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 | |||||
|---|---|---|---|---|---|
| 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: | 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 |