Document ID: chunk:federal_register_of_legislation:C2009A00038:clause:4_6
Version: federal_register_of_legislation:C2009A00038
Segment Type: clause
Provision Reference: sch 4 cl 6
Character Range: 37803–39235

6  Subsection 3(1) (definition of standard)
Repeal the definition, substitute:
standard, in relation to therapeutic goods, means any of the following:
 (a) a standard that is constituted by the matters specified in an order under section 10 that is applicable to the goods;
 (b) if the goods are the subject of one or more monographs (other than a monograph exempt under subsection 3C(1)) in the British Pharmacopoeia—a standard that is constituted by the statements (other than statements exempt under subsection 3C(2)) in those monographs, as interpreted in accordance with the General Notices section of the British Pharmacopoeia;
 (c) if the goods are the subject of one or more monographs (other than a monograph exempt under subsection 3C(1)) in the European Pharmacopoeia—a standard that is constituted by the statements (other than statements exempt under subsection 3C(2)) in those monographs, as interpreted in accordance with the General Notices section of the European Pharmacopoeia;
 (d) if the goods are the subject of one or more monographs (other than a monograph exempt under subsection 3C(1)) in the United States Pharmacopeia‑National Formulary—a standard that is constituted by the statements (other than statements exempt under subsection 3C(2)) in those monographs, as interpreted in accordance with the General Notices section of the United States Pharmacopeia‑National Formulary.
Note: See also section 13.