# The Veterinary Medicines Regulations 2007, 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
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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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Source: https://www.legislation.gov.uk/uksi/2007/2539/schedule/7/paragraph/12 (the official version)
Page: https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-7/paragraph-12
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.