NEW AUSTRALIAN REGULATION FOR
NICOTINE PRODUCTS
TGO 110
The Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021 (TGO 110) is a product standard made under section 10 of the Therapeutic Goods Act 1989 (Act)
Commencement Date - Oct 1, 2021
Nicotine vaping products captured by TGO 110
1. Both nicotine base products (salt and freebase)
2. Nicotine mixed Flavoured E-liquids (3mg-36mg)
TGO 110 doesn't apply to:
1. Vaping products carried by travellers to AU in accordance with the *Traveller’s Exemption.
2. Vaping products that do not contain nicotine (0mg/0%/Non-Nicotine)
PIS - PERSONAL IMPORTATION SCHEME
The Personal Importation Scheme provided for by Item 1 of Schedule 5 to the Therapeutic Goods Regulations 1990 allows a person to import up to 3 months’ worth of an unregistered nicotine vaping product for themselves or an immediate family member with a valid prescription (which may include a prescription issued under the APS or SAS). This includes where a person fills their prescription online using an overseas supplier.
REQUIREMENTS
1. Maximum Nicotine concentration/content is 100mg/ml.
2. Should clearly specify the concentration on the label as ingredient requirement.
*Customs can deny the package if this is not met
SPONSOR
The sponsor of a nicotine vaping product is the person who:
• imports, exports, or manufactures (for supply in Australia), the product, or
• arranges for another person to do any of those things in relation to the product.
*HILIQ is considered a Sponsor
RECORDS MUST BE KEPT:
1. Design that conforms to child-resistant packaging
2. Label of the product and info sheet provided with it (if there's any)
3. Certificate of Analysis (COA)
UPDATES AND RECORD RETENTION:
1. Keep it at least 12 months after the expiry date.
2. 5 years after the product is last imported, exported or manufactured for supply in Australia, or supplied by you or on your behalf, whichever comes later.
LABELLING OF NICOTINE PRODUCTS:
1. Ingredient list,
2. Statement of nicotine concentration:
HILIQ can sell salt in this maximum concentration:
Nicotine Salt | Equivalent Nicotine Content |
200mg/ml Salt A | 80.4mg/ml |
200mg/ml Salt B | 92mg/ml |
3. Three specific warning statements.
- • KEEP OUT OF REACH OF CHILDREN’
- • ‘Avoid contact with eyes’
- • ‘Avoid contact with skin’
4. Must be in English, legible, visible (and not obscured) and durable
5. Add "Flavour" e.g Cherry Flavour
6. CRP (Child-Resistant Packaging)
CONTAINER VOLUME
TGO 110 has set no limit no restriction with the volume of order so it is dependent on the prescription of the HP.
People will only be able to purchase the amount of the product they have been prescribed.
People using the Personal Importation Scheme can only import up to 3 months’ supply per importation.
ACTIVE INGREDIENTS
Nicotine is the only allowed active ingredients.
Ingredients such as cannabinoids, vitamins, amino acids, caffeine and other stimulants that have a physiological or pharmacological effect in the final formulation.
PROHIBITED INGREDIENTS
Acetoin, Benzaldehyde, Cinnamaldehyde, Diacetyl, Diethylene Glycol, Ethylene Gycol, Pentane-2,3-dione (2,3-pentanedione or acetylpropionyl), Vitamin E Acetate.
HILIQ does not use these ingredients on our products.
OTHER IMPORTANT NOTES:
1. Vaping devices are not regulated by the TGA (disposablws, e-cigs, pods, e-pen, e-cigars, e-pipes etc)
2. Refillable devices that are used with medicines are regulated by TGA
3. Must report side effects to the TGA
This is a summarized version brought to you by HILIQ Australia.
To fully understand the laws, you may read it entirely through this link:
*Contact us if there are changes or other important information we can add.
How to get prescription:
1. Contact your general physician or any registered medical practitioner (MD) in your area.
2. Discuss your personal usage of Nicotine with the MD. They will prescribe you the amount of nicotine you would need.
3. Pay the cost, around $80-$100 AUD depending on the charge of your MD. Some % can be refunded using your health card or insurance. Please talk with your doctor/agent with this.
4. Place your Nicotine order on our website, www.hiliqau.com based from your MD's prescription.
5. Upload the issued prescription on our website at the checkout before payment.
6. Keep the original copy of your prescription and present to the authorities in case asked.
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Non-nicotine HILIQ products can be ordered without Prescription.