xmlns:atom="http://www.w3.org/2005/Atom" xmlns:atom="http://www.w3.org/2005/Atom"
28.—[F1(1)] The fee for an application for a manufacturing authorisation for a veterinary medicinal product [F2is £762]
[F3(2) Fees relating to an application for a manufacturing authorisation are payable with the application.]
Textual Amendments
F1Sch. 7 para. 28 renumbered as Sch. 7 para. 28(1) (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 175(a)
F2Words in Sch. 7 para. 28(1) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 175(b)
F3Sch. 7 para. 28(2) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 175(c)
28. The fee for an application for a manufacturing authorisation for a veterinary medicinal product is—
(a)£3,040; or
(b)£530 if the authorisation only covers veterinary medicinal products manufactured under Schedule 6 (exemptions for small pet animals).
29. The fee for an application for the variation of a manufacturing authorisation is—
(a)[F4£684] if the variation requires scientific or pharmaceutical assessment;
[F5(b)£105 if the variation only involves an administrative variation such as a change of ownership.”;]
F6(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F7(d). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Extent Information
E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F4Sum in Sch. 7 para. 29(a) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 176(a)
F5Sch. 7 para. 29(b) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 176(b)
F6Sch. 7 para. 29(c) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 176(c)
F7Sch. 7 para. 29(d) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 176(c)
29. The fee for an application for the variation of a manufacturing authorisation is—
(a)£636 if the variation requires scientific or pharmaceutical assessment;
(b)£443 if the variation only involves a change of ownership;
(c)£210 if the authorisation only covers veterinary medicinal products manufactured under Schedule 6 (exemptions for small pet animals); and
(d)otherwise £350.
Extent Information
E10This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
30.—F9(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
[F10(2) The fees for the inspection of sites in connection with an authorisation (or an application for authorisation) for the manufacture of unauthorised veterinary medicinal products for administration under the cascade are set out in the following table—
Type of site | Fee (£) | |
---|---|---|
United Kingdom site | Site outside the United Kingdom | |
Super site | 21,416 | 22,710 |
Major site | 12,850 | 14,144 |
Standard site | 6,425 | 7,719 |
Minor site | 4,283 | 5,577] |
F11(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F12(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Extent Information
E2This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F8Sch. 7 para. 30 heading substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 177(d)
F9Sch. 7 para. 30(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), 177(a)
F10Sch. 7 para. 30(2) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 177(b)
F11Sch. 7 para. 30(3) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 177(c)
F12Sch. 7 para. 30(4) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 177(c)
30.—(1) The fee for an application for a standard authorisation to manufacture an autogenous vaccine or a veterinary medicinal product for administration under the cascade is—
(a)£3,435 for a site in the United Kingdom;
(b)£3,270 for a site outside the United Kingdom.
(2) The fee for each inspection after a standard authorisation has been granted is (in each case) the same as the fee specified in paragraph (1).
(3) In the case of an application for an individual authorisation to manufacture a single batch of autogenous vaccine, or a single batch of veterinary medicinal product for administration under the cascade the fee is £1,635.
(4) The fee to vary an authorisation is £305 if no further inspection is required, and otherwise is the full application fee.
Extent Information
E11This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
30A.—(1) The fee for the scientific assessment of an authorisation (or an application for authorisation) to manufacture an autogenous vaccine is £6,962.
(2) The fees for the inspection of sites in connection with an authorisation (or an application for authorisation) to manufacture autogenous vaccines are set out in the following table—]
Type of site | Fee (£) | |
---|---|---|
United Kingdom site | Site outside the United Kingdom | |
Super site | 21,416 | 22,710 |
Major site | 12,850 | 14,144 |
Standard site | 6,425 | 7,719 |
Minor site | 4,283 | 5,577 |
Textual Amendments
F13Sch. 7 paras. 30A, 30B inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 178
30B. The fee for the scientific assessment of an application for the variation of an authorisation to manufacture an autogenous vaccine is—
(a)£2,895 if the variation requires complex scientific or pharmaceutical assessment;
(b)£885 if the variation requires simple scientific or pharmaceutical assessment;
(c)£455 in relation to an administrative variation.]
Textual Amendments
F13Sch. 7 paras. 30A, 30B inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 178
31. An annual fee of £575 is payable in respect of each manufacturing authorisation held.]
Extent Information
E3This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F14Sch. 7 para. 31 substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 179
31.—(1) An annual fee of £550 is payable in respect of each manufacturing authorisation held (other than as specified in this paragraph).
(2) The annual fee for a manufacturing authorisation for an autogenous vaccine or a veterinary medicinal product for administration under the cascade is 0.67% of the turnover in the previous calendar year rounded to the next £1, with a minimum fee of £10.
(3) There is no annual fee for a manufacturing authorisation for a veterinary medicinal product manufactured in accordance with Schedule 6 for small pet animals.
(4) In this paragraph “turnover” means the sales value at manufacturers’ prices net of value added tax of all authorised veterinary medicinal products sold or supplied in the United Kingdom.
Extent Information
E12This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
32. For the purposes of deciding the fee for a site inspection—
“super site” is a site at which 250 or more relevant persons are employed;
“major site” is a site at which 60 or more, but fewer than 250, relevant persons are employed;
“standard site” is a site at which 10 or more, but fewer than 60 relevant persons are employed;
“minor site” is a site at which fewer than 10 relevant persons are employed;
“relevant person” means a person employed on the premises and systems inspected.
