# The Medicines (Products for Human Use) (Fees) Regulations 2016, Paragraph 24: Marketing authorisations


(1) Unless sub-paragraphs (2) or (4) or paragraphs 25, 26, 28 or 29 apply, the fee payable under regulation 12(1)(a) in connection with an application for a marketing authorisation of a kind described in column 1 of the following table is the fee specified in the corresponding entry in column 2 of that table.
(2) This paragraph applies—
(a) to a complex application for a marketing authorisation of a kind described in item 2 in column 1 of the following table; and
(b) where the application only concerns a new source or supply of a substance listed in Part 7 of this Schedule.
(3) If sub-paragraph (2) applies the appropriate fee is the amount specified for an application of the same type under item 3 of the following table.
(4) This paragraph applies—
(a) to a complex application for a parallel import licence of a kind described in item 5(c) in column 1 of the following table; and
(b) where the application only concerns a new source or supply of a relevant substance listed in Part 7 of this Schedule.
(5) If sub-paragraph (4) applies the appropriate fee is the amount specified for item 5(b) in the following table.
Fees for marketing authorisation applications
Column 1
Kind of application
Column 2
Fee payable
1. Major Application
(a)
in respect of an application relating to an orphan medicinal product to which point 6 of Part II of Annex 1 to the 2001 Directive applies
£39,811
(b)
which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)
£83,580
(c)
which is a European reference product application in the case of a product for sale or supply in Northern Ireland
£83,580
(d)
which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for UKMA(GB)
£83,580
(e)
in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004
£24,688
. . .
. . .
. . .
. . .
. . .
. . .
(h)
in any other case
£124,194
2. Complex application
(a)
which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)
£23,205
(b)
which is a European reference product application in the case of a product for sale or supply in Northern Ireland
£23,205
(c)
which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)
£23,205
(d)
in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004
£13,983
. . .
. . .
. . .
. . .
. . .
. . .
(g)
in any other case
£34,335
3. Standard application
(a)
which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)
£8,503
(b)
which is a European reference product application in the case of a product for sale or supply in Northern Ireland
£8,503
(c)
which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)
£8,503
(d)
in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004
£7,743
. . .
. . .
. . .
. . .
. . .
. . .
(g)
in any other case
£12,589
4. Simple application
(a)
which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)
£3,433
(b)
which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)
£3,433
(c)
in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004
£3,433
. . .
. . .
. . .
. . .
. . .
. . .
(f)
in any other case
£3,433
5. Parallel import licence applications
(a)
in respect of a simple parallel import licence
£2,400
(b)
in respect of a standard parallel import licence
£10,617
(c)
in respect of a complex parallel import licence
£24,343
6. Change of ownership application
£592
(6) Each reference in paragraphs 25, 27 and 28 to an amount payable under paragraph 24 in respect of an application refers to the amount payable under this paragraph in respect of an application of the kind in question.

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Source: https://www.legislation.gov.uk/uksi/2016/190/schedule/2/paragraph/24 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-24
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.