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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-XA1U7I6B/2021*</td><td>01/09/2021</td><td>30/10/2021</td><td><ul><li>Ivermectin</li></ul></td><td><ul></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>s42DLB(7) - Advertisement refers to substances, or goods containing substances, included in Schedule 3, 4 or 8 of the current Poisons Standard but not in Appendix H, other than a reference authorised/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>s21B(4) - Civil penalty relating to advertising medicines included in the Register for an indication not accepted in relation to that inclusion</li></ul></div><span class="divheadingtwo">Summary</span><div class="breachDiv"><div data-wrapper="true" style="font-size:9pt;font-family:'Segoe UI','Helvetica Neue',sans-serif;">
<div>The advertisement was promoting the use or supply of a therapeutic good containing a substance included in Schedule 4 to the current Poisons Standard. Advertisements of goods containing substances included in Schedule 3, 4 or 8 to the current Poisons Standard but not in Appendix H of the current Poisons Standard cannot be advertised to the public. Therefore, the TGA alleged that the company contravened subsection 42DLB(7) of the Act.<br>
The advertisement also included therapeutic claims for products in relation to COVID-19. Any claims or references to COVID-19 (and related terms) are restricted representations under the Act. The use of restricted representations in advertisements for therapeutic goods is unlawful without the permission of the TGA. It was determined by the TGA that no permission under section 42DK of the Act was in force in relation to the restricted representation. Accordingly, the TGA alleged that the company contravened subsection 42DLB(4)(a) of the Act.<br>
In addition, the advertisement promoted the use of the therapeutic good for COVID-19, which is not an indication accepted in relation to the inclusion of that therapeutic good in the Australian Register of Therapeutic Goods (the Register). As such, the TGA alleged that the company contravened subsection 21B(4) 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>08/09/2021</td><td>Warning Letter requiring action sent to advertiser</td><td>The TGA required removal of non-compliant material from their advertising and advised of the sanctions and penalties that may apply.</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>09/09/2021</td><td>Case resolved</td><td>The non-compliant advertising was removed following contact by the TGA.</td></tr></table></div></div><div id="previewDiv"></div>
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