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Paragraph 1 Product licences

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

(1)

Subject to paragraphs 2 to 6 inclusive, the fee payable under regulation 14(3) in connection with the holding of a product licence relating to a medicinal product of a kind described in Column 1 of the following Table shall be the fee specified in the corresponding entry in Column 2 of that Table.

(2)

Where Column 1 of the following Table or paragraph 2 refers to a standard fee, a reduced rate fee or a maintenance fee, the fee specified in the corresponding entry in Column 2 of that Table or in that paragraph shall be payable in the circumstances specified in Part I of this Schedule.

TABLE

Column 1Column 2
Kind of ProductFee Payable
1

New Active Substance

1

£10,000

2

Other kinds of Medicinal Product

(a)

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

2
(a)

£5,000

(b)

Prescription Only Medicine

(i)

Standard Fee

2
(b)
(i)

£900

(ii)

Reduced Rate Fee

2
(b)
(ii)

£450

(iii)

Maintenance Fee

2
(b)
(iii)

£150

(c)

Pharmacy Medicine

(i)

Standard Fee

2
(c)
(i)

£450

(ii)

Reduced Rate Fee

2
(c)
(ii)

£225

(iii)

Maintenance Fee

2
(c)
(iii)

£100

(d)

General Sales List Medicine

(i)

Standard Fee

2
(d)
(i)

£200

(ii)

Reduced Rate Fee

2
(d)
(ii)

£100

(iii)

Maintenance Fee

2
(d)
(iii)

£75

(e)

Herbal Product

2
(e)

£50

(f)

omoeopathic Product and Anthroposophic Product

2
(f)

£25