Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:6:p13
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 6 (pt 13/19)
Character Range: 249776–252325

application of a kind covered by paragraph (a) or (b) of item 1.15 of the table in Part 1 of Schedule 5; and
 (b) the application was made in relation to the application of one or more of clauses 13.1 to 13.4 of Schedule 1 to the medical device or devices; and
 (c) the reason for the medical device or devices not complying with one or more of those clauses was that the device or devices were affected by the EU transition (within the meaning of subregulation 9.1AA(3) of these Regulations); and
 (d) the 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.

Division 11.16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022

11.69  Fee for application for consent of Secretary
 (1) The amendments of regulation 9.1AA made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 apply in relation to an application for consent that is made on or after the commencement of this regulation.
 (2) If:
 (a) on or after 1 January 2022 and before the commencement of this regulation, a person made an application of a kind covered by paragraph (a) or (b) of item 1.15 of the table in Part 1 of Schedule 5; and
 (b) the application was made in relation to the application of one or more of clauses 13.1 to 13.4 of Schedule 1 to the medical device or devices; and
 (c) the reason for the medical device or devices not complying with one or more of those clauses was that the device or devices were affected by the EU transition (within the meaning of subregulation 9.1AA(3) of these Regulations as in force at the commencement of this regulation); and
 (d) the 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