Chwilio Deddfwriaeth

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The Health Service Products (Provision and Disclosure of Information) Regulations 2018

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Dyma’r fersiwn wreiddiol (fel y’i gwnaed yn wreiddiol).

Provision of general information about costs incurred in connection with the manufacture or distribution of health service medicines and appliances

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26.—(1) If the Secretary of State requires the information for the statutory purpose, the Secretary of State may by request, in writing, require a UK producer—

(a)to provide information about any costs incurred by the producer—

(i)in connection with the manufacturing or distribution of a particular presentation of health service medicine, and

(ii)which relate to any transaction between the producer and a UK producer for that presentation;

(b)to provide information about any costs incurred by the producer—

(i)in connection with the manufacturing or distribution of a particular appliance which—

(aa)is a UK health service product, and

(bb)is, in the month in which the request is made, listed in a Drug Tariff, and

(ii)which relate to any transaction between the producer and a UK producer for that appliance;

(c)to provide information about any costs (other than supply costs) incurred by the producer in connection with the manufacturing, or distribution of—

(i)any health service medicine, or

(ii)any appliance which is—

(aa)a UK health service product, and

(bb)in the month in which the request is made, listed in a Drug Tariff.

(2) But a request under paragraph (1)(a), (b) or (c) may not require a UK producer to provide any information which the producer could not reasonably be expected to record and keep for the purpose of understanding the producer’s relevant costs.

(3) In addition, a request under paragraph (1)(c) may not require a UK producer to provide any information to which regulation 25 applies.

(4) A UK producer who is given a written request under paragraph (1)(a), (b) or (c) must comply with the request.

(5) The producer must provide the requested information—

(a)in an electronic spreadsheet provided for that purpose by the Secretary of State, or

(b)if the Secretary of State does not provide such a spreadsheet, via the NHS Digital online gateway.

(6) The producer must provide the requested information within the period of 28 days beginning with the day on which the producer is given the request.

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