# The Medicines (Products for Human Use — Fees) Regulations 1995, Paragraph 1: Marketing authorizations


(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 1
Column 2
Kind of application
Fee 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/EEC 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.

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Source: https://www.legislation.gov.uk/uksi/1995/1116/schedule/1/part/II/paragraph/1 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/schedule-1/part-II/paragraph-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.