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The Veterinary Medicines Regulations 2007

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Application for a provisional marketing authorisation (pharmaceutical)

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12.  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

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