Document ID: chunk:federal_register_of_legislation:C2025C00090:section:85:p3
Version: federal_register_of_legislation:C2025C00090
Segment Type: section
Provision Reference: s 85 (pt 3/3)
Character Range: 135279–137869

more other brands of pharmaceutical items, the specification is taken to have been made following a determination to that effect under subsection (6A).

Prescriptions of pharmaceutical benefits in certain circumstances
 (7) The Minister may, by legislative instrument, determine:
 (a) that a particular pharmaceutical benefit is to be a relevant pharmaceutical benefit for the purposes of section 88A; and
 (b) the circumstances in which a prescription for the supply of the pharmaceutical benefit may be written.

Pharmaceutical benefits that can only be supplied under the prescriber bag provisions
 (7A) The Minister may, by legislative instrument, determine that a particular pharmaceutical benefit can only be supplied under one or more of the prescriber bag provisions.

Pharmaceutical benefits that can only be supplied under special arrangements
 (8) The Minister may, by legislative instrument, determine that:
 (a) a particular pharmaceutical benefit (other than a pharmaceutical benefit that has a drug covered by subsection (2A)) can only be supplied under special arrangements under section 100; or
 (b) one or more of the circumstances in which a prescription for the supply of a pharmaceutical benefit may be written under paragraph (7)(b) are circumstances in which the benefit can only be supplied under special arrangements under section 100.

Brand or pharmaceutical item that is biosimilar or bioequivalent to listed item is taken to have the same drug
 (9) If:
 (a) a listed brand of a pharmaceutical item (the listed brand) has a drug; and
 (b) another brand of the pharmaceutical item, or a brand of another pharmaceutical item, is biosimilar or bioequivalent to the listed brand;
then, for the purposes of this Part, the other brand or pharmaceutical item is taken to have the same drug as the listed brand.
 (10) Subsection (9) does not affect the separate declarations of the following drugs made under subsection (2) before the commencement of this subsection:
 (a) epoetin lambda;
 (b) epoetin alfa.

Alternative names or terminology
 (11) The Minister may, by notifiable instrument, determine that, for the purposes of this Part:
 (a) more than one name is recognised for the same listed drug; or
 (b) more than one description is recognised for the same form of a listed drug; or
 (c) more than one description is recognised for the same manner of administration of a form of a listed drug.
 (12) Without limiting subsection (11), the Minister may determine a name or description as being used during a period of time, such as before or after a specified date.