Document ID: chunk:federal_register_of_legislation:F2021L00333:reg:4
Version: federal_register_of_legislation:F2021L00333
Segment Type: reg
Provision Reference: reg 4
Character Range: 1746–4465

4  Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) batch;
(b) container;
(c) export only medicine;
(d) label;
(e) medicine;
(f) primary pack;
(g) product information;
(h) standard.
  In this instrument:
Act means the Therapeutic Goods Act 1989.
Barcode Specifications means the document titled Barcode specifications for blood and blood products funded under the National Blood Arrangements published by the National Blood Authority (5 September 2014), as in force or existing at the commencement of this instrument.
Note: This document is available on the internet at www.blood.gov.au.
data matrix code means a two-dimensional arrangement of data consisting of blocks or dots in a square or rectangular pattern but does not include a QR code.
GS1 means the not-for-profit standards organisation known as GS1 that has its headquarters in Belgium.
GS1 General Specifications means the standard titled GS1 General Specifications published by GS1, as in force from time to time.
Note: This standard is available on the internet at www.gs1.org.
GTIN, or Global Trade Item Number, means the GS1 identification key used to identify trade items as defined in the GS1 General Specifications.
Note: A GTIN comprises a GS1 company prefix, an item reference and check digit.
national blood arrangements has the same meaning as in the National Blood Authority Act 2003.
Regulations means the Therapeutic Goods Regulations 1990.
relevant level of packaging, in relation to a medicine, means one of the following:
 (a) the primary pack;
 (b) the container;
 (c) single unit packaging within a container.
Note 1: Primary pack is defined in subsection 3(1) of the Act as meaning the complete pack in which the goods, or the goods and their container, are to be supplied to consumers.
Note 2: Container is defined in subsection 3(1) of the Act as meaning the vessel, bottle, tube, ampoule, syringe, vial, sachet, strip pack, blister pack, wrapper, cover or other similar article that immediately covers the goods, but does not include an article intended for ingestion.
Note 3 Single unit packaging within a container includes an individual segment of a strip or blister pack, which immediately covers a single dosage unit, and which can be readily detached.
serialisation, in relation to a medicine, means the unique identification of each unit of the medicine in a batch, at a relevant level of packaging.
Note: Other grammatical forms of the word serialisation (such as serialised) have a corresponding meaning (see section 18A of the Acts Interpretation Act 1901).
serial number means a number that uniquely identifies a unit of a medicine.