32HAPublic notification, and recall, of biologicals

32HA Public notification, and recall, of biologicals

(1) The Secretary may, by notice in writing, impose requirements, relating to a biological, on a person if: (a) any of the circumstances referred to in the 2nd column of an item in the following table occur in relation to the biological; and (b) the person is referred to in the 3rd column of that item.

<table cellspacing="0" cellpadding="0" style="width:357.5pt; margin-left:0.05pt; border-collapse:collapse"><thead><tr><td colspan="3" style="width:346.8pt; 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="Tabletext" style="margin-top:1.95pt"><span style="font-weight:bold">Circumstances in which requirements may be imposed</span></p></td></tr><tr><td style="width:22.3pt; 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" style="margin-top:1.95pt"><span style="font-weight:bold">Item</span></p></td><td style="width:192.8pt; 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" style="margin-top:1.95pt"><span style="font-weight:bold">Circumstance relating to biological</span></p></td><td style="width:110.3pt; 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" style="margin-top:1.95pt"><span style="font-weight:bold">Person subject to requirements</span></p></td></tr></thead><tbody><tr><td style="width:22.3pt; 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="Tabletext" style="margin-top:1.95pt"><span>1</span></p></td><td style="width:192.8pt; 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="Tabletext" style="margin-top:1.95pt"><span>It is supplied while it is included in the Register, but the Secretary is satisfied that it does not conform with a standard applicable to it</span></p></td><td style="width:110.3pt; 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="Tabletext" style="margin-top:1.95pt"><span>The person in relation to whom it is included in the Register</span></p></td></tr><tr><td style="width:22.3pt; 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" style="margin-top:1.95pt"><a id="CU_4422484"></a><a id="CU_4463494"></a><span>2</span></p></td><td style="width:192.8pt; 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" style="margin-top:1.95pt"><span>It is a biological, other than a Class 1 biological, and it is supplied while it is included in the Register, but the Secretary is satisfied that the manufacturing principles have not been observed in its manufacture</span></p></td><td style="width:110.3pt; 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" style="margin-top:1.95pt"><span>The person in relation to whom it is included in the Register</span></p></td></tr><tr><td style="width:22.3pt; 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" style="margin-top:1.95pt"><span>3</span></p></td><td style="width:192.8pt; 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" style="margin-top:1.95pt"><span>It is supplied while:</span></p><p class="Tablea" style="margin-top:1.95pt; margin-left:9.35pt; text-indent:-9.35pt"><span>(a) the person is exempt under subsection</span><span> </span><span>32CA(1) in relation to the biological or the biological is exempt under subsection</span><span> </span><span>32CA(2); or</span></p><p class="Tablea" style="margin-top:1.95pt; margin-left:9.35pt; text-indent:-9.35pt"><span>(b) it is exempt under section</span><span> </span><span>32CB; or</span></p><p class="Tablea" style="margin-top:1.95pt; margin-left:9.35pt; text-indent:-9.35pt"><span>(c) it is the subject of an approval under subsection</span><span> </span><span>32CK(1); or</span></p><p class="Tablea" style="margin-top:1.95pt; margin-left:9.35pt; text-indent:-9.35pt"><span>(d) it is the subject of an authority under subsection</span><span> </span><span>32CM(1) or (7A); or</span></p><p class="Tablea" style="margin-top:1.95pt; margin-left:9.35pt; text-indent:-9.35pt"><span>(e) it is the subject of an approval under subsection</span><span> </span><span>32CO(1), (1A) or (2);</span></p><p class="Tabletext" style="margin-top:1.95pt"><span>but the Secretary is satisfied that it does not conform with a standard applicable to it</span></p></td><td style="width:110.3pt; 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" style="margin-top:1.95pt"><span>The person supplying it</span></p></td></tr><tr><td style="width:22.3pt; 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" style="margin-top:1.95pt"><a id="CU_6423220"></a><a id="CU_6464308"></a><span>4</span></p></td><td style="width:192.8pt; 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" style="margin-top:1.95pt"><span>It is a biological, other than a Class 1 biological, and it is supplied while:</span></p><p class="Tablea" style="margin-top:1.95pt; margin-left:9.35pt; text-indent:-9.35pt"><span>(a) the person is exempt under subsection</span><span> </span><span>32CA(1) in relation to the biological or the biological is exempt under subsection</span><span> </span><span>32CA(2); or</span></p><p class="Tablea" style="margin-top:1.95pt; margin-left:9.35pt; text-indent:-9.35pt"><span>(b) it is exempt under section</span><span> </span><span>32CB; or</span></p><p class="Tablea" style="margin-top:1.95pt; margin-left:9.35pt; text-indent:-9.35pt"><span>(c) it is the subject of an approval under subsection</span><span> </span><span>32CK(1); or</span></p><p class="Tablea" style="margin-top:1.95pt; margin-left:9.35pt; text-indent:-9.35pt"><span>(d) it is the subject of an authority under subsection</span><span> </span><span>32CM(1) or (7A); or</span></p><p class="Tablea" style="margin-top:1.95pt; margin-left:9.35pt; text-indent:-9.35pt"><span>(e) it is the subject of an approval under subsection</span><span> </span><span>32CO(1), (1A) or (2);</span></p><p class="Tabletext" style="margin-top:1.95pt"><span>but the Secretary is satisfied that the manufacturing principles have not been observed in its manufacture</span></p></td><td style="width:110.3pt; 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" style="margin-top:1.95pt"><span>The person supplying it</span></p></td></tr><tr><td style="width:22.3pt; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext" style="margin-top:1.95pt"><a id="_Hlk66267408"><span>4A.