Federal Register of Legislation
Therapeutic Goods (Standard for Export Only Medicines) (TGO 114) Order 2024
I, Nicholas Henderson, as delegate of the Minister for Health and Aged Care, make the following order.
Dated 25 September 2024
Nicholas Henderson First Assistant Secretary Medicines Regulation Division Health Products Regulation Group Department of Health and Aged Care
Contents 1 Name 2 Commencement 3 Authority 4 Definitions 5 Standard 6 Application 7 Requirements 8 Repeals Schedule 1—Repeals Therapeutic Goods Order No. 70C – Standards for Export Only Medicine
1 Name (1) This instrument is the Therapeutic Goods (Standard for Export Only Medicines) (TGO 114) Order 2024. (2) This instrument may also be cited as TGO 114.
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 30 September 2024. 30 September 2024
Note: This table relates only to the provisions of this instrument as originally made.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.
3 Authority This instrument is made under section 10 of the Therapeutic Goods Act 1989.
4 Definitions Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following: (a) British Pharmacopoeia; (b) European Pharmacopoeia; (c) export only medicine; (d) standard; (e) United States Pharmacopoeia-National Formulary. In this instrument: Act means the Therapeutic Goods Act 1989. Japanese Pharmacopoeia means the English edition of the publication of that name, published by the Japanese Pharmaceuticals and Medical Devices Agency or any replacement body, as in force or existing from time to time.
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