The Veterinary Medicines Regulations 2009

Fees for 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.

Menu	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:	950	1,885	1,885	2,410	470
The following fees are in addition to the base fee:
Quality assessment (if quality data are assessed):	3,970	3,365	2, 825	3,620	1, 880
Safety assessment (if safety data are assessed):	3,970	3, 165	1,075	1,380	1,880
Efficacy assessment (if efficacy data are assessed):	3,970	3,165	1,075	1,380	1,880
Ecotoxicology assessment: (if ecotoxicology data are assessed):	670	535	335	430	405
Additional fee if any of the target species is a food-producing animal (not payable if neither safety data nor ecotoxicology data are assessed):	3,905	3,585	2,155	2,760	1,415
Reduced by—
if no safety data are assessed:	2,190	2,190	1,340	1,715	670
if no ecotoxicology data are assessed:	1,035	790	305	390	305
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	5,855	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
Reduced by—
if no quality data are assessed:	365	365	365	465	120
if no safety data are assessed:	185	185	120	155	60
if no efficacy data are assessed:	60	60	60	80	60
if no ecotoxicity data are assessed:	60	60	-	-	60
Additional fee for each additional active ingredient (food-producing animal):	6,465	6,125	4,040	5,165	2,085
Reduced by—
if no quality data are assessed:	1,460	1,460	1,460	1,870	485
if no safety data are assessed:	2,740	2,740	1,645	2,100	850
if no efficacy data are assessed:	915	730	550	700	305
if no ecotoxicity data are assessed:	730	610	-	-	245
Additional fee for each additional active ingredient (non-food-producing animal):	4,310	4,105	3,235	4,135	1,475
Reduced by—
if no quality data are assessed:	1,460	1,460	1,460	1,870	485
if no safety data are assessed:	1,460	1,460	915	1,170	485
if no efficacy data are assessed:	915	730	550	700	305
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):	3,970	3,565	2,425	3,100	1,280
Reduced by—
if no quality data are assessed:	185	185	185	235	60
if no safety data are assessed:	1,460	1,460	915	1,170	485
if no efficacy data are assessed:	1,825	1,460	1,095	1,400	550
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):	2,495	2,090	1,550	1,980	805
Reduced by—
if no quality data are assessed:	185	185	185	235	60
if no safety data are assessed:	185	185	120	155	60
if no efficacy data are assessed:	1,825	1,460	1,095	1,400	550
if no ecotoxicity data are assessed:	60	60	-	-	60
Additional fee for each additional recommended route of administration (food-producing animal):	2,695	2,490	1,620	2,070	940
Reduced by—
if no safety data are assessed:	1,460	1,460	915	1,170	485
if no efficacy data are assessed:	915	730	550	700	305
if no ecotoxicity data are assessed:	60	60	-	-	60
Additional fee for each additional recommended route of administration (non- food-producing animal):	1,215	1,010	740	945	405
Reduced by—
if no safety data are assessed:	185	185	120	155	60
if no efficacy data are assessed:	915	730	550	700	305
Simultaneous applications: fee for each additional product in the application:	2,895	2,895	2,895	3,705	1,685