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THERAPEUTIC GOODS REGULATIONS 1990 - REG 43AAGB

Exemption from liability to pay annual charge--2017 - 18 financial year

Inclusion of IVD device in Register commencing in 2017 - 18 financial year

  (1)   A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1   July 2017 (the 2017 - 18 financial year ) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017 - 18 financial year if:

  (a)   the inclusion of the device in the Register commenced in the 2017 - 18 financial year; and

  (b)   the person's turnover of the device for the 2017 - 18 financial year is of low value; and

  (c)   the person gives the Secretary, on or before 22   July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person's turnover of the device for the 2017 - 18 financial year was of low value.

Inclusion of IVD device in Register on or before 30   June 2017

  (2)   A person in relation to whom an IVD device is included in the Register on or before 30   June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017 - 18 financial year if:

  (a)   the inclusion of the device in the Register commenced on or before 30   June 2017; and

  (b)   the person's turnover of the device for the financial year commencing on 1   July 2016 (the 2016 - 17 financial year ) is of low value; and

  (c)   the person gives the Secretary, on or before 22   July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person's turnover of the device for the 2016 - 17 financial year was of low value; and

  (d)   the person's turnover of the device for the 2017 - 18 financial year was of low value; and

  (e)   the person gives the Secretary, on or before 22   July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person's turnover of the device for the 2017 - 18 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 2017 - 18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017 - 18 financial year under regulation   43AAGD.

Note 4:   If a person becomes aware during the 2017 - 18 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 a financial year for which a declaration was given under this regulation, 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 2017 - 18 financial year.


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