8Application

8 Application

(1) In this section: amending determination means the Therapeutic Goods (Manufacturing Principles) Amendment (PIC/S Guide) Determination 2025. sterile therapeutic goods means therapeutic goods that are: (a) sterile medicines; or (b) sterile active pharmaceutical ingredients. (2) The amendment of this instrument made by item 1 in Schedule 1 to the amending determination applies to the manufacture of therapeutic goods that occurs on or after 1 September 2025. (3) Despite subsection (2), the amendment of this instrument made by item 1 in Schedule 1 to the amending determination, only to the extent that the amendment has the effect of incorporating clauses 2.1, 2.3, 7.14 and 9.31 of Annex 1 to the PIC/S Guide to GMP, applies to the manufacture of sterile therapeutic goods that occurs on or after 1 March 2026.

Schedule 1—Manufacturing Principles

Note: See sections 6 and 7.