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The Veterinary Medicines Regulations 2013

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Regulation 16

SCHEDULE 7U.K.Fees

This Atodlen has no associated Memorandwm Esboniadol

PART 1U.K.Introduction

InterpretationE+W+S

1.— [F1(1)]  In this Schedule—

F2...

“pharmaceutical product” means any veterinary medicinal product other than an immunological product [F3or a biological veterinary medicinal product that is not immunological];

“simultaneous application” is an application in which, at the time an authorisation for a product is applied for, one or more additional applications are submitted for products that are identical to the first product except that—

(a)

in the case of an immunological product, they have a lesser number of antigens than the first product, but only contain antigens contained in the first product; and

(b)

in the case of a pharmaceutical product, they have different strengths of the active substance,

F4...

[F5(2) For the purposes of this Schedule “manufacturing authorisation” means the following activities—

(a)manufacture or import of an authorised veterinary medicinal product;

(b)manufacture of a product to which paragraph 2 of Schedule 6 relates;

(c)manufacture of a product for administration under the cascade;

(d)manufacture of—

(i)an autogenous vaccine;

(ii)a stem cell product; or

(iii)a blood product for administration to non-food animals.]

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

F1Sch. 7 para. 1 renumbered as Sch. 7 para. 1(1) (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 162(a)

InterpretationN.I.

1.  In this Schedule—

“national application” means an application for a marketing authorisation that does not involve another member State;

“pharmaceutical product” means any veterinary medicinal product other than an immunological product;

“simultaneous application” is an application in which, at the time an authorisation for a product is applied for, one or more additional applications are submitted for products that are identical to the first product except that—

(a)

in the case of an immunological product, they have a lesser number of antigens than the first product, but only contain antigens contained in the first product; and

(b)

in the case of a pharmaceutical product, they have different strengths of the active substance,

and, in the case of an application involving more than one member State, the additional applications do not include a member State that was not included in the first application.

Extent Information

E36This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Payment of feesU.K.

2.  All fees under this Schedule are payable to the Secretary of State.

Time of paymentU.K.

3.  All fees are payable on invoice unless otherwise specified.

Multiple inspectionsU.K.

4.  If a site, premises or establishment is inspected for more than one type of authorisation [F6, approval] or registration at the same time, [F7and in relation to the same legal entity,] the fee is the sum of—

(a)the highest fee payable; and

(b)50% of each of the other fees.

Textual Amendments

Expenses for inspections outside the United KingdomU.K.

5.  Whenever premises outside the United Kingdom are inspected, the travel and subsistence costs of the inspectors and interpreters’ fees are payable in addition to the inspection fee specified.

TranslationU.K.

6.  All translation costs are charged additionally.

PART 2U.K.Fees relating to marketing authorisations

[F8Application for a marketing authorisation for a pharmaceutical [F9, immunological or biological that is not immunological] veterinary medicinal product]E+W+S

7.  The following table sets out the fees relating to a pharmaceutical [F10, immunological or biological that is not immunological] veterinary medicinal product for—

(a)[F11an application] for a marketing authorisation that is—

(i)a full application under Part 1 of Schedule 1; [F12or]

(ii)a bibliographic application [F13for a pharmaceutical veterinary medicinal product]; F14...

F15(iii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F16(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F17(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F18ApplicationFee (£) per authorisation
Base fee27,995
Fee for 1st additional strength4,590
Fee for each subsequent additional strength1,465]

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

Specified pharmaceutical applicationsN.I.

7.  The following table sets out the fees relating to a pharmaceutical veterinary medicinal product for—

(a)a national application for a marketing authorisation that is—

(i)a full application under Part 1 of Schedule 1;

(ii)a bibliographic application; or

(iii)an application based on pharmacological equivalence;

(b)an application for a marketing authorisation using the decentralised procedure where the United Kingdom is a concerned member State;

(c)an application for the mutual recognition of a product authorised in another member State.

ApplicationFull national application under Part 1 of Schedule 1 (£)Bibliographic national application (£)Pharmacologically equivalent national applicationDecentralised application where the UK is a concerned member State or recognition of a product authorised in another member State (£)
Reference product authorised in UK (£)Reference product not authorised in UK (£)
Base Fee:13,53012,1157,1959,2206,515
Additional fee if any of the target species is a food-producing animal:3,9053,5852,1552,7601,415
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom—
food-producing animal:7,4656,5955,8857,4952,630
non-food-producing animal:6,5255,8555,5907,1552,295
Additional fee for each additional pack type:740740605775330
Additional fee for each additional active ingredient (food-producing animal):6,4656,1254,0405,1652,085
Additional fee for each additional active ingredient (non-food-producing animal):4,3104,1053,2354,1351,475
Additional fee if there is more than one target species, for each additional species (food-producing animal):3,9703,5652,4253,100

1,280

Applies for a maximum of 2 additional species

Additional fee if there is more than one target species, for each additional species (non- food-producing animal):2,4952,0901,5501,980

805

Applies for a maximum of 2 additional species

Additional fee for each additional recommended route of administration (food-producing animal):2,6952,4901,6202,070940
Additional fee for each additional recommended route of administration (non- food-producing animal):1,2151,010740945405
Simultaneous applications: fee for each additional product in the application:2,8952,8952,8953,7051,685

Extent Information

E37This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F19Application for a marketing authorisation for specific applicationsE+W+S

7A.  The fee for an application for a marketing authorisation which involves one or more of the following is £45,000—

(a)any biotechnical process involving recombinant DNA or the controlled expression of genes;

(b)a veterinary medicinal product containing a new active substance;

(c)a biopharmaceutical product.]

Textual Amendments

Decentralised pharmaceutical application where the United Kingdom is the reference member StateE+W+S

F208.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Decentralised pharmaceutical application where the United Kingdom is the reference member StateN.I.

8.  The fee for a decentralised application for a pharmaceutical product where the United Kingdom is the reference member State is the same as for a national application as set out in the table in paragraph 7, with the addition of the fees in the following table.

