Document ID: chunk:federal_register_of_legislation:C2004A01293:clause:1_100aa
Version: federal_register_of_legislation:C2004A01293
Segment Type: clause
Provision Reference: sch 1 cl 100AA
Character Range: 11695–14040

100AA  Special pharmaceutical products

Special pharmaceutical products

 (1) A special pharmaceutical product is a drug or medicinal preparation:
 (a) declared to be a drug or medicinal preparation to which this section applies; or
 (b) composed of:
 (i) one or more of the drugs or medicinal preparations covered by paragraph (a); and
 (ii) one or more additives declared to be additives to which this section applies; or
 (c) declared under subsection 85(2).

 (2) The Minister may declare in writing:
 (a) that a drug or medicinal preparation is a drug or medicinal preparation to which this section applies; or
 (b) that an additive to a drug or medicinal preparation covered by paragraph (a) is an additive to which this section applies.

Note: For declaration by class, see subsection 46(2) of the Acts Interpretation Act 1901.

 (3) The Minister may vary or revoke a declaration under subsection (2) by written instrument.

Note: This subsection expresses a contrary intention for the purposes of subsection 33(3) of the Acts Interpretation Act 1901.

Role of the Pharmaceutical Benefits Advisory Committee

 (4) The Minister must not:
 (a) make a declaration under subsection (2); or
 (b) make a written instrument varying a declaration made under subsection (2) so that the declaration covers an additional drug or medicinal preparation or additive;
unless the Pharmaceutical Benefits Advisory Committee (the Committee) has recommended that the Minister do so.

 (5) The Minister must obtain the written advice of the Committee before making a written instrument:
 (a) revoking a declaration made under subsection (2); or
 (b) varying a declaration made under subsection (2) so that the declaration no longer covers a drug or medicinal preparation or additive.

Parliamentary scrutiny

 (6) Each of the following is a disallowable instrument for the purposes of section 46A of the Acts Interpretation Act 1901:
 (a) a declaration made under subsection (2);
 (b) a written instrument made under subsection (3).

 (7) The Minister must cause a copy of an advice described in subsection (5) to be presented to each House of the Parliament:
 (a) with the corresponding instrument described in that subsection; and
 (b) when that instrument is presented to that House in accordance with section 46A of the Acts Interpretation Act 1901.