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TOTAL RESULTS: 277
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- Date
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03 Dec 2008
- Chamber
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Senate
- Status
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Act
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Portfolio
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Health and Ageing
- Summary
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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.
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- Date
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14 Feb 2002
- Chamber
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House of Representatives
- Status
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Act
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Portfolio
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Health and Ageing
- Summary
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Introduced with the Therapeutic Goods (Charges) Amendment Bill 2002, the bill amends the
Therapeutic Goods Act 1989
to introduce a medical device regulatory system, including a new electronic application lodgment system for inclusion of medical devices on the Australian Register of Therapeutic Goods; and provides transitional arrangements.
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- Date
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14 Feb 2008
- Chamber
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House of Representatives
- Status
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Act
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Portfolio
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Health and Ageing
- Summary
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Amends the
Therapeutic Goods Act 1989
to address legal consequences arising from the Federal Court decision in Roche Products v National Drugs and Poisons Schedule Committee
[2007] FCA 1352 (30 August 2007) by: providing that the Poisons Standard and its amendments are legislative instruments for the purposes of the Legislative Instruments Act 2003
; retrospectively reinstating certain amendments made to the Standard before the Roche decision; exempting the Standard from section 42 of the Legislative Instruments Act 2003
relating to disallowance; and providing for ‘just terms’ compensation in the event that these measures could result in any acquisition of property.
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- Date
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20 Feb 2002
- Chamber
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House of Representatives
- Status
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Act
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Portfolio
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Health and Ageing
- Summary
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Amends the
Therapeutic Goods Act 1989
to enable the Minister to allow the importation, manufacture or supply of unapproved therapeutic goods that are needed to treat large numbers of patients in a national emergency. Also provides for strengthened offence provisions and recording keeping and reporting requirements in relation to such unapproved therapeutic goods.
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- Date
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09 Mar 2000
- Chamber
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House of Representatives
- Status
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Act
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Portfolio
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Health and Aged Care Portfolio
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- Date
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29 Jun 2000
- Chamber
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Senate
- Status
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Act
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Portfolio
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Health and Aged Care Portfolio
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- Date
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07 Dec 2000
- Chamber
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Senate
- Status
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Act
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Portfolio
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Health and Aged Care Portfolio
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- Date
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25 Nov 1999
- Chamber
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House of Representatives
- Status
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Act
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Portfolio
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Health and Aged Care Portfolio
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- Date
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20 Jun 2007
- Chamber
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Senate
- Status
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Act
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Portfolio
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Health and Ageing
- Summary
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Amends the
Therapeutic Goods Act 1989
, Therapeutic Goods Amendment Act (No. 1) 2006
and Therapeutic Goods Amendment (Medical Devices) Act 2002
to extend transitional registration arrangements for certain patient treatment devices beyond 4 October 2007 to enable reassessment by the Therapeutic Goods Administration prior to entry in Australian Register of Therapeutic Goods as ‘included’ devices.
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- Date
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21 Mar 2002
- Chamber
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House of Representatives
- Status
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Act
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Portfolio
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Health and Ageing
- Summary
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Amends the:
Therapeutic Goods Act 1989
to: clarify the powers, functions and duties of Commonwealth officials and authorities within the Commonwealth-State cooperative scheme for the regulation of therapeutic goods (as a consequence of the High Court’s decision in R v Hughes); enable the implementation of the mutual recognition agreement entered into between Australia and Singapore relating to the manufacture of medicines; provide for implementation of other similar mutual recognition agreements; enable collection of information and documents in relation to blood and blood component manufacturing processes and practices; clarify the timeframe for payment of evaluation fees; and allow the Minister to impose conditions for the listing of goods on the Australian Register of Therapeutic Goods; Industrial Chemicals (Notification and Assessment) Act 1989
and National Occupational Health and Safety Commission Act 1985
to reflect new administrative and financial arrangements required as a result of changed portfolio responsibilities; and proposed Therapeutic Goods Amendment (Medical Devices) Act 2002
, if it commences after this proposed Act, in relation to the definition of “conformity assessment certificate”.
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