PART 3Quarterly information about special health service medicines
Meaning of “special health service medicine”, “imported special health service medicine”, “made special health service medicine” and listing of a presentation of special health service medicine in a Drug Tariff10
1
In these Regulations—
“imported special health service medicine” means a special health service medicine which is imported into the United Kingdom;
“made special health service medicine” means a special health service medicine which is manufactured in the United Kingdom;
“special health service medicine” means a health service medicine which is a special medicinal product (within the meaning of regulation 167 M1 of the 2012 Regulations).
2
For the purposes of this Part, a presentation of special health service medicine is listed in a Drug Tariff if a price for that presentation is listed—
a
in the Drug Tariff (England) for the given month,
b
in the Drug Tariff (Wales) for the given month,
c
in the Drug Tariff (Scotland) for the given month, or
d
in the Drug Tariff (Northern Ireland) for the given month.
3
For the purposes of determining whether a reimbursement price is listed for a presentation, any pack size specified in the relevant Drug Tariff is to be disregarded.
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.
Information to be recorded about supply of made special health service medicines: medicines wholesalers12
1
A UK producer who is a medicines wholesaler must—
a
record the information mentioned in paragraph (2) for each presentation of made special health service medicine which—
i
the wholesaler purchases for supply, and
ii
is, in the month in which the wholesaler purchases it, listed in a Drug Tariff, and
b
keep that information until it is provided to the Secretary of State in accordance with regulation 14.
2
The information is—
a
the quantity, by pack size, purchased,
b
the excipient formulations purchased (if any), and
c
the net purchase amount, or a reasonable estimate of the net purchase amount, for the purchase.
3
A UK producer who is a medicines wholesaler must also—
a
record the information mentioned in paragraph (4) for each presentation of made special health service medicine (other than a presentation of such medicine which the wholesaler has manufactured) which—
i
the producer supplies to any UK primary medical services provider or Health Service chemist, and
ii
is, in the month in which the wholesaler supplies it, listed in a Drug Tariff, and
b
keep that information until it is provided to the Secretary of State in accordance with regulation 14.
4
The information is—
a
the quantity, by pack size, supplied,
b
the excipient formulations supplied (if any), and
c
the net sales income, or a reasonable estimate of the net sales income, from the supply.
Information to be recorded and kept about supply of imported special health service medicines: medicines wholesalers and importers13
1
A UK producer who is a medicines wholesaler or an importer must—
a
record and keep the information mentioned in paragraph (2) for each presentation of imported special health service medicine—
i
which the producer purchases for supply, and
ii
which is, in the month in which the producer purchases it, listed in a Drug Tariff, and
b
keep that information until it is provided to the Secretary of State in accordance with regulation 14.
2
The information for a presentation is—
a
the number of packs purchased, and
b
the net purchase amount paid, or a reasonable estimate of the net purchase amount paid, for that purchase.
3
A UK producer who is a medicines wholesaler or an importer must also—
a
record the information mentioned in paragraph (4) for each presentation of imported special health service medicine which—
i
the producer supplies to any relevant person, and
ii
is, in the month in which the producer supplies it, listed in a Drug Tariff, and
b
keep that information until it is provided to the Secretary of State in accordance with regulation 14.
4
The information for a presentation is—
a
the number of packs supplied to relevant persons, and
b
the net sales income, or a reasonable estimate of the net sales income, for that supply.
5
In this regulation, “relevant person”—
a
in relation to a producer who is an importer, means—
i
a UK primary medical services provider,
ii
a Health Service chemist, or
iii
a medicines wholesaler;
b
in relation to a producer who is a medicines wholesaler, means—
i
a UK primary medical services provider, or
ii
a Health Service chemist.
Requirement to provide information about the supply of special health service medicines14
1
A UK producer must provide the Secretary of State with the information which the producer is required to record and under regulation 11, 12, or 13 in accordance with this regulation.
2
The information must be provided, in each year, for the following quarterly periods—
a
1st August to 31st October;
b
1st November to 31st January;
c
1st February to 30th April;
d
1st May to 31st July.
3
The information for a quarterly period must be provided—
a
in an electronic spreadsheet provided for that purpose by the Secretary of State, or
b
if the Secretary of State does not provide such a spreadsheet, via the F1NHS England online gateway.
4
The information for a quarterly period must be provided within the period of 28 days beginning with the first day of the month which begins immediately after the last day of that quarterly period.