This standard does not apply to export only products. Unapproved products (other than those imported via the Personal Importation Scheme) will need to comply with subsection 11(1) of the Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018. Unapproved and export only nicotine vaping products that are subject to TGO 110 are not required to comply with monograph(s) in the British Pharmacopoeia, European Pharmacopoeia or United States Pharmacopeia-National Formulary that would otherwise apply to those products as default standards. Australian sponsors of unapproved and export only nicotine vaping products must maintain records demonstrating conformance to the requirements of TGO 110.įurther information on the requirements of TGO 110 is available in our Guidance for Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021 and related matters (Guidance on TGO 110). All of the requirements of TGO 110 apply when the products are supplied within Australia. Some, but not all, of the requirements of TGO 110 apply at the time a product is imported into, or exported from, Australia. records that need to be kept by the Australian sponsor for the product.requiring actual nicotine concentration/content to reflect what the product's label says.maximum nicotine concentration (although people will still only be able to access the nicotine concentration in their prescription).product labelling (including an oversticker or in an information sheet provided with the product).TGO 110 includes minimum safety and quality requirements for unapproved and export only nicotine vaping products. The TGA has introduced a standard for unapproved and export only nicotine vaping products, known as the Therapeutic Goods (Standard for Nicotine Vaping Products (TGO 110) Order 2021 (TGO 110), that came into effect on 1 October 2021. Product standard for unapproved and export only nicotine vaping products Export only nicotine vaping products are not subject to TGA assessment prior to listing in the ARTG. These are known as ‘export only’ products. ![]() Prescription medicines that are intended for export only must generally be listed in the ARTG prior to export. The pathways through which unapproved nicotine vaping products can be imported, manufactured and supplied are outlined below. Medicines that are not in the ARTG are known as ‘unapproved’ medicines. There are currently no TGA approved nicotine vaping products registered in the ARTG. ![]() ![]() Generally, prescription medicines must be approved by the Therapeutic Goods Administration (TGA) and registered in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully imported into, or supplied in, Australia. Unapproved and export only nicotine vaping products Nicotine replacement therapies (NRTs) (including sprays, patches, lozenges, chews and gums) that do not require a prescription will continue to be available from pharmacies and some retail outlets. Further information about the reasons for this change is available on the Nicotine vaping product access page. It remains illegal for other Australian retailers, such as tobacconists, 'vape' shops and convenience stores, to sell consumers nicotine vaping products. This includes purchases from Australian pharmacies and overseas. Consumers require a prescription for all purchases of nicotine vaping products. Nicotine vaping products are prescription medicinesĪs of 1 October 2021, all nicotine vaping products, such as nicotine e-cigarettes, nicotine pods and liquid nicotine, are Schedule 4 (prescription only) medicines. This page provides an overview of how Australian sponsors can import, manufacture, supply and export nicotine vaping products and how wholesalers can supply nicotine vaping products to Australian pharmacies.
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