7Medical device standard

7 Medical device standard

(1) The matters specified in Schedule 1 constitute a medical device standard for therapeutic vaping devices and therapeutic vaping device accessories. (2) Therapeutic vaping devices and therapeutic vaping device accessories that comply with the standard in subsection 7(1) are to be treated as complying with all parts of the essential principles in Schedule 1 to the MD Regulations.

8 Application, saving and transitional provisions

(1) In this section: former order means the Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Order 2023, as in force immediately before the commencement of the Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Amendment Order 2024. (2) Despite the amendments to the former order made by the Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Amendment Order 2024, the former order continues to apply in relation to therapeutic vaping devices and therapeutic vaping device accessories that are: (a) imported or manufactured before 1 March 2025; and (b) supplied before 1 July 2025. (3) This section ceases to apply on 1 July 2025.

Schedule 1—Medical device standard for therapeutic vaping devices and therapeutic vaping device accessories

Note: See section 7.

<table cellspacing="0" cellpadding="0" style="width:100%; border-collapse:collapse"><thead><tr style="height:2.85pt"><td colspan="2" style="border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><a id="_Hlk161917346"><span>Medical Device Standard</span></a></p></td></tr><tr style="height:2.85pt"><td style="width:12.8%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 1</span></p></td><td style="width:87.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p></td></tr><tr style="height:2.85pt"><td style="width:12.8%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Item</span></p></td><td style="width:87.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Matters</span></p></td></tr></thead><tbody><tr style="height:1pt"><td style="width:12.8%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:87.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>all of the following matters:</span></p><p class="ListParagraph" style="margin-top:3pt; margin-left:19.25pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.75pt; text-indent:0pt; display:inline-block"> </span><span>ISO 13485 certification for the manufacture of the therapeutic vaping device or the therapeutic vaping device accessory, issued by one of the following:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>an IAF accredited organisation;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>a notified body;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>an auditing organisation recognised by Health Canada;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iv)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>an Australian conformity assessment body determined under the MD</span><span> </span><span>Regulations;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>compliance to ISO 13485 for the manufacture of the therapeutic vaping device or the therapeutic vaping device accessory</span></p></td></tr><tr style="height:1pt"><td style="width:12.8%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:23.25pt; text-indent:-23.25pt"><span>2</span></p></td><td style="width:87.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="ListParagraph" style="margin-top:3pt; margin-left:0pt; line-height:115%; font-size:10pt"><span>all of the following matters:</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>ISO 14971 compliance for the application of risk management to the therapeutic vaping device or the therapeutic vaping device accessory, including but not limited to the management of:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>hazards or risks relating to the toxicity of emissions from the therapeutic vaping device or the therapeutic vaping device accessory, for the expected lifetime of the device, as identified in a toxicological risk assessment; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>hazards or risks relating to the toxicity of the materials within the therapeutic vaping device or therapeutic vaping device accessory, and any residues or contaminants, for the expected lifetime of the device; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>hazards or risks relating to batteries (if applicable), including risk of fire or explosion; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iv)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>electrical hazards or risks; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(v)</span><span style="width:6.19pt; text-indent:0pt; display:inline-block"> </span><span>hazards or risks relating to the usability of the therapeutic vaping device or the therapeutic vaping device accessory; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(vi)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>hazards or risks relating to the reasonably foreseeable misuse of the therapeutic vaping device or the therapeutic vaping device accessory; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(vii)</span><span style="width:0.63pt; text-indent:0pt; display:inline-block"> </span><span>hazards or risks relating to the containment of a therapeutic vaping substance in, and the administration of a therapeutic vaping substance by, the therapeutic vaping device or the therapeutic vaping device accessory; and</span></p><p class="ListParagraph" style="margin-left:40.5pt; text-indent:-21.25pt; line-height:115%; font-size:10pt"><span>(viii)</span><span style="width:1.25pt; text-indent:0pt; display:inline-block"> </span><span>hazards or risks relating to heating of the therapeutic vaping device or therapeutic vaping device accessory;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>the manufacturer must establish and maintain a risk management file, which documents the risk assessment process for managing all hazards or risks associated with a therapeutic vaping device or a therapeutic vaping device accessory, including the hazards or risks mentioned in paragraph</span><span> </span><span>(a)</span></p></td></tr><tr style="height:1pt"><td style="width:12.8%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:23.25pt; text-indent:-23.25pt"><span>3</span></p></td><td style="width:87.