35Withdrawal of notice of intent or submission, and refund of fee or liability for deposit

35 Withdrawal of notice of intent or submission, and refund of fee or liability for deposit

Notice of intent or submission may be withdrawn at any time (1) Either of the following may be withdrawn by written notice given to the Department: (a) a notice of intent in relation to a proposed submission given under subsection 30(1); (b) a submission. Refund of fee amount that was paid (2) If: (a) a notification is given under subsection 33(1) after receipt of a notice of intent in relation to a proposed submission; and (b) the notice of intent or the submission is withdrawn: (i) on or before the submission due day for the submission; or (ii) if the proposed submission is likely to be in, or the submission is in, the early re‑entry pathway category, the early resolution pathway category or the facilitated resolution pathway category—within 10 business days after the day the notification was given; and (c) all or part of the fee for providing submission services in response to the submission was paid before the withdrawal of the notice of intent or the submission; the fee amount paid, except the deposit included in the fee, must be refunded.

Note: See also subsection (5) in relation to refund of the fee relating to a submission in the facilitated resolution pathway category.

(3) If: (a) a notification is given under subsection 33(2) after receipt of a notice of intent in relation to a proposed submission; and (b) the submission is withdrawn within 10 business days after the day the notification was given; and (c) all or part of the fee for providing submission services in response to the submission was paid before the withdrawal of the submission; the fee amount paid, except the deposit included in the fee, must be refunded.

Note: See also subsection (5) in relation to refund of the fee relating to a submission in the facilitated resolution pathway category.

(4) If: (a) a notification is given under subsection 33(3) after receipt of a submission; and (b) the submission is withdrawn within 10 business days after the day the notification was given; and (c) all or part of the fee for providing submission services in response to the submission was paid before the withdrawal of the submission; the fee amount paid, except the deposit included in the fee, must be refunded.

Note: See also subsection (5) in relation to refund of the fee relating to a submission in the facilitated resolution pathway category.

(5) Despite subsection (2), (3) or (4), the Department need not make a refund under that subsection relating to a proposed submission in the facilitated resolution pathway category if the withdrawal occurs after the last business day before the workshop (including on or after the day of the workshop) referred to in subsection 29(6) in connection with the submission. Liability for part of fee if no fee amount was paid (6) If: (a) a notice of intent in relation to a proposed submission, or a submission, is withdrawn as described in paragraph (2)(b), (3)(b) or (4)(b); and (b) no fee amount for providing submission services in response to the submission was paid before the withdrawal of the notice of intent or the submission; the Secretary must notify the person who gave the notice of intent or made the submission, in writing, that a fee of $465 is payable for the provision of administrative services by the Department in relation to the notice of intent or the submission. (7) Subsection (6) does not apply in relation to: (a) a submission in the new brand or new oral form of existing pharmaceutical item category; or (b) a notice of intent in relation to a proposed submission in the facilitated resolution pathway category, or a submission in that category.