# The Veterinary Medicines Regulations 2007, Paragraph 7: Fees for specified pharmaceutical applications


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
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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:
930
1,860
1,860
2,380
460
The following fees are in addition to the base fee:
Quality assessment (if quality data are assessed):
3,900
3,320
2,790
3,560
1,860
Safety assessment (if safety data are assessed):
3,900
3,120
1,060
1,360
1,860
Efficacy assessment (if efficacy data are assessed):
3,900
3,120
1,060
1,360
1,860
Ecotoxicology assessment:(if ecotoxicology data are assessed):
660
530
330
420
400
Additional fee if any of the target species is a food-producing animal (not payable if neither safety data nor ecotoxicology data are assessed):
3,850
3,520
2,120
2,710
1,390
Reduced by— if no safety data are assessed:
2,160
2,160
1,320
1,690
660
if no ecotoxicology data are assessed:
1,020
780
300
380
300
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom—
food-producing animal:
7,350
6,500
5,770
7,370
2,590
non-food-producing animal:
6,430
5,770
5,510
7,030
2,260
Additional fee for each additional pack type:
730
730
600
760
330
Reduced by— if no quality data are assessed:
360
360
360
460
120
if no safety data are assessed:
180
180
120
150
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):
6,360
6,030
3,980
5,090
2,060
Reduced by— if no quality data are assessed:
1,440
1,440
1,440
1,840
480
if no safety data are assessed:
2,690
2,690
1,620
2,070
840
if no efficacy data are assessed:
900
720
540
690
300
if no ecotoxicity data are assessed:
720
600
–
–
240
Additional fee for each additional active ingredient(non-food-producing animal):
4,250
4,050
3,180
4,070
1,460
Reduced by— if no quality data are assessed:
1,440
1,440
1,440
1,840
480
if no safety data are assessed:
1,440
1,440
900
1,150
480
if no efficacy data are assessed:
900
720
540
690
300
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):
3,910
3,520
2,390
3,050
1,260
Reduced by— if no quality data are assessed:
180
180
180
230
60
if no safety data are assessed:
1,440
1,440
900
1,150
480
if no efficacy data are assessed:
1,800
1,440
1,080
1,380
540
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):
2,460
2,060
1,530
1,950
800
Reduced by— if no quality data are assessed:
180
180
180
230
60
if no safety data are assessed:
180
180
120
150
60
if no efficacy data are assessed:
1,800
1,440
1,080
1,380
540
if no ecotoxicity data are assessed:
60
60
–
–
60
Additional fee for each additional recommended route of administration(food-producing animal):
2,650
2,460
1,590
2,040
930
Reduced by— if no safety data are assessed:
1,440
1,440
900
1,150
480
if no efficacy data are assessed:
900
720
540
690
300
if no ecotoxicity data are assessed:
60
60
–
–
60
Additional fee for each additional recommended route of administration(non- food-producing animal):
1,190
1,000
730
930
400
Reduced by— if no safety data are assessed:
180
180
120
150
60
if no efficacy data are assessed:
900
720
540
690
300
Simultaneous applications: fee for each additional product in the application:
2,850
2,850
2,850
3,640
1,660

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Source: https://www.legislation.gov.uk/uksi/2007/2539/schedule/7/paragraph/7 (the official version)
Page: https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-7/paragraph-7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.