Guidance

Fees applied to animal medicine authorisation applications

Definitive fees charged for applications under Schedule 7 of the Veterinary Medicines Regulations 2013.

Definitive fees charged for applications are set out in Schedule 7 of the Veterinary Medicines Regulations 2013 and are reproduced here for reference.

The fees listed below are Pound Sterling (£) and apply to each:

  • GB Marketing Authorisation (MA)
  • NI MA, whether national or via Mutual recognition or Decentralised procedure
  • Existing UK wide MA, whether national or via Mutual recognition or Decentralised procedure

Parallel submission administrative reductions

As we operate on a cost recovery basis, fees are charged in order to cover the work undertaken by the VMD. In cases where parallel submissions are made the fees for the parallel NI applications will be administratively reduced.

The reduced fees will take account of the additional administrative activities we will need to perform for each application, MA or product.

Fee code Description Fee from 01/01/2021
NI01 New pharmaceutical or immunological parallel submission for identical national GB and NI MAs. Full fee in respect of the GB MA plus reduced fee per application 685
NI02 New pharmaceutical or immunological parallel submission for identical GB MA and mutually recognised MA with NI as CMS. Full fee in respect of the GB MA plus reduced fee per application 1,504
NI03 Variation - Type IA: parallel submission for identical variations to identical national GB MA and NI MAs. Full fee in respect of the GB MA plus reduced fee per application 273
NI04 Variation - Type IB: parallel submission for identical variations to identical national GB MA and NI MAs. Full fee in respect of the GB MA plus reduced fee per application 273
NI05 Variation - Type II: parallel submission for identical variations to identical national GB MA and NI MAs. Full fee in respect of the GB MA plus reduced fee per application 273
NI06 Variation - Type II: parallel submission for identical variations to identical national GB MA and mutually recognised MA with NI as CMS. Full fee in respect of the GB MA plus reduced fee per application 531
NI07 Renewal parallel submission for identical national GB MA and NI MAs. Full fee in respect of the GB MA plus reduced fee per application 531
NI08 Renewal parallel submission for identical national GB MA and mutually recognised MA with NI as CMS. Full fee in respect of the GB MA plus reduced fee per application 531

Maximum Residue Limits

The application fee to establish an MRL in GB that is set out in legislation is £62,300, based on the current EU fee. However, we will administratively reduce this to £15,000 and, in accordance with our cost recovery principles, we will review this fee in 12 months in light of our experience.

The fees for making amendments (including extensions) to currently approved MRLs, that are also set out in legislation, are £20,103 based on the current EU fee. However, we will administratively reduce this to £5,390 and, in accordance with our cost recovery principles, we will review these fees in 12 months in light of our experience.

Provision of advice

Fee Code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
ADV1 The fee for an application for written advice from the Secretary of State as to whether a product requires a marketing authorisation 885 885 54

New pharmaceutical marketing authorisation

Full national pharmaceutical applications

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
J1010 Base Fee 13,530 13,530 7
K101-080 Food-producing target species 3,905 3,905 7
K101-090 For each active ingredient not previously included in a veterinary medicinal product authorised in the UK - food-producing animal 7,465 7,465 7
K101-100 For each active ingredient not previously included in a veterinary medicinal product authorised in the UK - non-food producing animal 6,525 6,525 7
K101-150 For each additional pack type 740 740 7
K101-160 For each additional active ingredient - food-producing animal 6,465 6,465 7
K101-170 For each additional active ingredient - non-food-producing animal 4,310 4,310 7
K101-180 For each additional target species - food-producing animal 3,970 3,970 7
K101-190 For each additional target species - non-food-producing animal 2,495 2,495 7
K101-210 For each additional recommended route of administration - food-producing animal 2,695 2,695 7
K101-220 For each additional recommended route of administration - non-food-producing animal 1,215 1,215 7
K101-300 Simultaneous applications: fee for each additional product in the application 2,895 2,895 7

