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

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Information to be recorded and kept about supply of listed health service appliances: medical supplies wholesalers

This section has no associated Explanatory Memorandum

21.—(1) A medical supplies wholesaler must—

(a)record the information mentioned in paragraph (2) for each purchase by the wholesaler of any appliance (including any purchase which requires the appliance to be imported into the United Kingdom) which—

(i)is a UK health service product, and

(ii)is, in the month in which the wholesaler purchases it, listed in a Drug Tariff, and

(b)keep that information for the period of four years beginning with the day on which it is recorded.

(2) The information is—

(a)the name of the person from whom the appliance is purchased,

(b)the number of appliances purchased,

(c)the net purchase amount, or a reasonable estimate of the net purchase amount, paid for the purchase,

(d)the terms on which any discounts, payments, or payments or benefits in kind taken into account when calculating that amount were given, and

(e)the name of the person to whom they are given, if the person to whom they are given is not the producer.

(3) A medical supplies wholesaler must also—

(a)record the information mentioned in paragraph (4) for each supply by the wholesaler of any appliance (other than an appliance which the wholesaler has manufactured or imported) which—

(i)is a UK health service product, and

(ii)is, in the month in which the wholesaler supplies it, listed in a Drug Tariff, and

(b)keep that information for the period of four years beginning with the day on which it is recorded.

(4) The information is—

(a)the name of the person to whom the appliance is supplied (“the purchaser”),

(b)if known to the producer, whether the purchaser is in Category A, B, C or D,

(c)the number of appliances supplied,

(d)the net sales income, or a reasonable estimate of the net sales income, from the supply,

(e)the terms on which any discounts, payments, or payments or benefits in kind taken into account when calculating that income were given,

(f)the name of any person to whom they were given if the person to whom they were given is not the purchaser, and

(g)if known to the wholesaler, whether the appliance is an English health service product, a Welsh health service product, a Scottish health service product or a Northern Ireland health service product.

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