Medicines and Medical Devices Act 2021 (c. 3)

SCHEDULES

Prospective

SCHEDULE 2 U.K. Medical devices: civil sanctions

PART 1 U.K. Monetary penalties

Information to be included in notices under paragraph 2 U.K.

3 (1) A notice under paragraph 2(1) must include information as to— U.K.

(a) the grounds for the proposal to impose the monetary penalty;

(b) the effect of payment of the sum referred to in paragraph 2(2);

(c) the right to make representations and objections;

(d) the circumstances in which the Secretary of State may not impose the monetary penalty.

(2) A notice under paragraph 2(1) must also specify—

(a) the period within which payment may be made so as to avoid liability for a monetary penalty, and

(b) the period within which representations and objections may be made.

Neither period may be more than 28 days beginning with the day on which the notice is served.

(3) A notice under paragraph 2(4) imposing a monetary penalty must include information as to—

(a) the grounds for imposing the monetary penalty;

(b) how payment may be made;

(c) the period within which payment is to be made;

(d) any early payment discounts or late payment penalties (including interest on payments);

(e) rights of appeal;

(f) the consequences of non-payment.

The period referred to in paragraph (c) must be at least 28 days beginning with the day on which the notice is served.