Paragraph 12 Application for a provisional marketing authorisation (pharmaceutical)
The fee for an application for a provisional marketing authorisation for a pharmaceutical product is in accordance with the following table.
Fees for a provisional marketing authorisation for a pharmaceutical product
| 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 |