandum: Accompanies and provides an explanation of the content of the introduced version (first reading) of the bill.
  • Supplementary explanatory memorandum: Accompanies and explains amendments proposed by the government to the bill.
  • Revised explanatory memorandum: Accompanies and explains the amended version (third reading) of the bill. It supersedes the explanatory memorandum.

Proposed amendments

Circulated by members and senators when they propose to make changes to the bill. For details about the outcome of proposed amendments please refer to either the Votes and Proceedings (House of Representatives) or the Journals (Senate).

Schedules of amendments

Schedules of amendments list amendments agreed to by the second house are communicated to the first house for consideration. Subsequent action by either house may also be included in a schedule.

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