Bill
Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016
passed, as at 2017-06-19. Health and Aged Care portfolio.
- Sponsor
- Not recorded
- Portfolio
- Health and Aged Care
Recorded stages
- introduced — 2016-12-01
- second reading — 2016-12-01
- second reading — 2017-03-27
- second reading — 2017-03-27
- third reading — 2017-03-27
- introduced — 2017-03-27
- second reading — 2017-03-27
- second reading — 2017-06-14
- second reading — 2017-06-14
- third reading — 2017-06-14
- passed — 2017-06-14
- royal assent — 2017-06-19
Divisions
No divisions recorded. Most questions are decided on the voices; this does not establish that a bill was unopposed.
Plain-language summary
Written by a model from the explanatory memorandum; not the record, as at 2016-12-01.
The bill would implement eight expert panel recommendations aimed at streamlining regulation of medicines and medical devices while maintaining safety and quality.
It would create new regulation-making powers for priority approval pathways for medicines and devices, and for notifiable variations to medicines that do not affect safety.
The bill would also allow the Minister to set up a scheme for health practitioners to supply certain unregistered therapeutic goods to patients without prior approval, provided they notify the TGA within 28 days.
- Establishes legislative bases for fast-tracked approval of medicines and medical devices through new priority pathways.
- Introduces a notification scheme for low-risk variations to medicines, replacing the need for prior approval.
- Provides for private Australian bodies to be designated by the TGA to conduct conformity assessment of medical devices.
- Creates a notification scheme for health practitioners to supply certain unregistered therapeutic goods to patients.
- Adds review and appeal rights for sponsors applying to include new ingredients in listed complementary medicines.
Sponsors of therapeutic goods, manufacturers of medical devices, health practitioners, and patients would be affected by the bill.
Sources
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billhome
frl act