Document ID: chunk:federal_register_of_legislation:C2025C00090:section:85:p2
Version: federal_register_of_legislation:C2025C00090
Segment Type: section
Provision Reference: s 85 (pt 2/3)
Character Range: 132701–135568

then the Minister must, by legislative instrument, declare that the drug can only be supplied under that provision or those provisions.
Note: If the Minister makes a declaration in relation to a drug or medicinal preparation under this subsection, the Minister cannot vary or revoke that declaration without first satisfying the conditions set out in subsection 101(4AACC).

Drugs etc. that can only be supplied under special arrangements
 (2A) If:
 (a) the Minister makes a declaration under subsection (2) in relation to a drug or medicinal preparation (the drug); and
 (b) the Pharmaceutical Benefits Advisory Committee has recommended under subsection 101(4AAD) that the drug be made available only under special arrangements under section 100;
then the Minister must, by legislative instrument, declare that the drug can only be supplied under such special arrangements.
Note: If the Minister makes a declaration in relation to a drug or medicinal preparation under this subsection, the Minister cannot vary or revoke that declaration without first satisfying the conditions set out in subsection 101(4AAF).

Forms
 (3) The Minister may, by legislative instrument, determine, by reference to strength, type of unit, size of unit or otherwise, the form or forms of a listed drug.
 (4) A form of a listed drug as determined by the Minister under subsection (3) may be such as to require the addition of a substance or substances to the drug so that it will be suitable for administration in a particular manner or at a particular strength.

Manners of administration
 (5) The Minister may, by legislative instrument, determine the manner of administration of a form of a listed drug, being a form of the drug in relation to which a determination under subsection (3) is in force.

Brands
 (6) The Minister may, by legislative instrument, determine a brand of a pharmaceutical item.

Schedule equivalents
 (6A) If the Minister determines a brand of a pharmaceutical item under subsection (6), the Minister may, by legislative instrument, determine that, for the purposes of paragraph 103(2A)(b), the brand is to be treated as equivalent to one or more other brands of pharmaceutical items.
 (6B) In deciding whether the brand of pharmaceutical item is to be treated as equivalent to one or more other brands of pharmaceutical items, the Minister must have regard to any advice given by the Pharmaceutical Benefits Advisory Committee.
 (6C) If, on 1 November 2015, the Schedule of Pharmaceutical Benefits specifies that a brand of a pharmaceutical item is equivalent to one or more other brands of pharmaceutical items, the specification is taken to have been made following a determination to that effect under subsection (6A).

Prescriptions of pharmaceutical benefits in certain circumstances
 (7) The Minister may, by legislative instrument, determine:
 (a) that