The Medicines (Products for Human Use) (Fees) Regulations 2010

Marketing authorizations

24.—(1) Unless paragraphs 25, 26, 28 or 29 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			£32,135	£33,709
	(b)			which is a mutual recognition procedure incoming application			£67,468	£70,774
	(c)			which is a European reference product application			£67,468	£70,774
	(d)			which is a decentralised procedure application where the United Kingdom is a concerned Member State			£96,797	£101,541
	(e)			which is a decentralised procedure application where the United Kingdom is a reference Member State			£147,479	£154,706
	(f)			in any other case			£100,252	£105,146
2. Complex application
			(a)		which is a mutual recognition procedure incoming application		£18,732	£19,650
			(b)		which is a European reference product application		£18,732	£19,650
			(c)		which is a decentralised procedure application where the United Kingdom is a concerned Member State		£26,762	£28,073
			(d)		which is a decentralised procedure application where the United Kingdom is a reference Member State		£43,195	£45,312
			(e)		in any other case		£27,716	£29,068
3. Standard application
			(a)		which is a mutual recognition procedure incoming application		£6,864	£7,200
			(b)		which is a European reference product application		£6,864	£7,200
			(c)		which is a decentralised procedure application where the United Kingdom is a concerned Member State		£9,812	£10,294
			(d)		which is a decentralised procedure application where the United Kingdom is a reference Member State		£18,980	£19,910
			(e)		in any other case		£10,162	£10,659
4. Simple application
			(a)		which is a decentralised procedure application where the United Kingdom is a concerned Member State		£2,771	£2,906
			(b)		which is a decentralised procedure application where the United Kingdom is a reference Member State		£9,788	£10,303
			(c)		in any other case		£2,771	£2,906
5. Parallel import licence applications
		(a)				in respect of a simple parallel import licence	Not applicable	£1,937
		(b)				in respect of a standard parallel import licence	Not applicable	£7,201
		(c)				in respect of a complex parallel import licence	Not applicable	£19,650
6. Change of ownership application							Not applicable	£478

(2) 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 that paragraph in respect of an application of the kind in question.