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• Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018

  Track (What's this?)

  Date

  28 Jun 2018 

  Chamber

  House of Representatives 

  Status

  Act 

  Portfolio

  Health 

  Summary

  Amends the

  Therapeutic Goods Act 1989

  to: introduce mandatory reporting requirements for sponsors of mainly prescription medicines to report shortages of, and any decision to permanently discontinue, their products; and make miscellaneous amendments in relation to: enabling standards to adopt other documents as in force from time to time; enabling the Secretary to require priority pathway applicants to provide supporting information; streamlining of health practitioner notifications under the Special Access Scheme and certain advertising requirements; variations to registered medicines through notification; and a minor technical amendment. 

  Bill | Explanatory Memorandum

• Therapeutic Goods Amendment (2020 Measures No. 1) Bill 2020

  Track (What's this?)

  Date

  04 Mar 2020 

  Chamber

  House of Representatives 

  Status

  Act 

  Portfolio

  Health 

  Summary

  Amends the:

  Therapeutic Goods Act 1989

  to: align certain device-related definitions with the equivalent definition in the European Union; enable the secretary to provide early scientific advice to a sponsor about the safety, quality or efficacy of a registrable medicine; enable a clinical trial sponsor to request variations to approved clinical trials; introduce a new preliminary assessment procedure for applications for new ingredients for listed and assessed listed medicines; remove a limitation on the circumstances in which medical practitioners may be authorised to supply specified unapproved therapeutic goods to their patients; remove certain offences for persons claiming to be able to arrange supply of therapeutic goods; impose a condition of registration or listing of therapeutic goods; specify the circumstances in which a sponsor may apply for the provisional registration of a medicine, without having to first obtain a provisional determination; introduce a data protection regime for assessed listed medicines; and make minor amendments and corrections; and

  Patents Act 1990

  to remove a reference to therapeutic devices. 

  Bill | Explanatory Memorandum

• Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020

  Track (What's this?)

  Date

  09 Dec 2020 

  Chamber

  House of Representatives 

  Status

  Act 

  Portfolio

  Health 

  Summary

  Amends the

  Therapeutic Goods Act 1989

  to: enable pharmacists to substitute a different medicine for one that has been prescribed where there is a serious scarcity of the prescribed medicine; allow the making of regulations to establish a unique device identification database for the traceability and monitoring of medical devices in Australia; enable authorised employees in the Department of Health to obtain and possess prescription medicines, or unapproved therapeutic goods, without contravening state and territory laws; allow the making of regulations to prohibit the import, export, supply or manufacture of therapeutic goods that are prohibited under international agreements; ensure the timely availability of COVID-19 vaccines by enabling the secretary to consent to the importation and supply of registered or listed therapeutic goods that do not have their registration or listing number on the label; make amendments in relation to the operation of the data protection scheme for assessed listed medicines; and make minor and technical amendments. 

  Bill | Explanatory Memorandum

• Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022

  Track (What's this?)

  Date

  01 Dec 2022 

  Chamber

  House of Representatives 

  Status

  Act 

  Portfolio

  Health and Aged Care 

  Summary

  Amends the

  Therapeutic Goods Act 1989

  to: require mandatory reporting of adverse events involving medical devices; provide a marketing approval pathway for biologicals that are for export only; remove merits review rights for a decision by the secretary to require a person to provide information or documents under the Act; enable the secretary to extend the period for a person to pay the amount stated in an infringement notice, and require a person to provide information or documents that are relevant to a contravention of the Act; extend the period for which seized goods can be held; provide that therapeutic goods advertising is excluded from advertising restrictions for certain health professionals or to persons purchasing goods on behalf of governments, registered charities or health facilities; enable the secretary to withdraw approval for the use of a restricted representation in an advertisement about therapeutic goods; enable the secretary to approve the importation or supply of substitute overseas prescription medicine that has been previously approved within Australia; provide that the secretary is not required to observe any requirements of the natural justice hearing rule when releasing therapeutic goods information; provide that sponsors of reportable medicines that are in shortage must provide updated information to the secretary; and make technical amendments. 

  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 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 (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