Therapeutic Goods Regulations 1990

A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.

The requirements in this subregulation are met if:

the registration, listing or inclusion in the Register of the goods commenced in the 2015‑16 financial year; and

the person’s turnover of the goods for the 2015‑16 financial year is of low value; and

the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.

The requirements in this subregulation are met if:

the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and

the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and

the person’s turnover of the goods for the 2014‑15 financial year was of low value; and

the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and

the person’s turnover of the goods for the 2015‑16 financial years was of low value; and

the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.

The requirements in this subregulation are met if:

the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and

either:

the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or

before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and

the person’s turnover of the goods for the 2014‑15 financial was of low value; and

the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and

the person’s turnover of the goods for the 2015‑16 financial years was of low value; and

the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.

The requirements in this subregulation are met if:

the registration, listing or inclusion in the Register of the goods commenced on or before 30 June 2014; and

for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015, either:

the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or

before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and

the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and

the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and

the person’s turnover of the goods for the 2015‑16 financial years was of low value; and

the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.

The requirements in this subregulation are met if:

the therapeutic goods are a joint replacement medical device; and

the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and

the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and

the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and

the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and

the person’s turnover of the medical device for the 2015‑16 financial year was of low value; and

the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.

The requirements in this subregulation are met if:

the therapeutic goods are a joint replacement medical device; and

the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and

the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and

the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and

the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and

the person’s turnover of the medical device for the 2015‑16 financial year was of low value; and

the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.

A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:

the inclusion of the biological in the Register commenced in the 2015‑16 financial year; and

the person’s turnover of the goods for the 2015‑16 financial year is of low value; and

the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.

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

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).

If a person is not exempt from liability to pay an annual charge for the 2015‑16 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 2015‑16 financial year under regulation 43AAE.

If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.

If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.