Document ID: chunk:federal_register_of_legislation:C2024C00632:section:3:p9
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 3 (pt 9/14)
Character Range: 41711–44649

goods and any advertising or other informational material associated with the goods.
primary pack, in relation to therapeutic goods, means the complete pack in which the goods, or the goods and their container, are to be supplied to consumers.
product information, in relation to therapeutic goods, means information relating to the safe and effective use of the goods, including information regarding the usefulness and limitations of the goods.
protected information, in relation to therapeutic goods, has the meaning given by section 25A.
quality, in relation to therapeutic goods, includes the composition, strength, potency, stability, sterility, purity, bioburden, design, construction and performance characteristics of the goods.
refurbishment has the meaning given by the regulations.
Register means the Australian Register of Therapeutic Goods maintained under section 9A.
registered goods means:
 (a) therapeutic goods included in the part of the Register for goods known as registered goods; or
 (b) therapeutic goods included in the part of the Register for goods known as provisionally registered goods.
Note: Subsection (8) provides that a reference in this Act to therapeutic goods that are registered, or to the registration of therapeutic goods, includes a reference to a medicine that is provisionally registered under section 29.
registration number, in relation to registered goods, means any combination of numbers, symbols and letters assigned to the goods under section 27.
related body corporate has the same meaning as in the Corporations Act 2001.
reportable medicine has the meaning given by section 30EH.
restricted information has the meaning given by section 26AF.
restricted medicine means:
 (a) a medicine specified in an instrument under subsection (2A); or
 (b) a medicine included in a class of medicine specified in an instrument under subsection (2B).
scheduling has the meaning given by section 52A.
Secretary means the Secretary of the Department.
shortage of a medicine in Australia has the meaning given by section 30EI.
sponsor, in relation to therapeutic goods, means:
 (a) a person who exports, or arranges the exportation of, the goods from Australia; or
 (b) a person who imports, or arranges the importation of, the goods into Australia; or
 (c) a person who, in Australia, manufactures the goods, or arranges for another person to manufacture the goods, for supply (whether in Australia or elsewhere);
but does not include a person who:
 (d) exports, imports or manufactures the goods; or
 (e) arranges the exportation, importation or manufacture of the goods;
on behalf of another person who, at the time of the exportation, importation, manufacture 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