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The Branded Health Service Medicines (Costs) Regulations 2018

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25.—(1) If on a review of any information provided to the Secretary of State under these Regulations the Secretary of State considers that a manufacturer or supplier has paid an amount different to the amount required by regulation 3 or by a direction given under regulation 4, the Secretary of State may—

(a)by way of issuing a notice to the manufacturer or supplier require that person to pay an additional amount; or

(b)pay an amount to the manufacturer or supplier.

(2) The Secretary of State is to determine the amount referred to in paragraph (1) by determining the difference between the amount the manufacturer or supplier should have paid had the payment been made in accordance with regulation 3 or a direction given under regulation 4 and the amount actually received by the Secretary of State.

(3) In determining the amount under paragraph (1) the Secretary of State may take into account any information on medicinal products, whether or not the Secretary of State obtained that information under these Regulations.

(4) A notice made under paragraph (1)(a) must be in writing and must specify—

(a)the period to which the amount to be paid relates;

(b)the amount to be paid referred to in paragraph (1);

(c)the period, which must not be less than 28 days from the date that the notice is issued by the Secretary of State, within which the payment must be made; and

(d)the manufacturer’s or supplier’s appeal rights.

(5) Where the Secretary of State considers that the information provided by a manufacturer or supplier under these Regulations does not reflect the information that is required to be kept and recorded by these Regulations, the Secretary of State may require that the manufacturer or supplier record and keep for a period of six years what the Secretary of State considers to be the correct information and provide that information or part of that information to the Secretary of State on request.

(6) In this regulation, “review of any information provided to the Secretary of State” includes review of estimated or audited information.

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