Article 1

Regulation (EC) No 488/2005 is hereby amended as follows:

1. 1..

   Article 2, point (g) is amended as follows:

   1. (g)

      ‘“indirect costs” means the share of the Agency’s general infrastructure, organisation and management costs attributable to the performance of certification tasks, other than direct and specific costs, including those resulting from development of part of the regulatory material;’

2. 2..

   Article 12 is replaced by the following:

   ‘Article 12

   1.

   The fee shall be payable by the applicant. It shall be payable in euro.

   2.

   The issue, maintenance or amendment of a certificate or an approval shall be subject to prior payment of the full amount of the fee due, unless agreed differently by the Agency and the applicant. In the event of non-payment, the Agency may revoke the relevant certificate or approval after having given formal warning to the applicant.

   3.

   The scale of fees applied by the Agency, and the terms of payment, shall be communicated to applicants when they submit their applications.

   4.

   For all certification tasks which give rise to the payment of a variable part, the Agency may, on request, provide the applicant with an estimate. The estimate shall be amended by the Agency if it appears that the task is simpler or can be carried out faster than initially foreseen or, on the contrary, if it is more complex and takes longer to carry out than the Agency could reasonably have foreseen.

   5.

   Fees for the maintenance of existing certificates and approvals shall be payable in accordance with a timetable decided by the Agency and communicated to the holders of such certificates and approvals. The timetable shall be based on the inspections carried out by the Agency to check that such certificates and approvals are still valid.

   6.

   If, after a first check, the Agency decides not to accept an application, any fees already paid shall be returned to the applicant, with the exception of an amount to cover the administrative costs of handling the application. That amount shall be equivalent to the fixed fee D set out in the Annex.

   7.

   If a certification task has to be interrupted by the Agency because the applicant has insufficient resources or fails to comply with the applicable requirements, the balance of any fees due shall be payable in full at the time the Agency stops working.’

3. 3..

   Points (i), (ii), (v), (vi), (x), (xii) and (xiii) of the Annex are amended in accordance with the Annex to this Regulation.