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="ListParagraph" style="margin-top:3pt; margin-left:0pt; line-height:115%; font-size:10pt"><span>all of the following matters, as applicable to the therapeutic vaping device or the therapeutic vaping device accessory:</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>for a primary battery (other than a button battery)—IEC 60086-1 certification (as</span><span> </span><span>applicable) issued by an accredited certification body;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>for a secondary battery (other than a button battery) that is a lithium battery—both of the following:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>UN/DOT 38.3 certification, or declaration of conformity with UN/DOT 38.3, supported by independent test reports from an ISO 17025 accredited laboratory;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>IEC 62133-2 certification issued by an accredited certification body;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(c)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>for a secondary battery (other than a button battery) that is a nickel system battery—IEC 62133-1 certification issued by an accredited certification body;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(d)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>for a button battery—compliance with all of the following:</span></p><p class="ListParagraph" style="margin-left:41.25pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.56pt; text-indent:0pt; display:inline-block"> </span><span>the </span><span style="font-style:italic">Consumer Goods (Button/Coin Batteries) Information Standard 2020</span><span>;</span></p><p class="ListParagraph" style="margin-left:41.25pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.78pt; text-indent:0pt; display:inline-block"> </span><span>the </span><span style="font-style:italic">Consumer Goods (Button/Coin Batteries) Safety Standard 2020</span><span>;</span></p><p class="ListParagraph" style="margin-left:41.25pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:3pt; text-indent:0pt; display:inline-block"> </span><span>the </span><span style="font-style:italic">Consumer Goods (Products Containing Button/Coin Batteries) Safety Standard 2020</span><span>;</span></p><p class="ListParagraph" style="margin-left:41.25pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(iv)</span><span style="width:3.56pt; text-indent:0pt; display:inline-block"> </span><span>the </span><span style="font-style:italic">Consumer Goods (Products Containing Button/Coin Batteries) Information Standard 2020</span></p><p class="ListParagraph" style="margin-top:3pt; margin-left:55pt; text-indent:-31.75pt; line-height:115%; font-size:9pt"><span>Note:</span><span style="width:11.75pt; text-indent:0pt; display:inline-block"> </span><span>These legislative instruments are published on the Federal Register of Legislation at www.legislation.gov.au</span></p></td></tr><tr style="height:1pt"><td style="width:12.8%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:23.25pt; text-indent:-23.25pt"><span>4</span></p></td><td style="width:87.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="ListParagraph" style="margin-top:3pt; margin-left:0pt; line-height:115%; font-size:10pt"><span>all of the following matters, as applicable to the therapeutic vaping device or the therapeutic vaping device accessory:</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>AS/NZS 3820 compliance with essential safety requirements for low voltage electrical equipment;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>AS/NZS 4417.1 compliance with marking of electrical products to indicate compliance with regulations</span></p></td></tr><tr style="height:1pt"><td style="width:12.8%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:23.25pt; text-indent:-23.25pt"><span>5</span></p></td><td style="width:87.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="ListParagraph" style="margin-top:3pt; margin-left:0pt; line-height:115%; font-size:10pt"><span>a therapeutic vaping device, and a therapeutic vaping device accessory as applicable, must be designed and constructed in a way that:</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>when operated in accordance with the instructions for use, the device provides the emitted mass or dose as specified and verified by the manufacturer; and</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>incorporates a reliable venting mechanism that channels the pressure wave in the direction where the harm is minimised; and</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(c)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>minimises the risk of inadvertent actuation; and</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(d)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>ensures that any external parts or accessible surfaces, other than the mouthpiece, of the device that may be held or grasped during use does not exceed 48°C during use; and</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(e)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>ensures that the external surface of the mouthpiece does not exceed 55°C during use; and</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(f)</span><span style="width:8.01pt; text-indent:0pt; display:inline-block"> </span><span>ensures that the device will withstand regular use, and foreseeable misuse or abuse, without breaking, leaking or failing in an unsafe manner; and</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(g)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>incorporates child-resistant features to prevent:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>the operation of the device by children; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>the accidental ingestion of components of, or substances contained in, the device; and</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(h)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>for a therapeutic vaping device or a therapeutic vaping device accessory that is, or contains, a battery—accords with relevant electrical safety standards to protect against overheating, short-circuiting, and the risk of explosion during use and recharging; and</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.56pt; text-indent:0pt; display:inline-block"> </span><span>prevents leaks of the therapeutic vaping substance being vaporised; and</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(j)</span><span style="width:8.56pt; text-indent:0pt; display:inline-block"> </span><span>ensures that all materials used in the inhalation pathway of the device, including any by-products or degradants, are biocompatible and the amount of harmful chemicals (such as heavy metals, volatile organic compounds, and other toxic substances) that the patient receives is less than the tolerable exposure limit below which there would be no appreciable risk to human health</span></p></td></tr><tr style="height:1pt"><td style="width:12.8%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:23.25pt; text-indent:-23.25pt"><span>6</span></p></td><td style="width:87.