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TOTAL RESULTS: 277

  • Date
    03 Dec 2008 
    Chamber
    Senate 
    Status
    Act 
    Portfolio
    Health and Ageing 
    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. 

    Bill | Explanatory Memorandum

  • Date
    14 Feb 2002 
    Chamber
    House of Representatives 
    Status
    Act 
    Portfolio
    Health and Ageing 
    Summary
    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. 

    Bill | Explanatory Memorandum

  • Date
    14 Feb 2008 
    Chamber
    House of Representatives 
    Status
    Act 
    Portfolio
    Health and Ageing 
    Summary
    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. 

    Bill | Explanatory Memorandum

  • Date
    20 Feb 2002 
    Chamber
    House of Representatives 
    Status
    Act 
    Portfolio
    Health and Ageing 
    Summary
    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. 

    Bill | Explanatory Memorandum

  • Date
    09 Mar 2000 
    Chamber
    House of Representatives 
    Status
    Act 
    Portfolio
    Health and Aged Care Portfolio 

    Bill | Explanatory Memorandum

  • Date
    29 Jun 2000 
    Chamber
    Senate 
    Status
    Act 
    Portfolio
    Health and Aged Care Portfolio 

    Bill | Explanatory Memorandum

  • Date
    07 Dec 2000 
    Chamber
    Senate 
    Status
    Act 
    Portfolio
    Health and Aged Care Portfolio 

    Bill | Explanatory Memorandum

  • Date
    25 Nov 1999 
    Chamber
    House of Representatives 
    Status
    Act 
    Portfolio
    Health and Aged Care Portfolio 

    Bill

  • Date
    20 Jun 2007 
    Chamber
    Senate 
    Status
    Act 
    Portfolio
    Health and Ageing 
    Summary
    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. 

    Bill | Explanatory Memorandum

  • Date
    21 Mar 2002 
    Chamber
    House of Representatives 
    Status
    Act 
    Portfolio
    Health and Ageing 
    Summary
    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”. 

    Bill | Explanatory Memorandum

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