Bibliographic national pharmaceutical applications

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
J1020 Base fee 12,115 12,115 7
K102-080 Food-producing target species 3,585 3,585 7
K102-090 For each active ingredient not previously included in a veterinary medicinal product authorised in the UK - food producing animal 6,595 6,595 7
K102-100 For each active ingredient not previously included in a veterinary medicinal product authorised in the UK - non-food producing animal 5,855 5,855 7
K102-150 For each additional pack type 740 740 7
K102-160 For each additional active ingredient - food-producing animal 6,125 6,125 7
K102-170 For each additional active ingredient - non-food-producing animal 4,105 4,105 7
K102-180 For each additional target species - food-producing animal 3,565 3,565 7
K102-190 For each additional target species - non-food-producing animal 2,090 2,090 7
K102-210 For each additional recommended route of administration - food-producing animal 2,490 2,490 7
K102-220 For each additional recommended route of administration - non-food-producing animal 1,010 1,010 7
K102-300 Simultaneous applications: fee for each additional product in the application 2,895 2,895 7

Pharmacologically-equivalent product – national MAs - UK authorised reference product

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
J1030 Base fee 7,195 7,195 7
K103-080 Food-producing target species 2,155 2,155 7
K103-090 For each active ingredient not previously included in a veterinary medicinal product authorised in the UK - food producing animal 5,885 5,885 7
K103-100 For each active ingredient not previously included in a veterinary medicinal product authorised in the UK - non-food producing animal 5,590 5,590 7
K103-150 For each additional pack type 605 605 7
K103-160 For each additional active ingredient - food-producing animal 4,040 4,040 7
K103-170 For each additional active ingredient - non-food-producing animal 3,235 3,235 7
K103-180 For each additional target species - food-producing animal 2,425 2,425 7
K103-190 For each additional target species - non-food-producing animal 1,550 1,550 7
K103-210 For each additional recommended route of administration - food-producing animal 1,620 1,620 7
K103-220 For each additional recommended route of administration - non-food-producing animal 740 740 7
K103-300 Simultaneous applications: fee for each additional product in the application 2,895 2,895 7

Pharmacologically‐equivalent product – mutually recognised MAs ‐ EU authorised reference product (NI only):

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
J1040 Base fee 9,220 9,220 7
K104-080 Food-producing target species 2,760 2,760 7
K104-090 For each active ingredient not previously included in a veterinary medicinal product authorised in the UK - food producing animal 7,495 7,495 7
K104-100 For each active ingredient not previously included in a veterinary medicinal product authorised in the UK - non-food producing animal 7,155 7,155 7
K104-150 For each additional pack type 775 775 7
K104-160 For each additional active ingredient - food-producing animal 5,165 5,165 7
K104-170 For each additional active ingredient - non-food-producing animal 4,135 4,135 7
K104-180 For each additional target species - food-producing animal 3,100 3,100 7
K104-190 For each additional target species - non-food-producing animal 1,980 1,980 7
K104-210 For each additional recommended route of administration - food-producing animal 2,070 2,070 7
K104-220 For each additional recommended route of administration - non-food-producing animal 945 945 7
K104-300 Simultaneous applications: fee for each additional product in the application 3,705 3,705 7

Decentralised (NI CMS) or Mutual Recognition (NI CMS)

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
J1050 Base Fee 6,515 6,515 7
K105-080 Food-producing target species 1,415 1,415 7
K105-090 For each active ingredient not previously included in a veterinary medicinal product authorised in the UK - food producing animal 2,630 2,630 7
K105-100 For each active ingredient not previously included in a veterinary medicinal product authorised in the UK - non-food producing animal 2,295 2,295 7
K105-150 For each additional pack type 330 330 7
K105-160 For each additional active ingredient - food-producing animal 2,085 2,085 7
K105-170 For each additional active ingredient - non-food-producing animal 1,475 1,475 7
K105-180 For each additional target species - food-producing animal (applies for a maximum of 2 additional species) 1,280 1,280 7
K105-190 For each additional target species - non-food-producing animal (applies for a maximum of 2 additional species) 805 805 7
K105-210 For each additional recommended route of administration - food-producing animal 940 940 7
K105-220 For each additional recommended route of administration - non-food-producing animal 405 405 7
K105-300 Simultaneous applications: fee for each additional product in the application 1,685 1,685 7