Fees for decentralised pharmaceutical application where the United Kingdom is the reference member State
ApplicationAdditional fee for a pharmacologically equivalent product (£)Additional fee otherwise (£)
Food-producing animal: one member State:5,2303,705
Non-food-producing animal: one member State:3,9853,220
Each additional member State:530530
Simultaneous application: fee for each additional product in the application:
one member State:6,6706,670
each additional member State:120120

Extent Information

E38This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Application for a marketing authorisation for an immunological or biosimilar productE+W+S

F219.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Application for a marketing authorisation for an immunological or biosimilar productN.I.

9.—(1) The fee for a national application for a marketing authorisation relating to an immunological or biosimilar product, a decentralised application where the United Kingdom is the concerned member State or the mutual recognition of a product authorised in another member State is in accordance with the following table.

(2) In this paragraph a biosimilar application means an application made in accordance with Article 13(4) of Directive 2001/82/EC and a biosimilar product means a product which is the subject of such an application.

Fees for specified immunological and biosimilar applications
ApplicationNational application for a marketing authorisation(£)Decentralised application where the UK is a concerned member State or recognition of a product authorised in another member State (£)
1. Immunological or biosimilar product other than in paragraph 2 below: Base fee:11,7755,785
The following fees are in addition to the base fee—
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom, and for each new combination of active ingredients:7,4052,490
Additional fee for each adjuvant or preservative not previously included in a veterinary medicinal product authorised in the United Kingdom and for each new combination of adjuvants or preservatives:1,345675
More than one antigenic component – fee for each additional component:1,350405
More than one species – fee for each additional species:5,380

1,615

Applies for a maximum of 2 additional species

More than one route of administration – fee for each additional route of administration:5,3801,615
Simultaneous application - fee for each additional product in the application:2,8951,685
2. Immunological or product that is identical to a product already authorised in the United Kingdom but with a lesser number of antigens and that only contains antigens contained in that product:10,4305,380

Extent Information

E39This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Decentralised immunological application where the United Kingdom is the reference member StateE+W+S

F2210.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Decentralised immunological application where the United Kingdom is the reference member StateN.I.

10.  The fee for a decentralised application for a marketing authorisation for an immunological product where the United Kingdom is the reference member State is the same as for a national application set out in the previous table, with the addition of the fees in the following table—

Fees for decentralised immunological application where the United Kingdom is the reference member State
ApplicationAdditional fee (£)
One member State:3,470
Each additional member State:530
Simultaneous applications: fee for each additional product in the application:
one member State:6,670
each additional member State:120

Extent Information

E40This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F23Application for a marketing authorisation based on informed consentE+W+S

11.  The fee for applications for marketing authorisations using identical data submitted simultaneously or on the basis of information provided under paragraph 9 of Schedule 1 is as follows—

ApplicationFee (£) per authorisation
Application1,465]

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

Applications for a marketing authorisation using data already assessedN.I.

11.  The fees for applications for marketing authorisations using identical data submitted simultaneously or on the basis of information provided under Article 13(c) of Directive 2001/82/EC are in accordance with the following table.

Fees for a marketing authorisation using data already assessed
ApplicationFee (£)per authorisation
Decentralised application where the United Kingdom is the reference member State—
one member State:4,165
each additional member State:530
Any other application:945

Extent Information

E41This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Application for an exceptional marketing authorisation (pharmaceutical)U.K.

12.  The fee for an application for an exceptional marketing authorisation for a pharmaceutical product is in accordance with the following table.

Fees for an exceptional marketing authorisation for a pharmaceutical product
ApplicationProvisional (£)Limited (£)
Base Fee:12,0156,765
The following fees are in addition to the base fee—
Additional fee if any of the target species is a food-producing animal:3,9051,952
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom—
food-producing animal:5,8503,732
non-food-producing animal:4,9103,262
Additional fee for each additional pack type:710370
Additional fee for each additional active ingredient (food-producing animal):5,9553,232
Additional fee for each additional active ingredient (non-food-producing animal):3,8002,155
Additional fee if there is more than one target species, for each additional species (food-producing animal):2,9651,985
Additional fee if there is more than one target species, for each additional species (non-food-producing animal):1,4851,247
Additional fee for each additional recommended route of administration (food-producing animal):2,1851,347
Additional fee for each additional recommended route of administration (non-food-producing animal):710608
Simultaneous applications— fee for each additional product in the application:2,8951,447

Fees for an application for an exceptional marketing authorisation [F24(immunological or biological non-immunological)]E+W+S

13.  The fee for an application for an exceptional marketing authorisation for an immunological product [F25or a biological veterinary medicinal product that is not immunological] is in accordance with the following table.

Fees for an exceptional marketing authorisation for an immunological product [F25or a biological veterinary medicinal product that is not immunological]
ApplicationProvisional (£)Limited (£)
Base fee:10,8105,887
The following fees are in addition to the base fee—
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom, and for each new combination of active ingredients:5,6503,702
Additional fee for each adjuvant or preservative not previously included in a veterinary medicinal product authorised in the United Kingdom and for each new combination of adjuvants or preservatives:1,350672
More than one antigenic component – fee for each additional component:1,190675
More than one species – fee for each additional species:4,0602,690
More than one route of administration – fee for each additional route of administration:4,0602,690
Simultaneous application - fee for each additional product in the application:2,8951,447

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

Fees for an application for an exceptional marketing authorisation (immunological)N.I.

13.  The fee for an application for an exceptional marketing authorisation for an immunological product is in accordance with the following table.

Fees for an exceptional marketing authorisation for an immunological product
ApplicationProvisional (£)Limited (£)
Base fee:10,8105,887
The following fees are in addition to the base fee—
Additional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom, and for each new combination of active ingredients:5,6503,702
Additional fee for each adjuvant or preservative not previously included in a veterinary medicinal product authorised in the United Kingdom and for each new combination of adjuvants or preservatives:1,350672
More than one antigenic component – fee for each additional component:1,190675
More than one species – fee for each additional species:4,0602,690
More than one route of administration – fee for each additional route of administration:4,0602,690
Simultaneous application - fee for each additional product in the application:2,8951,447

Extent Information

E42This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Fee for the conversion from an exceptional to a full marketing authorisationU.K.

