Nicovape Q50 - Freshmint (50 mg/mL) – Notification ID: VG-2024-NTF-00235 , Liber Pharmaceuticals Ltd , CON-1380

1. Liber Pharmaceuticals Ltd must take every reasonable effort to inform each pharmacist, medical practitioner or nurse practitioner (or the practice manager or purchasing officer of that person) (the Recipient) who possesses, supplies or prescribes any quantity of the goods at any time while this consent is effective that: a. the goods do not conform with an applicable standard, being TGO 110, from 1 July 2025, in relation to labelling requirements; b. Liber Pharmaceuticals Ltd has been granted a consent to supply the Goods for a period of 3 months, subject to conditions; c. the goods should not be supplied without a hardcopy Patient Information Leaflet (PIL) approved for distribution by the Therapeutic Good Administration (TGA); and d. the Recipient can request hardcopy PILs from Liber. 2. The Patient Information Leaflet (PIL) must: a. be at least A5 size; a. include the following statements (or alternative statement(s) prescribed by the Approver), in text size that is at least 4mm:   i. a warning statement in capital letters that “THIS PRODUCT CONTAINS NICOTINE, WHICH IS A HIGHLY ADDICTIVE SUBSTANCE”;   ii. the words “the form of nicotine in this product is nicotine benzoate”;   iii. the words “Poisons Information Centre” followed immediately by Poisons Information Centre contact information; and   iv. the warning statement “Do not swallow”. b. not contain any statement which:   v. could minimise the seriousness or accuracy of the statements specified in para 2.b.; or   vi. is promotional in nature. 3. Liber Pharmaceuticals Ltd must, at its own cost, take every reasonable effort to ensure that PIL’s in A5 size are available to each Recipient, who may reasonably be anticipated by Liber will possess, supply or prescribe any quantity of the goods at any time while this consent is effective. At a minimum, Liber Pharmaceuticals Ltd must as soon as reasonably practicable: Wholesalers a. provide a number of hardcopies of the PIL to each wholesaler of the goods which is equal to or greater than the quantity of the goods possessed by the wholesaler; b. instruct each wholesaler to include, in each shipment of goods to a Recipient, a number of PIL’s equal to or greater than the quantity of the goods in the shipment; Recipients c. establish a facility on its website where any Recipient can:   i. access and print one or more copies of the PIL; and   ii. request one or more printed PILs from Liber;  d. if requested by a Recipient to provide one or more printed PIL, provide to the Recipient the quantity requested by them (unless that quantity is unreasonably greater than the number of goods possessed by the Recipient);  e. take every reasonable effort to establish a mechanism in pharmacy dispensing software to, at the point of dispensing, alert pharmacists to the matters specified above in Condition 1 and provide them with the option to print a PIL.