New immunological or biosimilar marketing authorisations

Full national immunological or biosimilar applications

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
J3010 Base fee 11,775 11,775 9
K301-110 For each active ingredient not previously included in a veterinary medicinal product authorised in the UK and for each new combination of active ingredients 7,405 7,405 9
K301-120 For each adjuvant or preservative not previously included in a veterinary medicinal product authorised in the UK and for each new combination of adjuvants or preservatives 1,345 1,345 9
K301-140 For each additional antigenic component 1,350 1,350 9
K301-200 For each additional species 5,380 5,380 9
K301-230 For each additional route of administration 5,380 5,380 9
K301-304 Simultaneous application—fee for each additional product in the application 2,895 2,895 9
K301-307 Application for a marketing authorisation for an immunological product that is identical to a product already authorised in the UK but with a lesser number of antigens and that only contains antigens contained in that product 10,430 10,430 9

Decentralised (NI CMS) or Mutual Recognition (NI CMS)

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
J3020 Base fee 5,785 5,785 9
K302-110 For each active ingredient not previously included in a veterinary medicinal product authorised in the UK and for each new combination of active ingredients 2,490 2,490 9
K302-120 For each adjuvant or preservative not previously included in a veterinary medicinal product authorised in the UK and for each new combination of adjuvants or preservatives 675 675 9
K302-140 For each additional antigenic component 405 405 9
K302-200 For each additional species (maximum of 2) 1,615 1,615 9
K302-230 For each additional route of administration 1,615 1,615 9
K302-305 Simultaneous application—fee for each additional product in the application 1,685 1,685 9
K302-308 Application for a marketing authorisation for an immunological product that is identical to a product already authorised in the UK but with a lesser number of antigens and that only contains antigens contained in that product 5,380 5,380 9

Exceptional pharmaceutical marketing authorisation

Provisional exceptional pharmaceutical marketing authorisation

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
J1130 Base fee 12,015 12,015 12
K113-080 Additional fee if any of the target species is a food-producing target species 3,905 3,905 12
K113-090 For each active ingredient not previously included in a veterinary medicinal product authorised in the UK - food producing animal 5,850 5,850 12
K113-100 For each active ingredient not previously included in a veterinary medicinal product authorised in the UK - non-food producing animal 4,910 4,910 12
K113-150 For each additional pack type 710 710 12
K113-160 For each additional active ingredient - food-producing animal 5,955 5,955 12
K113-170 For each additional active ingredient - non-food-producing animal 3,800 3,800 12
K113-180 For each additional target species - food-producing animal 2,965 2,965 12
K113-190 For each additional target species - non-food-producing animal 1,485 1,485 12
K113-210 For each additional recommended route of administration - food-producing animal 2,185 2,185 12
K113-220 For each additional recommended route of administration - non food-producing animal 710 710 12
K113-110 Simultaneous applications: fee for each additional product in the application 2,895 2,895 12
J3110 Conversion of an exceptional marketing authorisation to full MA 3,000 5,865 14

