The Veterinary Medicines Regulations 2009

Application for an exceptional marketing authorisation (pharmaceutical)

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—
food-producing animal:	5,850
non-food-producing animal:	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