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• Therapeutic Goods Amendment (Medical Devices) Bill 2001

  Track (What's this?)

  Date

  29 Mar 2001 

  Chamber

  House of Representatives 

  Status

  Not Proceeding 

  Portfolio

  Health and Aged Care Portfolio 

  Bill | Explanatory Memorandum

• Therapeutic Goods Amendment (Medical Devices) Bill 2002

  Track (What's this?)

  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

• Therapeutic Goods Amendment (Pharmaceutical Transparency) Bill 2013

  Track (What's this?)

  Date

  28 Feb 2013 

  Chamber

  Senate 

  Status

  Not Proceeding 

  Sponsor

  DI NATALE, Sen Richard 

  Summary

  Amends the

  Therapeutic Goods Act 1989

  to: create offences related to the provision of payments, services or certain other inducements to medical practitioners by pharmaceutical companies; and provide for: penalties for making such inducements; and reporting requirements. 

  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 (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 [2006]

  Track (What's this?)

  Date

  08 Dec 2005 

  Chamber

  Senate 

  Status

  Act 

  Sponsor

  NASH, Sen Fiona
  TROETH, Sen Judith
  ALLISON, Lyn
  MOORE, Sen Claire 

  Summary

  Amends the

  Therapeutic Goods Act 1989

  to transfer the responsibility for regulatory approval of RU486 from the Minister for Health and Ageing to the Therapeutic Goods Administration. 

  Bill | Explanatory Memorandum

• Therapeutic Goods Amendment Bill (No. 1) 2002

  Track (What's this?)

  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

• Therapeutic Goods Amendment Bill (No. 1) 2003

  Track (What's this?)

  Date

  27 Jun 2002 

  Chamber

  House of Representatives 

  Status

  Act 

  Portfolio

  Health and Ageing 

  Summary

  Amends the

  Therapeutic Goods Act 1989

  to clarify the definition of a “therapeutic good”; transfer advertising offences from the regulations to the Act; create new offences for publishing advertisements that breach the Therapeutic Goods Advertising Code and extend the coverage of existing offences to broadcast media; and strengthen existing requirements on manufacturers and sponsors of therapeutic goods to ensure the quality, safety and efficacy of therapeutic goods supplied in, or exported from, Australia; and

  Broadcasting Services Act 1992

  to remove provisions relating to pre-approval of therapeutic goods advertisements in the broadcast media, to enable these functions to be transferred to the Therapeutic Goods Regulations. 

  Bill | Explanatory Memorandum

• Therapeutic Goods Amendment Bill (No. 1) 2006

  Track (What's this?)

  Date

  17 Aug 2005 

  Chamber

  House of Representatives 

  Status

  Act 

  Portfolio

  Health and Ageing 

  Summary

  Amends the

  Therapeutic Goods Act 1989

  to provide the Therapeutic Goods Administration with additional sanctions and enforcement options for dealing with suppliers and manufacturers who fail to comply with regulatory requirements including product and manufacturing standards, including: introduction of a tiered offence regime and civil penalties for breaches; providing for infringement notices, enforceable undertakings and strict liability offences; and extending territorial jurisdiction in certain circumstances. Also makes a consequential amendment to the

  Therapeutic Goods Amendment (Medical Devices) Act 2002

  . 

  Bill | Explanatory Memorandum

• Therapeutic Goods Amendment Bill (No. 2) 2000

  Track (What's this?)

  Date

  09 Mar 2000 

  Chamber

  House of Representatives 

  Status

  Act 

  Portfolio

  Health and Aged Care Portfolio 

  Bill | Explanatory Memorandum

• Therapeutic Goods Amendment Bill (No. 2) 2006

  Track (What's this?)

  Date

  14 Sep 2005 

  Chamber

  House of Representatives 

  Status

  Act 

  Portfolio

  Health and Ageing 

  Summary

  Amends the

  Therapeutic Goods Act 1989

  to narrow the circumstances in which patent certification is required by applicants seeking to list or register a therapeutic good on the Australian Register of Therapeutic Goods. 

  Bill | Explanatory Memorandum