The Veterinary Medicines Regulations 2013

Application for an exceptional marketing authorisation (pharmaceutical)U.K.

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
ApplicationProvisional (£)Limited (£)
Base Fee:12,0156,765
The following fees are in addition to the base fee—
Additional fee if any of the target species is a food-producing animal:3,9051,952
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom—
food-producing animal:5,8503,732
non-food-producing animal:4,9103,262
Additional fee for each additional pack type:710370
Additional fee for each additional active ingredient (food-producing animal):5,9553,232
Additional fee for each additional active ingredient (non-food-producing animal):3,8002,155
Additional fee if there is more than one target species, for each additional species (food-producing animal):2,9651,985
Additional fee if there is more than one target species, for each additional species (non-food-producing animal):1,4851,247
Additional fee for each additional recommended route of administration (food-producing animal):2,1851,347
Additional fee for each additional recommended route of administration (non-food-producing animal):710608
Simultaneous applications— fee for each additional product in the application:2,8951,447