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Following our Essential Principles presentations on 11-12 September 2024, we have collated questions asked into themes to simplify finding information of relevance to you.

We are introducing strengthened product standards for therapeutic vapes including vaping substances, vaping substance accessories, vaping devices and vaping device accessories.

Patients 18 years or over can purchase therapeutic vapes from participating pharmacies without a prescription. A consultation with a pharmacist is required, and purchase is subject to certain conditions as well as any state and territory restrictions.

This instrument is made under section 39 of the current Poisons Standard.

The TGA is working with participating businesses to arrange the surrender of their vaping goods.

A two-day joint enforcement operation has led to the seizure of more than 10,000 nicotine pouches and hundreds of illicit vaping goods.

The Scheme allows businesses to surrender certain quantities of vaping goods that were lawful prior to 1 July 2024. Notify us before September 2024 to participate.

The Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 will take effect on 1 July 2024, following passage through the Australian Parliament.

The Bill is part of reforms to prevent and reduce the use of vapes in Australia, unless clinically appropriate for stopping smoking or the management of nicotine dependence.  

The Minister for Health and Aged Care, the Hon Mark Butler MP, introduced a bill that aims to reduce the widespread availability of vapes by controlling all levels of the supply chain.

The Australian Border Force (ABF) and partners have seized more than five and a half million cigarette sticks and prevented hundreds of thousands of prohibited vapes and drug items from reaching the streets of Sydney.

This instrument is made under regulation 97 of the Therapeutic Goods Regulations 1990.

This instrument is made under Schedule 5A to the Therapeutic Goods Regulations 1990 and Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002.

The TGA has issued 18 infringement notices totalling $157,752 to Kilpatrick & Douglas Pty Ltd and two directors, for the alleged unlawful advertising of nicotine vapes

On 1 January 2024, as part of the reforms to the regulation of vaping products, the Advertising Permission for Nicotine was repealed.

This instrument is made under Schedule 5A of the Therapeutic Goods Regulations 1990 and Schedule 4 of the Therapeutic Goods (Medical Devices) Regulations 2022.

This instrument is made under regulation 97 of the Therapeutic Goods Regulations 1990.

From 1 January 2024, the importation of disposable vapes will be prohibited, subject to very limited exceptions. Read more about the first stage of Australia’s vaping reforms.

The changes will help address the significant public health issues caused by vaping in Australia, while keeping legitimate patient access to therapeutic vapes.

To help sponsors and manufacturers transition to new manufacturer evidence.

The TGA has issued 38 infringement notices totalling $588,840 to four Sydney-based entities for allegedly importing 22 consignments containing a total of 379,600 nicotine vaping products.

Transition period for accepting ISO 13485 ends 26 May 2023.

The TGA will recognise the extended transition for the European Union Medical Device Regulation (EU MDR).

The TGA has issued nine infringement notices to three companies and two associated individuals for the alleged unlawful importation of nicotine vaping products.

The TGA has issued a direction notice to a Melbourne-based individual to cease advertising of all nicotine vaping products.