Paragraph 17 Application for a variation to a marketing authorisation ....F3E1
England, Wales and Scotland
This paragraph applies in relation to an application for a variation to one or more marketing authorisations except where paragraph F1... 21 applies.
The fees for the variations to which this paragraph applies are set out in the following table.
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.
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.
| F2Type 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 | ||
Annotations
Textual amendments
- F1
Words in Sch. 7 para. 17(1) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 171(a)
- F2
Sch. 7 para. 17 Table substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 171(b)
- F3
Words in Sch. 7 para. 17 heading omitted (E.W.S.) (31.12.2020) by virtue of The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(4)(i); 2020 c. 1, Sch. 5 para. 1(1)
Extent
- E1
This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only