This instrument is the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Estradiol Valerate) Instrument 2021.

(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	The day after this instrument is registered.

Note: This table relates only to the provisions of this instrument as originally made.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;

In this instrument:

Act means the Therapeutic Goods Act 1989.

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.

scarce medicine has the meaning given by section 5.

substitutable medicine has the meaning given by section 6.

5 Declaration of serious scarcity

For paragraph 30EK(1)(a) of the Act, a serious scarcity of the medicine specified in column 2 of each item in the table in Schedule 1 (the scarce medicine) across the whole of Australia is declared.

6 Substitution of scarce medicine by pharmacists

For paragraph 30EK(1)(b) of the Act, in relation to each item mentioned in the table in Schedule 1, the medicine specified in column 3 (the substitutable medicine) is permitted to be dispensed by a pharmacist in substitution for the scarce medicine specified in column 2, in the circumstances specified in:

(a) column 5 of that item (the specific permitted circumstances); and

(b) the table in Schedule 2 (the general permitted circumstances).

Note: Substitution is only permitted where both the specific permitted circumstances and the general permitted circumstances exist.

7 Period instrument in force

This instrument remains in force until 1 May 2022.

Schedule 1—Scarce medicine, substitutable medicine, dose unit equivalence and specific permitted circumstances

Note: See sections 5 and 6.

Scarce medicine, substitutable medicine, dose unit equivalence and specific permitted circumstances
Column 1	Column 2	Column 3	Column 4	Column 5
Item	Scarce medicine	Substitutable medicine	Dose unit equivalence	Specific permitted circumstances
1	PROGYNOVA estradiol valerate 1 milligram tablet, registration number 10708	ESTROFEM estradiol (as hemihydrate) 1 milligram tablet, registration number 188520	one tablet of substitutable medicine is equivalent to one tablet of scarce medicine	the pharmacist has advised the patient, or person acting on behalf of the patient, of the number of dose units of substitutable medicine that must be taken by the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified in column 4
2	PROGYNOVA estradiol valerate 1 milligram tablet, registration number 10708	ZUMENON estradiol (as hemihydrate) 2 milligram tablet, registration number 75888	one-half of a tablet of substitutable medicine is equivalent to one tablet of scarce medicine	the pharmacist has advised the patient, or person acting on behalf of the patient, of: (a) the number of dose units of substitutable medicine that must be taken by the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified in column 4; and (b) where cutting of the tablet is required to obtain the correct dose of the substitutable medicine—the instructions for cutting the tablet
3	PROGYNOVA estradiol valerate 2 milligram tablet, registration number 323720	ESTROFEM estradiol (as hemihydrate) 2 milligram tablet, registration number 188521	one tablet of substitutable medicine is equivalent to one tablet of scarce medicine	the pharmacist has advised the patient, or person acting on behalf of the patient, of the number of dose units of substitutable medicine that must be taken by the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified in column 4
4	PROGYNOVA estradiol valerate 2 milligram tablet, registration number 323720	ZUMENON estradiol (as hemihydrate) 2 milligram tablet, registration number 75888	one tablet of substitutable medicine is equivalent to one table of scarce medicine	the pharmacist has advised the patient, or person acting on behalf of the patient, of the number of dose units of substitutable medicine that must be taken by the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified in column 4

Schedule 2—General permitted circumstances

Note: See section 6.

General permitted circumstances
Column 1	Column 2
Item	Circumstances
1	the patient, or person acting on behalf of the patient, has evidence of a valid prescription for the scarce medicine, unless otherwise permitted by law
2	the pharmacist does not have access to the scarce medicine
3	the prescriber has not indicated on the prescription for the scarce medicine that substitution is not permitted
4	the pharmacist has exercised professional judgement and determined that the patient is suitable to receive the substitutable medicine
5	the amount of substitutable medicine dispensed would result in the patient receiving sufficient medicine to ensure an equivalent dosage regimen and duration to that prescribed in relation to the scarce medicine
6	the patient, or person acting on behalf of the patient, has consented to receiving the substitutable medicine
7	the pharmacist makes a record of dispensing the substitutable medicine in substitution of the scarce medicine at the time of dispensing
8	the pharmacist has an established procedure to notify the prescriber of the substitution at the time of, or as soon as practical after, dispensing the substitutable medicine