12.—(1) This paragraph applies where, before 30th October 2005—
(a)the Medicines Commission have reported findings and advice to the licensing authority under paragraph 8(3) of Schedule 2 to the Marketing Authorization Regulations; and
(b)the licensing authority have not notified the applicant or holder of—
(i)that advice; or
(ii)the confirmation or alteration of their decision under paragraph 7 of Schedule 2 to those regulations.
(2) The licensing authority shall give notice to the applicant or holder of—
(i)the Medicines Commission’s advice and the reasons for it;
(ii)the confirmation or alteration of their decision.
(3) The applicant or holder may, within the time allowed—
(a)notify the licensing authority that he wishes to appear before and be heard by a person appointed by the licensing authority; or
(b)make written representations to the licensing authority.