Document ID: chunk:federal_register_of_legislation:C2025C00090:section:99acd:p2
Version: federal_register_of_legislation:C2025C00090
Segment Type: section
Provision Reference: s 99ACD (pt 2/5)
Character Range: 341092–343758

apply—the original approved ex‑manufacturer price of the first listed brand of the existing item;
  has, by virtue of previous price reductions, been reduced by 60% or more.
 (1B) If the approved ex‑manufacturer price mentioned in subparagraph (1A)(d)(i) or (ii) is by reference to a different pricing quantity than the pricing quantity on the day before the determination day, the approved ex‑manufacturer price mentioned in that subparagraph is taken to be the amount that the approved ex‑manufacturer price would have been had the pricing quantity been the same as the pricing quantity on the day before the determination day.
 (2) This section does not apply in relation to the new brand of the trigger combination item if a listed provision (see subsection (2A)) has applied in relation to:
 (a) the new brand, or another listed brand, of the trigger combination item; or
 (b) a brand of another combination item that:
 (i) has a drug that contains the same component drugs as the new brand of the trigger combination item; and
 (ii) has the same manner of administration as the new brand of the trigger combination item; or
 (c) if the drug in the trigger combination item is in a therapeutic group—a combination item that:
 (i) has another drug that is in that group; and
 (ii) has the same manner of administration as the new brand of the trigger combination item.
Note: For the purposes of this subsection, subsections (5) and (5A) of this section are taken not to have applied in relation to a brand of a pharmaceutical item in some cases: see section 99AEI and subsection (7B) of this section.
 (2A) For the purposes of subsection (2), listed provision means:
 (a) subsection (5) or (5A); or
 (b) a determination under paragraph (7A)(b); or
 (c) subsection 99ACF(1) or (2) because of item 4A, 4B or 8 in the table in subsection 99ACF(1); or
 (d) section 99ACQ; or
 (e) subsection 99ACR(3) or (4); or
 (f) repealed section 99ACE.
 (3) This section does not apply in relation to the new brand of the trigger combination item if:
 (a) all of the following apply:
 (i) the new brand of the trigger combination item is a new presentation of an existing listed brand of a pharmaceutical item;
 (ii) a declaration under subsection 85(2) is in force in relation to the drug in the pharmaceutical item;
 (iii) the determination day in relation to the new brand of the trigger combination item is on or before the fifth anniversary of the declaration under subsection 85(2) being made;
 (iv) the responsible person for the new brand of the trigger combination item is the same as the responsible person for the existing listed brand of the pharmaceutical item;
 (v)