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NATIONAL HEALTH ACT 1953 - SECT 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.


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