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The Veterinary Medicines Regulations 2013

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PART 2U.K.Fees relating to marketing authorisations

[F1Application for a marketing authorisation for a pharmaceutical [F2, 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 [F3, immunological or biological that is not immunological] veterinary medicinal product for—

(a)[F4an application] for a marketing authorisation that is—

(i)a full application under Part 1 of Schedule 1; [F5or]

(ii)a bibliographic application [F6for a pharmaceutical veterinary medicinal product]; F7...

F8(iii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F9(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F10(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F11ApplicationFee (£) per authorisation
Base fee27,995
Fee for 1st additional strength4,590
Fee for each subsequent additional strength1,465]

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

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

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

[F12Application 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

F138.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

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

E17This 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

F149.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

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

E18This 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

F1510.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

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

E19This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F16Application 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

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

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

E20This 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 [F17(immunological or biological non-immunological)]E+W+S

13.  The fee for an application for an exceptional marketing authorisation for an immunological product [F18or 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 [F18or 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

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

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

E21This 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

F1915.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

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

E22This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F20Fee 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

F2116.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 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

E23This 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 F22....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 F23... 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.

[F24Type 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

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 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 [F34non-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

E24This 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

F2518.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

E25This 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

F2619.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 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

E26This 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

F2720.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

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

E27This 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 F28....

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

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

E28This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F29Application for a reassessment of an exceptional marketing authorisation]E+W+S

22.—F30(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

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

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

E29This 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

F3123.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 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

E30This 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 F32...—
not more than five stocks:160
more than five stocks:375

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

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

E31This 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.

[F3325.  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.

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