Bill
Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018
passed, as at 2018-09-21. Health portfolio.
- Sponsor
- Not recorded
- Portfolio
- Health
Recorded stages
- introduced — 2018-06-28
- second reading — 2018-06-28
- second reading — 2018-08-16
- second reading — 2018-08-20
- second reading — 2018-08-20
- third reading — 2018-08-20
- introduced — 2018-08-20
- second reading — 2018-08-20
- second reading — 2018-09-10
- second reading — 2018-09-10
- third reading — 2018-09-10
- passed — 2018-09-10
- royal assent — 2018-09-21
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 2018-06-28.
The bill introduces a mandatory scheme requiring sponsors of certain medicines to report shortages or permanent discontinuations to the Department of Health Secretary.
It creates penalties for non-compliance and makes miscellaneous amendments to improve regulatory efficiency, such as supporting online forms and clarifying requirements.
Sponsors must report critical-impact shortages within 2 working days, other shortages within 10 working days, critical discontinuations at least 12 months ahead, and other discontinuations at least 6 months ahead.
- Introduce a mandatory reporting scheme for medicine shortages and permanent discontinuations.
- Create civil penalties for non-compliance with reporting requirements.
- Make miscellaneous amendments to reduce inefficiencies in therapeutic goods regulation.
Sponsors of prescription medicines, medicines on a Medicines Watch List, and other medicines determined by the Minister for Health, as well as industry and the Therapeutic Goods Administration.
Sources
em
billhome
frl act