Document ID: chunk:federal_register_of_legislation:C2024C00632:section:3:p2
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 3 (pt 2/14)
Character Range: 23549–26362

Customs officer exercising powers in a Customs place (within the meaning of section 183UA of the Customs Act 1901).
batch means a quantity of a product that is:
 (a) uniform in composition, method of manufacture and probability of chemical or microbial contamination; and
 (b) made in one cycle of manufacture and, in the case of a product that is sterilised or freeze dried, sterilised or freeze dried in one cycle.
bioburden, in relation to therapeutic goods, means the quantity and characteristics of microorganisms present in the goods or to which the goods may be exposed in a manufacturing environment.
biological has the meaning given by section 32A.
biological number of a biological means:
 (a) the number assigned to the biological under subsection 32DB(2), 32DCB(2), 32DF(2) or 32DN(5); or
 (b) if, in accordance with regulations made for the purposes of paragraph 9A(4)(ca), a different number is assigned to the biological—that different number.
British Pharmacopoeia means the edition of the publication of that name, including any additions or amendments, that was in effect for the purposes of this Act immediately before the commencement of Schedule 4 to the Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2009 and, if additions or amendments of that publication are made after that commencement, or new editions of that publication are published after that commencement, includes those additions or amendments, or those new editions, from the effective date published by the British Pharmacopoeia Commission or any replacement body.
certification‑related activities, when used in relation to an Australian conformity assessment body, means activities that consist of, or relate to, the issue of certificates as mentioned in section 41FIA.
civil penalty provision has the meaning given by section 42YA.
Class 1 biological means a biological, other than an export only biological, included in a class of biologicals that is:
 (a) a class prescribed by the regulations for the purposes of section 32AA; and
 (b) a class referred to in those regulations as Class 1 biologicals.
commercial quantity of a kind of vaping goods means the quantity of that kind of vaping goods prescribed by the regulations.
Commonwealth authority includes:
 (a) a body corporate, or an unincorporated body, established for a public purpose by or under an Act; and
 (b) a tribunal or authority established by or in accordance with an Act.
Commonwealth officer includes:
 (a) a Minister; and
 (b) a person holding:
 (i) an office established by or under an Act; or
 (ii) an appointment made under an Act; or
 (iii) an appointment made by the Governor‑General or a Minister but not under an Act; and
 (c) a person who is a member or officer of a Commonwealth authority; and
 (d) a person who is in the