# The Veterinary Medicines Regulations 2013, Paragraph 17: Application for a variation to a marketing authorisation ....

Extent: E+W+S

(1) This paragraph applies in relation to an application for a variation to one or more marketing authorisations except where paragraph ... 21 applies.
(2) The fees for the variations to which this paragraph applies are set out in the following table.
(3) Where applications are made at the same time seeking an identical change to the terms of more than one marketing authorisation, and those applications are based on identical data, fees are payable as for a grouped variation.
(4) References in this paragraph to a grouped variation being “led” by a particular type of variation indicate that the principal variation in that group is a variation of that type.
Type of variations
Fee (£)
Single variations; one change for each product
Variation – standard
2,895
Unless the variation is—
(a) a change of route of administration, or the addition of a new one, of—
(i)
an immunological product, or a pharmaceutical product for a non-food-producing animal
5,390
(ii)
a pharmaceutical product for a food-producing animal
7,135
(b) a change of bioavailability
8,415
(c) a change of active substance, where the change is to—
(i)
use a different biologically active substance with a slightly different molecular structure
8,415
(ii)
modify the vector used to produce the antigen or the source material, including a new master cell bank from a different source
8,415
(d) a change of pharmacokinetics
8,415
Simultaneous application falling within (a) to (d): fee for each additional product in the application
1,465
Variation – reduced
885
Variation - no assessment
455
Grouped variations
Variation – standard led
For the first nine changes
6,280
For each subsequent group of five or fewer changes
2,250
Variation – reduced led:
For the first nine changes
1,770
For each subsequent group of five or fewer changes
2,250

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Source: https://www.legislation.gov.uk/uksi/2013/2033/schedule/7/paragraph/17 (the official version)
Page: https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-7/paragraph-17
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.