SCHEDULES

SCHEDULE 11Advice and representations

PART 2Type II variation applications, complex variation applications and new excipient variation applications

Decision of licensing authority following report

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.

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.