22.—(1) This regulation applies to any UK producer who supplies UK health service products which are not health service medicines to patients.
(2) A UK producer to whom this regulation applies must—
(a)record the information mentioned in paragraph (3) for each supply by the producer to patient otherwise than by sale of an appliance, food or dermatological product—
(i)which is a UK health service product, and
(ii)is, in the month in which the producer supplies it, listed in a Drug Tariff, and
(b)keep that information for a period of four years beginning with the day on which it is recorded.
(3) The information is—
(a)the invoice for the purchase of the appliance, food or dermatological product,
(b)if any discounts, payments or payments or benefits in kind given in connection with the purchase are not included in the invoice, a statement of those discounts, payments or payments or benefits in kind,
(c)the name of the person from whom the appliance, food or product is purchased,
(d)the number of appliances or quantity, by pack size, of product purchased,
(e)the net purchase amount, or a reasonable estimate of the net purchase amount, paid for the purchase,
(f)the terms on which any discounts, payments, or payments or benefits in kind taken into account when calculating that amount were given, and
(g)the name of the person to whom those discounts, payments or payments or benefits in kind were given, if that person is not the purchaser.
(4) For the purposes of paragraph (2), a food or dermatological product is listed in a Drug Tariff if the food or product is listed—
(a)in Part XV of the Drug Tariff (England) for the given month,
(b)in Part XV of the Drug Tariff (Wales) for the given month, or
(c)in Part X of the Drug Tariff (Northern Ireland) for the given month.
(5) In this regulation “supply” means supply otherwise than by sale.