6Exemption of parts of monographs

6 Exemption of parts of monographs

For subsection 3C(2) of the Act, in relation to each item mentioned in the table in Schedule 2, the statements in monographs specified in column 2, in the pharmacopoeia specified in column 3, are exempt for the purposes of paragraph (b), (c) or (d) of the definition of standard in subsection 3(1) of the Act, in relation to the therapeutic goods specified in column 4.

Schedule 1—Exempt monographs

Note: See section 5.

<table cellspacing="0" cellpadding="0" style="width:426.95pt; margin-right:auto; margin-left:auto; border-collapse:collapse"><thead><tr><td colspan="4" style="width:415.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Monographs exempt from the definition of standard</span></p></td><td style="border-bottom:0.75pt solid #000000; vertical-align:top"></td></tr><tr><td style="width:47pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 1</span></p></td><td style="width:145.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p></td><td style="width:102.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 3</span></p></td><td colspan="2" style="width:89.2pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 4</span></p></td></tr><tr><td style="width:47pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Item</span></p></td><td style="width:145.25pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Monograph</span></p></td><td style="width:102.7pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Pharmacopoeia</span></p></td><td colspan="2" style="width:89.2pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Therapeutic goods</span></p></td></tr></thead><tbody><tr><td style="width:47pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><a id="_Hlk97026955"><span>2</span></a></p></td><td style="width:145.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>antithrombin III human</span></p></td><td style="width:102.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>United States Pharmacopeia-National Formulary</span></p></td><td colspan="2" style="width:89.2pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>therapeutic goods</span></p></td></tr><tr><td style="width:47pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:145.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>factor IX complex</span></p></td><td style="width:102.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>United States Pharmacopeia-National Formulary</span></p></td><td colspan="2" style="width:89.2pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>therapeutic goods</span></p></td></tr><tr><td style="width:47pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td style="width:145.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>pancreatin</span></p></td><td style="width:102.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>United States Pharmacopeia-National Formulary</span></p></td><td colspan="2" style="width:89.2pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>therapeutic goods</span></p></td></tr><tr><td style="width:47pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>5</span></p></td><td style="width:145.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>pancrelipase</span></p></td><td style="width:102.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>United States Pharmacopeia-National Formulary</span></p></td><td colspan="2" style="width:89.2pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>therapeutic goods</span></p></td></tr><tr><td style="width:47pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>6</span></p></td><td style="width:145.25pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>plasma protein fraction</span></p></td><td style="width:102.7pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>United States Pharmacopeia-National Formulary</span></p></td><td colspan="2" style="width:89.2pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>therapeutic goods</span></p></td></tr><tr style="height:0pt"><td style="width:57.7pt"></td><td style="width:155.95pt"></td><td style="width:113.4pt"></td><td style="width:99.6pt"></td><td style="width:0.3pt"></td></tr></tbody></table>