Paragraph 2 Marketing authorizations
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—
if the application is an eCTD format application, the fee specified in the corresponding entry in column 2 of that table; or
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 | ||||
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.