8Repeals

8 Repeals

Unless repealed earlier, this instrument is repealed at the start of 1 March 2027.

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

Note: See sections 5 and 6.

<table cellspacing="0" cellpadding="0" style="width:432.35pt; border-collapse:collapse"><thead><tr style="height:2.85pt"><td colspan="5" style="width:421.55pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p id="navPoint_10" class="ActHead1" style="font-size:10pt"><span>Scarce medicine, substitutable medicine, dose unit equivalence and specific permitted circumstances</span></p></td></tr><tr style="height:2.85pt"><td style="width:42.45pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 1</span></p></td><td style="width:77.6pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p></td><td style="width:88.4pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 3</span></p></td><td style="width:67.1pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span style="font-weight:bold">Column 4</span></p></td><td style="width:102.8pt; border-top:1pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 5</span></p></td></tr><tr style="height:2.85pt"><td style="width:42.45pt; border-top:1pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Item</span></p></td><td style="width:77.6pt; border-top:1pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Scarce medicine</span></p></td><td style="width:88.4pt; border-top:1pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Substitutable medicine</span></p></td><td style="width:67.1pt; border-top:1pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span style="font-weight:bold">Dose unit equivalence</span></p></td><td style="width:102.8pt; border-top:1pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Specific permitted circumstances</span></p></td></tr></thead><tbody><tr style="height:56.7pt"><td style="width:42.45pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:77.6pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>each of the following:</span></p><p class="Tablea"><span>(a)</span><span style="width:3.1pt; text-indent:0pt; display:inline-block"> </span><span>ESTRADERM MX 25 estradiol 25</span><span> </span><span>microgram/24 hours transdermal drug delivery system sachet, registration number 67089;</span></p><p class="Tablea"><span>(b)</span><span style="width:2.54pt; text-indent:0pt; display:inline-block"> </span><span>ESTRADOT 25 estradiol 25</span><span> </span><span>microgram transdermal drug delivery system sachet, registration number 338056</span></p></td><td style="width:88.4pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablei" style="margin-left:1.85pt; text-indent:0pt"><span>a registered medicine, or a medicine subject to an approval under section 19A of the Act, that:</span></p><p class="Tablea"><span>(a)</span><span style="width:3.1pt; text-indent:0pt; display:inline-block"> </span><span>contains estradiol as the only active ingredient; and</span></p><p class="Tablea"><span>(b)</span><span style="width:2.54pt; text-indent:0pt; display:inline-block"> </span><span>is manufactured in the dosage form of a patch; and</span></p><p class="Tablea"><span>(c)</span><span style="width:3.1pt; text-indent:0pt; display:inline-block"> </span><span>releases 25</span><span> </span><span>micrograms of estradiol per day</span></p></td><td style="width:67.1pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>one patch of the scarce medicine is equivalent to one patch of the substitutable medicine</span></p></td><td style="width:102.8pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>the pharmacist has advised the patient, or person acting on behalf of the patient, of:</span></p><p class="Tabletext" style="margin-right:8.55pt; margin-left:15.55pt; text-indent:-15.55pt"><span>(a)</span><span style="width:4.45pt; text-indent:0pt; display:inline-block"> </span><span>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</span></p><p class="Tablea"><span>(b)</span><span style="width:2.54pt; text-indent:0pt; display:inline-block"> </span><span>suitable instructions for administering the substitutable medicine</span></p></td></tr><tr style="height:56.7pt"><td style="width:42.45pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:77.6pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>each of the following:</span></p><p class="Tablea"><span>(a)</span><span style="width:3.1pt; text-indent:0pt; display:inline-block"> </span><span>ESTRADERM MX 50 estradiol 50</span><span> </span><span>microgram/24</span><span> </span><span>hours transdermal drug delivery system sachet, registration number 56658;</span></p><p class="Tablea"><span>(b)</span><span style="width:2.54pt; text-indent:0pt; display:inline-block"> </span><span>ESTRADOT 50 estradiol 50</span><span> </span><span>microgram transdermal drug delivery system sachet, registration number 338058</span></p></td><td style="width:88.4pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>either of the following:</span></p><p class="Tablea"><span>(a)</span><span style="width:3.1pt; text-indent:0pt; display:inline-block"> </span><span>a registered medicine, or a medicine subject to an approval under section 19A of the Act, that:</span></p><p class="Tablea" style="margin-left:37.3pt; text-indent:-21.3pt"><span>(i)</span><span style="width:11.86pt; text-indent:0pt; display:inline-block"> </span><span>contains estradiol as the only active ingredient; and</span></p><p class="Tablea" style="margin-left:37.3pt; text-indent:-21.3pt"><span>(ii)</span><span style="width:9.08pt; text-indent:0pt; display:inline-block"> </span><span>is manufactured in the dosage form of a patch; and</span></p><p class="Tablea" style="margin-left:37.3pt; text-indent:-21.3pt"><span>(iii)</span><span style="width:6.3pt; text-indent:0pt; display:inline-block"> </span><span>releases 50 micrograms of estradiol per day;</span></p><p class="Tablea"><span>(b)</span><span style="width:2.54pt; text-indent:0pt; display:inline-block"> </span><span>a registered medicine, or a medicine subject to an approval under section 19A of the Act, that:</span></p><p class="Tablea" style="margin-left:37.3pt; text-indent:-21.3pt"><span>(i)</span><span style="width:11.86pt; text-indent:0pt; display:inline-block"> </span><span>contains estradiol as the only active ingredient; and</span></p><p class="Tablea" style="margin-left:37.3pt; text-indent:-21.3pt"><span>(ii)</span><span style="width:9.08pt; text-indent:0pt; display:inline-block"> </span><span>is manufactured in the dosage form of a patch; and</span></p><p class="Tablea" style="margin-left:37.3pt; text-indent:-21.3pt"><span>(iii)</span><span style="width:6.3pt; text-indent:0pt; display:inline-block"> </span><span>releases 25 micrograms of estradiol per day</span></p></td><td style="width:67.1pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tablea" style="margin-left:0pt; text-indent:0pt"><span>one patch of the scarce medicine is equivalent to:</span></p><p class="Tablea"><span>(a)</span><span style="width:3.1pt; text-indent:0pt; display:inline-block"> </span><span>one patch of the substitutable medicine in paragraph (a) in column 3; or</span></p><p class="Tablea"><span>(b)</span><span style="width:2.54pt; text-indent:0pt; display:inline-block"> </span><span>two patches of the substitutable</span><span style="font-family:Calibri, sans-serif"> </span><span>medicine in paragraph (b) in column 3</span></p></td><td style="width:102.8pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>all of the following:</span></p><p class="Tabletext" style="margin-right:8.55pt; margin-left:15.55pt; text-indent:-15.55pt"><span>(a)</span><span style="width:4.45pt; text-indent:0pt; display:inline-block"> </span><span>when substituting with the substitutable medicine in paragraph</span><span> </span><span>(b) in column 3—the pharmacist:</span></p><p class="Tabletext" style="margin-right:8.55pt; margin-left:30pt; text-indent:-15.55pt"><span>(i)</span><span style="width:6.11pt; text-indent:0pt; display:inline-block"> </span><span>does not have access to the substitutable medicine in paragraph (a) of column 3; and</span></p><p class="Tabletext" style="margin-right:8.55pt; margin-left:30pt; text-indent:-15.55pt"><span>(ii)</span><span style="width:3.33pt; text-indent:0pt; display:inline-block"> </span><span>dispenses patches that are of the same brand;</span></p><p class="Tabletext" style="margin-right:8.55pt; margin-left:15.55pt; text-indent:-15.55pt"><span>(b)</span><span style="width:3.89pt; text-indent:0pt; display:inline-block"> </span><span>the pharmacist has advised the patient, or person acting on behalf of the patient, of:</span></p><p class="Tablei"><span>(i)</span><span style="width:4.76pt; text-indent:0pt; display:inline-block"> </span><span>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</span></p><p class="Tablei"><span>(ii)</span><span style="width:1.98pt; text-indent:0pt; display:inline-block"> </span><span>suitable instructions for administering the substitutable medicine</span></p></td></tr><tr style="height:56.7pt"><td style="width:42.45pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:77.6pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>each of the following:</span></p><p class="Tablea"><span>(a)</span><span style="width:3.1pt; text-indent:0pt; display:inline-block"> </span><span>ESTRADERM