Document ID: chunk:federal_register_of_legislation:F2020C01070:clause:3_4:p1
Version: federal_register_of_legislation:F2020C01070
Segment Type: clause
Provision Reference: sch 3 cl 4 (pt 1/3)
Character Range: 5455–8539

4  Interpretation
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
               (a)      British Pharmacopoeia;
               (b)      default standard;
               (c)      European Pharmacopoeia;
               (d) export only medicine;
(e) label;
(f) listed goods;
(g) medicine;
(h) registered goods;
(i) standard;
(j) United States Pharmacopeia-National Formulary.
 (1) In this instrument:
Act means the Therapeutic Goods Act 1989.
active ingredient has the same meaning as in the Regulations.
applicable monograph, in relation to therapeutic goods, means a default standard specified with reference to:
 (a) a formulated preparation in the British Pharmacopoeia;
 (b) a pharmaceutical preparation in the European Pharmacopoeia; or
 (c) an official product in the United States Pharmacopeia-National Formulary;
whether or not those goods are labelled as conforming to that standard, and comprises:
 (d) a specific monograph;
 (e) one or more applicable general monographs; and
 (f) one or more applicable general chapters;
interpreted in accordance with the General Notices section of the relevant pharmacopoeia.
Note 1:  Subsection 3(1) of the Act provides that the default standard must be interpreted in accordance with the General Notices section of the relevant pharmacopoeia.
Note 2: Subsection 13(7) of the Act specifies how to work out whether therapeutic goods conform with a default standard at a particular time.
Australian specific requirements has the meaning given by section 8.
capsule means a solid preparation with a hard or soft shell of various shapes and capacities, containing one or more active ingredients.
chewable, in relation to a tablet, means a tablet which has been formulated to be chewed rather than swallowed whole and for which the label includes a direction to chew the tablet.
dispersible, in relation to a tablet, means an uncoated or film-coated tablet intended to be dispersed in water before administration, giving a homogeneous dispersion.
effervescent, in relation to a tablet, means an uncoated tablet generally containing acid substances and carbonates or hydrogen carbonates which react rapidly in the presence of water to release carbon dioxide, and that is intended to be dissolved or dispersed in water before administration.
enzyme means a protein that acts as a catalyst for biochemical reactions.
homoeopathic preparation has the same meaning as in the Regulations.
ICH Q3D Guideline means ICH Harmonised Guideline: Guideline for Elemental Impurities Q3D, Current Step 4 version, dated 16 December 2014.
Note: The ICH Q3D Guideline is published by the International Council of Harmonisation at: https://www.ich.org.
mineral means an inorganic material of defined composition.
mineral compound means a salt or other compound of one or more elements that has a Recommended Dietary Intake for that element in the publication Nutrient Reference Values for Australia and New Zealand Including Recommended Dietary Intakes endorsed by the National Health and