Document ID: chunk:federal_register_of_legislation:F2024L01037:clause:4_4:p2
Version: federal_register_of_legislation:F2024L01037
Segment Type: clause
Provision Reference: sch 4 cl 4 (pt 2/2)
Character Range: 5064–7688

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 subsection 38(1B) of the Act.
Ph Eur means the European Pharmacopoeia.
plant derived psilocybine means the following substances:
 (a) psilocybine extract;
 (b) psilocybine isolate.
plant derived psilocybine product means a therapeutic good that is:
 (a) a psilocybine extract product; or
 (b) a psilocybine isolate product.
plant material means the dried or fresh fruiting body of the psilocybine mushroom that has not been homogenised.
psilocin means the substance with the chemical formula C12H16N2O.
psilocybine means the substance with the chemical formula C12H17N2O4P.
psilocybine extract means a substance that is extracted from the psilocybine mushroom and that:
 (a) contains psilocybine and psilocin; and
 (b) may contain other components, including tryptamines.
psilocybine extract product means a therapeutic good that:
 (a) contains psilocybine extract as the active ingredient; and
 (b) is manufactured in a dosage form for human therapeutic use.
psilocybine isolate means psilocybine that is isolated from the psilocybine mushroom.
psilocybine isolate product means a therapeutic good that:
 (a) contains psilocybine isolate as the active ingredient; and
 (b) is manufactured in a dosage form for human therapeutic use.
psilocybine mushroom means a mushroom, or part of a mushroom, of the species Psilocybe cubensis, including, but not limited to, the fruiting body or mycelium.
psilocybine product means a therapeutic good that is:
 (a) a psilocybine extract product; or
 (b) a psilocybine isolate product; or
 (c) a synthetic psilocybine product.
quantity of the psilocybine product means the stated number of units in the container.
Regulations means the Therapeutic Goods Regulations 1990.
stated content means the amount or quantity of each substance that is stated on the label to be present in a psilocybine product.
synthetic psilocybine means psilocybine that is produced using precursor ingredients, rather than compounds obtained from the psilocybine mushroom.
synthetic psilocybine product means a therapeutic good that:
 (a) contains synthetic psilocybine as the active ingredient; and
 (b) is manufactured in a dosage form for human therapeutic use.
tryptamines mean the group of monoamine alkaloids, excluding psilocybine and psilocin, derived from the amino acid tryptophan.
USP means the United States Pharmacopeia-National Formulary.