National Health Act 1953

A brand of a pharmaceutical item is a guaranteed brand of a guaranteed item for the purposes of this Division (other than section 99AED) if subsection (2) applies to the brand of the pharmaceutical item.

This subsection applies to a brand (the guaranteed brand) of a pharmaceutical item (the guaranteed item) if:

a determination under subsection 85(6) comes into force in relation to the guaranteed brand of the guaranteed item on a day (the determination day); and

on the day before the determination day, the guaranteed brand was not a listed brand of the guaranteed item; and

on the determination day, or on the day before that day:

a brand (the existing brand) of a pharmaceutical item (the existing item) is a listed brand of the existing item; and

the guaranteed brand of the guaranteed item is bioequivalent or biosimilar to the existing brand of the existing item; and

the guaranteed item and the existing item have the same drug and manner of administration.

For the purposes of paragraph (c), the guaranteed brand and the existing brand may be the same brand, or the guaranteed item and the existing item may be the same pharmaceutical item.

The guaranteed period for the guaranteed brand of the guaranteed item is the period that commences on the determination day and ends on the earliest of the following days:

the last day of the 24 month period beginning on the determination day;

if, after the determination day:

a determination under subsection 85(6) comes into force on a day (the later determination day) in relation to a brand (the later brand) of a pharmaceutical item (the later item); and

the later brand of the later item is bioequivalent or biosimilar to the guaranteed brand of the guaranteed item; and

on the day before the later determination day, the later brand was not a listed brand of the later item;

if, after the determination day, subsection 99AED(2) applies to:

a brand of the guaranteed item; or

a brand of a pharmaceutical item that is bioequivalent or biosimilar to the guaranteed brand of the guaranteed item;

the day that is the first whole day on which the guaranteed brand is not a listed brand of the guaranteed item.

For the purposes of paragraph (b), the later brand and the guaranteed brand may be the same brand, or the later item and the guaranteed item may be the same item.

For the purposes of paragraph (c), the brand mentioned in that paragraph and the guaranteed brand may be the same brand, or the pharmaceutical item mentioned in that paragraph and the guaranteed item may be the same pharmaceutical item.