PART 3Clinical investigations under Regulation (EU) 2017/745
Arbitration following the refusal of a clinical investigation application13
1
A sponsor notified of a refusal under Article 70(3), 71(4), or 78(10) may, within 28 days of being notified, apply to the Institute to appoint an adjudicator to review the refusal.
2
The adjudicator must provide a report to the Secretary of State and the sponsor setting out any recommendations in respect of the disputed refusal.
3
The Secretary of State must take the report of the adjudicator into account and decide whether to—
a
confirm or alter the grounds for the refusal of the application,
b
authorise the clinical investigation, or
c
in the case of a refusal under Article 70(3), proceed to consider the application under Article 70.
4
The Secretary of State must notify the sponsor of the decision in paragraph (3).
5
The sponsor must pay any fees, costs or expenses of the Institute and its appointed adjudicator that are payable in connection with the application made under paragraph (1).
6
In this regulation, “Institute” means the charitable organisation with registered number 803725 and known as the Chartered Institute of Arbitrators.