Application for an exceptional marketing authorisation (pharmaceutical)
This section has no associated Explanatory Memorandum
12. The fee for an application for an exceptional marketing authorisation for a pharmaceutical product is in accordance with the following table.
Fees for an exceptional marketing authorisation for a pharmaceutical product
| Menu | Fee (£) |
|---|---|
| Base Fee: | 950 |
| The following fees are in addition to the base fee: | |
| Quality assessment (if quality data are assessed): | 3,970 |
| Safety assessment (if safety data are assessed): | 3,970 |
| Efficacy assessment (if efficacy data are assessed): | 2,455 |
| Ecotoxicology assessment (if ecotoxicology data are assessed): | 670 |
| Additional fee if any of the target species is a food-producing animal (not payable if neither safety data nor ecotoxicology data are assessed): | 3,905 |
| Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom— | |
| 5,850 |
| 4,910 |
| Additional fee for each additional pack type: | 710 |
| Additional fee for each additional active ingredient (food-producing animal): | 5,955 |
| Additional fee for each additional active ingredient (non-food-producing animal): | 3,800 |
| Additional fee if there is more than one target species, for each additional species (food-producing animal): | 2,965 |
| Additional fee if there is more than one target species, for each additional species (non- food-producing animal): | 1,485 |
| Additional fee for each additional recommended route of administration (food-producing animal): | 2,185 |
| Additional fee for each additional recommended route of administration (non- food-producing animal): | 710 |
Simultaneous applications— fee for each additional product in the application: | 2,895 |