Document ID: chunk:federal_register_of_legislation:C2007A00111:clause:1_85ab
Version: federal_register_of_legislation:C2007A00111
Segment Type: clause
Provision Reference: sch 1 cl 85AB
Character Range: 19584–21279

85AB  Minister may determine that a listed drug is on F1 or F2

 (1) Subject to subsection (5), the Minister may, by legislative instrument, determine that a listed drug is on F1 or F2.

 (2) The Minister may only determine that the drug is on F1 if the drug satisfies all the criteria for F1.

Note: For other circumstances in which the Minister may determine that a listed drug is on F1, see section 99AEJ.

 (3) The Minister may only determine that the drug is on F2 if the drug does not satisfy one or more of the criteria for F1.

 (4) The criteria for F1 are as follows:
 (a) there are no brands of pharmaceutical items that:
 (i) have the drug; and
 (ii) are bioequivalent or biosimilar; and
 (iii) are listed brands of the pharmaceutical items on any day in the relevant period;
 (b) there are no brands of pharmaceutical items that:
 (i) have another listed drug that is in the same therapeutic group as the drug; and
 (ii) are bioequivalent or biosimilar; and
 (iii) are listed brands of the pharmaceutical items on any day in the relevant period;
 (c) the drug was not on F2 on the day before the determination under subsection (1) comes into force.

 (5) This section does not apply to the drug if:
 (a) the drug is in a combination item; and
 (b) there are no brands of combination items that:
 (i) have the drug; and
 (ii) are bioequivalent or biosimilar; and
 (iii) are listed brands of the combination items on any day in the relevant period.

 (6) In this section:

relevant period means the period that consists of:
 (a) the day before the day the determination under subsection (1) comes into force; and
 (b) the day the determination under subsection (1) comes into force.