National Health Act 1953

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

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

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

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.

The criteria for F1 are as follows:

there are no brands of pharmaceutical items that:

have the drug; and

are bioequivalent or biosimilar; and

are listed brands of the pharmaceutical items on any day in the relevant period;

there are no brands of pharmaceutical items that:

have another listed drug that is in the same therapeutic group as the drug; and

are bioequivalent or biosimilar; and

are listed brands of the pharmaceutical items on any day in the relevant period;

the drug was not on F2 on the day before the determination under subsection (1) comes into force.

For the purposes of working out whether paragraph (4)(a) or (b) is satisfied, a brand of a pharmaceutical item that has the drug is to be disregarded if:

both:

subsection 99ACB(3A) or (3B) applies to the brand of the pharmaceutical item that has the drug; and

there is not another brand of the pharmaceutical item that has the drug that is a listed brand; or

both:

subsection 99ACB(3A) or (3B) applies to the brand of the pharmaceutical item that has the drug; and

the drug is not on F2; or

both:

subsection 99ACB(3B) applies to the brand of the pharmaceutical item that has the drug; and

the tenth anniversary of the drug in the pharmaceutical item being on F1 has not occurred.

This section does not apply to the drug if:

the drug is in a combination item; and

there are no brands of combination items that:

have the drug; and

are bioequivalent or biosimilar; and

are listed brands of the combination items on any day in the relevant period.

In this section:

the day before the day the determination under subsection (1) comes into force; and

the day the determination under subsection (1) comes into force.