Document ID: chunk:federal_register_of_legislation:C2025C00090:section:99adhc:p2
Version: federal_register_of_legislation:C2025C00090
Segment Type: section
Provision Reference: s 99ADHC (pt 2/3)
Character Range: 408414–410785

the Therapeutic Goods Act 1989 and as in force from time to time) by reference to a quantity or amount of the drug; and
 (b) that quantity or amount of the drug is equal to or greater than the total quantity or amount of the drug contained in the quantity or number of units of the brand of the pharmaceutical item in any pack quantity of the brand of the pharmaceutical item.

Limits on price reductions
 (4) The approved ex‑manufacturer price of the designated brand of the pharmaceutical item is not to be reduced under this Part unless:
 (a) the reduction is the result of the making of a price agreement; or
 (b) the reduction is under section 99ADH as the result of subparagraph 99ADH(1)(c)(ii) or (iii).
 (5) If, apart from this subsection:
 (a) the approved ex‑manufacturer price of the designated brand of the pharmaceutical item is to be reduced under a provision of this Part; and
 (b) the reduction would result in the approved ex‑manufacturer price being less than $4;
then:
 (c) the approved ex‑manufacturer price is not to be reduced under that provision to an amount less than $4; and
 (d) the approved ex‑manufacturer price is instead to be reduced by an amount that would result in the approved ex‑manufacturer price being $4; and
 (e) the reduction mentioned in paragraph (d) is taken to be a reduction under that provision.

When the drug and manner of administration of a pharmaceutical item is taken to have been on F2 for at least 42 months
 (6) For the purposes of paragraph (1)(a), the drug and manner of administration of a pharmaceutical item is taken to have been on F2 for at least 42 months if:
 (a) at end of the previous data collection period, the drug in the designated brand of the pharmaceutical item had been on F2 for at least 42 months; and
 (b) on a day at least 42 months before the end of the previous data collection period:
 (i) there was a related brand of the designated brand of the pharmaceutical item that had the same pharmaceutical item as, or was bioequivalent or biosimilar to, the designated brand of the pharmaceutical item; or
 (ii) there were 2 or more related brands of the designated brand of the pharmaceutical item that had the same pharmaceutical item as, or were bioequivalent or biosimilar to, each other.
 (7) For the purposes of this section, data collection period has the same meaning as in Division 3B.