THERAPEUTIC GOODS REGULATIONS 1990 - REG 43AAGC Exemption from liability to pay annual charge--financial years commencing on or after 1 July 2018

THERAPEUTIC GOODS REGULATIONS 1990 - REG 43AAGC

    A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1   July 2018 (the current financial year ) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:

  (a)   either:

  (i)   the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or

  (ii)   the inclusion in the Register of the device commenced in the current financial year;

  (b)   the person's turnover of the device for the current financial year is of low value;

  (c)   the person gives the Secretary, on or before 22   July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person's turnover of the device for the current financial year was of low value.

Note 1:   See regulation   43AAA for the meaning of turnover and when turnover is of low value.

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 ).

Note 3:   If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation   43AAGD.

Note 4:   If a person becomes aware during the current financial year that the person's turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation   43AAGE.

Note 5:   If the Secretary becomes aware that a person's turnover of the device for the current financial year was not of low value, the Secretary may, under regulation   43AAGF, notify the person that the person is liable to pay the charge for the current financial year.