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="ListParagraph" style="margin-top:3pt; margin-left:0pt; line-height:115%; font-size:10pt"><span>the name (including brand name) of a therapeutic vaping device or a therapeutic vaping device accessory must not:</span></p><p style="margin-top:3pt; margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>be in any way attractive to children or adolescents; and</span></p><p style="margin-left:19.4pt; text-indent:-18pt"><span style="font-size:10pt">(b)</span><span style="width:6.34pt; text-indent:0pt; font-size:10pt; display:inline-block"> </span><span style="font-size:10pt">whether expressly or by implication—</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>suggest that the device is a food, beverage or cosmetic product; or</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>suggest that the device has health benefits other than its intended purpose, including healing, vitalising, natural, organic or rejuvenating properties; or</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>suggest that the device is safe, without harm or without side effects; or</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iv)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>promote the use or supply of the device; or</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(v)</span><span style="width:6.19pt; text-indent:0pt; display:inline-block"> </span><span>exaggerate, or be likely to exaggerate, the efficacy or performance of the device; or</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(vi)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>encourage, or be likely to encourage, inappropriate or excessive use of the device</span></p></td></tr><tr style="height:1pt"><td style="width:12.8%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:23.25pt; text-indent:-23.25pt"><span>7</span></p></td><td style="width:87.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="ListParagraph" style="margin-top:3pt; margin-left:0pt; line-height:115%; font-size:10pt"><span>all of the following matters:</span></p><p style="margin-top:3pt; margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>a therapeutic vaping device or a therapeutic vaping device accessory must be supplied with instructions for use of the device that are:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>in English (noting the instructions may also be provided in any other language); and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>clearly legible; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>supplied in paper or electronic format that is readily accessible to patients;</span></p><p class="Tabletext" style="margin-left:19.4pt; text-indent:-18pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>where the instructions for use are supplied in electronic format—a paper copy must be provided, without charge, to a patient upon request;</span></p><p class="Tabletext" style="margin-left:19.4pt; text-indent:-18pt"><span>(c)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>the instructions for use must contain the following information, in a text size of at least 3</span><span> </span><span>mm:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>the manufacturer’s name, or trading name, and address;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>the intended purpose of the device, the intended user of the device, and the kind of patient on whom the device is intended to be used;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>the device name, brand name and model;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iv)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>the batch code, lot number or serial number that identifies the kind of medical device;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(v)</span><span style="width:6.19pt; text-indent:0pt; display:inline-block"> </span><span>any particular handling or storage requirements applying to the device, including recommended storage conditions;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(vi)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>any warnings, restrictions or precautions that may apply in relation to the use of the device, including a statement that informs the patient or user to seek advice from a healthcare professional if the device is not functioning correctly;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(vii)</span><span style="width:0.63pt; text-indent:0pt; display:inline-block"> </span><span>if applicable, information about the risks associated with button or coin batteries;</span></p><p class="ListParagraph" style="margin-left:33.75pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(viii)</span><span style="width:0.1pt; text-indent:0pt; display:inline-block"> </span><span>any actions that need to be performed prior to using the device, including any preparatory actions for first-time use;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ix)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>information about how to use the device, including instructions for assembly;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(x)</span><span style="width:6.19pt; text-indent:0pt; display:inline-block"> </span><span>any cleaning requirements for the device;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(xi)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>information about the replacement of the consumable components of the device during its expected lifetime, including the size and type of battery;</span></p><p class="ListParagraph" style="margin-left:40.85pt; text-indent:-21.25pt; line-height:115%; font-size:10pt"><span>(xii)</span><span style="width:4.03pt; text-indent:0pt; display:inline-block"> </span><span>either the expiry date for the device or the expected lifetime of the device, indicated as duration of use after the first use or the number of actuations before being discarded;</span></p><p class="ListParagraph" style="margin-left:40.85pt; text-indent:-21.25pt; line-height:115%; font-size:10pt"><span>(xiii)</span><span style="width:1.25pt; text-indent:0pt; display:inline-block"> </span><span>any precautions a patient or user should take if there are risks associated with the disposal of the device, including instructions on how to dispose of the device or its parts, or how to recycle used batteries</span></p></td></tr><tr style="height:1pt"><td style="width:12.8%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:23.25pt; text-indent:-23.25pt"><a id="_Hlk175314291"><span>8</span></a></p></td><td style="width:87.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="ListParagraph" style="margin-top:3pt; margin-left:0pt; line-height:115%; font-size:10pt"><span>all of the following matters:</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>a therapeutic vaping device must be labelled with information that is:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>in English; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>clearly legible; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%"><span style="line-height:115%; font-size:10pt">(iii)</span><span style="width:2.85pt; text-indent:0pt; line-height:115%; font-size:10pt; display:inline-block"> </span><span style="line-height:115%; font-size:10pt">printed in a manner that is durable;</span><span> </span><span style="line-height:115%; font-size:10pt">and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iv)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>in a text colour that is matte grey or matte black, unless required by an applicable standard to be another