The Veterinary Medicines Regulations 2006

Fees for specified pharmaceutical applications

6.  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.

Fees for specified pharmaceutical applications

			Pharmacologically equivalent national application
Menu	Full national application under Part 1 of Schedule 1 (£)	Bibliographic national application (£)	Reference product authorised in UK (£)	Reference product not authorised in UK (£)	Decentralised application where the UK is a concerned member State or recognition of a product authorised in another member State (£)
Base Fee: The following fees are in addition to the base fee—	910	1,800	1,800	2,320	460
Quality assessment (if quality data are assessed):	3,810	3,230	2,710	3,470	1,810
Safety assessment (if safety data are assessed):	3,810	3,030	1,030	1,330	1,810
Efficacy assessment (if efficacy data are assessed):	3,810	3,030	1,030	1,330	1,810
Ecotoxicology assessment (if ecotoxicology data are assessed):	640	520	320	410	390
Additional fee if any of the target species is a food-producing animal (not payable if neither safety data nor ecotoxicology data are assessed):	3,740	3,420	2,070	2,650	1,350
Reduced by—
if no safety data are assessed:	2,100	2,100	1,290	1,650	640
if no ecotoxicology data are assessed:	990	760	290	370	290
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom—
food-producing animal:	7,170	6,330	5,610	7,200	2,520
non-food-producing animal:	6,260	5,620	5,360	6,870	2,200
Additional fee for each additional pack type:	720	720	590	740	330
Reduced by—
if no quality data are assessed:	350	350	350	450	120
if no safety data are assessed:	180	180	120	150	60
if no efficacy data are assessed:	60	60	60	70	60
if no ecotoxicity data are assessed:	60	60	—	—	60
Additional fee for each additional active ingredient (food-producing animal):	6,210	5,870	3,880	4,960	2,000
Reduced by—
if no quality data are assessed:	1,400	1,400	1,400	1,790	470
if no safety data are assessed:	2,630	2,630	1,580	2,020	820
if no efficacy data are assessed:	880	700	530	670	290
if no ecotoxicity data are assessed:	700	580	—	—	230
Additional fee for each additional active ingredient (non-food-producing animal):	4,140	3,940	3,110	3,960	1,430
Reduced by—
if no quality data are assessed:	1,400	1,400	1,400	1,790	470
if no safety data are assessed:	1,400	1,400	880	1,120	470
if no efficacy data are assessed:	880	700	530	670	290
if no ecotoxicity data are assessed:	60	60	—	—	60
Additional fee if there is more than one target species, for each additional species (food-producing animal):	3,820	3,430	2,330	2,980	1,240
Reduced by—
if no quality data are assessed:	180	180	180	220	60
if no safety data are assessed:	1,400	1,400	880	1,120	470
if no efficacy data are assessed:	1,750	1,400	1,050	1,350	530
if no ecotoxicity data are assessed:	120	120	—	—	60
Additional fee if there is more than one target species, for each additional species (non-food-producing animal):	2,400	2,010	1,490	1,900	780
Reduced by—
if no quality data are assessed:	180	180	180	220	60
if no safety data are assessed:	180	180	120	150	60
if no efficacy data are assessed:	1,750	1,400	1,050	1,350	530
if no ecotoxicity data are assessed:	60	60	—	—	60
Additional fee for each additional recommended route of administration (food-producing animal):	2,590	2,390	1,560	1,980	910
Reduced by—
if no safety data are assessed:	1,400	1,400	880	1,120	470
if no efficacy data are assessed:	880	700	530	670	290
if no ecotoxicity data are assessed:	60	60	—	—	60
Additional fee for each additional recommended route of administration (non- food-producing animal):	1,170	970	720	910	390
Reduced by—
if no safety data are assessed:	180	180	120	150	60
if no efficacy data are assessed:	880	700	530	670	290
Simultaneous applications: fee for each additional product in the application:	2,780	2,780	2,780	3,560	1,610