The Veterinary Medicines Regulations 2013

Specified pharmaceutical applications

7.  The following table sets out the fees relating to a pharmaceutical veterinary medicinal product for—

(a) a national application for a marketing authorisation that is—

(i) a full application under Part 1 of Schedule 1;

(ii) a bibliographic application; or

(iii) an application based on pharmacological equivalence;

(b) an application for a marketing authorisation using the decentralised procedure where the United Kingdom is a concerned member State;

(c) an application for the mutual recognition of a product authorised in another member State.

Application		Full national application under Part 1 of Schedule 1 (£)	Bibliographic national application (£)	Pharmacologically equivalent national application		Decentralised application where the UK is a concerned member State or recognition of a product authorised in another member State (£)
				Reference product authorised in UK (£)	Reference product not authorised in UK (£)
Base Fee:		13,530	12,115	7,195	9,220	6,515
Additional fee if any of the target species is a food-producing animal:		3,905	3,585	2,155	2,760	1,415
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom—
	food-producing animal:	7,465	6,595	5,885	7,495	2,630
	non-food-producing animal:	6,525	5,855	5,590	7,155	2,295
Additional fee for each additional pack type:		740	740	605	775	330
Additional fee for each additional active ingredient (food-producing animal):		6,465	6,125	4,040	5,165	2,085
Additional fee for each additional active ingredient (non-food-producing animal):		4,310	4,105	3,235	4,135	1,475
Additional fee if there is more than one target species, for each additional species (food-producing animal):		3,970	3,565	2,425	3,100	1,280 Applies for a maximum of 2 additional species
Additional fee if there is more than one target species, for each additional species (non- food-producing animal):		2,495	2,090	1,550	1,980	805 Applies for a maximum of 2 additional species
Additional fee for each additional recommended route of administration (food-producing animal):		2,695	2,490	1,620	2,070	940
Additional fee for each additional recommended route of administration (non- food-producing animal):		1,215	1,010	740	945	405
Simultaneous applications: fee for each additional product in the application:		2,895	2,895	2,895	3,705	1,685