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Paragraph 1 Marketing authorizations

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

Subject to paragraphs 2 to 6 inclusive, the fee payable under regulation 14(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 shall be the appropriate fee specified in the corresponding entry in Column 2 of that Table.

TABLE

Column 1Column 2
Kind of productFee payable
1

New Active Substance

1

£11,900

2

Other kinds of Medicinal Product—

(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

2
(a)

£5,950

(b)

Prescription Only Medicine

(i)

Standard Fee

2
(b)
(i)

£1,075

(ii)

Reduced Rate Fee

2
(b)
(ii)

£535

(iii)

Maintenance Fee

2
(b)
(iii)

£180

(c)

Pharmacy Medicine

(i)

Standard Fee

2
(c)
(i)

£535

(ii)

Reduced Rate Fee

2
(c)
(ii)

£270

(iii)

Maintenance Fee

2
(c)
(iii)

£120

(d)

General Sale List Medicine

(i)

Standard Fee

2
(d)
(i)

£240

(ii)

Reduced Rate Fee

2
(d)
(ii)

£120

(iii)

Maintenance Fee

2
(d)
(iii)

£90

(e)

Herbal Remedy

2
(e)

£60

(f)

Homoeopathic Medicinal Product or Authroposophic Product

2
(f)

£30