SCHEDULE 4PERIODIC FEES FOR LICENCES

PART 3Periodic Fees for Marketing Authorizations and Licences

Marketing authorizations5

Unless paragraphs 6 to 10 apply, the fee payable under regulation 33(3) in connection with the holding of a marketing authorization relating to a medicinal product of a kind described in column 1 of the following table is the applicable fee specified in the corresponding entry in column 2 of that table.

Periodic fees for holding marketing authorization

Column 1

Type of Medicinal Product

Column 2

Fee payable

1. New Active Substance

£23,025

2. Parallel Import

£300

3. Others

(a)

Any product (not being a derivative of a new active substance) in respect of which a marketing authorization has been granted in consequence of a complex application submitted on or after 1st April 1989

£9,481

(b)

Prescription Only Medicine

(i)

Standard Fee

£2,371

(ii)

Reduced Rate Fee

£1,183

(iii)

Lower Fee

£300

(c)

Pharmacy

£300

(d)

General Sale List

£300

(e)

Herbal remedy

£75

(f)

Traditional herbal registrations

£75

(g)

National homoeopathic product

£75

(h)

Homoeopathic or anthroposophic product which is the subject of a licence of right

£75