14.  The fee for the conversion of an exceptional marketing authorisation to a full marketing authorisation is £3,000.

Application for a marketing authorisation relating to a parallel importE+W+S

F2615.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Application for a marketing authorisation relating to a parallel importN.I.

15.  The fee for a marketing authorisation for a parallel import is in accordance with the following table.

Parallel imports
ApplicationFee (£)
Application where the imported product has been authorised in accordance with the mutual recognition procedure or decentralised procedure, and the United Kingdom is included in these procedures—
import from one or more member States:1,755
Application to add an additional member State after the marketing authorisation has been granted – fee for each member State:455
Application where the imported product has not been authorised in accordance with the mutual recognition procedure or the decentralised procedure but where the imported product originates from the same manufacturing site as the product authorised in the United Kingdom to which the imported product is considered to be essentially similar:2,130
Any other application – fee for each member State from which the product is imported:4,710

Extent Information

E43This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F27Fee for a generic marketing authorisationE+W+S

15A.—(1) The fee for a marketing authorisation in respect of a generic veterinary medicinal product is to be calculated in accordance with the following table.

ApplicationFee (£) per authorisation
HybridStandard
Base Fee13,95012,390
Fee for 1st additional strength4,590
Fee for each subsequent additional strength1,465.

(2) In this paragraph “hybrid” means an application to which paragraph 10A of Schedule 1 applies.]

Textual Amendments

Application to change the distribution category of a product authorised through the centralised procedureE+W+S

F2816.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Application to change the distribution category of a product authorised through the centralised procedureN.I.

16.  The fee to change the distribution category of a product authorised through the centralised procedure is £3,135.

Extent Information

E44This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Application for a variation to a marketing authorisation F29....E+W+S

17.—(1) This paragraph applies in relation to an application for a variation to one or more marketing authorisations except where paragraph F30... 21 applies.

(2) The fees for the variations to which this paragraph applies are set out in the following table.

(3) 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.

(4) 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.

[F31Type of variationsFee (£)
Single variations; one change for each product
Variation – standard2,895
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 animal5,390
(ii)a pharmaceutical product for a food-producing animal7,135
(b) a change of bioavailability8,415
(c) a change of active substance, where the change is to—
(i)use a different biologically active substance with a slightly different molecular structure8,415
(ii)modify the vector used to produce the antigen or the source material, including a new master cell bank from a different source8,415
(d) a change of pharmacokinetics8,415
Simultaneous application falling within (a) to (d): fee for each additional product in the application1,465
Variation – reduced885
Variation - no assessment455
Grouped variations
Variation – standard led
For the first nine changes6,280
For each subsequent group of five or fewer changes2,250
Variation – reduced led:
For the first nine changes1,770
For each subsequent group of five or fewer changes2,250]

Extent Information

E10This 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 to a marketing authorisation dealt with under national or mutual recognition variation procedures.N.I.

17.—(1) This paragraph applies in relation to an application for a variation to one or more marketing authorisations except where paragraph 18, 19 or 21 applies.

(2) The fees for the variations to which this paragraph applies are set out in the following table.

(3) 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.

(4) 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.

Type of variationNationalUK is the reference member StateUK is a concerned member State
Single variations; one change for each product
Extension:
Change of strength or potency or the addition of a new strength or potency:6,670-1,998
Change of pharmaceutical form or the addition of a new pharmaceutical form:8,415-2,301
Change of route of administration, or the addition of a new one, of—-
(i) an immunological product, or a pharmaceutical product for a [F107non-food-producing] animal:5,390-1,737
(ii) a pharmaceutical product for a food-producing animal:7,135-2,058
Change or addition of a food producing target species:9,620-2,547
Change of active substance, including:8,415-2,301
use of a different salt, ester, complex or derivative of the same therapeutic moiety:
use of a different biologically active substance with a slightly different molecular structure:
modification of the vector used to produce the antigen or the source material, including a new master cell bank from a different source:
use of a new ligand or coupling mechanism for a radiopharmaceutical:
change of the extraction solvent or change of the ratio of herbal drug to herbal drug preparation:
Change of bioavailability:8,415-2,301
Change of pharmacokinetics:8,415-2,301
Simultaneous application: fee for each additional product in the application:2,895-1,011
Type II:2,8956,0301,872
Type IB:8851,325531
Type IA:455685273
Grouped variations
Extension-led:
The fee for an application for an extension-led grouped variation is the fee for that extension as specified above plus —
(a) if there is one variation in addition to the extension, the fee for that variation as specified above; or
(b) if there is more than one variation in addition to the extension, the fee that would be payable for a grouped variation of that type as specified below.
Type II led:
For the first nine changes:6,28012,0603,768
For each subsequent group of up to ten changes:4,5004,5002,700
Type IB led:
For the first nine changes:1,7702,6501,062
For each subsequent group of up to ten changes:4,5004,5002,700
Type IA led:
For the first nine changes:8851,325531
For each subsequent group of up to ten changes:4,5004,5002,700

Extent Information

E45This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Application for a variation to a marketing authorisation dealt with under worksharing proceduresE+W+S

F3218.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Application for a variation to a marketing authorisation dealt with under worksharing proceduresN.I.

18.—(1) This paragraph applies in relation to an application for a variation to a marketing authorisation dealt with in accordance with worksharing procedures as set out in Article 20 of Commission Regulation (EC) No 1234/.

(2) The fee for a worksharing application, involving marketing authorisations obtained by a national procedure in the United Kingdom only, is the fee specified in the following table in the column headed “UK Only”.

