Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016

Health and Aged Care
Originating house
House of Representatives
Parliament no

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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.


House of Representatives
Introduced and read a first time 01 Dec 2016
Second reading moved 01 Dec 2016
Second reading debate 27 Mar 2017
Second reading agreed to 27 Mar 2017
Third reading agreed to 27 Mar 2017
Introduced and read a first time 27 Mar 2017
Second reading moved 27 Mar 2017
Second reading debate 14 Jun 2017
Second reading agreed to 14 Jun 2017
Third reading agreed to 14 Jun 2017
Finally passed both Houses 14 Jun 2017
  • Act no: 47
  • Year: 2017
19 Jun 2017

Documents and transcripts

Text of bill

Explanatory memoranda

Proposed amendments


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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