Circumstances in which a fee is payable
2.—(1) Subject to paragraph (2), a notified body shall pay a fee in connection with the services and facilities provided by the Department of Health as the competent body in respect of any consultation in relation to the safety, quality and usefulness of a medicinal substance incorporated in a medical device if, in consequence of that consultation, the competent body is under a duty to express views to that notified body.
(2) No fee shall be payable in respect of the first consultation in relation to the safety, quality and usefulness of a medicinal substance incorporated in a medical device for which a product licence is held.