(3) The fee for a worksharing application, involving marketing authorisations obtained through a national procedure in the United Kingdom and any other member State, is specified in the following table by reference to the United Kingdom’s role in the procedure, as “UK Reference Authority”, “UK Co-Reference Authority” or “Other”.

(4) The fee for a worksharing application, involving at least one marketing authorisation obtained through the mutual recognition or decentralised procedure, is specified in the following table by reference to the United Kingdom’s role in the procedure, as “UK Reference Authority”, “UK Co-Reference Authority” or “UK Concerned member State”.

(5) The fee for any kind of variation where the Agency co-ordinates worksharing is £455 for each marketing authorisation.

Type of applicationUK OnlyWhere the application involves nationally authorised products in more than one member StateApplication involves mutually recognised products

UK

Only

UK Reference Authority

UK

Co-Reference

Authority

Other

UK

Reference Authority

UK

Co-Reference Authority

UK

Concerned member State

Worksharing applications

The following fees apply for each change to each product:

Type II
For the first nine changes:6,24012,0607,48512,06013,2656,7453,372
For each subsequent group of up to ten changes:4,5004,5004,5004,5004,5004,5002,700
Type IB
For the first nine changes:1,7702,6502,1202,6502,9151,905954
For each subsequent group of up to ten changes:4,5004,5004,5004,5004,5004,5002,700

Extent Information

E46This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Application for an extension dealt with under the decentralised procedure where the United Kingdom is the reference member StateE+W+S

F3319.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E11This 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 extension dealt with under the decentralised procedure where the United Kingdom is the reference member StateN.I.

19.  The fee for a decentralised application for an extension where the United Kingdom is the reference member State is the same as for a national application as set out in the table in paragraph 17, with the addition of the supplementary fees in the following table (save that, where the application is for the addition of more than one species, only one supplementary fee applies).

Decentralised application for an extension where the United Kingdom is the reference member State
ApplicationSupplementary fee (£)
Pharmaceutical product for a food-producing animal – one member State:3,705
Pharmaceutical product for a non-food-producing animal – one member State:3,220
Immunological product – one member State:3,460
Each additional member State:530
Simultaneous application: fee for each additional product in the application:
one member State:6,670
each additional member State:120

Extent Information

E47This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Provision of information relating to the recognition of a United Kingdom marketing authorisation or an extensionE+W+S

F3420.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E12This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Provision of information relating to the recognition of a United Kingdom marketing authorisation or an extensionN.I.

20.—(1) Where an application is made for the Secretary of State to provide information to other member States to enable them to recognise a marketing authorisation already granted by the United Kingdom the following fees are payable.

(2) Those fees also apply where a marketing authorisation has been granted in more than one member State, the holder applies for an extension for that marketing authorisation and the United Kingdom acts as reference member State.

(3) Where a valid application to provide information to another member State is received within six months of the original grant of the marketing authorisation, or where the Secretary of State has already provided the information to a member State, and a further valid application is made to provide the information to an additional member State within six months of the date the last information was provided, the fees are—

Type of applicationFee for a pharmacologically equivalent product(a)Fee (other products) (£)
(a)

This fee is payable if the application for the marketing authorisation was on the basis that the product was pharmacologically equivalent to another veterinary medicinal product.

Pharmaceutical product for a food-producing animal – one member State:3,9402,440
Pharmaceutical product for a non-food-producing animal ‑ one member State:2,6451,895
Immunological product – one member State:2,1302,130
Each additional member State:535535

(4) Where the information to be provided relates to a product granted a marketing authorisation using identical data submitted simultaneously or on the basis of information provided under Article 13(c) of Directive 2001/82/EC the fees are—

ApplicationFee (£)
Provision of information to—
one member State:4,165
each additional member State:530

(5) In any other case the fees are—

Type of applicationFee for a pharmacologically equivalent product (£)(a)Fee (other products) (£)
(a)

This fee is payable if the application for the marketing authorisation was on the basis that the product was pharmacologically equivalent to another veterinary medicinal product.

Pharmaceutical product for a food-producing animal – one member State:12,01510,515
Pharmaceutical product for a non-food-producing animal – one member State:8,1157,365
Immunological product – one member State:8,9408,940
Each additional member State:535535

(6) In the case of simultaneous applications, the above fees are payable for each additional product in the application for one member State, with a fee of £115 for each additional product for each additional member State.

Extent Information

E48This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Exception for a variation relating to animal testingE+W+S

21.  If the only purpose of a variation is to remove animal testing or to reduce the numbers of animals used in testing, no fee is payable for the variation F35....

Extent Information

E13This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Exception for a variation relating to animal testingN.I.

21.  If the only purpose of a variation is to remove animal testing or to reduce the numbers of animals used in testing, no fee is payable for the variation in the case of a national authorisation, and the United Kingdom element of the fee for the variation is not payable for an authorisation obtained through the mutual recognition procedure or the decentralised procedure.

Extent Information

E49This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F36Application for a reassessment of an exceptional marketing authorisation]E+W+S

22.—F37(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) The fee for the first reassessment of an exceptional marketing authorisation is £305, and the fee for each subsequent reassessment is £1,360.

Extent Information

E14This 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 the renewal of a national marketing authorisationN.I.

22.—(1) The fee for an application for the renewal of a marketing authorisation is £1,360.

(2) The fee for the first reassessment of an exceptional marketing authorisation is £305, and the fee for each subsequent reassessment is £1,360.

Extent Information

E50This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Application for the renewal of a marketing authorisation obtained through mutual recognition or the decentralised procedureE+W+S

F3823.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E15This 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 the renewal of a marketing authorisation obtained through mutual recognition or the decentralised procedureN.I.

23.  The fee for an application for the renewal of a marketing authorisation obtained through mutual recognition or the decentralised procedure is —

(a)£1,835 if the United Kingdom is the reference member State; and

(b)£1,225 if the United Kingdom is a concerned member State.

