Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year ), except that the person did not give the Secretary a declaration, or declarations, relating to the person's turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.
(2) The person may, on or before 15 September in the next financial year, give the Secretary, in writing:
(a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and
(b) a declaration stating that the person's turnover of the device for the relevant financial year was of low value; and
(c) if the relevant financial year is the year commencing on 1 July 2017--a declaration in accordance with paragraph 43AAGB(2)(c).
Note: 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 ).
(3) The documents given under subregulation (2) must be accompanied by the fee payable.
(4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:
(a) the notice referred to in paragraph (2)(a); and
(b) the declaration referred to in paragraph (2)(b); and
(c) if the relevant financial year is the year commencing on 1 July 2017--the declaration referred to in paragraph (2)(c); and
(d) the fee referred to in subregulation (3).
(5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.
(6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:
(a) states that the person is liable to pay the charge for the relevant financial year; and
(b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:
(i) the person did not give the documents to the Secretary by the required date;
(ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);
(iii) the documents were not accompanied by the correct fee; and
(c) specifies the date on which the charge for the relevant financial year becomes payable.