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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-PUVHB1RM/2021*</td><td>07/06/2021</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(1) - Advertise or cause advertising of therapeutic goods and subsection (2), (3), (4), (5), (6), (7), (8) or (9) applies to the advertisement.</li><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>s42DMA - Advertises or  causes the advertising, by any means, of therapeutic goods and the advertisement does not comply with the Therapeutic Goods Advertising Code.</li></ul></div><div id="allegationAdvertisingTherapeutic Goods Advertising Code (No.2) 2018" class="divadvertisingcode"><span class="allegationtype"><a href="https://www.legislation.gov.au/Series/F2018L01524" target="_blank">Therapeutic Goods Advertising Code (No.2) 2018</a></span><ul><li>s10(d)(i) - Advertising for therapeutic goods must not contain any claim, statement, implication or representation that the therapeutic goods are safe or that their use cannot cause harm, or that they have no side-effects</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 TGA received a complaint about alleged unlawful advertising in relation to COVID-19. The advertisement published on the ‘Twitter’ social media platform claimed that a medicine containing ivermectin is effective for the treatment of COVID-19. Any claims or references to COVID-19 in the advertising of therapeutic goods are restricted representations under the Act. A restricted representation refers to a serious form or a disease, condition, ailment or defect. The use of restricted representations in advertisements for therapeutic goods is unlawful without the permission of the TGA. It was determined that no permission under section 42DK of the Act nor approval under 42DF of the Act was in force at the time of the representation. Accordingly, the TGA alleged that the entity contravened subsection 42DLB(1) of the Act, where subsection 42DLB(4) of the Act applied.<br>
The advertisement also referred to a substance, being Ivermectin, that is included in Schedule 4 to the Poisons Standard as made under section 52D of the Act. Accordingly, the TGA alleged that the entity contravened subsection 42DLB(1) of the Act, where subsection 42DLB(7) of the Act applied. In most circumstances, prescription only medicines cannot be advertised to the public in Australia.<br>
The advertisement contained a claim the Ivermectin is safe in contravention of 42DMA of the Act, where 10(d)(i) of the Code applies as advertising for therapeutic goods must not contain any claim, statement, implication or representation that the goods are safe or that their use cannot cause harm, or that they have no side-effects.<br>
The alleged illegal post was removed from social media after the TGA issued a warning letter requiring it be removed.<br>
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</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>10/06/2021</td><td>Cease and Desist letter sent to Advertiser</td><td></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>11/06/2021</td><td>Case resolved</td><td></td></tr></table></div></div><div id="previewDiv"></div>
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