Legislation

Therapeutic Goods Regulations 1990 (Cth)

Office of Parliamentary Counsel. Regulation, Australia-wide.

Version
Compilation No. 130, 8 September 2026
Last read
5 October 2026

The Regulations under the Therapeutic Goods Act. They define minimal manipulation and homologous use, set the conditions of the exemptions for goods made from a patient's own cells or tissues, define the seriously ill patient the notification pathway for unapproved goods is built around, prescribe the medical practitioners who can hold an authorised prescriber authority, and exempt goods an individual imports for their own treatment or their immediate family's.

What changed

  • 5 October 2026Amendment not yet incorporated in a compilation (F2026L01167, Schedule 1, Part 4)The Federal Register lists Schedule 1, items 50 to 58 of the Therapeutic Goods Legislation Amendment (2026 Measures No. 1) Regulations 2026 as amending these Regulations from 5 October 2026. The items insert definitions of master file, plasma master file and technical master file in regulation 2, change the reference to the Schedule 5A table in subregulations 12(2) and (3), set that table out as clause 1 and add items 18 and 19 to it for human blood and blood components and for imported plasma for fractionation, add clauses 2 to 6 to Schedule 5A on applying for and approving master files, amend item 9 and repeal item 10 of the Schedule 5 table, add two decisions to subregulation 48(1AB), and add a master file fee as item 9B in clause 3 of Schedule 9.
  • 8 September 2026Compilation No. 130The Federal Register records this compilation as taking in Schedule 1, items 8 to 35, 37, 41 to 45 and 47 of the Therapeutic Goods Legislation Amendment (2026 Measures No. 1) Regulations 2026.
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