33. The fees for the inspection of a site where immunological veterinary medicinal products are manufactured are in accordance with the following table.
Type of site | Fee (£) | |
---|---|---|
United Kingdom site | Site outside the United Kingdom | |
Super site | 32,124 | 33,418 |
Major site | 21,416 | 22,710 |
Standard site | 10,708 | 12,002 |
Minor site | 6,425 | 7,719] |
Extent Information
E4This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F15Sch. 7 para. 33 Table substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 180
33. The fees for the inspection of a site where immunological veterinary medicinal products are manufactured are in accordance with the following table.
Type of site | Fee (£) | |
---|---|---|
United Kingdom site | Site outside United Kingdom | |
Super site | 24,071 | 22,867 |
Major site | 16,785 | 15,946 |
Standard site | 6,661 | 6,327 |
Minor site | 4,757 | 4,519 |
Extent Information
E13This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
34. The following fees are payable for the inspection of a site where no immunological veterinary medicinal products are manufactured, but where sterile products are manufactured.
Type of site | Fee (£) | |
---|---|---|
United Kingdom site | Site outside the United Kingdom | |
Super site | 27,841 | 29,135 |
Major site | 19,274 | 20,569 |
Standard site | 10,708 | 12,002 |
Minor site | 6,425 | 7,719] |
Extent Information
E5This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F16Sch. 7 para. 34 Table substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 181
34. The following fees are payable for the inspection of a site where no immunological veterinary medicinal products are manufactured, but where sterile products are manufactured.
Type of site | Fee (£) | |
---|---|---|
United Kingdom site | Site outside the United Kingdom | |
Super site | 23,324 | 22,157 |
Major site | 13,010 | 12,359 |
Standard site | 8,244 | 7,832 |
Minor site | 5,022 | 4,770 |
Extent Information
E14This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
35. The following fees are payable for the inspection of a site where only non-immunological and non-sterile veterinary medicinal products are manufactured—
Type of site | Fee (£) | ||
---|---|---|---|
United Kingdom site | Site outside the United Kingdom | ||
Super site | 21,416 | 22,710 | |
Major site | 12,850 | 14,144 | |
Standard site | 8,566 | 9,861 | |
Minor site | 4,283 | 5,577 | |
If the site is only involved in the manufacture of veterinary medicinal products authorised under Schedule 6 (exemptions for small pet animals)— | |||
Standard site | 3,212 | 4,507 | |
Minor site | 2,142 | 3,436] |
Extent Information
E6This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F17Sch. 7 para. 35 Table substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 182
35. The following fees are payable for the inspection of a site where only non-immunological and non-sterile veterinary medicinal products are manufactured—
Type of site | Fee (£) | ||
---|---|---|---|
United Kingdom site | Site outside the United Kingdom | ||
Super site | 14,180 | 13,471 | |
Major site | 8,325 | 7,909 | |
Standard site | 6,854 | 6,511 | |
Minor site | 3,789 | 3,600 | |
If the site is only involved in the manufacture of veterinary medicinal products authorised under Schedule 6 (exemptions for small pet animals— | |||
Standard site | 5,055 | 4,802 | |
Minor site | 2,728 | 2,592 |
Extent Information
E15This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
36. The following fees are payable for the inspection of a site where the only manufacturing process in relation to veterinary medicinal products is their assembly after the product has been put into its immediate container.
Type of site | Fee (£) | |
---|---|---|
United Kingdom site | Site outside the United Kingdom | |
Super site | 17,133 | 18,427 |
Major site | 10,708 | 12,002 |
Standard site | 6,425 | 7,719 |
Minor site | 4,283 | 5,577] |
Extent Information
E7This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F18Sch. 7 para. 36 Table substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 183
36. The following fees are payable for the inspection of a site where the only manufacturing process in relation to veterinary medicinal products is their assembly after the product has been put into its immediate container.
Type of site | Fee (£) | |
---|---|---|
United Kingdom site | Site outside the United Kingdom | |
Super site | 11,025 | 10,474 |
Major site | 5,949 | 5,652 |
Standard site | 4,917 | 4,671 |
Minor site | 2,035 | 1,933 |
Extent Information
E16This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
37. The fee for the inspection of a test site is [F19£3,212], or [F20£4,507] for a site outside the United Kingdom.
Extent Information
E8This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F19Sum in Sch. 7 para. 37 substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 184(a)
F20Sum in Sch. 7 para. 37 substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 184(b)
37. The fee for the inspection of a test site is £3,344, or £3,177 for a site outside the United Kingdom.
Extent Information
E17This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
38.—(1) The fee for the inspection of a blood bank is—
(a)£3,212 for a site in the United Kingdom; and
(b)£4,507 for a site outside the United Kingdom.
(2) The fee for the inspection of a non-food animal stem cell centre is—
(a)£2,142 for a site in the United Kingdom; and
(b)£3,436 for a site outside the United Kingdom]
Extent Information
E9This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F21Sch. 7 para. 38 substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 185
38.—(1) The fee for an authorisation to operate a blood bank is—
(a)on a first inspection £3,113; and
(b)on each subsequent inspection—
(i)£3,113 for a site in the United Kingdom; and
(ii)£2,966 for a site outside the United Kingdom.
(2) The fee for an authorisation to operate an equine stem cell centre is £3,427, and £3,092 for each subsequent inspection.
(3) The fee for a variation to an authorisation to operate a blood-bank or equine stem cell centre is £320.
Extent Information
E18This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only