21When cost‑recovery fee must be paid

21 When cost‑recovery fee must be paid

(1) For the purposes of section 72‑30 of the Act, this section specifies the time when cost‑recovery fees become due and payable.

Note 1: The Minister may not list a medical device in Schedule 1 as a result of a listing application until any cost‑recovery fee payable in connection with the initial listing of the kind of medical device has been paid (see subsection 72‑10(5) of the Act).

Note 2: The Minister may remove a kind of medical device from Schedule 1 if a person is liable to pay a cost‑recovery fee in connection with the kind of medical device and the person fails to pay that fee in accordance with this instrument (see section 72‑20 of the Act).

Note 3: Activities may not be carried out under Division 72 of the Act in relation to a person who is liable to pay a cost‑recovery fee that is due and payable until the fee has been paid (see section 72‑25 of the Act).

Note 4: A cost‑recovery fee that is due and payable may be recovered as a debt due to the Commonwealth by action in a court of competent jurisdiction (see section 72‑40 of the Act).

Standard application fee (2) A standard application fee in relation to a listing application is due and payable at the time the application is made.

Note: Paragraph 72‑10(3)(b) of the Act requires a listing application to be accompanied by any cost‑recovery fee that the applicant is liable to pay at the time the application is made.

(3) A standard application fee in relation to a variation application is due and payable at the time the relevant request is made. Other cost‑recovery fees (4) A clinical assessment fee, economic assessment fee, or full health technology assessment pathway fee is due and payable before the end of 28 days starting on the day a demand for payment of the fee is made.