# The Veterinary Medicines (Amendment etc.) Regulations 2024, Regulation 171: Amendment to paragraph 17


In paragraph 17 (application for variation to marketing authorisation under national or mutual recognition procedure)—
(a) in sub-paragraph (1) omit “18, 19 or”;
(b) for the table substitute—
“
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/ukdsi/2024/9780348258523/regulation/171 (the official version)
Page: https://openlegislation.uk/draft-veterinary-medicines-amendment-etc-regulations-2024/regulation-171
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

