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.
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— | |||||
| 2,100 | 2,100 | 1,290 | 1,650 | 640 |
| 990 | 760 | 290 | 370 | 290 |
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom— | |||||
| 7,170 | 6,330 | 5,610 | 7,200 | 2,520 |
| 6,260 | 5,620 | 5,360 | 6,870 | 2,200 |
Additional fee for each additional pack type: | 720 | 720 | 590 | 740 | 330 |
Reduced by— | |||||
| 350 | 350 | 350 | 450 | 120 |
| 180 | 180 | 120 | 150 | 60 |
| 60 | 60 | 60 | 70 | 60 |
| 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— | |||||
| 1,400 | 1,400 | 1,400 | 1,790 | 470 |
| 2,630 | 2,630 | 1,580 | 2,020 | 820 |
| 880 | 700 | 530 | 670 | 290 |
| 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— | |||||
| 1,400 | 1,400 | 1,400 | 1,790 | 470 |
| 1,400 | 1,400 | 880 | 1,120 | 470 |
| 880 | 700 | 530 | 670 | 290 |
| 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— | |||||
| 180 | 180 | 180 | 220 | 60 |
| 1,400 | 1,400 | 880 | 1,120 | 470 |
| 1,750 | 1,400 | 1,050 | 1,350 | 530 |
| 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— | |||||
| 180 | 180 | 180 | 220 | 60 |
| 180 | 180 | 120 | 150 | 60 |
| 1,750 | 1,400 | 1,050 | 1,350 | 530 |
| 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— | |||||
| 1,400 | 1,400 | 880 | 1,120 | 470 |
| 880 | 700 | 530 | 670 | 290 |
| 60 | 60 | — | — | 60 |
Additional fee for each additional recommended route of administration (non- food-producing animal): | 1,170 | 970 | 720 | 910 | 390 |
Reduced by— | |||||
| 180 | 180 | 120 | 150 | 60 |
| 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 |
Commencement Information
I1Sch. 7 para. 6 in force at 1.10.2006, see reg. 1