The Human Medicines Regulations 2012

Other decisions of the appropriate committeeU.K.

21.—(1) This paragraph applies if the applicant—U.K.

(a)requests the opportunity to make written representations, but fails to make those written representations within the period for doing so; or

(b)requests the opportunity to make oral representations, but—

(i)fails to provide a summary of those representations or the documents in support of them within the period for doing so, or

(ii)fails to make oral representations at a hearing before the appropriate committee.

(2) The appropriate committee must notify the licensing authority of that fact.