S.L. 458.46 Art. 3Payment of fees.

(1) The fees listed in the Schedules shall be paid to the Medicines Authority.

(2) The validation and, or processing of applications shall commence only upon receipt by the Medicines Authority of proof of payment.

(3) Such fees shall not include any fees charged by other competent authorities in relation to any documentation, reports, or services required by the Medicines Authority for final issue of authorisations and licences, where these are required.

(4) Any additional expenses incurred by the Medicines Authority shall be charged separately.

(5) In exceptional circumstances and at the discretion of the Chief Executive Officer of the Medicines Authority, in consultation with the designated Minister, waivers for fees due under these regulations may be granted.

(6) The failure to remit payment of any annual fee pertaining to marketing authorisations or other product licences may result in administrative measures on authorisations or licences.

(7) Where any fee or charge payable in accordance with these regulations remains outstanding after the due date, the Medicines Authority may, without prejudice to any other legal remedy available for the recovery thereof, suspend or decline to provide any service or to undertake any regulatory procedure until such time as the full amount due, together with any applicable interest, has been received.