Bill
Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013
passed, as at 2014-02-28. Health portfolio.
- Sponsor
- Not recorded
- Portfolio
- Health
Recorded stages
- introduced — 2013-12-12
- second reading — 2013-12-12
- second reading — 2014-02-11
- second reading — 2014-02-11
- committee — 2014-02-11
- third reading — 2014-02-11
- introduced — 2014-02-12
- second reading — 2014-02-12
- second reading — 2014-02-13
- second reading — 2014-02-13
- third reading — 2014-02-13
- passed — 2014-02-13
- royal assent — 2014-02-28
Divisions
Plain-language summary
Written by a model from the explanatory memorandum; not the record, as at 2013-12-12.
The bill would change the Therapeutic Goods Act 1989 in several areas, aiming to cut red tape, improve clarity, reduce health risks and increase transparency.
It would let the Minister declare by legislative instrument that certain goods are not therapeutic goods for the Act's purposes, and allow the Secretary to set a longer period than the current 20 working days to decide whether to audit applications for some medical devices.
The longer audit period is intended to manage the high number of Class III applications expected before the 1 July 2014 deadline for hip, knee and shoulder joint implants.
- Introduces a power for the Minister to determine that specified goods are not therapeutic goods.
- Allows the Secretary to prescribe an alternative number of days for deciding whether to audit certain medical device applications.
- Requires the Secretary to publish details when a regulatory decision overturned on review.
- Clarifies that references to advertising requirements in the Act include the Therapeutic Goods Advertising Code.
- Clarifies the process for approving registered medicines under section 25 and the source of the Secretary's power to approve product information under section 25AA.
Sponsors of medical devices, particularly joint implant manufacturers, and businesses marketing products that may be considered therapeutic goods.
Sources
em
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frl act