Therapeutic Goods (Standard for MDMA) (TGO 112) Order 2024 (Cth)

Therapeutic Goods (Standard for MDMA) (TGO 112) Order 2024

I, Tracey Duffy, as delegate of the Minister for Health and Aged Care, make the following Order.

Dated 19 August 2024

Tracey Duffy First Assistant Secretary Medical Devices and Product Quality Division Health Products Regulation Group Department of Health and Aged Care

Contents Part 1Preliminary 1 Name 2 Commencement 3 Authority 4 Definitions USP means the United States Pharmacopeia-National Formulary.5 Standard 6 Application Part 2Requirements for MDMA hydrochloride 7 Application of this Part 8 Assay limits 9 Tests Part 3Requirements for MDMA hydrochloride products 10 Application of this Part 11 General 12 Assay limits 13 Tests 14 Information to be included on the label Schedule 1—Specified tests for MDMA hydrochloride Schedule 2—Specified tests for MDMA hydrochloride products

Part 1Preliminary

1 Name (1) This instrument is the Therapeutic Goods (Standard for MDMA) (TGO 112) Order 2024. (2) This instrument may also be cited as TGO 112.

2 Commencement (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information Column 1 Column 2 Column 3 Provisions Commencement Date/Details 1. The whole of this instrument 6 January 2025. 6 January 2025

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument. (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.