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F2025L00414, Sch 3 item 1, reg 43AG; Sch 3 items 2 to 3
Claim the refund of certain condition fees
The Secretary, for a person who paid a qualifying fee. If a person paid a fee under Schedule 9 item 1AFA or Schedule 9A Part 2 item 2B between 1 January 2025 and the day before the regulation commenced, the Secretary must refund it.
Reader note for unit 21: this provision sits in Schedule 3, under Fees. The first action it calls for is to check the ledger for the window. The evidence it names first is the fee payment record. The provision read on this page is Sch 3 item 1, reg 43AG; Sch 3 items 2 to 3. It is unit 21 of 21 in the register.
What the provision requires
If a person paid a fee under Schedule 9 item 1AFA or Schedule 9A Part 2 item 2B between 1 January 2025 and the day before the regulation commenced, the Secretary must refund it. The two fee items are repealed.
Source pointer: reg 43AG; Sch 3 items 2-3.
What it means in practice
The clause returns fees paid for certain requests about conditions on registered therapeutic goods during the window before the amendment commenced.
A sponsor should check its fee ledger for the window and claim the refund if it paid either item. The text does not set a claim form or a deadline for the refund.
Source pointer: reg 43AG.
Evidence to keep
An auditor or a regulator will ask for the record that shows the duty was met, not a description of the process. Keep these artefacts with the device or facility file.
- The fee payment record. The refund depends on a payment in the window.
- The item under which the fee was paid. Only items 1AFA and 2B qualify.
- The refund request and the receipt. Shows the refund was claimed and received.
Source pointer: reg 43AG. The artefacts are our suggested evidence, not a form prescribed by the instrument.
Common gaps
- No reconciliation of the fee ledger.
- Assuming the refund is automatic.
- A payment outside the window.
Preparation steps
- Check the ledger for the window.
- Identify the item.
- Request the refund and record it.
Dates that matter for this unit
| Date | What happens | Note |
|---|---|---|
| 2025-01-01 | Refund window opens | reg 43AG |
| 2025-03-24 | Refund window closes at the end of the day before commencement | reg 43AG |
| 2025-03-25 | Schedule 3 commenced | s 2 table item 5 |
Source pointer: reg 43AG; s 2 table item 5.
Where it sits
- Fee items repealed, Sch 3 items 2 to 3.
- All dates, s 2 table.
Questions this provision raises
Who gets the refund?
A person who paid a fee covered by Schedule 9 item 1AFA or Schedule 9A Part 2 item 2B in the window. The Secretary must refund the fee to that person.
Is there a claim deadline?
The text does not state one. The obligation to refund is stated, but no form or deadline is prescribed. A sponsor should claim early and keep the payment record.
Which fees are covered?
Only the two named items. The clause is specific. A fee paid under another item is outside the refund, even if it relates to a similar request.
Source pointer for the page
- Citation
- Sch 3 item 1, reg 43AG; Sch 3 items 2 to 3
- Instrument
- Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 (F2025L00414)
- Official text
- https://www.legislation.gov.au/F2025L00414/latest/text
- Binding party
- reg 43AG
- Requirement
- reg 43AG; Sch 3 items 2-3
- Evidence
- reg 43AG
- Dates
- reg 43AG; s 2 table item 5
- Silent fields
- Where the instrument does not state a form, a period or a frequency, this page says so rather than filling the gap.
Back to the register. Next: Establish and maintain the UDI database.