Document ID: chunk:federal_register_of_legislation:C2025C00090:section:99adhc:p1
Version: federal_register_of_legislation:C2025C00090
Segment Type: section
Provision Reference: s 99ADHC (pt 1/3)
Character Range: 405981–408612

99ADHC  Floor price of a brand of a pharmaceutical item

When this section applies
 (1) Subject to subsection (3), this section applies to a brand (the designated brand) of a pharmaceutical item if:
 (a) both:
 (i) the drug and manner of administration of the pharmaceutical item has been on F2 for at least 42 months; and
 (ii) at the end of the previous data collection period for the designated brand of the pharmaceutical item, at least 30 months have passed since the first price reduction under Division 3B of any listed brand of a pharmaceutical item that has the same drug and manner of administration of the pharmaceutical item; or
 (b) the approved ex‑manufacturer price of the designated brand of the pharmaceutical item is $4 or less; or
 (c) both:
 (i) the approved ex‑manufacturer price of a brand of the pharmaceutical item has been increased on or after 1 July 2022 as a result of the making of a price agreement; and
 (ii) a determination is in force under subsection (2) in relation to the designated brand of the pharmaceutical item; or
 (d) the approved ex‑manufacturer price of the designated brand of the pharmaceutical item has been increased under section 104B.
Note 1: Section 104B commences on 1 October 2022.
Note 2: There are various consequences of a brand being a designated brand, including the changed threshold in subparagraphs 99ADH(1)(c)(ii) and (iii), the limits on price reductions in subsections (4) and (5) of this section, the Minister's powers under Division 3CA of this Part relating to certain discounting and incentives, and the minimum stockholding requirements in Division 3CAA of this Part. For example, if a brand satisfies paragraphs (1)(a)(i) and (ii) of this section at the end of the data collection period ending on 31 March 2024, the brand will become a designated brand, and these consequences will apply to the brand, on and from 1 April 2025 (subject to subsection (3) of this section).
 (2) If the approved ex‑manufacturer price of a brand of a pharmaceutical item is increased on or after 1 July 2022 as a result of a new agreed price coming into force, the Minister may, by notifiable instrument, determine that paragraph (1)(c) applies to the brand of the pharmaceutical item.
 (3) This section does not apply to a brand of a pharmaceutical item if:
 (a) the drug in the pharmaceutical item is included in Schedule 2 to the current Poisons Standard (within the meaning of 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