18.— (1) The supplier of an item may make an application in the specified form, accompanied by the fee (if any) prescribed in regulations made under section 29 in respect of this section, to the Executive requesting the Executive to add the item to the Reimbursement List.

(2) Subject to this section and section 19, where the Executive receives an application under subsection (1), it shall, before the expiration of a period of 180 days from the day on which it received the application or such longer period as may be required by the operation of subsection (3), determine the application, after consulting such experts (if any) as it thinks fit, by—

(a) subject to section 21(2), adding the item the subject of the application to the Reimbursement List at a price (being the ingredient cost, reimbursement price or the reference price, as the case requires) agreed with the applicant, subject to any conditions attached to such listing in accordance with section 20, or

(b) refusing to add the item the subject of the application to the Reimbursement List.

(3) Where the Executive receives an application under subsection (1) but is unable to determine the application under subsection (2) because it requires additional information from the applicant—

(a) the Executive shall give notice in writing to the applicant specifying the additional information that it requires from the applicant in order to so determine the application, and

(b) the running of the period of 180 days referred to in subsection (2) is, upon the giving of the notice referred to in paragraph (a) to the applicant, suspended in the case of that application unless and until the applicant gives the Executive the additional information that the Executive requires to so determine the application.

(4) The Executive shall, not later than the 3rd anniversary of the date of commencement of section 17 (or such longer period expiring on or before the 5th anniversary of that commencement as the Minister permits upon the request of the Executive), treat each deemed listed item (including its relevant price and any deemed condition attached to its listing) as if it were not on the Reimbursement List but were the subject of an application under subsection (1), and subsections (2) and (3) set out in Schedule 2 shall, for the purposes of this subsection, be deemed to be substituted for subsections (2) and (3) of this section.

(5) The Executive may at any time treat a listed item (including a listed item which was once a deemed listed item) as if it were not on the Reimbursement List but were the subject of an application under subsection (1) and, in any such case, subsections (2) and (3) set out in Schedule 2 shall, for the purposes of this subsection, be deemed to be substituted for subsections (2) and (3) of this section.

(6) Subject to section 19, the Executive shall remove a listed item from the Reimbursement List which it is satisfied has permanently ceased to be marketed in the State.

(7) Subject to section 19, where the Executive is satisfied that a listed item has temporarily ceased to be marketed in the State, it may, after having regard to how long it is expected that the cesser will last and the degree of disruption that the cesser causes or may cause patients who have been using the listed item, remove the listed item from the Reimbursement List.

(8) Subject to section 19, where the Executive is satisfied that a listed item is marketed in the State in insufficient quantity to meet the demand in the State for the listed item, it may remove the listed item from the Reimbursement List.

(9) The supplier of an item who has made an application under subsection (1) in respect of the item may, by notice in writing given to the Executive at any time before the determination under subsection (2) of the application, withdraw the application without prejudice to his or her right to make, at a later date, another such application in respect of that item.

(10) The supplier of an item which has been removed from the Reimbursement List may make, at a later date, another application under subsection (1) in respect of that item.