Document ID: chunk:federal_register_of_legislation:F2024C00866:clause:1_1:p3
Version: federal_register_of_legislation:F2024C00866
Segment Type: clause
Provision Reference: sch 1 cl 1 (pt 3/8)
Character Range: 16569–20159

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
   6                     the name (including brand name) of a therapeutic vaping device or a therapeutic vaping device accessory must not:
                           (a) be in any way attractive to children or adolescents; and
                           (b) whether expressly or by implication—
                              (i) suggest that the device is a food, beverage or cosmetic product; or
                              (ii) suggest that the device has health benefits other than its intended purpose, including healing, vitalising, natural, organic or rejuvenating properties; or
                              (iii) suggest that the device is safe, without harm or without side effects; or
                              (iv) promote the use or supply of the device; or
                              (v) exaggerate, or be likely to exaggerate, the efficacy or performance of the device; or
                              (vi) encourage, or be likely to encourage, inappropriate or excessive use of the device
   7                     all of the following matters:
                           (a) a therapeutic vaping device or a therapeutic vaping device accessory must be supplied with instructions for use of the device that are:
                              (i) in English (noting the instructions may also be provided in any other language); and
                              (ii) clearly legible; and
                              (iii) supplied in paper or electronic format that is readily accessible to patients;
                           (b) where the instructions for use are supplied in electronic format—a paper copy must be provided, without charge, to a patient upon request;
                           (c) the instructions for use must contain the following information, in a text size of at least 3 mm:
                              (i) the manufacturer's name, or trading name, and address;
                              (ii) 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;
                              (iii) the device name, brand name and model;
                              (iv) the batch code, lot number or serial number that identifies the kind of medical device;
                              (v) any particular handling or storage requirements applying to the device, including recommended storage conditions;
                              (vi) 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;
                              (vii) if applicable, information about the risks associated with button or coin batteries;
                             (viii) any actions that need to be performed prior to using the device, including any preparatory actions for first-time use;
                              (ix) information about how to use the device, including instructions for assembly;
                              (x) any cleaning requirements for the device;
                              (xi) information about the replacement of the consumable components of the device during its expected lifetime, including the size and type of battery;
                              (xii) either the expiry date