Extent Information

E51This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Registration of a homeopathic remedyE+W+S

24.  The fee for an application for the registration of a homeopathic remedy is in accordance with the following table.

Fee for the registration of a homeopathic remedy
Type of applicationFees(£)
If all stocks and the formulation have already been assessed by the Secretary of State—
not more than five stocks:160
more than five stocks:375
If either all the stocks have already been assessed by the Secretary of State but there is a new formulation, or if the formulation has already been assessed by the Secretary of State but one or more of the stocks have not been already assessed—
not more than five stocks:455
more than five stocks:665
If the formulation and at least one of the stocks has not already been assessed by the Secretary of State—
not more than five stocks:760
more than five stocks:985
If the product is already authorised for human use in the United Kingdom, or for human or veterinary use in the United Kingdom F39...—
not more than five stocks:160
more than five stocks:375

Extent Information

E16This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Registration of a homeopathic remedyN.I.

24.  The fee for an application for the registration of a homeopathic remedy is in accordance with the following table.

Fee for the registration of a homeopathic remedy
Type of applicationFees(£)
If all stocks and the formulation have already been assessed by the Secretary of State—
not more than five stocks:160
more than five stocks:375
If either all the stocks have already been assessed by the Secretary of State but there is a new formulation, or if the formulation has already been assessed by the Secretary of State but one or more of the stocks have not been already assessed—
not more than five stocks:455
more than five stocks:665
If the formulation and at least one of the stocks has not already been assessed by the Secretary of State—
not more than five stocks:760
more than five stocks:985
If the product is already authorised for human use in the United Kingdom, or for human or veterinary use in the United Kingdom or in another member State—
not more than five stocks:160
more than five stocks:375

Extent Information

E52This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Renewal of a homeopathic remedyU.K.

[F4025.  The fee for the renewal of a homeopathic remedy is £320.]

Textual Amendments

Annual fees for marketing authorisationsU.K.

26.—(1) Within 30 days of receiving a written demand from the Secretary of State, a holder of a marketing authorisation must provide the Secretary of State with a statement of turnover for the previous calendar year.

(2) The annual fee, rounded to the next £1, is—

where—

(a)

T is the annual turnover in the previous calendar year;

(b)

and n is the number of active marketing authorisations held at any time during the previous calendar year.

(3) In the case of an authorisation holder with a turnover relating to all marketing authorisations held of less than £230,000, the annual fee, rounded to the next £1 is—

where—

(a)

T is the annual turnover in the previous calendar year;

(b)

and n is the number of active marketing authorisations held at any time during the previous calendar year.

(4) In this paragraph—

“turnover” means the sales value at manufacturers’ prices of all authorised veterinary medicinal products sold or supplied in the United Kingdom;

“manufacturers’ prices” means the prices charged (excluding value added tax) for authorised products by manufacturers to wholesalers, except to the extent that—

(a)

the products are supplied by manufacturers direct to retailers, in which case it means the prices charged for the products by the manufacturers to the retailers reduced by such sum as, in the opinion of the Secretary of State, represents the difference between the prices paid by the retailers and those which could be expected to be charged by the manufacturers to wholesalers according to the practice prevailing during the period in question with regard to such products;

(b)

a marketing authorisation holder sells or supplies products that the marketing authorisation holder has neither manufactured nor obtained from the manufacturer, in which case it means the prices paid by the marketing authorisation holder for those products.

Auditor’s certificateU.K.

27.—(1) The Secretary of State may at any time require an audit certificate in support of a statement of turnover.

(2) If the holder of the marketing authorisation does not provide an audit certificate before the date stipulated in the demand, an additional fee is payable for that year of £11,300 plus an additional £2,245 in respect of each marketing authorisation held.

(3) If the Secretary of State is not satisfied that the audit certificate provides sufficient assurance that the figures fairly present the financial records of the company, the Secretary of State may require the marketing authorisation holder to produce a further certificate and specify what further assurances are needed; and if these are not provided by the required date, the additional fee specified in sub-paragraph (2) is payable.

(4) Nothing in this paragraph limits the powers of an inspector to examine financial records.

PART 3U.K.Fees payable by manufacturers

Application for a manufacturing authorisationE+W+S

28.—[F41(1)] The fee for an application for a manufacturing authorisation for a veterinary medicinal product [F42is £762]

[F43(2) Fees relating to an application for a manufacturing authorisation are payable with the application.]

Textual Amendments

F41Sch. 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)[F44£684] if the variation requires scientific or pharmaceutical assessment;

[F45(b)£105 if the variation only involves an administrative variation such as a change of ownership.”;]

F46(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F47(d). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E17This 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

E53This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F48Inspection of sites authorised to manufacture a product for administration under the cascade]E+W+S

30.—F49(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F50(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]

F51(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F52(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E18This 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

E54This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F53Autogenous 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

[F53Assessment 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

[F54Annual fee (manufacturing authorisations)E+W+S

31.  An annual fee of £575 is payable in respect of each manufacturing authorisation held.]

Extent Information

E19This 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

E55This 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.

[F55Sites 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

E20This 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

E56This 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.

[F56Sites 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

E21This 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

E57This 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—

[F57Sites 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

E22This 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

E58This 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.

[F58Sites 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

E23This 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

E59This 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 [F59£3,212], or [F60£4,507] for a site outside the United Kingdom.

Extent Information

E24This 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

E60This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F61Animal 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

E25This 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

E61This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

PART 4U.K.Fees relating to a wholesale dealer’s authorisation

[F62Application for a wholesale dealer’s authorisationE+W+S

39.—(1) The fee for an application for a wholesale dealer’s authorisation is £344.

(2) Fees relating to an application for a wholesale dealer’s authorisation are payable with the application.]

Extent Information

E26This 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 wholesale dealer’s authorisationN.I.

39.—(1) The fee for an application for a wholesale dealer’s authorisation is—

(a)£1,745;

(b)£785 if the application is accompanied by an estimate that the first year’s turnover will be less than £35,000; or

(c)£785 if the authorisation only relates to products classified as AVM-GSL, homeopathic remedies, or products authorised under Schedule 6 (exemptions for small pet animals).

