1

each of the following:

(a) ESTRADERM MX 25 estradiol 25 microgram/24 hours transdermal drug delivery system sachet, registration number 67089;

(b) ESTRADOT 25 estradiol 25 microgram transdermal drug delivery system sachet, registration number 338056

a registered medicine, or a medicine subject to an approval under section 19A of the Act, that:

(a) contains estradiol as the only active ingredient; and

(b) is manufactured in the dosage form of a patch; and

(c) releases 25 micrograms of estradiol per day

one patch of the scarce medicine is equivalent to one patch of the substitutable 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 administered to the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified in column 4; and

(b) suitable instructions for administering the substitutable medicine

2

each of the following:

(a) ESTRADERM MX 50 estradiol 50 microgram/24 hours transdermal drug delivery system sachet, registration number 56658;

(b) ESTRADOT 50 estradiol 50 microgram transdermal drug delivery system sachet, registration number 338058

either of the following:

(a) a registered medicine, or a medicine subject to an approval under section 19A of the Act, that:

(i) contains estradiol as the only active ingredient; and

(ii) is manufactured in the dosage form of a patch; and

(iii) releases 50 micrograms of estradiol per day;

(b) a registered medicine, or a medicine subject to an approval under section 19A of the Act, that:

(i) contains estradiol as the only active ingredient; and

(ii) is manufactured in the dosage form of a patch; and

(iii) releases 25 micrograms of estradiol per day

one patch of the scarce medicine is equivalent to:

(a) one patch of the substitutable medicine in paragraph (a) in column 3; or

(b) two patches of the substitutable medicine in paragraph (b) in column 3

all of the following:

(a) when substituting with the substitutable medicine in paragraph (b) in column 3—the pharmacist:

(i) does not have access to the substitutable medicine in paragraph (a) of column 3; and

(ii) dispenses patches that are of the same brand;

(b) the pharmacist has advised the patient, or person acting on behalf of the patient, of:

(i) the number of dose units of substitutable medicine that must be administered to the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified in column 4; and

(ii) suitable instructions for administering the substitutable medicine

3

each of the following:

(a) ESTRADERM MX 75 estradiol 75 microgram/24 hr transdermal drug delivery system sachet, registration number 76117;

(b) ESTRADOT 75 estradiol 75 microgram transdermal drug delivery system, registration number 338059

either of the following:

(a) a registered medicine, or a medicine subject to an approval under section 19A of the Act, that:

(i) contains estradiol as the only active ingredient; and

(ii) is manufactured in the dosage form of a patch; and

(iii) releases 75 micrograms of estradiol per day;

(b) a registered medicine, or a medicine subject to an approval under section 19A of the Act, that:

(i) contains estradiol as the only active ingredient; and

(ii) is manufactured in the dosage form of a patch; and

(iii) releases 37.5 micrograms of estradiol per day

one patch of the scarce medicine is equivalent to:

(a) one patch of the substitutable medicine in paragraph (a) in column 3; or

(b) two patches of the substitutable medicine in paragraph (b) in column 3

all of the following:

(a) when substituting with the substitutable medicine in paragraph (b) of column 3—the pharmacist:

(i) does not have access to the substitutable medicine in paragraph (a) of column 3; and

(ii) dispenses patches that are of the same brand;

(b) the pharmacist has advised the patient, or person acting on behalf of the patient, of:

(i) the number of dose units of substitutable medicine that must be administered to the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified in column 4; and

(ii) suitable instructions for administering the substitutable medicine

4

each of the following:

(a) ESTRADERM MX 100 estradiol 100 microgram/24 hours transdermal drug delivery system sachet, registration number 67090;

(b) ESTRADOT 100 estradiol 100 microgram transdermal drug delivery system, registration number 338060

either of the following:

(a) a registered medicine, or a medicine subject to an approval under section 19A of the Act, that:

(i) contains estradiol as the only active ingredient; and

(ii) is manufactured in the dosage form of a patch; and

(iii) releases 100 micrograms of estradiol per day;

(b) a registered medicine, or a medicine subject to an approval under section 19A of the Act, that:

(i) contains estradiol as the only active ingredient; and

(ii) is manufactured in the dosage form of a patch; and

(iii) releases 50 micrograms of estradiol per day

one patch of the scarce medicine is equivalent to:

(a) one patch of the substitutable medicine in paragraph (a) in column 3; or

(b) two patches of the substitutable medicine in paragraph (b) in column 3

all of the following:

(a) when substituting with the substitutable medicine in paragraph (b) of column 3—the pharmacist:

(i) does not have access to the substitutable medicine in paragraph (a) of column 3; and

(ii) dispenses patches that are of the same brand;

(b) the pharmacist has advised the patient, or person acting on behalf of the patient, of:

(i) the number of dose units of substitutable medicine that must be administered to the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified in column 4; and

(ii) suitable instructions for administering the substitutable medicine

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

ad = added or inserted

orig = original

am = amended

p = page(s)

amdt = amendment

para = paragraph(s)/subparagraph(s)

C[x] = Compilation No. x

/sub‑subparagraph(s)

ch = Chapter(s)

pres = present

cl = clause(s)

prev = previous

cont. = continued

(prev…) = previously

def = definition(s)

pt = Part(s)

Dict = Dictionary

r = regulation(s)/Court rule(s)

disallowed = disallowed by Parliament

reloc = relocated

div = Division(s)

renum = renumbered

exp = expires/expired or ceases/ceased to have

rep = repealed

effect

rs = repealed and substituted

gaz = gazette

s = section(s)/subsection(s)

LA = Legislation Act 2003

/rule(s)/subrule(s)/order(s)/suborder(s)

LIA = Legislative Instruments Act 2003

sch = Schedule(s)

(md not incorp) = misdescribed amendment

SLI = Select Legislative Instrument

cannot be given effect

SR = Statutory Rules

mod = modified/modification

sub ch = Sub‑Chapter(s)

No. = Number(s)

sub div = Subdivision(s)

Ord = Ordinance

sub pt = Subpart(s)

underlining = whole or part not

commenced or to be commenced

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

14 Nov 2024

(F2024L01453)

19 Nov 2024

—

Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Estradiol) Amendment Instrument 2026

22 Jan 2026

(F2026L00040)

31 Jan 2026

—

s 2………………………………….

rep LA s 48D

s 7………………………………….

rs F2026L00040

s 8………………………………….

rs F2026L00040