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I, Chris Bedford, as delegate of the Secretary of the Department of Health and Aged Care, make the following approval.
Dated 31 January 2024
Chris Bedford
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—Sponsor Notice 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.
Column 1 | Column 2 | Column 3 |
---|---|---|
Provisions | Commencement | Date/Details |
1. The whole of this instrument | The day after this instrument is made. |
Note: This table relates only to the provisions of this instrument as originally made.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:
(a) items 15 and 16 in the table in Schedule 5A to the Therapeutic Goods Regulations 1990; and
(b) items 2.17 and 2.18 in the table in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002.
4 Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) medical device;
(b) Secretary;
(c) therapeutic goods.
In this instrument:
Act means the Therapeutic Goods Act.
MD Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.
Regulations means the Therapeutic Goods Regulations 1990.
5 Approved notice form
For the purposes of items 15 and 16 in the table in Schedule 5A to the Regulations and items 2.17 and 2.18 in the table in Part 2 of Schedule 4 to the MD Regulations, the approved form for a sponsor notice mentioned in those items is the form titled Sponsor notice – Vaping goods (January 2024).
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Each instrument that is specified in Schedule 1 is repealed as set out in the applicable items in that Schedule.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—Sponsor Notice Form) Approval 2023
1 The whole of the instrument
Repeal the instrument.