Therapeutic Goods Act 1989

This section applies if:

an application is made under section 23 in relation to a medicine for listing under section 26AE; and

the application has passed preliminary assessment.

A fee (the evaluation fee) specified in or determined in accordance with the regulations is payable by the applicant in respect of the evaluation of a medicine for listing under section 26AE.

The Secretary must notify each applicant of the amount of the evaluation fee.

The evaluation fee payable by an applicant:

is due and payable on the day on which the applicant is notified of the amount of the evaluation fee; and

may be recovered by the Commonwealth as a debt due to the Commonwealth.

If:

an application is made under section 23 in relation to a medicine for listing under section 26AE; and

the applicant has paid the whole of the evaluation fee; and

regulations made for the purposes of paragraph 63(2)(daaaa) prescribe a period within which evaluations under section 26AE in relation to the medicine must be completed; and

the evaluation is completed, but not within that period;

For the purposes of paragraph (5)(d), the evaluation is taken to be completed when the applicant is notified of the Secretary’s decision under subsection 26AE(3) in relation to the medicine.