SCHEDULE 7Fees

PART 2Fees relating to marketing authorisations

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

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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