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Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022

Type
Government
Portfolio
Health and Aged Care
Originating house
House of Representatives
Status
Before Senate
Parliament no
47

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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.

Progress

House of Representatives
Introduced and read a first time 01 Dec 2022
Second reading moved 01 Dec 2022
Second reading debate 07 Feb 2023
Referred to Federation Chamber 07 Feb 2023
Second reading agreed to 08 Feb 2023
Reported from Federation Chamber 08 Feb 2023
Third reading agreed to 08 Feb 2023

Documents and transcripts

Text of bill

Explanatory memoranda

Proposed amendments

No proposed amendments have been circulated.

Schedules of amendments

No documents at present

Bills digest

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.

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