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<div id="overviewDiv" class="divsummary"><span class="divheading">Overview</span><div class="tableddiv"><table class="tablesummary"><tr><th>Case Number</th><th>Received Date</th><th>Finalised Date</th><th>Product/s</th><th>Responsible Person</th></tr><tr><td>CC-Y7YKWE2Z/2020*</td><td>25/06/2020</td><td>30/10/2021</td><td><ul><li>Thermal Imaging System</li></ul></td><td><ul><li>C R Kennedy &amp; Co Pty Ltd</li></ul></td></tr></table></div></div><div id="summaryDiv" class="divsummary"><span class="divheading">Case Summary</span><div class="tableddiv"><span class="divheadingtwo">Alleged Breaches</span><div id="allegationAdvertisingTherapeutic Goods Act 1989" class="divadvertisingcode"><span class="allegationtype"><a href="https://www.legislation.gov.au/Series/C2004A03952" target="_blank">Therapeutic Goods Act 1989</a></span><ul><li>s42DL(7)(a) - Advertisement contains a restricted representation and neither an approval under section 42DF nor a permission under section 42DK is in force in relation to the restricted representation</li><li>s42DL(12) - Advertisement refers to therapeutic goods that are not entered in the Register and that are prescribed by the regulations for the purposes of this subsection, other than a reference authorised or required by a government/government authority (not including a foreign government/authority)</li><li>s42DLB(4)(a) - Advertisement contains a restricted representation and neither an approval under section 42DF nor a permission under section 42DK is in force in relation to the restricted representation</li><li>s42DLB(9) - Advertisement refers to therapeutic goods that are not entered in the Register and that are prescribed by the regulations for the purposes of this subsection, other than a reference authorised/required by a government/Government authority (not including a foreign government/authority)</li></ul></div><span class="divheadingtwo">Summary</span><div class="breachDiv"><div data-wrapper="true" style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt">
<div>The TGA reviewed advertisement for thermal imaging system on an online platform.&nbsp;</div>

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The TGA considered that the advertisement for the thermal imaging system contained restricted representations because they referred to serious forms of diseases, COVID-19. These representations had not been approved by the Secretary of the Department of Health and, accordingly, the advertisements containing these restricted representations breached subsections 42DL(7)(a) and 42DLB(4)(a) of the Therapeutic Goods Act 1989 (Cth)(Act).&nbsp;</div>

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Enquiries conducted by the TGA identified that the thermal imaging system was not entered in the Australian Register of Therapeutic Goods (ARTG) and was required to be because there was not any excluded goods determination applicable to it and it was neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act. Accordingly, the advertising of the thermal imaging system on the online platform when it was not included in the ARTG contravened subsections 42DL(12) and 42DLB(9) of the Act.</div>
</div></div></div></div><div id="actionsDiv" class="divsummary"><span class="divheading">Actions</span><div class="tableddiv"><table class="tablesummary"><tr><th>Date</th><th>Action</th><th> </th></tr><tr><td>29/06/2020</td><td>Warning Letter requiring action sent to advertiser</td><td>The TGA contacted the advertiser to advise them immediate action was required, to remove all reference to COVID-19.</td></tr></table></div></div><div id="outcomeDiv" class="divsummary"><span class="divheading">Case Outcome</span><div class="tableddiv"><table class="tablesummary"><tr><th>Date</th><th>Case Outcome</th><th> </th></tr><tr><td>09/10/2020</td><td>Case resolved</td><td>The Advertiser removed COVID-19 references from all online platforms.</td></tr></table></div></div><div id="previewDiv"></div>
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