colour; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(v)</span><span style="width:6.19pt; text-indent:0pt; display:inline-block"> </span><span>in a text colour that contrasts with the colour of the therapeutic vaping device;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>the label on the therapeutic vaping device must be matte white or matte grey, unless required by an applicable standard to be another colour;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(c)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>the label must contain the following information on the device itself:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>the sponsor’s name;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>the device name, brand name and model;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>the batch code, lot number or serial number that identifies the kind of medical device;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iv)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>the warning statement “Risk of fire or explosion. Replace only with the same size and type of battery”;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(d)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>the label must contain the following information on the device itself, or on the packaging of the device if it is impracticable or inappropriate to be on the device itself:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>the address of the sponsor;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>the name and address of the manufacturer;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(e)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>the information required by paragraphs (c) and (d) must be displayed in a text size of at least 3</span><span> </span><span>mm</span></p></td></tr><tr style="height:1pt"><td style="width:12.8%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:23.25pt; text-indent:-23.25pt"><span>9</span></p></td><td style="width:87.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="ListParagraph" style="margin-top:3pt; margin-left:0pt; line-height:115%; font-size:10pt"><span>all of the following matters:</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>a therapeutic vaping device accessory must be labelled with information that is:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>in English; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>clearly legible; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>printed in a manner that is durable; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iv)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>in a text colour that is matte grey or matte black, unless required by an applicable standard to be another colour; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(v)</span><span style="width:6.19pt; text-indent:0pt; display:inline-block"> </span><span>in a text colour that contrasts with the colour of the therapeutic vaping device;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>the label on the therapeutic vaping device accessory must be matte white, matte grey or matte black, unless required by an applicable standard to be another colour;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(c)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>the label must contain the following information on the vaping device accessory itself:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>the device name and model;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>the batch code, lot number or serial number that identifies the kind of medical device;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>if the therapeutic vaping device accessory contains a battery (of any kind)—the warning statement “Risk of fire or explosion. Replace only with the same size and type of battery”;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(d)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>the label must contain the following information on the vaping device accessory itself, or on the packaging or instructions for use of the vaping device accessory if it is impracticable or inappropriate to be on the vaping device accessory itself:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>the brand name;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>the sponsor’s name;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>the address of the sponsor;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iv)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>the name and address of the manufacturer;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(e)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>the information required by paragraphs (c) and (d) must be displayed in a text size of at least 1</span><span> </span><span>mm</span></p></td></tr><tr style="height:1pt"><td style="width:12.8%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:23.25pt; text-indent:-23.25pt"><a id="_Hlk175318673"><span>10</span></a></p></td><td style="width:87.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="ListParagraph" style="margin-top:3pt; margin-left:0pt; line-height:115%; font-size:10pt"><span>all of the following matters:</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>a therapeutic vaping device must be predominantly either matte white or matte grey, and feature no more than 3 other matte colours or shades, including the colour or shade of any text;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>a therapeutic vaping device accessory must be predominantly either matte white, matte grey or matte black, and feature no more than 3 other matte colours or shades, including the colour or shade of any text;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(c)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>where the therapeutic vaping device or therapeutic vaping device accessory features a colour or shade other than matte white or matte grey, that colour must not be visible when the device is fully assembled for use;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(d)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>a therapeutic vaping device or a therapeutic vaping device accessory may have a clear panel, which must be the smallest size that enables visibility of the amount of therapeutic vaping substance in the device;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(e)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>any information on a therapeutic vaping device or therapeutic vaping device accessory must be:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>in English; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>clearly legible; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>printed in a manner that is durable; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iv)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>in a text colour that is matte grey or matte black, unless required by an applicable standard to be another colour; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(v)</span><span