Document ID: chunk:federal_register_of_legislation:C2024C00632:section:3:p6
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 3 (pt 6/14)
Character Range: 34108–36806

by subsection 3AA(2).
included in the Register:
 (a) in relation to a biological—means included in the Register under Part 3‑2A; and
 (b) in relation to a medical device to which Chapter 4 applies—means included in the Register under Chapter 4.
indications, in relation to therapeutic goods, means the specific therapeutic uses of the goods.
international instrument means:
 (a) any treaty, convention, protocol, agreement or other instrument that is binding in international law; and
 (b) a part of such a treaty, convention, protocol, agreement or other instrument.
issuing officer means:
 (a) a magistrate; or
 (b) a registrar or other officer of a court of a State or Territory who is authorised under a law of the State or Territory to issue search warrants.
kind, in relation to a medical device, has the meaning given by section 41BE.
label, in relation to therapeutic goods, means a display of printed information:
 (a) on or attached to the goods; or
 (b) on or attached to a container or primary pack in which the goods are supplied; or
 (c) supplied with such a container or pack.
licence means a licence under Part 3‑3.
listable goods means therapeutic goods that are required under the regulations to be included in the part of the Register relating to listed goods.
listed goods means therapeutic goods that are included in the Part of the Register for goods known as listed goods.
listing number, in relation to listed goods, means any combination of numbers, symbols and letters assigned to the goods under section 27.
major interest holder of a body corporate means a person who:
 (a) is in a position to cast, or control the casting of, more than one‑fifth of the maximum number of votes that might be cast at a general meeting of the body corporate; or
 (b) holds more than one‑fifth of the issued share capital of the body corporate (excluding any part of that issued share capital that carries no right to participate beyond a specified amount in a distribution of either profits or capital).
manufacture, in relation to therapeutic goods, or vaping goods, that are not medical devices, means:
 (a) to produce the goods; or
 (b) to engage in any part of the process of producing the goods or of bringing the goods to their final state, including engaging in the processing, assembling, packaging, labelling, storage, sterilising, testing or releasing for supply of the goods or of any component or ingredient of the goods as part of that process.
manufacturer, of a medical device, has the meaning given by section 41BG.
manufacturing principles means the principles for the time being having effect under section 36.
manufacturing site means premises:
 (a) that are for use in