Therapeutic Goods (Medicines Advisory Statements) Specification 2021
5Interpretation
Start here
Get a plain-English read of 5
Turn the raw legal text into a practical explanation grounded in Therapeutic Goods (Medicines Advisory Statements) Specification 2021.
5 Interpretation
References to substances
(1) In this instrument, unless the contrary intention appears, a reference to a substance includes the following:
(a) that substance prepared from natural sources or artificially;
(b) if the substance is a plant (other than a plant included in Schedule 8 or 9 to the current Poisons Standard)—that plant or any part of that plant when packed or prepared for therapeutic use;
(c) every salt, active principle or derivative of the substance, including esters and ethers, and every salt of such an active principle or derivative;
(d) every alkaloid of the substance and every salt of such an alkaloid;
(e) every stereoisomer of the substance and every salt of such a stereoisomer, other than where the stereoisomer is defined in the substance name (for example, dextromethorphan);
(f) a preparation or admixture containing any proportion of the substance;
but does not include:
(g) a preparation or product included in Appendix A of the current Poisons Standard; or
(h) a substance included in Appendix G of the current Poisons Standard at a concentration not exceeding the concentration specified in that Appendix in relation to the substance; or
(i) any other substance included in Schedules 1 to 6 to the current Poisons Standard, at a concentration not exceeding 10 mg per litre or 10 mg per kilogram, unless that substance is also included in Schedule 7 or 8 to the current Poisons Standard.
References to concentration, strength or quantity of substances
(2) In this instrument, unless the contrary intention appears, for a reference to a concentration, strength or quantity of a substance:
(a) if the substance is present as a salt, active principle or derivative (including an ester or ether), the concentration, strength or quantity is calculated as the equivalent amount of the substance; and
(b) the expression “1%” means:
(i) in the case of a liquid preparation, 1 gram of the substance per 100 mL of the preparation; or
(ii) in the case of a solid or semi-solid preparation, 1 gram of the substance per 100 grams of the preparation; and
(iii) any expression of greater or lesser percentages shall have a corresponding meaning.
References to symbols
(3) A reference in column 4 of the table in Schedule 1, to a symbol in column 2 of an item in the following table, has the meaning set out in column 3 of that item.
- Meaning of symbols
- Column 1 Column 2 Column 3
- Item Symbol Meaning