# The Medicines (Products for Human Use-Fees) Regulations 2008, Paragraph 2: Marketing authorizations


(1) Unless paragraphs 3, 4, 6 or 7 apply, the fee payable under regulation 12(1)(a) in connection with an application for a marketing authorization of a kind described in column 1 of the following table is—
(a) if the application is an eCTD format application, the fee specified in the corresponding entry in column 2 of that table; or
(b) if the application is not an eCTD format application, the fee specified in the corresponding entry in column 3 of that table.
Fees for marketing authorization applications
Column 1
Kind of application
Column 2
Fee payable if application is in eCTD format
Column 3
Fee payable if application is not in eCTD format
1. Major application
(a)
in respect of an application relating to an orphan medicinal product to which point 6 of Part 2 of Annex 1 to the 2001 Directive applies
£30,101
£31,576
(b)
which is a mutual recognition procedure incoming application
£63,198
£66,295
(c)
which is a European reference product application
£63,198
£66,295
(d)
which is a decentralised procedure application where the United Kingdom is a concerned member State
£90,671
£95,114
(e)
which is a decentralised procedure application where the United Kingdom is a reference Member State
£138,145
£144,914
(f)
in any other case
£93,907
£98,491
2. Complex application
(a)
which is a mutual recognition procedure incoming application
£17,546
£18,406
(b)
which is a European reference product application
£17,546
£18,406
(c)
which is a decentralised procedure application where the United Kingdom is a concerned member State
£25,068
£26,296
(d)
which is a decentralised procedure application where the United Kingdom is a reference Member State
£40,461
£42,444
(e)
in any other case
£25,962
£27,228
3. Standard application
(a)
which is a mutual recognition procedure incoming application
£6,430
£6,745
(b)
which is a European reference product application
£6,430
£6,745
(c)
which is a decentralised procedure application where the United Kingdom is a concerned member State
£9,191
£9,642
(d)
which is a decentralised procedure application where the United Kingdom is a reference Member State
£17,779
£18,650
(e)
in any other case
£9,519
£9,984
4. Simple application
(a)
which is a decentralised procedure application where the United Kingdom is a concerned member State
£2,596
£2,722
(b)
in any other case
£2,596
£2,722
5. Application for a parallel import licence
Not applicable
£1,815
6. Change of ownership application
Not applicable
£448
(2) Each reference in paragraphs 3, 5 and 6 to an amount payable under paragraph 2 in respect of an application refers to the amount payable under that paragraph in respect of an application of the kind in question.

---
Source: https://www.legislation.gov.uk/uksi/2008/552/schedule/1/paragraph/2 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.