Document ID: chunk:federal_register_of_legislation:C2024C00632:section:3:p10
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 3 (pt 10/14)
Character Range: 44411–47187

or arrangements, is a resident of, or is carrying on business in, Australia.
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 relation to the goods) in the British Pharmacopoeia—a standard that is constituted by the statements (other than statements exempt under subsection 3C(2) in relation to the goods) 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 relation to the goods) in the European Pharmacopoeia—a standard that is constituted by the statements (other than statements exempt under subsection 3C(2) in relation to the goods) 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 relation to the goods) in the United States Pharmacopeia‑National Formulary—a standard that is constituted by the statements (other than statements exempt under subsection 3C(2) in relation to the goods) in those monographs, as interpreted in accordance with the General Notices section of the United States Pharmacopeia‑National Formulary;
 (e) a homoeopathic standard;
 (f) an anthroposophic standard.
Note: See also section 13.
State includes the Australian Capital Territory and the Northern Territory.
State law means a law of a State, of the Australian Capital Territory or of the Northern Territory.
supply includes:
 (a) supply by way of sale, exchange, gift, lease, loan, hire or hire‑purchase; and
 (b) supply, whether free of charge or otherwise, by way of sample or advertisement; and
 (c) supply, whether free of charge or otherwise, in the course of testing the safety or efficacy of therapeutic goods or vaping goods in persons; and
 (d) supply by way of administration to, or application in the treatment of, a person.
system or procedure pack has the meaning given by section 41BF.
tamper: therapeutic goods are tampered with if:
 (a) they are interfered with in a way that affects, or could affect, the quality, safety or efficacy of the goods; and
 (b) the interference has the potential to cause, or is done for the purpose of causing, injury or harm to any person.
therapeutic goods means goods:
 (a) that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely