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Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Simvastatin) Instrument 2025
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Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Simvastatin) Instrument 2025
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Turn the raw legal text into a practical explanation grounded in Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Simvastatin) Instrument 2025.
Unless repealed earlier, this instrument is repealed at the start of 1 June 2026.
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:432pt; border-collapse:collapse"><thead><tr style="height:2.85pt"><td colspan="5" style="width:421.2pt; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><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:88.35pt; 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:102.5pt; 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:88.35pt; 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:102.5pt; 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:39.35pt"><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><span style="font-size:10pt">ZIMSTAT simvastatin 5</span><span style="font-size:10pt"> </span><span style="font-size:10pt">mg tablet blister pack, registration number 95672</span></p></td><td style="width:88.35pt; 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 that:</span></p><p class="Tablea"><span>(a)</span><span style="width:3.1pt; text-indent:0pt; display:inline-block"> </span><span>contains 10</span><span> </span><span>mg simvastatin 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 tablet</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>half a tablet of the substitutable medicine is equivalent to one tablet of the scarce medicine</span></p></td><td style="width:102.5pt; 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>the pharmacist has advised the patient, or person acting on behalf of the patient, of:</span></p><p class="Tablea"><span>(a)</span><span style="width:3.1pt; text-indent:0pt; display:inline-block"> </span><span>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 in column</span><span> </span><span>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 cutting a tablet of the substitutable medicine; and</span></p><p class="Tablea"><span>(c)</span><span style="width:3.1pt; text-indent:0pt; display:inline-block"> </span><span>the differences between the scarce medicine and the substitutable medicine</span></p></td></tr></tbody></table>
Schedule 2—General permitted circumstances
Note: See section 6.
<table cellspacing="0" cellpadding="0" style="width:100%; border-collapse:collapse"><thead><tr style="height:2.85pt"><td colspan="2" style="border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>General permitted circumstances</span></p></td></tr><tr style="height:2.85pt"><td style="width:13.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt 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:86.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p></td></tr><tr style="height:2.85pt"><td style="width:13.64%; border-top:0.75pt 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:86.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Circumstances</span></p></td></tr></thead><tbody><tr style="height:1pt"><td style="width:13.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:86.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="paragraph" style="margin-left:0pt; text-indent:0pt; font-size:10pt"><span>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</span></p></td></tr><tr style="height:1pt"><td style="width:13.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:86.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="paragraph" style="margin-left:0pt; text-indent:0pt; font-size:10pt"><span>the pharmacist does not have access to the scarce medicine</span></p></td></tr><tr style="height:1pt"><td style="width:13.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:86.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="paragraph" style="margin-left:0pt; text-indent:0pt; font-size:10pt"><span>the prescriber has not indicated on the prescription for the scarce medicine that substitution is not permitted</span></p></td></tr><tr style="height:1pt"><td style="width:13.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td style="width:86.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="paragraph" style="margin-left:0pt; text-indent:0pt; font-size:10pt"><span>the pharmacist has exercised professional judgement and determined that the patient is suitable to receive the substitutable medicine</span></p></td></tr><tr style="height:1pt"><td style="width:13.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>5</span></p></td><td style="width:86.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>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</span></p></td></tr><tr style="height:1pt"><td style="width:13.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>6</span></p></td><td style="width:86.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>the patient, or person acting on behalf of the patient, has consented to receiving the substitutable medicine</span></p></td></tr><tr style="height:1pt"><td style="width:13.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>7</span></p></td><td style="width:86.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>the pharmacist makes a record of dispensing the substitutable medicine in substitution of the scarce medicine at the time of dispensing</span></p></td></tr><tr style="height:1pt"><td style="width:13.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>8</span></p></td><td style="width:86.36%; border-top:0.75pt 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 an established procedure to notify the prescriber of the substitution at the time of, or as soon as practical after, dispensing the substitutable medicine</span></p></td></tr></tbody></table>