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

Type
Government
Portfolio
Health
Originating house
House of Representatives
Status
Assent
Parliament no
46

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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

Bill progress
House of Representatives
Introduced and read a first time 04 Mar 2020
Second reading moved 04 Mar 2020
Second reading debate 14 May 2020
Second reading debate 17 Jun 2020
Second reading agreed to 17 Jun 2020
Third reading agreed to 17 Jun 2020
Bill progress
Senate
Introduced and read a first time 17 Jun 2020
Second reading moved 17 Jun 2020
Second reading debate 18 Jun 2020
Second reading agreed to 18 Jun 2020
Third reading agreed to 18 Jun 2020
Bill progress
Finally passed both Houses 18 Jun 2020
Assent
  • Act no: 75
  • Year: 2020
25 Jun 2020

Documents and transcripts

Text of bill

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Word Format PDF Format HTML Format

Explanatory memoranda

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Proposed amendments

No proposed amendments have been circulated.

Schedules of amendments

No documents at present

Notes

Helpful information

Text of bill

  • First reading: Text of the bill as introduced into the Parliament
  • Third reading: Prepared if the bill is amended by the house in which it was introduced. This version of the bill is then considered by the second house.
  • As passed by both houses: Final text of bill agreed to by both the House of Representatives and the Senate which is presented to the Governor-General for assent.

Explanatory memoranda

  • Explanatory memorandum: Accompanies and provides an explanation of the content of the introduced version (first reading) of the bill.
  • Supplementary explanatory memorandum: Accompanies and explains amendments proposed by the government to the bill.
  • Revised explanatory memorandum: Accompanies and explains the amended version (third reading) of the bill. It supersedes the explanatory memorandum.

Proposed amendments

Circulated by members and senators when they propose to make changes to the bill. For details about the outcome of proposed amendments please refer to either the Votes and Proceedings (House of Representatives) or the Journals (Senate).

Schedules of amendments

Schedules of amendments list amendments agreed to by the second house are communicated to the first house for consideration. Subsequent action by either house may also be included in a schedule.