Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Estradiol) Instrument 2024 (Cth)

Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Estradiol) Instrument 2024

I, Andrew Simpson, as delegate of the Minister for Health and Aged Care, make the following instrument.

Dated 13 November 2024

Andrew Simpson Acting 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 Declaration of serious scarcity 6 Substitution of scarce medicine by pharmacists 7 Period instrument in force 8 Repeals Schedule 1—Scarce medicine, substitutable medicine, dose unit equivalence and specific permitted circumstances Schedule 2—General permitted circumstances

1 Name This instrument is the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Estradiol) Instrument 2024.

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 19 November 2024. 19 November 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Note: This table relates only to the provisions of this instrument as originally made.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 30EK 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) medicine; (b) Register; (c) registered goods; (b) registration number. In this instrument: Act means the Therapeutic Goods Act 1989. generic product has the same meaning as in the Therapeutic Goods Regulations 1990. patch means transdermal drug delivery system. pharmacist has the same meaning as in subsection 30EK(6) of the Act. prescriber means the person who: (a) is authorised under a law of a State or Territory to prescribe medicine, and (b) prescribed the scarce medicine for the patient. registered medicine means a medicine that is included in the part of the Register for goods known as registered goods. scarce medicine has the meaning given by section 5. substitutable medicine has the meaning given by section 6.