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


Type
Government
Originating house
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.

Progress of bill

For committee reference information, please see the Notes section at the end of this page.

House of Representatives
Introduced and read a first time 14/09/17  
Second reading moved 14/09/17  
Second reading debate 25/10/17  
Referred to Federation Chamber 25/10/17  
Second reading debate 04/12/17  
Second reading agreed to 04/12/17  
Reported from Federation Chamber 04/12/17  
Third reading agreed to 04/12/17  
     
Senate
Introduced and read a first time 04/12/17  
Second reading moved 04/12/17  
Second reading debate 05/02/18  
Second reading debate 15/02/18  
Second reading agreed to 15/02/18  
Committee of the Whole debate 15/02/18 Amendment details: 1 Government agreed to
Third reading agreed to 15/02/18  
     
House of Representatives
Consideration of Senate message 15/02/18 Details: House agreed to Senate amendment
     
Finally passed both Houses 15/02/18  
Assent 05/03/18 Act no: 7 - Year: 2018
     

Text of bill

  • First reading

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  • As passed by both Houses

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Explanatory memoranda

  • Explanatory memorandum

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  • Addendum to explanatory memorandum

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  • Supplementary explanatory memorandum

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Second reading speeches


Proposed amendments

Senate
  • Australian Greens [sheet 8353]
DI NATALE, Sen Richard

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  • Government [sheet JC487]

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  • Liberal Democratic Party [sheet 8358]
LEYONHJELM, Sen David

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Schedules of amendments

  • Schedule of the amendment made by the Senate

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Bills Digest



Notes