(2) An applicant who has paid a fee of £785 on the grounds of turnover must send a declaration of turnover for the first year of trading on the anniversary of the grant of the authorisation, and if the figure is more than £35,000 must pay the balance of £960 within 30 days.

(3) If the applicant paid £1,745 but the turnover for the first year of trading was lower than £35,000, if the applicant sends a declaration certifying the turnover, the Secretary of State must refund the excess.

(4) Nothing in this paragraph limits the powers of an inspector to examine financial records.

(5) In this paragraph “turnover” means the sales value net of value added tax of all veterinary medicinal products (whether or not authorised for use in the United Kingdom) sold by way of wholesale dealing by the holder in the United Kingdom.

Extent Information

E62This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F63Variation of a wholesale dealer’s authorisationE+W+S

40.  The fee for an application to vary a wholesale dealer’s authorisation is—

(a)£265 if the variation requires scientific or pharmaceutical assessment;

(b)£105 for a change of ownership or other administrative variation.]

Extent Information

E27This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Variation of a wholesale dealer’s authorisationN.I.

40.  The fee for an application to vary a wholesale dealer’s authorisation is—

(a)£515 if the variation requires scientific or pharmaceutical assessment;

(b)£430 if the variation only involves a change of ownership; and

(c)otherwise £300.

Extent Information

E63This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F64Annual fee for a wholesale dealer’s authorisationE+W+S

41.  The annual fee for a wholesale dealer’s authorisation is £427.]

Extent Information

E28This 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 fee for a wholesale dealer’s authorisationN.I.

41.—(1) The annual fee for a wholesale dealer’s authorisation is—

(a)£483; or

(b)£315, if—

(i)the holder certifies when making the payment that the turnover during the previous year was less than £35,000; or

(ii)the authorisation only relates to products classified as AVM-GSL or homeopathic remedies;

(c)£215 if the authorisation only relates to products authorised under Schedule 6 (exemptions for small pet animals).

(2) In this paragraph “turnover” means the sales value net of value added tax of all veterinary medicinal products (whether or not authorised for use in the United Kingdom) sold by way of wholesale dealing by the holder in the United Kingdom.

Extent Information

E64This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F65Inspection of a wholesale dealer’s sitesE+W+S

42.  The fee for inspection of a wholesale dealer’s site is—

(a)£1,177; or

(b)£877 if—

(i)the authorisation only relates to products classified as AVM-GSL or homeopathic remedies; or

(ii)the authorisation only relates to products marketed under Schedule 6 (exemptions for small pet animals).]

Extent Information

E29This 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 wholesale dealer’s premisesN.I.

42.  The fee for the inspection of a wholesale dealer’s premises is—

(a)£3,058; or

(b)£1,442 if—

(i)the authorisation only relates to products classified as AVM-GSL or homeopathic remedies; or

(ii)the turnover relating to all veterinary medicinal products in the calendar year preceding the inspection was less than £35,000;

(c)£830 if the authorisation only relates to products authorised under Schedule 6 (exemptions for small pet animals).

Extent Information

E65This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

PART 5U.K.Fees relating to feedingstuffs

Fees for [F66applications for authorisation] and annual fees relating to feedingstuffs in Great BritainU.K.

43.—(1) Subject to sub-paragraph (3) the fee for the application for [F67authorisation] of [F68premises] manufacturing feedingstuffs and [F67authorisation] of distributors of feedingstuffs in Great Britain is [F69£105].

(2) An annual fee of [F70£122] is payable in respect of any such [F71authorisation].

(3) No fee is payable under sub-paragraph (1) in respect of [F72premises] where specified feed additives are manufactured if a [F73medicinal premix] is manufactured at [F74those premises] in accordance with a manufacturing authorisation.

(4) Fees relating to feedingstuffs are payable with the application F75....

(5) Where more than one manufacturing activity is carried out at one [F76premises by the same legal entity] only one fee (the highest) is payable.

Textual Amendments

Inspection fees relating to feedingstuffs in Great BritainU.K.

44.  Fees for the inspection of [F77premises] manufacturing or distributing feedingstuffs in Great Britain are in accordance with the following table.

[F78Inspection Fees
Type of premises inspectedFee payable (£)
Manufacturer of a specified feed additive (SFA)1,610
Manufacturer of an intermediate feedingstuff (including balancers) containing a medicinal premix or an SFA976

Manufacturer of a feedingstuff for sale containing—

a medicinal premix and/or an SFA, and/or

an intermediate feedingstuff containing a medicinal premix or an SFA

841

Manufacturer of a feedingstuff for feeding to their own animals only, containing—

a medicinal premix and/or an SFA incorporated at a rate of at least 2kg/t, and/or

an intermediate feedingstuff containing a medicinal premix and/or an SFA incorporated at a rate of at least 2kg/t

476

Distributor or trader of Schedule 5 products

(A distributor of specified feed additives, or intermediate feedingstuffs containing specified feed additives or medicinal premixes; or feedingstuffs containing a medicinal premix)

350]

Textual Amendments

Fees payable in relation to feedingstuffs in Northern IrelandE+W+S

F7945.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E30This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Fees payable in relation to feedingstuffs in Northern IrelandN.I.

45.—(1) The annual fees payable for the approval of establishments manufacturing and distributing feedingstuffs in Northern Ireland are in accordance with the following table.

(2) Fees are payable with the application or, for the subsequent annual fee, on invoice.

(3) Where more than one manufacturing activity is carried out at one establishment only the highest fee is payable.

Approval fees
Type of establishmentFee payable (£)
(a)

No fee is payable for establishments that already have a manufacturing authority relating to veterinary medicinal products for incorporating into feedingstuffs.

