Regulation 13 Arbitration following the refusal of a clinical investigation applicationI1

Northern Ireland

(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).

F1(6)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annotations

Textual amendments

F1: Reg. 13(6) omitted (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 35

Commencement

I1: Reg. 13 in force at 27.7.2021, see reg. 1(2)