The Human Medicines Regulations 2012 No. 1916

SCHEDULES

SCHEDULE 11 U.K. Advice and representations

PART 2 U.K. Type II variation applications, complex variation applications and new excipient variation applications

Decision of licensing authority following report U.K.

22.—(1) After receiving the appropriate committee's report under paragraph 19 or 20 or notification under paragraph 21 the licensing authority must confirm or alter its decision. U.K.

(2) If the appropriate committee gives a report under paragraph 19 or 20, the licensing authority must take that into account in making its decision.

(3) The licensing authority must notify the applicant or holder of—

(a) its decision; and

(b) any advice given to it by the appropriate committee and the reasons for that advice.