MX 75 estradiol 75</span><span> </span><span>microgram/24</span><span> </span><span>hr transdermal drug delivery system sachet, registration number 76117;</span></p><p class="Tablea"><span>(b)</span><span style="width:2.54pt; text-indent:0pt; display:inline-block"> </span><span>ESTRADOT 75 estradiol 75</span><span> </span><span>microgram transdermal drug delivery system, registration number 338059</span></p></td><td style="width:88.4pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>either of the following:</span></p><p class="Tablea"><span>(a)</span><span style="width:3.1pt; text-indent:0pt; display:inline-block"> </span><span>a registered medicine, or a medicine subject to an approval under section 19A of the Act, that:</span></p><p class="Tablea" style="margin-left:37.3pt; text-indent:-21.3pt"><span>(i)</span><span style="width:11.86pt; text-indent:0pt; display:inline-block"> </span><span>contains estradiol as the only active ingredient; and</span></p><p class="Tablea" style="margin-left:37.3pt; text-indent:-21.3pt"><span>(ii)</span><span style="width:9.08pt; text-indent:0pt; display:inline-block"> </span><span>is manufactured in the dosage form of a patch; and</span></p><p class="Tablea" style="margin-left:37.3pt; text-indent:-21.3pt"><span>(iii)</span><span style="width:6.3pt; text-indent:0pt; display:inline-block"> </span><span>releases 75 micrograms of estradiol per day;</span></p><p class="Tablea"><span>(b)</span><span style="width:2.54pt; text-indent:0pt; display:inline-block"> </span><span>a registered medicine, or a medicine subject to an approval under section 19A of the Act, that:</span></p><p class="Tablea" style="margin-left:37.3pt; text-indent:-21.3pt"><span>(i)</span><span style="width:11.86pt; text-indent:0pt; display:inline-block"> </span><span>contains estradiol as the only active ingredient; and</span></p><p class="Tablea" style="margin-left:37.3pt; text-indent:-21.3pt"><span>(ii)</span><span style="width:9.08pt; text-indent:0pt; display:inline-block"> </span><span>is manufactured in the dosage form of a patch; and</span></p><p class="Tablea" style="margin-left:37.3pt; text-indent:-21.3pt"><span>(iii)</span><span style="width:6.3pt; text-indent:0pt; display:inline-block"> </span><span>releases 37.5 micrograms of estradiol per day</span></p></td><td style="width:67.1pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>one patch of the scarce medicine is equivalent to:</span></p><p class="Tablea"><span>(a)</span><span style="width:3.1pt; text-indent:0pt; display:inline-block"> </span><span>one patch of the substitutable medicine in paragraph (a) in column 3; or</span></p><p class="Tablea"><span>(b)</span><span style="width:2.54pt; text-indent:0pt; display:inline-block"> </span><span>two patches of the substitutable medicine in paragraph (b) in column 3</span></p></td><td style="width:102.8pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>all of the following:</span></p><p class="Tabletext" style="margin-right:8.55pt; margin-left:15.55pt; text-indent:-15.55pt"><span>(a)</span><span style="width:4.45pt; text-indent:0pt; display:inline-block"> </span><span>when substituting with the substitutable medicine in paragraph</span><span> </span><span>(b) of column 3—the pharmacist:</span></p><p class="Tabletext" style="margin-right:8.55pt; margin-left:30pt; text-indent:-15.55pt"><span>(i)</span><span style="width:6.11pt; text-indent:0pt; display:inline-block"> </span><span>does not have access to the substitutable medicine in paragraph (a) of column 3; and</span></p><p class="Tabletext" style="margin-right:8.55pt; margin-left:30pt; text-indent:-15.55pt"><span>(ii)</span><span style="width:3.33pt; text-indent:0pt; display:inline-block"> </span><span>dispenses patches that are of the same brand;</span></p><p class="Tabletext" style="margin-right:8.55pt; margin-left:15.55pt; text-indent:-15.55pt"><span>(b)</span><span style="width:3.89pt; text-indent:0pt; display:inline-block"> </span><span>the pharmacist has advised the patient, or person acting on behalf of the patient, of:</span></p><p class="Tablei"><span>(i)</span><span style="width:4.76pt; text-indent:0pt; display:inline-block"> </span><span>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</span></p><p class="Tablei"><span>(ii)</span><span style="width:1.98pt; text-indent:0pt; display:inline-block"> </span><span>suitable instructions for administering the substitutable medicine</span></p></td></tr><tr style="height:56.7pt"><td style="width:42.45pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td style="width:77.6pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>each