Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:6:p14
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 6 (pt 14/19)
Character Range: 252111–254936

application was made:
 (i) solely in relation to the application of one or more of those clauses; or
 (ii) also in relation to the application of either or both of clauses 13A.2 and 13A.3 of Schedule 1, but not any other provision; and
 (e) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the application under item 1.15 of the table in Part 1 of Schedule 5;
the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the application under regulation 9.1AA if the application had been made on the day on which this regulation commences.

11.70  Exempt medical devices
  The amendment of Schedule 4 made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a medical device that is imported into Australia on or after the commencement of this regulation.

Division 11.17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023

11.71  Clinical trials
  The amendments of item 2.3 of the table in Part 2 of Schedule 4 made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of a medical device on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.

Division 11.18—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023

11.72  Clinical trials
 (1) The amendments of subregulation 7.4(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.
 (2) The amendment of Schedule 4 to these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 applies in relation to:
 (a) requests made on or after the commencement of that amendment to give information acquired before, on or after that commencement; and
 (b) things mentioned in regulation 7.4 of these Regulations done on or after that commencement;
in relation to a clinical trial that began before, on or after that commencement.

Division 11.19—Application provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023

11.73  Application of amendments
  The amendments of these Regulations made by Part 1 of Schedule 2 to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023