Therapeutic Goods Regulations 1990

If:

therapeutic goods 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); and

the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and

the person has not paid 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; and

the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;

A notice given to a person under subregulation (1) must:

state that the person was not 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; or

for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and

specify the date on which the relevant charge, or charges, become payable.

If:

therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and

the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and

the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and

the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;

A notice given to a person under subregulation (3) must:

state that the person was not 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 relevant financial year; or

for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and

specify the date on which the relevant charge, or charges, become payable.