Therapeutic Goods (Therapeutic Vaping Goods - Transitional Manufacturer Notification Form) Approval 2024

I, Chris Bedford, as delegate of the Secretary of the Department of Health and Aged Care, make the following approval.

Acting First Assistant Secretary
Regulatory Practice and Support Division
Health Products Regulation Group
Department of Health and Aged Care

1  Name

This instrument is the Therapeutic Goods (Therapeutic Vaping Goods—Transitional Manufacturer Notification Form) Approval 2024.

2  Commencement

(1)    Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

^{Note:    This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.}

(2)    Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

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

4  Definitions

_{Note:    A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a)    Secretary;
(b)    therapeutic goods.}

In this instrument:

Act means the Therapeutic Goods Act 1989.

Regulations means the Therapeutic Goods Regulations 1990.

TGA, or Therapeutic Goods Administration, means the part of the Department known as the Therapeutic Goods Administration.

5  Approved form 

For the purposes of notifying the Secretary of a step in the manufacture of therapeutic goods under subregulation 97(1) of the Regulations, the approved form is the online form titled Notification to carry out steps in the manufacture of therapeutic vaping goods (January 2024), as in force or existing on 30 January 2024, and accessible via the transitional manufacturers link under the Manufacturing unapproved vapes for smoking cessation or the management of nicotine dependence heading, within the Vapes: information for importers, manufacturers and wholesalers page of the Vaping hub on the Therapeutic Goods Administration website.

_{Note:    The Therapeutic Goods Administration website can be accessed at www.tga.gov.au.}

6  Repeals

Each instrument that is specified in Schedule 1 is repealed as set out in the applicable items in that Schedule.

Schedule 1—Repeals

_{Note:    See section 6.}

Therapeutic Goods (Therapeutic Vaping Goods—Transitional Manufacturer Notification Form) Approval 2023

1  The whole of the instrument

Repeal the instrument.