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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:

(1)

Subject to paragraphs 2, 3 and 4, the fee payable under regulation 4(a) in connection with an application for a marketing authorization 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—

TABLE

Column 1Column 2
Kind of applicationFee payable
1

Major application

(a)

in respect of any such application to which Section G of Part 4 of the Annex to Council Directive 75/318/EECf1 applies

1
(a)

£20,165

(b)

which is a decentralised incoming application

1
(b)

£50,365

(c)

in any other case

1
(c)

£71,950

2

Complex application

(a)

which is a decentralised incoming application

2
(a)

£10,305

(b)

in any other case

2
(b)

£14,725

3

Standard application

(a)

which is a decentralised incoming application

3
(a)

£4,255

(b)

in any other case

3
(b)

£6,080

4

Simple application

4

£1,710

5

Application for a marketing authorization (parallel import)

5

£1,700

6

Change of ownership application

6

£790
(2)

Each reference in paragraphs 3 and 4 to an amount payable under paragraph 1 in respect of an application refers to the amount payable under that paragraph in respect of an application of the kind in question.

Annotations

Footnotes

f1

OJ No. L147, 9.6.75, p. 1. The Annex was replaced by the Annex to Council Directive 91/507/EEC (OJ No. L270, 26.9.91, p. 32).