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Therapeutic Goods Amendment (2022 Measures No. 1) 2022
✦ Plain-English Summary
# Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022
## What it does
This bill updates the rules for therapeutic goods (medicines, medical devices, and biologicals) sold in Australia. It makes 12 separate changes, including requiring manufacturers to report when medical devices cause harm, letting companies bring in replacement medicines more easily, and reducing paperwork requirements for people advertising health products.
## Why it matters
These changes aim to catch safety problems faster (especially with medical devices), keep medicines in stock when shortages happen, and cut through red tape for legitimate advertisers. On the flip side, some measures give regulators more power to gather information and seize goods, which affects how companies operate.
## Key details
- **Medical device safety**: Manufacturers must now report serious injuries or deaths caused by their devices — this kicks in within 24 months and helps spot dangerous products quickly.
- **Medicine shortages**: Companies must tell regulators when they can't supply essential medicines, giving the system early warning to find alternatives (starts 6 months after the bill passes).
- **Less paperwork for advertisers**: Health product advertisers face fewer restrictions on what claims they can make (effective immediately after passage), though false advertising can still be penalised.
- **More regulatory power**: The TGA can now gather information from companies and keep seized goods longer without needing court approval for every decision.
Official Description
Amends the Therapeutic Goods Act 1989 to: require mandatory reporting of adverse events involving medical devices; provide a marketing approval pathway for biologicals that are for export only; remove merits review rights for a decision by the secretary to require a person to provide information or documents under the Act; enable the secretary to extend the period for a person to pay the amount stated in an infringement notice, and require a person to provide information or documents that are relevant to a contravention of the Act; extend the period for which seized goods can be held; provide that therapeutic goods advertising is excluded from advertising restrictions for certain health professionals or to persons purchasing goods on behalf of governments, registered charities or health facilities; enable the secretary to withdraw approval for the use of a restricted representation in an advertisement about therapeutic goods; enable the secretary to approve the importation or supply of substitute overseas prescription medicine that has been previously approved within Australia; provide that the secretary is not required to observe any requirements of the natural justice hearing rule when releasing therapeutic goods information; provide that sponsors of reportable medicines that are in shortage must provide updated information to the secretary; and make technical amendments.
Committee Referrals
Senate Standing Committee for the Scrutiny of Bills
Audit History
Last updated on APH
10 Apr 2026
Last checked by Crossbench
yesterday
Full text indexed
yesterday
How Parliament Voted
Senate3 Aug 2022
Social Security (Administration) Amendment (Repeal of Cashless Debit Card and Other Measures) Bill 2022 - Third Reading - Pass the bill
Senate27 Sept 2022
Social Security (Administration) Amendment (Repeal of Cashless Debit Card and Other Measures) Bill 2022 - Third Reading - Pass the bill
Constituent votes
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