Document ID: chunk:federal_register_of_legislation:F2024L00839:clause:1_34
Version: federal_register_of_legislation:F2024L00839
Segment Type: clause
Provision Reference: sch 1 cl 34
Character Range: 24775–27131

34  In the appropriate position in Part 11
Insert:

Division 11.22—Application provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024

11.79  Definitions
  In this Division:
amending regulations means the 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.

Therapeutic Goods Regulations 1990