Limited exceptional pharmaceutical marketing authorisation

Fee Code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
J1150 Base fee 6,765 - 12
K115-080 Additional fee if any of the target species is a food-producing target species 1,952 - 12
K115-090 For each active ingredient not previously included in a veterinary medicinal product authorised in the UK - food producing animal 3,732 - 12
K115-100 For each active ingredient not previously included in a veterinary medicinal product authorised in the UK - non-food producing animal 3,262 - 12
K115-150 For each additional pack type 370 - 12
K115-160 For each additional active ingredient - food-producing animal 3,232 - 12
K115-170 For each additional active ingredient - non-food-producing animal 2,155 - 12
K115-180 For each additional target species - food-producing animal 1,985 - 12
K115-190 For each additional target species - non-food-producing animal 1,247 - 12
K115-210 For each additional recommended route of administration - food-producing animal 1,347 - 12
K115-220 For each additional recommended route of administration - non food-producing animal 608 - 12
K115-110 Simultaneous applications: fee for each additional product in the application 1,447 - 12
N/A Conversion of an exceptional marketing authorisation to full MA 3,000 5,865 14

Exceptional immunological authorisation

Provisional exceptional Immunological authorisation

Fee Code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
J3040 Base fee 10,810 10,810 13
K304-110 For each active ingredient not previously included in a veterinary medicinal product authorised in the UK and for each new combination of active ingredients 5,650 5,650 13
K304-120 For each adjuvant or preservative not previously included in a veterinary medicinal product authorised in the UK and for each new combination of adjuvants or preservatives 1,350 1,350 13
K304-140 For each additional antigenic component 1,190 1,190 13
K304-200 For each additional species 4,060 4,060 13
K304-230 For each additional route of administration 4,060 4,060 13
K304-304 Simultaneous application—fee for each additional product in the application 2,895 2,895 13
J3110 Conversion of an exceptional marketing authorisation to full MA 3,000 5,865 14

Limited exceptional Immunological authorisation

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
J3050 Base fee 5,887 - 13
K305-110 For each active ingredient not previously included in a veterinary medicinal product authorised in the UK and for each new combination of active ingredients 3,702 - 13
K305-120 For each adjuvant or preservative not previously included in a veterinary medicinal product authorised in the UK and for each new combination of adjuvants or preservatives 672 - 13
K305-140 For each additional antigenic component 675 - 13
K305-200 For each additional species 2,690 - 13
K305-230 For each additional route of administration 2,690 - 13
K305-304 Simultaneous application—fee for each additional product in the application 1,447 - 13
J3110 Conversion of an exceptional marketing authorisation to full MA 3,000 - 14

Parallel Import

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
MAP1 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 UK 2,130 2,130 15
MAP2 Where the imported product has been authorised in accordance with the mutual recognition procedure or decentralised procedure, and the NI is included in these procedures - import from 1 EU member State 1,755 1,755 15
MAP4 Application to add an additional EU member State after the marketing authorisation has been granted—fee for each member State 455 455 15
MAP5 Any other application—fee for each EU member State from which the product is imported 4,710 4,710 15

Animal Test Certificates

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
AL11 Application - Type A (as set out in para 48(1)(a), (b) and (c)) 345 345 48(1)
AL12 Application - Type S (as set out in para 48(2) 30 30 48(2)
AL10 Application - in any other case 815 815 48(3)
AV10 Variation (for each change) 265 265 48(4)
AR10 Renewal 130 130 48(5)

Variations to pharmaceutical, immunological or biosimilar MAs

Single variation applications

Single applications are for 1 change per product. However, a single change being made to the terms of several MAs will be applied for as separate applications (where the products are not different strengths or pharmaceutical forms of the same product). These can be considered a ‘grouped’ variation for fee purposes.

No fee is payable if the variation is to remove animal testing or reduce the number of animals used in testing from in-process testing or quality control.

