Information to be recorded about supply of made special health service medicines: manufacturers
11.—(1) A manufacturer must record the information mentioned in paragraph (3) for each presentation of made special health service medicine which—
(a)the manufacturer manufactures and supplies to any of the following—
(i)a UK primary medical services provider,
(ii)a Health Service chemist, or
(iii)a medicines wholesaler, and
(b)is, in the month in which the manufacturer supplies it, listed in a Drug Tariff.
(2) A manufacturer must keep the information recorded under paragraph (1) until it is provided to the Secretary of State in accordance with regulation 14.
(3) The information is—
(a)the type of manufacture,
(b)the excipient formulations (if any),
(c)the quantity, by pack size, supplied to the persons mentioned in paragraph (1)(a)(i) to (iii), and
(d)the net sales income, or a reasonable estimate of the net sales income, from the supply.