Commonwealth Consolidated Acts

NATIONAL HEALTH ACT 1953 - SECT 84AH

    The Minister may, by legislative instrument, determine that a pharmaceutical item (the relevant item ) is an exempt item if:

  (a)   there is only one listed brand of the relevant item; and

  (b)   there are no listed brands of other pharmaceutical items that are bioequivalent or biosimilar to the listed brand of the relevant item; and

  (c)   the relevant item and at least one listed brand of another pharmaceutical item have the same drug; and

  (d)   the Minister is satisfied, having regard to advice (if any) given to the Minister by the Pharmaceutical Benefits Advisory Committee (whether before or after the commencement of this section), that:

  (i)   the listed drug in the relevant item represents suitable therapy for a particular patient population; and

  (ii)   the relevant item is suitable for use by a particular subgroup of that population because of either or both of the form and manner of administration of the drug in the item; and

  (iii)   no other pharmaceutical item that has that drug is suitable for use by that subgroup because of either or both of the form and manner of administration of the drug in that other item.