Therapeutic Goods (Medicines Advisory Statements) Specification 2019
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5 Interpretation
(1) Unless the contrary intention appears, a reference to a substance in this instrument includes:
(a) that substance as prepared from natural sources or artificially; and
(b) where the substance is a plant (other than a plant referred to in Schedules 8 or 9 of the SUSMP), that plant or any part of that plant when packed or prepared for therapeutic use; and
(c) every salt, active principle or derivative of the substance, including esters and ethers and every salt of such an active principle or derivative; and
(d) every alkaloid of the substance and every salt of such an alkaloid; and
(e) except where the stereoisomer is defined in the substance name (e.g. dextromethorphan), every stereoisomer of the substance and every salt of such a stereoisomer; and
(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 SUSMP; or
(h) a substance included in Appendix G of the SUSMP at a concentration not exceeding the concentration specified in column 2 of that Appendix in respect of the substance; or
(i) any other substance included in Schedules 1 to 6 to the SUSMP, 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 SUSMP.
(2) Unless the contrary intention appears, where a concentration, strength or quantity is specified in this instrument in respect 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 that is listed in this instrument; and
(b) the expression “one per cent” 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; and
(c) in the case of codeine, such concentration, strength or quantity is calculated as anhydrous codeine.
(3) In Schedule 1, the following symbols in column 3 have the following meanings:
| Symbol | Meaning |
|---|---|
| [c] | Statement(s) must be included at the beginning of the directions for use on the label. |