17Application, savings and transitional provisions

17 Application, savings and transitional provisions

Sections 13, 14, 15 and 16 apply to medicinal cannabis products released for supply in Australia on or after 1 July 2023.

Schedule 1 Specified tests

(subsection 12(1))

1 Interpretation

(1) For each item specified in column 1 of this table, the parameter specified in column 2 must comply with the limits specified in column 4 under the test method from the European Pharmacopoeia specified in column 3.

(2) With the exception of item 2 of this table, each limit specified in column 4 applies on a dried basis.

2 Table of specified tests

<table cellspacing="0" cellpadding="0" style="width:418.2pt; border-collapse:collapse"><thead><tr style="height:16.1pt"><td colspan="4" style="width:407.4pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:14.5pt; text-indent:-14.5pt; page-break-after:avoid; line-height:12pt"><span style="font-weight:bold">Specified tests</span></p></td></tr><tr style="height:16.1pt"><td style="width:53pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:1.7pt; text-indent:-1.7pt; page-break-after:avoid; line-height:12pt"><span style="font-weight:bold">Column 1</span></p><p style="margin-top:3pt; margin-left:14.5pt; text-indent:-14.5pt; page-break-after:avoid; line-height:12pt"><span style="font-weight:bold">Item</span></p></td><td style="width:67.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:14.5pt; text-indent:-14.5pt; page-break-after:avoid; line-height:12pt"><span style="font-weight:bold">Column 2</span></p><p style="margin-top:3pt; margin-left:14.5pt; text-indent:-14.5pt; page-break-after:avoid; line-height:12pt"><span style="font-weight:bold">Parameter</span></p></td><td style="width:81.35pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:14.5pt; text-indent:-14.5pt; page-break-after:avoid; line-height:12pt"><span style="font-weight:bold">Column 3</span></p><p style="margin-top:3pt; margin-left:14.5pt; text-indent:-14.5pt; page-break-after:avoid; line-height:12pt"><span style="font-weight:bold">Test method</span></p></td><td style="width:173.5pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:14.5pt; text-indent:-14.5pt; page-break-after:avoid; line-height:12pt"><span style="font-weight:bold">Column 4</span></p><p style="margin-top:3pt; margin-left:14.5pt; text-indent:-14.5pt; page-break-after:avoid; line-height:12pt"><span style="font-weight:bold">Limits</span></p></td></tr></thead><tbody><tr style="height:16.1pt"><td style="width:53pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:14.5pt; text-indent:-14.5pt; line-height:115%"><span>1</span></p></td><td style="width:67.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%"><span>Aflatoxins</span></p></td><td style="width:81.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%"><span>Ph Eur 2.8.18</span></p></td><td style="width:173.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%"><span>Not more than 2 µg/kg of aflatoxin B1 and not more than 4 µg/kg for the sum of aflatoxins B1, B2, G1, G2</span></p></td></tr><tr style="height:16.1pt"><td style="width:53pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:14.5pt; text-indent:-14.5pt; line-height:115%"><span>2</span></p></td><td style="width:67.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%"><span>Foreign matter</span></p></td><td style="width:81.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%"><span>Ph Eur 2.8.2</span></p></td><td style="width:173.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%"><span>Not more than 2.0%</span></p></td></tr><tr style="height:16.1pt"><td style="width:53pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:14.5pt; text-indent:-14.5pt; line-height:115%"><span>3</span></p></td><td style="width:67.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%"><span>Heavy metals</span></p></td><td style="width:81.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%"><span>Ph Eur 2.4.27</span></p></td><td style="width:173.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%"><span>Not more than 3.0 mg/kg of arsenic</span></p><p style="margin-top:3pt; line-height:115%"><span>Not more than 0.5 mg/kg of cadmium</span></p><p style="margin-top:3pt; line-height:115%"><span>Not more than 5.0 mg/kg of lead</span></p><p style="margin-top:3pt; line-height:115%"><span>Not more than 0.5 mg/kg of mercury</span></p></td></tr><tr style="height:16.1pt"><td style="width:53pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:14.5pt; text-indent:-14.5pt; line-height:115%"><span>4</span></p></td><td style="width:67.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%"><span>Ochratoxin A</span></p></td><td style="width:81.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%"><span>Ph Eur 2.8.22</span></p></td><td style="width:173.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%"><span>Not more than 20 µg/kg</span></p></td></tr><tr style="height:16.1pt"><td style="width:53pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:14.5pt; text-indent:-14.5pt; line-height:115%"><span>5</span></p></td><td style="width:67.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%"><span>Pesticides</span></p></td><td style="width:81.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%"><span>Ph Eur 2.8.13</span></p></td><td style="width:173.5pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%"><span>Not more than the limits specified in Ph</span><span> </span><span>Eur 2.8.13</span></p></td></tr><tr style="height:16.1pt"><td style="width:53pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:14.5pt; text-indent:-14.5pt; line-height:115%"><span>6</span></p></td><td style="width:67.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%"><span>Total ash</span></p></td><td style="width:81.35pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%"><span>Ph Eur 2.4.16</span></p></td><td style="width:173.5pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%"><span>Not more than 20.0%</span></p></td></tr></tbody></table>