Bill
Therapeutic Goods Amendment (2020 Measures No. 1) Bill 2020
passed, as at 2020-06-25. Health portfolio.
- Sponsor
- Not recorded
- Portfolio
- Health
Recorded stages
- introduced — 2020-03-04
- second reading — 2020-03-04
- second reading — 2020-05-14
- second reading — 2020-06-17
- second reading — 2020-06-17
- third reading — 2020-06-17
- introduced — 2020-06-17
- second reading — 2020-06-17
- second reading — 2020-06-18
- second reading — 2020-06-18
- third reading — 2020-06-18
- passed — 2020-06-18
- royal assent — 2020-06-25
Divisions
Plain-language summary
Written by a model from the explanatory memorandum; not the record, as at 2020-03-04.
This bill would change the Therapeutic Goods Act 1989 in several ways.
It would update medical device definitions to match European Union rules, allow the Secretary to give early scientific advice to medicine sponsors, and create data protection for certain listed medicines.
The bill also includes minor amendments to cut red tape and fix an access issue for provisionally registered medicines.
- Aligns medical device definitions with the European Union.
- Lets the Secretary give early scientific advice to sponsors of registrable medicines.
- Introduces data protection for clinical trial data used for indications of assessed listed medicines.
- Makes minor amendments to reduce regulatory burden and remove an access barrier for provisionally registered medicines.
Sponsors of medicines and medical devices, the Secretary, Australian consumers, and the complementary medicines industry.
Sources
em
billhome
frl act