PART 3Quarterly information about special health service medicines
Information to be recorded about supply of made special health service medicines: manufacturers11
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.