Information for manufacturers and importers (notifiers)

Information on requirements for manufacturers and importers of vaping products.

Manufacturers and importers of notifiable products have certain requirements they need to follow in order to sell vaping, herbal smoking and smokeless tobacco products in New Zealand:

  • You need to notify the Vaping Regulatory Authority about the vaping, herbal smoking and smokeless tobacco products you intend to sell in New Zealand and also to renew any notifications that have expired. Learn more about the product notification process
  • You are obliged to report any adverse reactions to the products you manufacture or import as soon as you become aware of them. You can report this through a form on the New Zealand Pharmacovigilance Centre website.
  • Manufacturers and importers (and specialist vape retailers) must keep sales records and provide annual reports and returns to the Vaping Regulatory Authority. The reports and returns will be due with the Authority by 31 January each year for the previous calendar year.

Product notifications

All manufacturers and importers (notifiers) of vaping, herbal smoking and smokeless tobacco products (notifiable products) must notify the Vaping Regulatory Authority about the products they intend to sell in New Zealand. There is a $50 per product plus GST (renewed annually) for the processing of the product notification.

Note that:

  • replacement parts for a device can be notified as part of a device notification.
  • Different container sizes or nicotine strengths of the same brand or product can be notified under a single notification and will therefore attract only one notification fee.

Notifiers can notify their notifiable products through the Health Advisory and Regulatory Platform (HARP). All products must comply with the relevant product safety requirements outlined in the Smokefree Environments and Regulated Products Regulations 2021 before they can be notified. Each manufacturer or importer of a product must complete their own notification for that product.

Notifications must be renewed every 12 months, or they will expire. Manufacturers and importers must also complete a new notification, and cancel their existing notification, for a product if it undergoes a significant change after it has been notified.

The Director-General of Health may suspend or cancel product notifications, although manufacturers and importers have the right to appeal to an independent Appeals Committee about a proposed suspension or cancellation.

The Director-General may also ensure products do not pose an unacceptable risk of harm by:

  • declaring maximum limits for substances within a product
  • declaring substances that are prohibited for use in a product
  • requiring information about the safety of a product
  • issuing public warnings about the safety of a product
  • issuing a recall notice for a product.

Notifiable Products – products that are no longer notified

Notifiable products must not be sold in New Zealand if their notification has been withdrawn, suspended or cancelled.

Notifiable products must not be sold in New Zealand if their notification has been withdrawn, suspended or cancelled. If a notification expires, the product notifier must stop selling it immediately, but provided there are no safety concerns with the product, retailers can continue to sell-through their existing stock for up to three months. 

It can be difficult to keep track of the current status of each notified product. As a result, we have compiled a list of products that were previously notified and therefore were able to be sold in New Zealand but are now no longer notified. This means that they can no longer be legally sold, except for expired notifications with no safety concerns where retailers have the three months sell through period for their existing stock. 

Please note that this list is provided as guidance only and is intended to provide retailers with a quick way to identify products that they should no longer be selling. Due to the rate and volume of changes to notified products, we cannot guarantee this list is complete or up-to-date. Retailers, manufacturers and importers are still responsible for ensuring all notifiable products they sell have a current notification and that they meet all relevant statutory requirements. 

The list of notifiable products that are no longer notified is available here: Notified Products No Longer Notified (Excel, 53 KB) - current as of 22 December 2022 

The current status of all products can be found on the notified products register, which is available on the Ministry’s Notified Products Database 

Obligation to report adverse reactions

Manufacturers and importers of vaping, herbal smoking and smokeless tobacco products (notifiable products) must report any adverse reactions from those products to the Vaping Regulatory Authority as soon as they become aware of them via the New Zealand Pharmacovigilance Centre.

Record-keeping requirements

The Smokefree Environments and Regulated Products (Smoked Tobacco) Amendment Act received Royal assent on Friday 16 December 2022 and new provisions came into effect from 1 January 2023.

Under the new provisions, manufacturers, importers, exporters, distributors and retailers of regulated products (smoked tobacco, vaping, herbal smoking and smokeless tobacco products) are responsible for keeping accurate records relating to all of their regulated products.

Manufacturers, importers, exporters, distributors and retailers of a regulated product must take reasonable steps to keep accurate records of:

  1. all the regulated products that they manufacture, import, export, buy, sell, or supply; and
  2. for a manufacturer, the constituents required by regulations to be recorded that the manufacturer uses or intends to use in the manufacture of each regulated product.

Records must be kept for 3 years from the date of each transaction.

An enforcement officer may require a person to provide a copy of the records kept under this section by notice in writing.

The person must provide the enforcement officer with a copy of the records, in the format required in the notice, within 10 working days of receiving the notice.

Our expectation is that a manufacturer/importer/exporter will already be keeping accurate records as part of their normal business practice. There is no particular format that businesses must use for their records – it will depend on each business’s management system. The Act requires records to be kept for 3 years, and requires them to be provided to an enforcement officer upon request by written notice. The enforcement officer will stipulate in the notice whether the records should be provided in paper or electronic format, and how they should be delivered. Only existing records in their existing format will need to be provided.

The Act does not specify exactly what records must be kept but our expectation is that records would include:

  • What products they have purchased, who they purchased them from and when
  • What products they have sold and when
  • Purchase and sale prices
  • Who they sold products to and when
  • Batch/serial numbers of products bought and sold

In addition, for manufacturers

  • Constituents used or intended to be used in the manufacture of each regulated product
  • What constituents they have purchased, who they purchased them from and when
  • Batch/serial numbers of constituents bought and sold

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