SCHEDULES
SCHEDULE 11Advice and representations
PART 2Type II variation applications, complex variation applications and new excipient variation applications
Right to review after paragraph 22 notification
23
1
This paragraph applies if the licensing authority notifies the applicant of its decision under paragraph 22—
a
to refuse the application; or
b
to grant it otherwise than in accordance with the application.
2
The applicant may notify the licensing authority in writing that the person wishes the licensing authority to submit the decision to review upon oral representations.
3
The applicant must give the notification within the period of 28 days beginning with the day on which the notification is given or such longer period as the licensing authority may allow.
4
The review must be conducted in accordance with Schedule 5.
5
This paragraph does not apply if the person has not made any representations in accordance with paragraph 19 or 20.