Document ID: chunk:federal_register_of_legislation:F2024L01037:clause:4_4:p1
Version: federal_register_of_legislation:F2024L01037
Segment Type: clause
Provision Reference: sch 4 cl 4 (pt 1/2)
Character Range: 2515–5322

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) European Pharmacopoeia;
(d) label;
(e) manufacture;
(f) Secretary;
(g) sponsor;
(h) standard;
(i) therapeutic goods;
(j) United States Pharmacopeia-National Formulary.
  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 synthetic psilocybine, plant derived psilocybine or a psilocybine product 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 which 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 (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.
capsule has the same meaning as in the Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019.
Note: The Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019 is a legislative instrument published on the Federal Register of Legislation at www.legislation.gov.au.
contact details of the sponsor means information to enable a person to contact the sponsor that:
 (a) includes an address that is:
 (i) the sponsor's physical address in Australia; and
 (ii) not a post office, cable, telegraphic or code address; and
 (b) may also include a telephone number, website or email address.
expiry date has the same meaning as in the Regulations.
expiry date prefix means the prefix which precedes the expiry date, and consists of any words or symbols that clearly indicate that the information following those words or symbols is the expiry date (other than words indicating that the goods may be used after that date, including 'Best by' and 'Best before').
Note: Common forms of the expiry date prefix include (either in capital letters, lower case letters, or a combination of capital and lower case letters):
(a) Expiry date;
(b) Expiry;
(c) Expires;
(d) Exp. Date;
(e) Exp;
(f) Use by;
(g) Use before.
ICH Q3D guideline document means the ICH Harmonised Guideline: Guideline for Elemental Impurities Q3D, as in force from time to time.
Note: The ICH Q3D Guideline is published by the International Council of Harmonisation at www.ich.org.
manufacturing licence has the same meaning as in