# The Veterinary Medicines Regulations 2006, Paragraph 6: Fees for specified pharmaceutical applications Extent: E+W+S+N.I. 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 --- Source: https://www.legislation.gov.uk/uksi/2006/2407/schedule/7/paragraph/6 (the official version) Page: https://openlegislation.uk/veterinary-medicines-regulations-2006/schedule-7/paragraph-6 Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.