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

Type
Government
Portfolio
Health
Originating house
House of Representatives
Status
Before Reps
Parliament no
45

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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

House of Representatives
Introduced and read a first time 14 Sep 2017
Second reading moved 14 Sep 2017
Second reading debate 25 Oct 2017
Referred to Federation Chamber 25 Oct 2017

Documents and transcripts

Text of bill

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Explanatory memoranda

Word Format PDF Format HTML Format

Proposed amendments

No proposed amendments have been circulated.

Schedules of amendments

No documents at present

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.