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• Therapeutic Goods Amendment (2011 Measures No. 1) Bill 2011

  Track (What's this?)

  Date

  23 Mar 2011 

  Chamber

  House of Representatives 

  Status

  Act 

  Portfolio

  Health and Ageing 

  Summary

  Amends the

  Therapeutic Goods Act 1989

  in relation to: processes for the evaluation of prescription medicines; the refund of evaluation fees; and standard conditions for the registration or listing of therapeutic goods. 

  Bill | Explanatory Memorandum

• Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013

  Track (What's this?)

  Date

  12 Dec 2013 

  Chamber

  House of Representatives 

  Status

  Act 

  Portfolio

  Health 

  Summary

  Amends the

  Therapeutic Goods Act 1989

  to: enable the minister to specify products that are taken not to be therapeutic goods; enable the secretary to remove products that are not therapeutic goods from the Australian Register of Therapeutic Goods; clarify the secretary’s powers to approve product information for medicines accepted for registration in the register; and make amendments in relation to: compliance with advertising requirements; obtaining information and documents; use of restricted and prohibited representations in advertisements; conditions of registration or listing in the register; presentation of registered or listed goods; consent to the import, supply or export of goods; review of decisions; a package and its contents to constitute a kit; criminal offences and civil penalties for false or misleading statements in relation to variation requests; minimum notice period for cancellation of registration or listing in the register; secretary’s discretion to publish certain information on the department’s website; clarification of the merits review process; prescribing of alternative periods of time in relation to the secretary’s selection of an application for auditing; failure to comply with requirements to provide information; and revocation of requested cancellation of devices, licences or certificates. 

  Bill | Explanatory Memorandum

• Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013

  Track (What's this?)

  Date

  20 Mar 2013 

  Chamber

  House of Representatives 

  Status

  Not Proceeding 

  Portfolio

  Health and Ageing 

  Summary

  Amends the

  Therapeutic Goods Act 1989

  to: enable the minister to specify products that are taken not to be therapeutic goods; enable the secretary to remove products that are not therapeutic goods from the Australian Register of Therapeutic Goods; clarify the secretary’s powers to approve product information for medicines accepted for registration in the register; and make amendments in relation to: compliance with advertising requirements; obtaining information and documents; use of restricted and prohibited representations in advertisements; conditions of registration or listing in the register; presentation of registered or listed goods; consent to the import, supply or export of goods; review of decisions; a package and its contents to constitute a kit; criminal offences and civil penalties for false or misleading statements in relation to variation requests; minimum notice period for cancellation of registration or listing in the register; secretary’s discretion to publish certain information on the department’s website; clarification of the merits review process; public notification and/or recall of registered or listed therapeutic goods, biologicals and medical devices; failure to comply with requirements to provide information; and specified information required for certain applications and requests. 

  Bill | Explanatory Memorandum

• Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

  Track (What's this?)

  Date

  01 Dec 2016 

  Chamber

  House of Representatives 

  Status

  Act 

  Portfolio

  Health and Aged Care 

  Summary

  Amends the:

  Therapeutic Goods Act 1989

  to: enable certain variations that do not impact the quality, safety or efficacy of medicines to be made by notification to the Therapeutic Goods Administration (TGA); enable Australian designated bodies to undertake conformity assessment of manufacturers of medical devices; alter the requirements for the minister to consult with committees; provide review and appeal rights for persons applying to have new ingredients permitted for use in listed complementary medicines; enable priority approval of therapeutic goods, biologicals and medical devices; specify timeframes within which the secretary must complete actions or make decisions in relation to listed complementary medicines; amend record-keeping arrangements to assist with post-marketing monitoring of medicines and medical devices; provide further grounds on which applications to vary an entry in the register will not be considered to be effective; update terminology and provide for certain public notifications in relation to the recall of therapeutic goods; enable the secretary to obtain certain information from sponsors of listed medicines; and make miscellaneous amendments in relation to powers to approve unapproved goods in the event of a shortage, alignment of cancellation powers, revoking the cancellation of goods cancelled for non-payment of annual charges, information-gathering powers in relation to holders of manufacturing licences, and conditions of inclusion in the register of medical devices; and

  A New Tax System (Goods and Services Tax) Act 1999

  and

  Therapeutic Goods Act 1989

  to enable health practitioners to supply certain therapeutic goods not on the Australian Register of Therapeutic Goods to patients under a notification scheme. 

  Bill | Explanatory Memorandum

• Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017

  Track (What's this?)

  Date

  14 Sep 2017 

  Chamber

  House of Representatives 

  Status

  Act 

  Portfolio

  Health 

  Summary

  Introduced with the Therapeutic Goods (Charges) Amendment Bill 2017, the bill amends the:

  Therapeutic Goods Act 1989

  to: introduce a new approval pathway for prescription medicines by creating a class of therapeutic good to be known as ‘provisionally registered goods’; allow the minister to specify, by legislative instrument, permitted indications for use with listed medicines; establish an additional pathway for intermediate risk medicines through a new application and assessment process for sponsors of listed complementary medicines seeking to use indications that fall outside the permitted indications list; strengthen monitoring powers in relation to biologicals; implement stronger compliance and enforcement powers and graduated penalties for non-compliant behaviours; remove the distinctions between advertisements for therapeutic goods for which an approval is, or is not, required; enable the secretary to utilise the work of comparable overseas regulators in the course of making assessments of medical devices; enable the secretary to publish information in relation to Australian conformity assessment bodies; align the secretary’s powers relating to conformity assessment certificates issued by Australian conformity assessment bodies and conformity assessment certificates issued by the secretary; clarify that the secretary has the power to refuse an application for including medicines, biologicals and medical devices in the Australian Register of Therapeutic Goods prior to evaluating the application if it does not meet the application requirements; and make minor amendments to achieve consistency of regulatory requirements between different types of therapeutic goods and make other minor changes; and

  Broadcasting Services Act 1992

  to make consequential amendments. 

  Bill | Explanatory Memorandum

• 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