Document ID: chunk:federal_register_of_legislation:F2024L01036:clause:2_4:p2
Version: federal_register_of_legislation:F2024L01036
Segment Type: clause
Provision Reference: sch 2 cl 4 (pt 2/2)
Character Range: 4505–5488

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.
MDMA hydrochloride means the substance 3,4-methylenedioxy-N-methylamphetamine hydrochloride with the chemical formula C11H15NO2, HCl.
MDMA hydrochloride product means a therapeutic good that:
 (a) contains MDMA hydrochloride as the active ingredient; and
 (b) is manufactured in a dosage form for human therapeutic use.
Ph Eur means the European Pharmacopoeia.
quantity of the MDMA hydrochloride product means the stated number of units in the container.
Regulations means the Therapeutic Goods Regulations 1990.
stated content means the quantity of each substance that is stated on the label to be present in a MDMA hydrochloride product.

   USP means the United States Pharmacopeia-National Formulary.