Case Preview · Custom Portal

<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-YLBUUMIB/2018*</td><td>12/07/2018</td><td>30/10/2021</td><td><ul><li>Homeopathic Preparation - Melatonin</li></ul></td><td><ul><li>Australian Pharmaceutical Industries Limited (Priceline)</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(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 assessed the material provided by the complainant and the advertiser. The advertisement contained references to a restricted representation, without prior approval, and was therefore alleged to contravene subsections 42DL(7) and 42DLB(4) of the Act.</div>

<div><br>
The advertisement also contained a product that was not on the Australian Register of Therapeutic Goods (ARTG), where that product was required to be included in the ARTG before it could be advertised or supplied. It was therefore alleged that the advertisement contravened subsections 42DL(12) and 42DLB(9) of the Act.&nbsp;</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>17/04/2019</td><td>Warning Letter requiring action sent to advertiser</td><td>The TGA required that the advertiser remove the non-complaint material from their advertising, advised them of the complaint and of the sanctions and penalties which 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>22/12/2020</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>
NoYes