- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (a wnaed Fel)
Dyma’r fersiwn wreiddiol (fel y’i gwnaed yn wreiddiol). This item of legislation is currently only available in its original format.
12. The fee for an application for a provisional marketing authorisation for a pharmaceutical product is in accordance with the following table.
Menu | Fee (£) |
---|---|
Base Fee: | 930 |
The following fees are in addition to the base fee: | |
Quality assessment (if quality data are assessed): | 3,900 |
Safety assessment (if safety data are assessed): | 3,900 |
Efficacy assessment (if efficacy data are assessed): | 2,420 |
Ecotoxicology assessment (if ecotoxicology data are assessed): | 660 |
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 |
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom— | |
food-producing animal: | 5,770 |
non-food-producing animal: | 4,840 |
Additional fee for each additional pack type: | 700 |
Additional fee for each additional active ingredient (food-producing animal): | 5,860 |
Additional fee for each additional active ingredient (non-food-producing animal): | 3,750 |
Additional fee if there is more than one target species, for each additional species (food-producing animal): | 2,920 |
Additional fee if there is more than one target species, for each additional species (non- food-producing animal): | 1,460 |
Additional fee for each additional recommended route of administration (food-producing animal): | 2,160 |
Additional fee for each additional recommended route of administration (non-food-producing animal): | 700 |
Simultaneous applications—fee for each additional product in the application: | 2,850 |
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