style="width:6.19pt; text-indent:0pt; display:inline-block"> </span><span>in a text colour that contrasts with the colour of the therapeutic vaping device or therapeutic vaping device accessory;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(f)</span><span style="width:8.01pt; text-indent:0pt; display:inline-block"> </span><span>a therapeutic vaping device or a therapeutic vaping device accessory must not display:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>any words, symbols, trade marks, images, figures, logos or emblems, that are in contravention of another provision of this standard; or</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>any promotional statement, pictorial representation or design;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(g)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>a therapeutic vaping device or a therapeutic vaping device accessory must not include any features designed to change the appearance of the device, including the following:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>heat activated inks;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>inks or embellishments designed to appear gradually over time;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>inks that appear fluorescent in certain light;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iv)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>panels designed to be scratched or rubbed to reveal an image or text</span></p></td></tr><tr style="height:1pt"><td style="width:12.8%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:23.25pt; text-indent:-23.25pt"><a id="_Hlk175553060"><span>11</span></a></p></td><td style="width:87.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="ListParagraph" style="margin-top:3pt; margin-left:0pt; line-height:115%; font-size:10pt"><a id="_Hlk161745218"><span>all of the following matters:</span></a></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>a therapeutic vaping device or a therapeutic vaping device accessory must be supplied in a primary pack, where the label of the primary pack and the primary pack are white;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>any information on the label of the primary pack and the primary pack must be:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>in English; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>clearly legible; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>printed in a manner that is durable; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iv)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>in a text colour that is matte grey or matte black, unless required by an applicable standard to be another colour;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(c)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>the label of the primary pack and the primary pack must not contain the following:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>any feature that suggests, whether expressly or by implication, that the device has health benefits other than its intended purpose, including healing, vitalising, natural, organic, or rejuvenating properties;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>any words, symbols, trade marks, images, figures, logos or emblems that are in contravention of another provision of this standard;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>any promotional statement, pictorial representation or design;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(d)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>the label and packaging must not include any features designed to change the appearance of the primary pack, including the following:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>heat activated inks;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>inks or embellishments designed to appear gradually over time;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>inks that appear fluorescent in certain light;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iv)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>panels designed to be scratched or rubbed to reveal an image or text;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(v)</span><span style="width:6.19pt; text-indent:0pt; display:inline-block"> </span><span>removable tabs;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(vi)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>fold out panels;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(e)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>the label of the primary pack must include the warning statements:</span></p><p class="ListParagraph" style="margin-left:33.65pt; text-indent:-14.15pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:4.71pt; text-indent:0pt; display:inline-block"> </span><span>“KEEP OUT OF REACH OF CHILDREN”; and</span></p><p class="ListParagraph" style="margin-left:33.65pt; text-indent:-14.15pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:1.93pt; text-indent:0pt; display:inline-block"> </span><span>“WARNING CONTAINS BUTTON OR COIN BATTERY. HAZARDOUS IF SWALLOWED – SEE INSTRUCTIONS” (if applicable); and</span></p><p class="ListParagraph" style="margin-left:33.65pt; text-indent:-14.15pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:1.5pt; text-indent:0pt; display:inline-block"> </span><a id="_Hlk178153871"><span>“RISK OF FIRE OR EXPLOSION. REPLACE ONLY WITH THE SAME SIZE AND TYPE OF BATTERY”</span></a><span> (if applicable);</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(f)</span><span style="width:8.01pt; text-indent:0pt; display:inline-block"> </span><span>the warning statements required by paragraph (e) must be in bold</span><span>‑</span><span>face, sans serif, capital letters of uniform thickness and size</span></p></td></tr><tr style="height:1pt"><td style="width:12.8%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext" style="margin-left:23.25pt; text-indent:-23.25pt"><a id="_Hlk167172877"><span>12</span></a></p></td><td style="width:87.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="ListParagraph" style="margin-top:3pt; margin-left:0pt; line-height:115%; font-size:10pt"><span>a therapeutic vaping device or a therapeutic vaping device accessory must be subject to a toxicological risk assessment of the emissions from the device, for the expected lifetime of the device, including but not limited to an assessment of all of the following, having regard to the generally acknowledged state of the art:</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>the atomiser (or the part of the device that heats and vaporises the therapeutic vaping substance);</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>all materials within the device that the therapeutic vaping substance and its vapour come in contact with;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(c)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>any leachable substances, contaminants and thermal degradation products from the device</span></p></td></tr></tbody></table>