5Release of therapeutic goods information

5 Release of therapeutic goods information

For subsection 61(5AA) of the Act, in relation to each item, the kinds of therapeutic goods information specified in column 2 of the table in Schedule 1, may be released to the kinds of persons or bodies specified in column 3, for the purpose specified in column 4 of that table.

Note: Under subsection 61(5AA) of the Act, the Secretary may release to a person or body that is specified under subsection 61(5AB), specified kinds of therapeutic goods information for a specified purpose.

Schedule 1—Therapeutic goods information

Note: See section 5.

<table cellspacing="0" cellpadding="0" style="width:105.12%; border-collapse:collapse"><thead><tr><td colspan="4" style="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>Therapeutic goods information that may be released</span></p></td></tr><tr><td style="width:12.78%; 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:32.66%; 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:29.2%; 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:25.38%; 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 4</span></p></td></tr><tr><td style="width:12.78%; 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:32.66%; 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>Kinds of information</span></p></td><td style="width:29.2%; 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>Kinds of persons or bodies</span></p></td><td style="width:25.38%; 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>Purpose</span></p></td></tr></thead><tbody><tr><td style="width:12.78%; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-bottom:6pt"><span>1</span></p></td><td style="width:32.66%; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-bottom:6pt"><span>in relation to a clinical trial of therapeutic goods (the </span><span style="font-weight:bold; font-style:italic">relevant trial</span><span>), information about the conduct of the relevant trial that has been obtained by a relevant authorised officer, including information that relates to compliance of the relevant trial with:</span></p><p class="Tabletext" style="margin-left:22.7pt; margin-bottom:3pt; text-indent:-22.7pt"><span>(a)</span><span style="width:11.6pt; text-indent:0pt; display:inline-block"> </span><span>the National Statement;</span></p><p class="Tabletext" style="margin-left:22.7pt; margin-bottom:3pt; text-indent:-22.7pt"><span>(b)</span><span style="width:11.04pt; text-indent:0pt; display:inline-block"> </span><span>the procedural protocol;</span></p><p class="Tabletext" style="margin-left:22.7pt; margin-bottom:3pt; text-indent:-22.7pt"><span>(c)</span><span style="width:11.6pt; text-indent:0pt; display:inline-block"> </span><span>the Practice Guideline</span></p></td><td style="width:29.2%; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-bottom:3pt"><span>the following persons or bodies in relation to the relevant trial:</span></p><p class="Tabletext" style="margin-left:22.7pt; margin-bottom:3pt; text-indent:-22.7pt"><span>(a)</span><span style="width:11.6pt; text-indent:0pt; display:inline-block"> </span><span>the approving authority;</span></p><p class="Tabletext" style="margin-left:22.7pt; margin-bottom:3pt; text-indent:-22.7pt"><span>(b)</span><span style="width:11.04pt; text-indent:0pt; display:inline-block"> </span><span>the responsible ethics committee</span></p></td><td style="width:25.38%; border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-bottom:6pt"><span>to ensure that clinical trials are conducted in a safe and lawful manner, including in accordance with applicable ethics and good clinical practice considerations</span></p></td></tr></tbody></table>