Sponsor notice - Therapeutic vaping goods

About this form

This form allows sponsors to submit certain notices to the Secretary of the Department of Health and Aged Care (the Secretary) in relation to:

• unregistered therapeutic vaping goods that are intended for smoking cessation or the management of nicotine dependence; or
• nicotine in solution to be imported into Australia for use in the manufacture of therapeutic vaping goods or any other therapeutic good; or
• other starting material, ingredients, components or articles to be imported into Australia for use in the manufacture of therapeutic vaping goods. 

Sponsors must only submit this form where their goods meet regulatory requirements, including conformance with applicable product requirements (including applicable standards or the Essential Principles).

• A sponsor notice must be submitted before:
  • unapproved therapeutic vaping goods are imported into Australia or, for finished goods that are manufactured in Australia, before those goods are first supplied in Australia;
  • nicotine in solution, other starting material, ingredients, components or articles are imported into Australia.
• A re-statement of compliance notice must be submitted when the Secretary, or their delegate, formally requests the sponsor to submit a further notice for a particular therapeutic vaping good. 

A separate form must be completed for each type of therapeutic vaping good, starting material, ingredient, component or article. 

For therapeutic vaping goods:

• a sponsor must only submit this form if the goods comply with applicable standards or the Essential Principles. The sponsor must hold information evidence that demonstrates this compliance, and the Secretary may request this information or evidence from you at any time once a notice has been given.
• if a notice is intended to be made for therapeutic vaping goods imported for further manufacture in Australia, a separate notice will need to be made for each finished good prior to supply.

You should be aware that the TGA may publish certain information relating to your notice – such as your name and the details of your good.

What you’ll need to complete this form

• Your TGA client ID - see here guidance on setting up a TGA client ID.
• Details about your therapeutic vaping good, starting material, ingredient, component or article – you will need to tell us key details about the product you intend to import, or supply following domestic manufacture.
• (for sponsor notices) manufacturer information – we need to know the details of the manufacturer.

Legislation

The sponsor notice form is made under:

• paragraph (e) in column 2 of item 15, and paragraph (a) in column 3 of item 16, of Schedule 5A to the Therapeutic Goods Regulations 1990 (the TG Regulations).
• paragraph (b) in the column headed “Kinds of medical devices” of item 2.17, and paragraph (a) in the column headed “Conditions” of item 2.18, of Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations).

The re-statement of compliance notice form is made under:

• paragraph (e) in column 3 of item 15 of Schedule 5A to the TG Regulations.
• paragraph (e) in the column headed “Conditions” of item 2.17 of Part 2 of Schedule 4 to the MD Regulations.