Document ID: chunk:federal_register_of_legislation:F2024C00984:reg:5:p2
Version: federal_register_of_legislation:F2024C00984
Segment Type: reg
Provision Reference: reg 5 (pt 2/2)
Character Range: 10796–12662

therapeutic goods within the meaning of paragraph (a) or (b) of the definition of therapeutic goods in subsection 3(1) of the Therapeutic Goods Act 1989.
MSAC means the body known as the Medical Services Advisory Committee.
notification:
 (a) for an ATAGI application—means a notification given under whichever of subsections 11(1), (2) and (3) is relevant to the ATAGI application or a notice of intent in relation to the ATAGI application; or
 (b) for a pre‑submission meeting application—means a notification given under subsection 17(1); or
 (c) for a submission—means a notification given under whichever of subsections 33(1), (2) and (3) is relevant to the submission or a notice of intent in relation to the submission; or
 (d) for a pricing application—means a notification given under whichever of subsections 50(1), (2) and (3) is relevant to the pricing application or a notice of intent in relation to the pricing application; or
 (e) for a list management application—means a notification given under section 58.
PBS prescriber has the meaning given by subsection 84(1) of the Act.
pharmaceutical item has the meaning given by section 84AB of the Act.
pre‑submission meeting application has the meaning given by paragraph 14(a).
pricing application has the meaning given by subsection 40(1).
pricing category means a pricing category referred to in the table in subsection 41(1).
pricing services has the meaning given by subsection 40(1).
reviewable decision has the meaning given by section 71.
submission means a submission referred to in subsection 21(1).
submission due day has the meaning given by subsection 31(3).
submission services has the meaning given by subsection 22(1).
Therapeutic Goods Administration means the part of the Department known as the Therapeutic Goods Administration.

Part 2—Pre‑submission services

Division 1—Preliminary