About this form
This form allows sponsors of notified therapeutic vaping goods, which includes therapeutic vaping kits, to provide information to the Therapeutic Goods Administration (TGA) about the supply of those goods during a specified period, upon formal request by the Secretary or their delegate.
Legislation
The Supply of therapeutic vaping goods: Response to request for information form is made under:
- Subparagraph (j)(iii) in column 3 of item 15 of Schedule 5A to the Therapeutic Goods Regulations 1990 (the TG Regulations).
- Subparagraph (i)(iii) in the column headed “Conditions” of item 2.17 of Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations).
How to submit this form
The completed form should be submitted as an ‘.xlsx’ file to NVPcompliance@health.gov.au by the date specified in the request.
Please note that under subparagraph (j)(i) in column 3 of Item 15 and subparagraph (i)(i) in the column heading ‘Conditions” of Item 2.17, sponsors are required to keep records relating to the source and supply of the therapeutic vaping goods as a condition of exemption.
The TGA may request that sponsors provide further information or evidence in support of the information provided in response to the request. This may be in addition to taking other regulatory actions if the request for information is not complied with.