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;

gives such notification, but fails to make written representations to the licensing authority within the period for making those representations; or

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.

make a final determination as to whether the product is a medicinal product; and

inform the recipient in writing of its final determination and of the reasons for it.