4Definitions

4 Definitions

Note 1: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

(a) batch;
(b) British Pharmacopoeia;
(c) container;
(d) essential principles;
(e) European Pharmacopoeia;
(f) manufacture;
(g) medicine;
(h) primary pack;
(i) registered goods;
(j) sponsor;
(k) standard;
(l) supply;
(m) therapeutic goods;
(n) United States Pharmacopeia-National Formulary.

Note 2: The definition of container in the Act is as follows:

Note: container, in relation to therapeutic goods, means 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: To avoid doubt, the container of a therapeutic vaping substance or therapeutic vaping substance accessory is the bottle, cartridge, capsule, pod or other vessel that contains the therapeutic vaping substance, and not the blister pack, strip pack or other wrapper in which the container is supplied.

In this instrument:

Act means the Therapeutic Goods Act 1989.

active ingredient has the same meaning as in the Regulations.

batch number means a number, or a combination of letters, numerals, or symbols, which is given by the manufacturer to a batch of relevant goods or therapeutic vaping packs, to uniquely identify that batch.

Note: The batch number may be used to trace the batch through all stages of manufacture and distribution.

batch number prefix means the prefix that precedes the batch number, and consists of any words or symbols that clearly indicate that the information following those words or symbols is the batch number.

Note: Common forms of the batch number prefix include the following (either in capital letters, lower case letters or a combination of capital and lower case letters):

(a) Batch number;
(b) Batch no.;
(c) Batch;
(d) B;
(e) (B);
(f) B/N;
(g) Lot number;
(h) Lot No.;
(i) Lot.

capacity means the volume of the empty container.

contact details, in relation to a sponsor, means information that would enable a person to contact the sponsor and that:

(a) includes the address of the principal place of business of the sponsor in Australia; and
(b) may also include a telephone number, website or email address of the sponsor;
but is not a post office, cable, telegraphic or code address of the sponsor.