The Veterinary Medicines (Amendment etc.) Regulations 2024
Write the words of this act the way you think they should read. Solon shows your change as a redline against the published text and pins it to that exact text, so it can never be applied to wording you did not see.
Change 1
As published
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
.
Your change, as a redline
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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