Exemptions for the sale or supply of lawfully prescribed nicotine

From 1 October 2021, changes by the Therapeutic Goods Administration (TGA) to the national classification of nicotine in the Poisons Standard clarify the regulation of nicotine as a Schedule 4 Prescription Only Medicine.

The effect of the national changes will be that consumers who wish to legally access nicotine-containing e-cigarettes and nicotine vaping products in Australia will require a prescription from an Australian medical practitioner, including for accessing products that are imported into Australia. There are currently no nicotine vaping products approved by the TGA and registered in the Australian Register of Therapeutic Goods (ARTG). Medicines that are not in the ARTG are known as ‘unapproved’ medicines. Pharmacists can only dispense a prescription for nicotine vaping products with evidence that the prescriber has TGA approval through the TGA Authorised Prescriber or Special Access Scheme (Category B).

The TGA has information available for consumers, health professionals, sponsors, wholesalers and manufacturers, including links to resources and factsheets about access to nicotine vaping products at https://www.tga.gov.au/nicotine-vaping-products

See the Access to Nicotine Products Fact Sheet (236 KB)

A Proclamation under the Tobacco and E-Cigarette Products Act 1997 was issued so that pharmacists and medical practitioners, who may under the Controlled Substances Act 1984 sell or supply nicotine lawfully prescribed as a Schedule 4 Prescription Only Medicine, are exempt from:

  • the licence requirement for selling an e-cigarette product;
  • the offence of selling an e-cigarette product if the order for the e-cigarette product has been placed by mail, telephone, fax, email, Internet or other electronic means; and
  • the offence of selling or supplying an e-cigarette product to a minor.

These exemptions apply from 1 October 2021 and support the lawful sale or supply of nicotine as Schedule 4 Prescription Only Medicine for smoking cessation.

Download a copy of the Proclamation.

E-Cigarette liquids

On 1 October 2021, the Tobacco and E-Cigarette Products (E-Cigarette Liquid)
Variation Regulations 2021 were made to clarify the intent of the scope of the Tobacco and E-Cigarette Products Act 1997 to regulate liquids within the definition of 'e-cigarette product'.

These changes do not affect the current regulation of liquid nicotine, which is regulated under the South Australian Controlled Substances Act 1984Nicotine for use in e-cigarette products cannot be lawfully sold by tobacco or e-cigarette retailers in South Australia. It is also an offence to be in possession of a Schedule 4 Prescription Only Medicine, including nicotine, unless it has been lawfully prescribed and supplied to that person.

For queries about the changes to the national classification of nicotine and how to legally access nicotine-containing e-cigarettes and nicotine vaping products, please contact TGA at info@tga.gov.au or telephone 1800 020 653.

If you have queries about South Australia’s e-cigarette laws, please contact Health Protection Operations, SA Health, by email HealthProtectionOperations@sa.gov.au or telephone (08) 8226 7100.