1Establishment manufacturing a specified feed additive(a):545
2Establishment manufacturing a premixture:435
3Establishment manufacturing feedingstuffs using specified feed additives and veterinary medicinal products directly at any concentration, or using premixtures or specified feed additive complementary feedingstuffs:435
4Establishment manufacturing feedingstuffs for placing on the market using a veterinary medicinal product or premixture where the concentration of veterinary medicinal product in the feedingstuffs is 2 kg per tonne or more:320
5Establishment manufacturing feedingstuffs using premixtures or specified feed additive complementary feedingstuffs containing specified feed additives when the feedingstuffs are to be placed on the market:170
6Establishment manufacturing feedingstuffs for the manufacturers own use using a veterinary medicinal product or premixture where the concentration of veterinary medicinal product in the feedingstuffs is 2 kg per tonne or more:131
7Establishment manufacturing feedingstuffs using premixtures containing specified feed additives when the feedingstuffs are to be used by the person manufacturing the feedingstuffs:110
8Establishment distributing specified feed additives, premixtures or feedingstuffs containing specified feed additives, or premixtures or feedingstuffs containing veterinary medicinal products:70

Extent Information

E66This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Fees relating to premises for supply by suitably qualified personsE+W+S

46.—(1) The fee [F80for an application for the authorisation] of premises for the retail supply of veterinary medicinal products by suitably qualified persons is—

(a)[F81£105]; F82...

F82(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F83(1A) The fees for the inspection of sites authorised for the retail supply of veterinary medicinal products by suitably qualified persons are set out in the following table—

Inspection Fees
Type of sites inspectedFee payable (£)
Sites authorised to supply companion animal medicines285
Sites authorised to supply equine medicines285
Sites authorised to supply livestock medicines338
Sites authorised to supply avian medicines285.

(1B) Where a site is inspected in relation to a single authorisation, and falls within more than one of the categories in the table, only one fee (the highest) is payable.]

(2) The subsequent annual fee is—

(a)[F84£57]; F85...

F85(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F86(3) The application fee for authorisation of sites for supply is payable with the application.]

Extent Information

E31This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F81Sum in Sch. 7 para. 46(1) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 192(a)(ii)

F84Sum in Sch. 7 para. 46(2) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 192(c)(i)

Fees relating to premises for supply by suitably qualified personsN.I.

46.—(1) The fee to approve of premises for the retail supply of veterinary medicinal products by suitably qualified persons is—

(a)£265; or

(b)if the premises are only authorised to supply veterinary medicinal products for the treatment of—

(i)horses (or horses and companion animals) £145; or

(ii)companion animals £110.

(2) The subsequent annual fee is—

(a)£185; or

(b)if the premises are only authorised to supply veterinary medicinal products for the treatment of—

(i)horses (or horses and companion animals) £95; or

(ii)companion animals £70.

Extent Information

E67This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

PART 6U.K.General

Testing samplesU.K.

47.  The fee for testing a sample required to be submitted by the Secretary of State is the full economic cost of the test.

Animal test certificatesE+W+S

48.—(1) The fee for an animal test certificate is [F87£1,170].

(2) The fee for an animal test certificate to administer medicinal products in a small scale trial to test them for clinical safety or efficacy is [F88£40].

F89(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F90(4) The fee for an application for the variation of the certificate is—

(a)in the case of a small scale trial, £40; and

(b)in the case of any other trial, £390.]

[F91(5) The fee for an application to renew a certificate is—

(a)in the case of a small scale trial, £40; and

(b)in the case of any other trial, £190.]

(6) The Secretary of State may waive the fee if satisfied that the application is in relation to developing a veterinary medicinal product for a limited market (for example, for a minor species, a minor use, or for a disease with restricted regional distribution).

Extent Information

E32This 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 test certificatesN.I.

48.—(1) The fee for an animal test certificate is £345 in the case of—

(a)an immunological veterinary medicinal product that has been authorised in another member State for the species on which the proposed test will be conducted;

(b)a pharmaceutical veterinary medicinal product that has been authorised in another member State for use with a food-producing species on which the proposed test will be conducted where the same or similar dosage regime and method of administration is to be used in the medicinal test as is authorised; or

(c)a pharmaceutical veterinary medicinal product authorised in another member State for human or animal use where the test is to be conducted on companion animals only.

(2) The fee for an animal test certificate to administer medicinal products in a small scale trial to test them for clinical safety or efficacy is £30.

(3) In any other case the fee is £815.

(4) The fee for an application for a variation of the certificate is £265 for each change.

(5) The fee for an application to renew a certificate is £130.

(6) The Secretary of State may waive the fee if satisfied that the application is in relation to developing a veterinary medicinal product for a limited market (for example, for a minor species, a minor use, or for a disease with restricted regional distribution).

Extent Information

E68This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Importation of a veterinary medicinal product for treatment under the cascadeE+W+S

49.—(1) The fee for a certificate to import (if necessary) and be in possession of and administer a veterinary medicinal product under the cascade is—

F92(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)£30 if the veterinary medicinal product is authorised in [F93another] country.

(2) The fee is payable in respect of each animal treated, but in the case of administration to and treatment of a discrete group of animals, the Secretary of State may notify the applicant in writing that a fee for only one animal is payable.

(3) There is no fee if the application is made using the website of the Veterinary Medicines Directorate.

Extent Information

E33This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Importation of a veterinary medicinal product for treatment under the cascadeN.I.

49.—(1) The fee for a certificate to import (if necessary) and be in possession of and administer a veterinary medicinal product under the cascade is—

(a)£15 if the veterinary medicinal product is authorised in another member State;

(b)£30 if the veterinary medicinal product is authorised in a third country.

(2) The fee is payable in respect of each animal treated, but in the case of administration to and treatment of a discrete group of animals, the Secretary of State may notify the applicant in writing that a fee for only one animal is payable.

(3) There is no fee if the application is made using the website of the Veterinary Medicines Directorate.

Extent Information

E69This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Wholesale dealer’s import certificateU.K.

50.—(1) The fee payable by the holder of a wholesale dealer’s authorisation for a certificate to import and store a veterinary medicinal product not authorised in the United Kingdom to enable it to be supplied for administration under Schedule 4 is [F94£760] .

