Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:43aah:p1
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 43AAH (pt 1/3)
Character Range: 403645–406335

43AAH  Waiver of certain annual charges

Scope
 (1) This regulation applies in relation to a person who is liable to pay:
 (a) an annual registration charge for registered goods that are medicines; or
 (b) an annual charge for inclusion in the Register for a financial year of:
 (i) a biological; or
 (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or
 (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.

Application for waiver of charge
 (2) The person may apply to the Secretary, in writing, for the charge to be waived for a financial year.
 (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:
 (a) be made:
 (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and
 (ii) in any other case—at any time during the relevant financial year; and
 (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).
Note 1: No application fee is payable.
Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).

Decision by Secretary
 (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:
 (a) to waive the charge for the financial year; or
 (b) to refuse to waive the charge for the financial year.
 (5) In considering the application, the Secretary:
 (a) must take into account the information referred to in paragraph (3)(b); and
 (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.
 (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.
 (7) The Secretary may decide to waive the charge for a financial year only if the Secretary is satisfied that:
 (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and
 (b) it is in the interest of public health for the entry in relation to the goods to remain on the Register; and
 (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in