Smartstop products are not registered on the Australian Register of Therapeutic Goods (ARTG) and can only be prescribed through the Special Access Scheme (SAS), the Authorised Prescriber Scheme (AP) or by Clinical Trial as they are unapproved therapeutic goods. Unapproved therapeutic goods have not been evaluated for quality, safety, efficacy or performance. Therefore, the prescribing health practitioner must consider the available evidence to support the use of the unapproved product and any potential risks for the individual patient. The responsibilities of the prescribing health practitioner include adhering to relevant standards of the goods medical practice and obtaining informed consent. The long-term health risks of unapproved products, even those that comply with TGO 110, are still unclear. Patients can also call Quitline 13 78 48 or visit the Quit Now website. Smartstop is a pharmacy marketing group on behalf of Amcal Pharmacy Prahran.
