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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-RU3OAATU/2021*</td><td>03/03/2021</td><td>30/10/2021</td><td><ul><li>BIOINNOVATE PTY LTD - ViroCLEAR - Disinfectant, hospital grade</li></ul></td><td><ul><li>Procurement Australasia 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>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(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><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(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>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>s9(b) - Advertising for therapeutic goods must be truthful, balanced and not misleading or likely to mislead, including in its claims, presentations, representations or comparisons</li><li>s10(a) - Advertisement's for therapeutic goods must support the safe and proper use of therapeutic goods by  presenting the goods in accordance with directions or instructions for use and not exaggerate the products efficacy or performance</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 large number of complaints concerning Procurement Australasia Ltd (the Company) about alleged unlawful advertising of therapeutic goods in relation to COVID-19. The advertising on the website referred to therapeutic goods not included in the Australian Register of Therapeutic Goods (ARTG). Unless a specific exemption, approval or authority applies, therapeutic goods must be entered on the ARTG before they can be lawfully supplied or advertised in Australia. Accordingly, the TGA alleged that the company contravened subsection 42DLB(1) of the Therapeutic Goods Act 1989 (Cth) (Act), where subsection 42DLB(9) of the Act applied.&nbsp;<br>
The advertisements 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. &nbsp;<br>
The advertising contained a statement suggesting or implying the therapeutic good had been recommended or approved by or on behalf of a government or government authority and contravened subsection 42DLB(6) of the Act.<br>
Advertising of therapeutic goods is required to be truthful, balanced and not misleading or likely to mislead. The TGA considered the advertising on the website was likely to mislead consumers and contravened 42DMA of the Act by failing to comply with section 9 and section 10 of the Therapeutic Goods Advertising Code (No.2) 2018 (Cth).<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>17/03/2021</td><td>Warning Letter requiring action 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>04/05/2021</td><td>Case resolved</td><td></td></tr></table></div></div><div id="previewDiv"></div>
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