CTHIn ForceAct
National Health Act 1953
99AEJMinister may determine drug is on F1 if guaranteed brand delisted
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#### 99AEJ Minister may determine drug is on F1 if guaranteed brand delisted
The Minister may, by legislative instrument, determine that a listed drug is on F1 if:
(a) under section 99AEH, the Minister revokes or varies a determination under subsection 85(6) in relation to a brand (the delisted brand) of a pharmaceutical item (the existing item); and
(b) before the revocation or variation came into force, subsection 99AEC(2) applied to the delisted brand of the existing item; and
(c) after the revocation or variation comes into force, there is only one listed brand of a pharmaceutical item (the remaining item) that is bioequivalent or biosimilar to the delisted brand of the existing item; and
(d) apart from paragraph 85AB(4)(c), the drug in the remaining item satisfies the criteria for F1 referred to in subsection 85AB(4); and
(e) the drug in the remaining item was on F1 on the day before subsection 99AEC(2) began to apply to the delisted brand of the existing item.