Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:6:p17
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 6 (pt 17/19)
Character Range: 259659–262502

Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024.

11.80  Application of amendments
 (1) The amendment made by item 3 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.
 (2) The amendments made by items 4 and 5 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.
 (3) The amendments made by items 6 and 7 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported on or after 1 October 2024.
 (4) The amendment made by item 8 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.
 (5) The amendment made by item 12 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 October 2024.

11.81  Transitional vaping devices—exemption from Division 3 of Part 4‑11 of the Act
 (1) For the purposes of this regulation, medical devices that are exported from Australia are transitional vaping devices if:
 (a) the devices are therapeutic vaping devices, therapeutic vaping device accessories or therapeutic cannabis vaping goods; and
 (b) the devices were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and
 (c) as at that commencement, the importation or manufacture, or any supply, of the devices was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.

Exemption
 (2) For the purposes of paragraph 41HA(1)(b) of the Act, transitional vaping devices are exempt from the operation of Division 3 of Part 4‑11 of the Act.

When exemption ceases
 (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.

Division 11.23—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024

11.82  Definitions
  In this Division:
amending regulations means the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024.
commencement day means the day this Division commences.
conditions column means the column headed "Conditions" in the table in Part 2 of Schedule 4.
devices column means the column headed "Kinds of medical devices" in the table in Part 2 of Schedule 4.

11.83  Exempt therapeutic goods
 (1) Subject to this regulation, the amendments of these Regulations made by Part 1 of Schedule 1 to the amending regulations apply in relation to therapeutic goods that are:
 (a)