Medicines and Medical Devices Act 2021

PART 3 Enforcement costs recovery notices

Imposition of enforcement costs recovery notices

6 (1) The Secretary of State may serve an enforcement costs recovery notice on a person on whom a monetary penalty has been imposed.

(2) For the purposes of this Schedule an “enforcement costs recovery notice” is a notice requiring the person to pay to the Secretary of State the costs incurred by the Secretary of State in relation to the monetary penalty up to the time when it was imposed.

(3) In sub-paragraph (2), “costs” includes (in particular)—

(a) investigations costs;

(b) administration costs;

(c) costs of obtaining expert advice (including legal advice).

Information to be included in enforcement costs recovery notices

7 (1) An enforcement costs recovery notice must specify the amount to be paid and must include information as to—

(a) the grounds for serving the notice;

(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;

(e) rights to make written representations and objections in relation to the enforcement costs recovery notice;

(f) rights of appeal;

(g) 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 enforcement costs recovery notice is served.

(2) A person required by an enforcement costs recovery notice to pay an amount to the Secretary of State may require the Secretary of State to provide a detailed breakdown of that amount.

Appeals

8 (1) A person served with an enforcement costs recovery notice may appeal against the decision to serve it on the ground—

(a) that the decision was based on an error of fact,

(b) that the decision was wrong in law,

(c) that the decision was unreasonable, or

(d) that any of the costs to which the notice relates were unreasonably incurred or unreasonable in amount,

or on any other grounds that are set out in supplementary regulations (see Part 4 of this Schedule).

(2) An appeal under sub-paragraph (1) is to the First-tier Tribunal.