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The Veterinary Medicines Regulations 2013

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PART 3U.K.Fees payable by manufacturers

Application for a manufacturing authorisationE+W+S

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)

Application for a manufacturing authorisationN.I.

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).

Application for a variation of a manufacturing authorisationE+W+S

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

Application for a variation of a manufacturing authorisationN.I.

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

[F8Inspection of sites authorised to manufacture a product for administration under the cascade]E+W+S

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—

Inspection fees
Type of siteFee (£)
United Kingdom siteSite outside the United Kingdom
Super site21,41622,710
Major site12,85014,144
Standard site6,4257,719
Minor site4,2835,577]

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

Application for an authorisation to manufacture an autogenous vaccine or a product for administration under the cascadeN.I.

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

[F13Autogenous vaccinesE+W+S

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—]

Inspection fees
Type of siteFee (£)
United Kingdom siteSite outside the United Kingdom
Super site21,41622,710
Major site12,85014,144
Standard site6,4257,719
Minor site4,2835,577

Textual Amendments

[F13Assessment of a variation of an authorisation to manufacture an autogenous vaccineE+W+S

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

[F14Annual fee (manufacturing authorisations)E+W+S

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

Annual feesN.I.

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

Site inspections – type of siteU.K.

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.

Inspection of a site where immunological veterinary medicinal products are manufacturedE+W+S

33.  The fees for the inspection of a site where immunological veterinary medicinal products are manufactured are in accordance with the following table.

[F15Sites where immunological veterinary medicinal products are manufactured
Type of siteFee (£)
United Kingdom siteSite outside the United Kingdom
Super site32,12433,418
Major site21,41622,710
Standard site10,70812,002
Minor site6,4257,719]

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

Inspection of a site where immunological veterinary medicinal products are manufacturedN.I.

33.  The fees for the inspection of a site where immunological veterinary medicinal products are manufactured are in accordance with the following table.

Sites where immunological veterinary medicinal products are manufactured
Type of siteFee (£)
United Kingdom siteSite outside United Kingdom
Super site24,07122,867
Major site16,78515,946
Standard site6,6616,327
Minor site4,7574,519

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

Inspection of a site where sterile veterinary medicinal products are manufacturedE+W+S

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.

[F16Sites where sterile veterinary medicinal products are manufactured
Type of siteFee (£)
United Kingdom siteSite outside the United Kingdom
Super site27,84129,135
Major site19,27420,569
Standard site10,70812,002
Minor site6,4257,719]

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

Inspection of a site where sterile veterinary medicinal products are manufacturedN.I.

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.

Sites where sterile veterinary medicinal products are manufactured
Type of siteFee (£)
United Kingdom siteSite outside the United Kingdom
Super site23,32422,157
Major site13,01012,359
Standard site8,2447,832
Minor site5,0224,770

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

Inspection of a site where no immunological or sterile veterinary medicinal products are manufacturedE+W+S

35.  The following fees are payable for the inspection of a site where only non-immunological and non-sterile veterinary medicinal products are manufactured—

[F17Sites where no immunological or sterile veterinary medicinal products are manufactured
Type of siteFee (£)
United Kingdom siteSite outside the United Kingdom
Super site21,41622,710
Major site12,85014,144
Standard site8,5669,861
Minor site4,2835,577
If the site is only involved in the manufacture of veterinary medicinal products authorised under Schedule 6 (exemptions for small pet animals)—
Standard site3,2124,507
Minor site2,1423,436]

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

Inspection of a site where no immunological or sterile veterinary medicinal products are manufacturedN.I.

35.  The following fees are payable for the inspection of a site where only non-immunological and non-sterile veterinary medicinal products are manufactured—

Site where no immunological or sterile veterinary medicinal products are manufactured
Type of siteFee (£)
United Kingdom siteSite outside the United Kingdom
Super site14,18013,471
Major site8,3257,909
Standard site6,8546,511
Minor site3,7893,600
If the site is only involved in the manufacture of veterinary medicinal products authorised under Schedule 6 (exemptions for small pet animals—
Standard site5,0554,802
Minor site2,7282,592

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

Inspection of a site where veterinary medicinal products are assembledE+W+S

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.

[F18Sites where medicinal products are assembled
Type of siteFee (£)
United Kingdom siteSite outside the United Kingdom
Super site17,13318,427
Major site10,70812,002
Standard site6,4257,719
Minor site4,2835,577]

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

Inspection of a site where veterinary medicinal products are assembledN.I.

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.

Site where medicinal products are assembled
Type of siteFee (£)
United Kingdom siteSite outside the United Kingdom
Super site11,02510,474
Major site5,9495,652
Standard site4,9174,671
Minor site2,0351,933

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

Test sitesE+W+S

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

Test sitesN.I.

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

[F21Animal blood bank or non-food animal stem cell centre authorisationsE+W+S

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

Animal blood bank or equine stem cell centre authorisationsN.I.

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

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