Search all bills

TOTAL RESULTS: 741

• 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 (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 (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 (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 (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 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