Application for an exceptional marketing authorisation (pharmaceutical)U.K.
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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
Application | Provisional (£) | Limited (£) | |
---|---|---|---|
Base Fee: | 12,015 | 6,765 | |
The following fees are in addition to the base fee— | |||
Additional fee if any of the target species is a food-producing animal: | 3,905 | 1,952 | |
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom— | |||
food-producing animal: | 5,850 | 3,732 | |
non-food-producing animal: | 4,910 | 3,262 | |
Additional fee for each additional pack type: | 710 | 370 | |
Additional fee for each additional active ingredient (food-producing animal): | 5,955 | 3,232 | |
Additional fee for each additional active ingredient (non-food-producing animal): | 3,800 | 2,155 | |
Additional fee if there is more than one target species, for each additional species (food-producing animal): | 2,965 | 1,985 | |
Additional fee if there is more than one target species, for each additional species (non-food-producing animal): | 1,485 | 1,247 | |
Additional fee for each additional recommended route of administration (food-producing animal): | 2,185 | 1,347 | |
Additional fee for each additional recommended route of administration (non-food-producing animal): | 710 | 608 | |
Simultaneous applications— fee for each additional product in the application: | 2,895 | 1,447 |