(2) The fee is only payable if, in the twelve month period immediately before the application, the applicant has supplied the veterinary medicinal product to which the certificate relates in accordance with at least 100 certificates.

Textual Amendments

Specific batch controlU.K.

[F9551.  The fee for an authorisation to release a veterinary medicinal product under specific batch control is—

(a)£560; and

(b)£100 for each additional batch affected by the same issue where the specific batch control application is made at the same time.]

Textual Amendments

Submission of control tests of an immunological productU.K.

52.  The fee for the submission of the results of tests carried out on a batch of immunological products other than autogenous vaccines prior to release is £80.

Export certificatesE+W+S

53.  The fee for an application for an export certificate is [F96£54] F97....

Extent Information

E34This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F96Sum in Sch. 7 para. 53 substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 194(a)

Export certificatesN.I.

53.  The fee for an application for an export certificate is £30, and £15 for each certified copy.

Extent Information

E70This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Provision of adviceU.K.

54.  The fee for an application for written advice from the Secretary of State as to whether or not a product requires a marketing authorisation is £885.

[F98Provision of scientific adviceE+W+S

54A.  The fee for an application for written advice from the Secretary of State in relation to scientific matters is £4,487.]

Textual Amendments

Appeals to the Veterinary Products CommitteeU.K.

55.  The fee for an appeal to the Veterinary Products Committee is £1,500.

Fee relating to an appointed personU.K.

56.  The appellant is liable for the full economic cost of a referral to an appointed person subject to a maximum of £5,000.

Fees relating to a veterinary F99... practice premisesE+W+S

57.—[F100(1) The fees for the inspection of a veterinary practice premises are set out in the following table—

Type of premises inspectedFee payable (£)
Sites registered to supply companion animal medicines536
Sites registered to supply equine medicines536
Sites registered to supply livestock medicines536
Mixed practice premises698
Any other type of practice451]

(2) The initial registration and annual fee for the registration of veterinary practice premises with the Royal College of Veterinary Surgeons to supply veterinary medicinal products is [F101£38].

(3) Notwithstanding paragraph 2 of this Schedule, this is payable to the Royal College of Veterinary Surgeons.

[F102(4) For the purposes of sub-paragraph (1) “mixed practice” means premises supplying veterinary medicinal products to livestock in addition to any other category mentioned in that provision.]

Extent Information

E35This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Fees relating to a veterinary surgeon’s practice premisesN.I.

57.—(1) The fee for the inspection of a veterinary surgeon’s practice premises is £350.

(2) The initial registration and annual fee for the registration of veterinary practice premises with the Royal College of Veterinary Surgeons to supply veterinary medicinal products is £34.

(3) Notwithstanding paragraph 2 of this Schedule, this is payable to the Royal College of Veterinary Surgeons.

Extent Information

E71This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F103Fee in relation to verifying destruction of controlled drugE+W+S

57A.  The fee for verifying the destruction of a controlled drug listed in Schedule 2, 3 or 4 to the Misuse of Drugs Regulations 2001 is—

(a)£142; or

(b)£31 (where the verification takes place during the course of an inspection for other purposes).]

Textual Amendments

[F103Pharmacovigilance inspectionsE+W+S

57B.—(1) In relation to a pharmacovigilance inspection the fee is—

(a)£3,600 in the case of a large marketing authorisation holder; and

(b)£1,650 in the case of a small marketing authorisation holder.

(2) In sub-paragraph (1)—

“large marketing authorisation holder” means a marketing authorisation holder who holds 30 or more marketing authorisations;

“small marketing authorisation holder” means a marketing authorisation holder who holds fewer than 30 marketing authorisations.]

Textual Amendments

Refund of fees relating to the Veterinary Products Committee or appointed personsU.K.

58.  The Secretary of State must refund the fee payable in relation to an appeal to the Veterinary Products Committee or to an appointed person if, as a result of the appeal, the Secretary of State changes the decision that was the subject of the appeal.

Fees relating to an improvement noticeU.K.

59.  If an improvement notice is served under these Regulations, the fee for any subsequent inspection necessary as a result of the notice is the full economic cost of the inspection, payable by the person on whom the notice was served.

Non-payment of feesU.K.

60.  Where any fee [F104(other than any fee relating to a manufacturing authorisation or wholesale dealer’s authorisation)] is not paid, the Secretary of State may, after giving one month’s written warning, suspend the processing of any application from the person [F105or any authorisation held by the person] who has not paid the fee.

Textual Amendments

Waiver or reduction of feesU.K.

61.—(1) If the Secretary of State is satisfied that for reasons of human or animal health or the protection of the environment it is desirable that a product should be authorised for veterinary use or that an authorised product should remain on the market the Secretary of State may waive or reduce any fees payable under these Regulations.

[F106(1A) If the Secretary of State is satisfied that exceptional circumstances exist the Secretary of State may waive or reduce an inspection fee payable under these Regulations.]

(2) An applicant or the holder of a marketing authorisation must provide full written justification for any waiver or reduction.

Textual Amendments

Reduction of fees when an application is withdrawnU.K.

62.—(1) Where an application for a marketing authorisation, or any variation referred to in paragraph 17 or 18 as a Type II variation, an extension, an extension-led grouped variation or a Type II led grouped variation is withdrawn before determination, the fee is reduced in accordance with this paragraph.

(2) If no assessment (veterinary, scientific or pharmaceutical) has begun, the reduction is 90%.

(3) If assessment has begun but the Secretary of State has not yet requested further data, the reduction is 50%.

(4) If the Secretary of State has requested further information but it has not yet been provided, the reduction is 25%.

(5) If the further information requested has been supplied but has not yet been fully assessed or the application has not been referred to the Veterinary Products Committee, the reduction is 10%

(6) Once the further information has been fully assessed, or the application has been referred to the Veterinary Products Committee, there is no reduction.

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