of the following:</span></p><p class="Tablea"><span>(a)</span><span style="width:3.1pt; text-indent:0pt; display:inline-block"> </span><span>ESTRADERM MX 100 estradiol 100</span><span> </span><span>microgram/24</span><span> </span><span>hours transdermal drug delivery system sachet, registration number 67090;</span></p><p class="Tablea"><span>(b)</span><span style="width:2.54pt; text-indent:0pt; display:inline-block"> </span><span>ESTRADOT 100 estradiol 100</span><span> </span><span>microgram transdermal drug delivery system, registration number 338060</span></p></td><td style="width:88.4pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>either of the following:</span></p><p class="Tablea"><span>(a)</span><span style="width:3.1pt; text-indent:0pt; display:inline-block"> </span><span>a registered medicine, or a medicine subject to an approval under section 19A of the Act, that:</span></p><p class="Tablea" style="margin-left:37.3pt; text-indent:-21.3pt"><span>(i)</span><span style="width:11.86pt; text-indent:0pt; display:inline-block"> </span><span>contains estradiol as the only active ingredient; and</span></p><p class="Tablea" style="margin-left:37.3pt; text-indent:-21.3pt"><span>(ii)</span><span style="width:9.08pt; text-indent:0pt; display:inline-block"> </span><span>is manufactured in the dosage form of a patch; and</span></p><p class="Tablea" style="margin-left:37.3pt; text-indent:-21.3pt"><span>(iii)</span><span style="width:6.3pt; text-indent:0pt; display:inline-block"> </span><span>releases 100 micrograms of estradiol per day;</span></p><p class="Tablea"><span>(b)</span><span style="width:2.54pt; text-indent:0pt; display:inline-block"> </span><span>a registered medicine, or a medicine subject to an approval under section 19A of the Act, that:</span></p><p class="Tablea" style="margin-left:37.3pt; text-indent:-21.3pt"><span>(i)</span><span style="width:11.86pt; text-indent:0pt; display:inline-block"> </span><span>contains estradiol as the only active ingredient; and</span></p><p class="Tablea" style="margin-left:37.3pt; text-indent:-21.3pt"><span>(ii)</span><span style="width:9.08pt; text-indent:0pt; display:inline-block"> </span><span>is manufactured in the dosage form of a patch; and</span></p><p class="Tablea" style="margin-left:37.3pt; text-indent:-21.3pt"><span>(iii)</span><span style="width:6.3pt; text-indent:0pt; display:inline-block"> </span><span>releases 50 micrograms of estradiol per day</span></p></td><td style="width:67.1pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>one patch of the scarce medicine is equivalent to:</span></p><p class="Tablea"><span>(a)</span><span style="width:3.1pt; text-indent:0pt; display:inline-block"> </span><span>one patch of the substitutable medicine in paragraph (a) in column 3; or</span></p><p class="Tablea"><span>(b)</span><span style="width:2.54pt; text-indent:0pt; display:inline-block"> </span><span>two patches of the substitutable medicine in paragraph (b) in column 3</span></p></td><td style="width:102.8pt; border-top:1.5pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>all of the following:</span></p><p class="Tabletext" style="margin-right:8.55pt; margin-left:15.55pt; text-indent:-15.55pt"><span>(a)</span><span style="width:4.45pt; text-indent:0pt; display:inline-block"> </span><span>when substituting with the substitutable medicine in paragraph</span><span> </span><span>(b) of column 3—the pharmacist:</span></p><p class="Tabletext" style="margin-right:8.55pt; margin-left:30pt; text-indent:-15.55pt"><span>(i)</span><span style="width:6.11pt; text-indent:0pt; display:inline-block"> </span><span>does not have access to the substitutable medicine in paragraph (a) of column 3; and</span></p><p class="Tabletext" style="margin-right:8.55pt; margin-left:30pt; text-indent:-15.55pt"><span>(ii)</span><span style="width:3.33pt; text-indent:0pt; display:inline-block"> </span><span>dispenses patches that are of the same brand;</span></p><p class="Tabletext" style="margin-right:8.55pt; margin-left:15.55pt; text-indent:-15.55pt"><span>(b)</span><span style="width:3.89pt; text-indent:0pt; display:inline-block"> </span><span>the pharmacist has advised the patient, or person acting on behalf of the patient, of:</span></p><p class="Tablei"><span>(i)</span><span style="width:4.76pt; text-indent:0pt; display:inline-block"> </span><span>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</span></p><p class="Tablei"><span>(ii)</span><span style="width:1.98pt; text-indent:0pt; display:inline-block"> </span><span>suitable instructions for administering the substitutable medicine</span></p></td></tr></tbody></table>