</span></a></p></td><td style="width:192.8pt; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext" style="margin-top:1.95pt"><span>It is supplied and the Secretary is satisfied that:</span></p><p class="Tablea" style="margin-top:1.95pt; margin-left:9.35pt; text-indent:-9.35pt"><span>(a) if there are one or more absolute prohibitions in force for the purposes of subsection</span><span> </span><span>9K(1) or (3)—the supply contravenes one or more of those prohibitions; or</span></p><p class="Tablea" style="margin-top:1.95pt; margin-left:9.35pt; text-indent:-9.35pt"><span>(b) if there are one or more prohibitions in force for the purposes of subsection</span><span> </span><span>9K(1) or (3) that are subject to conditions—the supply contravenes one or more of those conditions</span></p></td><td style="width:110.3pt; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext" style="margin-top:1.95pt"><span>The person supplying it</span></p></td></tr><tr><td style="width:22.3pt; 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" style="margin-top:1.95pt"><span>5</span></p></td><td style="width:192.8pt; 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" style="margin-top:1.95pt"><span>It is supplied while:</span></p><p class="Tablea" style="margin-top:1.95pt; margin-left:9.35pt; text-indent:-9.35pt"><span>(a) it is not included in the Register; and</span></p><p class="Tablea" style="margin-top:1.95pt; margin-left:9.35pt; text-indent:-9.35pt"><span>(b) the person is not exempt under subsection</span><span> </span><span>32CA(1) in relation to the biological and the biological is not exempt under subsection</span><span> </span><span>32CA(2); and</span></p><p class="Tablea" style="margin-top:1.95pt; margin-left:9.35pt; text-indent:-9.35pt"><span>(c) it is not exempt under section</span><span> </span><span>32CB; and</span></p><p class="Tablea" style="margin-top:1.95pt; margin-left:9.35pt; text-indent:-9.35pt"><span>(d) it is not the subject of an approval under subsection</span><span> </span><span>32CK(1); and</span></p><p class="Tablea" style="margin-top:1.95pt; margin-left:9.35pt; text-indent:-9.35pt"><span>(e) it is not the subject of an authority under subsection</span><span> </span><span>32CM(1) or (7A); and</span></p><p class="Tablea" style="margin-top:1.95pt; margin-left:9.35pt; text-indent:-9.35pt"><span>(f) it is not the subject of an approval under subsection</span><span> </span><span>32CO(1), (1A) or (2)</span></p></td><td style="width:110.3pt; 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" style="margin-top:1.95pt"><span>The person supplying it</span></p></td></tr><tr><td style="width:22.3pt; 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" style="margin-top:1.95pt"><span>6</span></p></td><td style="width:192.8pt; 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" style="margin-top:1.95pt"><span>It is supplied while it is exempt under section</span><span> </span><span>32CB, and the Secretary is satisfied that it is not fit to be used for its intended purpose</span></p></td><td style="width:110.3pt; 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" style="margin-top:1.95pt"><span>The person supplying it</span></p></td></tr><tr><td style="width:22.3pt; 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" style="margin-top:1.95pt"><span>7</span></p></td><td style="width:192.8pt; 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" style="margin-top:1.95pt"><span>It is counterfeit goods (within the meaning of section</span><span> </span><span>42E)</span></p></td><td style="width:110.3pt; 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" style="margin-top:1.95pt"><span>The person supplying it</span></p></td></tr><tr><td style="width:22.3pt; 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" style="margin-top:1.95pt"><span>8</span></p></td><td style="width:192.8pt; 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" style="margin-top:1.95pt"><span>It is a biological, other than a Class 1 biological, and it is supplied while it is included in the Register, but the Secretary is satisfied that there is a breach of the condition set out in subsection</span><span> </span><span>32EA(5)</span></p></td><td style="width:110.3pt; 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" style="margin-top:1.95pt"><span>The person in relation to whom it is included in the Register</span></p></td></tr><tr><td style="width:22.3pt; 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" style="margin-top:1.95pt"><span>9</span></p></td><td style="width:192.8pt; 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" style="margin-top:1.95pt"><span>It appears to the Secretary that the quality, safety or efficacy of the biological is unacceptable or that the presentation of the biological is not acceptable</span></p></td><td style="width:110.3pt; 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" style="margin-top:1.95pt"><span>The person in relation to whom the biological is included in the Register</span></p></td></tr><tr><td style="width:22.3pt; 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" style="margin-top:1.95pt"><a id="CU_12466197"></a><span>10</span></p></td><td style="width:192.8pt; 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" style="margin-top:1.95pt"><span>It has been suspended from the Register</span></p></td><td style="width:110.3pt; 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" style="margin-top:1.95pt"><span>The person in relation to whom it is included in the Register</span></p></td></tr><tr><td style="width:22.3pt; 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" style="margin-top:1.95pt"><a id="CU_13425132"></a><span>11</span></p></td><td style="width:192.8pt; 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" style="margin-top:1.95pt"><span>Its entry has been cancelled from the Register</span></p></td><td style="width:110.3pt; 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" style="margin-top:1.95pt"><span>The person in relation to whom it is included in the Register</span></p></td></tr></tbody></table>