Bills of the current Parliament

Although every effort is made to ensure the accuracy of bills homepages, the authoritative sources for verifying the progress of bills are the House of Representatives Votes and Proceedings and the Journals of the Senate.

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

Type
Government
Originating house
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.

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 04/03/20  
Second reading moved 04/03/20  
Second reading debate 14/05/20  
Second reading debate 17/06/20  
Second reading agreed to 17/06/20  
Third reading agreed to 17/06/20  
     
Senate
Introduced and read a first time 17/06/20  
Second reading moved 17/06/20  
Second reading debate 18/06/20  
Second reading agreed to 18/06/20  
Third reading agreed to 18/06/20  
     
Finally passed both Houses 18/06/20  
Assent 25/06/20 Act no: 75 - Year: 2020
     

[Information on document types]

Text of bill

  • First reading

MS-Word PDF HTML
  • As passed by both Houses

MS-Word PDF HTML

Explanatory memoranda

  • Explanatory memorandum

MS-Word PDF HTML

Second reading speeches


Proposed amendments

No proposed amendments have been circulated.

Schedules of amendments

Bills Digest



Notes
  • Considered by scrutiny committee (02/04/2020): Senate Standing Committee for the Scrutiny of Bills; Scrutiny Digest 6 of 2020
  • An electronic version of this Act is available on the Federal Register of Legislation (www.legislation.gov.au)