Fees payable in connection with a consultation or further consultation on the safety, quality and usefulness of a medicinal substance incorporated in a device56C

1

Subject to regulation 56B(2) and paragraph (3), the fee in respect of a consultation in relation to a device which incorporates one or more medicinal substances is—

a

£4,550 if each medicinal substance is manufactured by an approved manufacturer of that substance;

b

£10,604 if any of the medicinal substances are not manufactured by an approved manufacturer of that substance.

2

Subject to paragraph (3), the fee in respect of a further consultation in relation to a device which incorporates one or more medicinal substances is—

a

£900 if each medicinal substance is manufactured by an approved manufacturer of that substance;

b

£2,451 if any of the medicinal substances are not manufactured by an approved manufacturer of that substance.

3

In relation to a device which incorporates a new medicinal substance, the fee is—

a

£46,526 for a consultation; and

b

£11,551 for a further consultation.

4

Where an approved body consults the Secretary of State in relation to more than one device at the same time and those devices—

a

are of similar construction and are designed to perform similar functions;

b

incorporate medicinal substances of the same specification which are manufactured by the same manufacturer or manufacturers; and

c

do not incorporate any other medicinal substance;

the fee payable for that consultation is the fee which would be payable under this regulation for a consultation in relation to one of those devices.

5

Any fee payable under this regulation must be paid to the Secretary of State not later than the day on which an approved body consults the Secretary of State.