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• Therapeutic Goods Amendment (2010 Measures No. 1) Bill 2010

  Track (What's this?)

  Date

  30 Sep 2010 

  Chamber

  House of Representatives 

  Status

  Act 

  Portfolio

  Health and Ageing 

  Summary

  Amends the

  Therapeutic Goods Act 1989

  in relation to: the supply of medical devices that are not on the Therapeutic Goods Register; the listing of export-only variations of certain medicines already on the register; permissible ingredients for inclusion in medicines; information that may be considered by the minister when reviewing initial decisions; the process for submission and approval of product information for medicines; the power of the secretary to make declarations that goods are therapeutic goods; the revised business processes which apply to prescription medicines; and the secretary’s information gathering powers. 

  Bill | Explanatory Memorandum

• Therapeutic Goods Amendment (2010 Measures No. 1) Bill 2010

  Track (What's this?)

  Date

  17 Mar 2010 

  Chamber

  House of Representatives 

  Status

  Not Proceeding 

  Portfolio

  Health and Ageing 

  Summary

  Amends the

  Therapeutic Goods Act 1989

  in relation to: the supply of medical devices that are not on the Therapeutic Goods Register; the listing of export-only variations of certain medicines already on the register; permissible ingredients for inclusion in medicines; information that may be considered by the minister when reviewing initial decisions; and the secretary’s information gathering powers. 

  Bill | Explanatory Memorandum

• Therapeutic Goods (Charges) Amendment Bill 2010

  Track (What's this?)

  Date

  25 Nov 2009 

  Chamber

  House of Representatives 

  Status

  Act 

  Portfolio

  Health and Ageing 

  Summary

  Amends the

  Therapeutic Goods (Charges) Act 1989

  to: impose an annual charge on biological therapeutic goods for inclusion in the Therapeutic Goods Register; and provide that when a registered or listed therapeutic or biological good is suspended from the Register it continues to be taken to be included in the Register for the purposes of the payment of the annual charge. 

  Bill | Explanatory Memorandum

• Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2010

  Track (What's this?)

  Date

  25 Nov 2009 

  Chamber

  House of Representatives 

  Status

  Act 

  Portfolio

  Health and Ageing 

  Summary

  Amends the

  Therapeutic Goods Act 1989

  to: introduce a framework to regulate biological therapeutic goods; provide immunity from civil actions, suit or proceedings for certain individuals performing duties under the Act; enable the recall of goods without suspending or cancelling the goods listing on the Therapeutic Goods Register; enable information to be sought from past sponsors and manufacturers of medicines and therapeutic devices; provide that unpaid annual charges remain payable if a therapeutic good is suspended from the Register; and make minor technical amendments. 

  Bill | Explanatory Memorandum

• Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009

  Track (What's this?)

  Date

  24 Jun 2009 

  Chamber

  House of Representatives 

  Status

  Act 

  Portfolio

  Health and Ageing 

  Summary

  Amends the

  Therapeutic Goods Act 1989

  in relation to: separate scheduling of medicines and poisons; the preclusion of certain kinds of medical devices from being entered in the Register; consultation with the Gene Technology Regulator; advertising therapeutic goods; exercising delegations; and the inclusion of advisory statements on the labels of specified medicines. 

  Bill | Explanatory Memorandum

• Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009

  Track (What's this?)

  Date

  19 Mar 2009 

  Chamber

  House of Representatives 

  Status

  Act 

  Portfolio

  Health and Ageing 

  Summary

  Amends the

  Therapeutic Goods Act 1989

  to enable: the suspension of registered or listed goods from the Australian Register of Therapeutic Goods; the issue of single site licences and allow for the transfer of licences between owners and variations to licence authorisations; samples of therapeutic and related goods to be taken from manufacturing premises and images and recordings to be made; the regulation of homoeopathic and anthroposophic medicines; standards to be set for the making of lists of permissible and prohibited ingredients in listed medicines; updated references to legislative instruments; and amendments in relation to: conditions imposed on registered and listed goods, the quality of overseas manufactured products, computer programs making certain decisions, the definition of accessory to a medical device, and an advertising code for therapeutic goods. 

  Bill | Explanatory Memorandum

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

  Track (What's this?)

  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

• Therapeutic Goods Legislation Amendment (Annual Charges) Bill 2008

  Track (What's this?)

  Date

  18 Jun 2008 

  Chamber

  House of Representatives 

  Status

  Act 

  Portfolio

  Health and Ageing 

  Summary

  Amends the

  Therapeutic Goods Act 1989

  and

  Therapeutic Goods (Charges) Act 1989

  in relation to the collection and imposition of annual charges and the granting of exemptions from a liability to pay annual charges, and makes technical and consequential amendments. 

  Bill | Explanatory Memorandum

• Therapeutic Goods Amendment (Poisons Standard) Bill 2008

  Track (What's this?)

  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

• Therapeutic Goods Amendment Bill 2007

  Track (What's this?)

  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