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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).

Information to be recorded and kept about supply of imported special health service medicines: medicines wholesalers and importers

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16.—(1) A UK producer who is a medicines wholesaler or an importer must—

(a)record the information mentioned in paragraph (2) for each purchase by the producer of a presentation of imported special health service medicine for supply, and

(b)keep that information for a 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 presentation is purchased,

(b)the quantity of packs purchased,

(c)the net purchase amount, or a reasonable estimate of the net purchase amount, 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 received, and

(e)the name of the person to whom the discounts, payments, or payments or benefits in kind were given, if that person is not the producer.

(3) A UK producer who is a medicines wholesaler or an importer must also—

(a)record the information mentioned in paragraph (4) for each supply of a presentation of imported special health service medicine by the producer, and

(b)keep that information for a 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 presentation is supplied (“the purchaser”),

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

(c)the quantity of packs supplied,

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

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

(f)the name of the person to whom any of those discounts, payments, or payments or benefits in kind were given, if that person is not the purchaser, and

(g)if known to the producer, whether the presentation 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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