Document ID: chunk:federal_register_of_legislation:F2024C00984:reg:5
Version: federal_register_of_legislation:F2024C00984
Segment Type: reg
Provision Reference: reg 5
Character Range: 111731–113022

5                                            Power under subsection 99AEKC(2) of the Act to determine an applicable quantity of a brand of a pharmaceutical item                                                            5,190

 (2) This subsection applies if:
 (a) either:
 (i) a price agreement under section 85AD of the Act is in force between the person and the Minister for the listed brand of the pharmaceutical item; or
 (ii) determinations under subsections 85B(2) and (3) of the Act are in force for the listed brand of the pharmaceutical item; and
 (b) since that agreement or those determinations entered into force, the Committee has not made a recommendation, or given advice, in response to a submission made by the person in relation to:
 (i) the listed brand of the pharmaceutical item; or
 (ii) the drug in the pharmaceutical item; and
 (c) in the list management application, the person is seeking:
 (i) through the exercise of the power in subsection 85AD(1) of the Act—an increase in the approved ex‑manufacturer price of the listed brand of the pharmaceutical item; or
 (ii) the making of a determination under subsection 85B(3) of the Act, or the increase in a price earlier determined under that subsection, in relation to the listed brand of the pharmaceutical item.