Final determination without representationsU.K.
163.—(1) This regulation applies if the recipient—
(a)does not give notification to the licensing authority that the recipient wishes to challenge its provisional determination within the period of four weeks beginning immediately after the determination date;
(b)gives such notification, but fails to make written representations to the licensing authority within the period for making those representations; or
(c)gives such notification, but fails to make oral representations at a hearing before the reviewers appointed for the purposes of advising on the provisional determination.
(2) The licensing authority must—
(a)make a final determination as to whether the product is a medicinal product; and
(b)inform the recipient in writing of its final determination and of the reasons for it.