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
K501-240 Extension - change of strength or potency or the addition of a new strength or potency 6,670 6,670 17(4)
K501-250 Extension - change of pharmaceutical form or the addition of a new pharmaceutical form 8,415 8,415 17(4)
K501-260 Extension - change of route of administration or the addition of a new one - immunological product or pharmaceutical product - non food-producing animal 5,390 5,390 17(4)
K501-270 Extension - change of route of administration or the addition of a new one - pharmaceutical product - food-producing animal 7,135 7,135 17(4)
K501-280 Extension - change or addition of food producing target species 9,620 9,620 17(4)
K501-300 Extension - change of active substance 8,415 8,415 17(4)
K501-310 Extension - other than above 8,415 8,415 17(4)
K501-504 Extension - Simultaneous application: fee for each additional product in the application 2,895 2,895 17(4)
TV11 Variation - Type II 1,504 2,895 17(4)
TVB1 Variation - Type IB 530 885 17(4)
TVA1 Variation - Type IA 400 455 17(4)

Grouped variation applications

The fee for an extension-led application is the fee for that extension plus:

  • if there is 1 variation in addition to the extension, the fee for that variation; or

  • if there is more than 1 variation in addition to the extension, the fee that would be payable under a grouped variation of that type

Fee code DESCRIPTION Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
TV11G Type II led - for the first 9 changes 2,181 6,280 17(4)
TV11X Type II led - for the 10th and each subsequent 10 changes 4,362 4,500 17(4)
TVB1G Type IB led - for the first 9 changes 708 1,770 17(4)
TVB2G Type IB led - for the 10th and each subsequent 10 changes 1,416 4,500 17(4)
TVA1G Type IA led - for the first 9 changes 530 885 17(4)
TVA2G Type IA led - for the 10th and each subsequent 10 changes 1,060 4,500 17(4)

Decentralised Extension NI CMS or Mutual Recognition NI CMS

Single Applications:

Single applications are for 1 change per product. However, a single change being made to the terms of several mas will be applied for as separate applications (where the products are not different strengths or pharmaceutical forms of the same product). These can be considered a ‘grouped’ variation for fee purposes.

No Type II fee is payable if the variation is to remove animal testing or reduce the number of animals used in testing from in-process testing or quality control.

Fee code DESCRIPTION Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
K502-240 Extension - change of strength or potency or the addition of a new strength or potency 1,998 1,998 17(4)
K502-250 Extension - change of pharmaceutical form or the addition of a new pharmaceutical form 2,301 2,301 17(4)
K502-260 Extension - change of route of administration or the addition of a new one - immunological product or pharmaceutical product - non food-producing animal 1,737 1,737 17(4)
K502-270 Extension - change of route of administration or the addition of a new one - pharmaceutical product - food-producing animal 2,058 2,058 17(4)
K502-280 Extension - change or addition of - food- producing target species 2,547 2,547 17(4)
K502-300 Extension - change of active substance 2,301 2,301 17(4)
K502-310 Extension - other than above 2,301 2,301 17(4)
K502-504 Extension - Simultaneous application: fee for each additional product in the application 1,011 1,011 17(4)
ECV1 Variation - Type II 1,872 1,872 17(4)
ENB1 Variation - Type IB 531 531 17(4)
ENA1 Variation - Type IA 273 273 17(4)

Grouped Applications:

The fee for an extension-led application is the fee for that extension plus:

  • if there is 1 variation in addition to the extension, the fee for that variation; or
  • if there is more than 1 variation in addition to the extension, the fee that would be payable under a grouped variation of that type
Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
EVC21 Type II led - for the first 9 changes 3,768 3,768 17(4)
EVC22 Type II led - for the tenth and each subsequent 10 changes 2,700 2,700 17(4)
EVCB1 Type IB led - for the first 9 changes 1,062 1,062 17(4)
EVCB2 Type IB led - for the 10th and each subsequent 10 changes 2,700 2,700 17(4)
EVCA1 Type IA led - for the first 9 changes 531 531 17(4)
EVCA2 Type IA led - for the 10th and each subsequent 10 changes 2,700 2,700 17(4)

Workshare variation applications

Each change per product is counted as a ‘change’; therefore, if you are applying for 3 changes to 6 products these count as 18 changes for fee purposes.

Worksharing applications apply only to those involving marketing authorisations obtained via national procedures in the UK.

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
TV12 Type II - base fee (including the first 9 changes) 2,181 6,240 18(2)
TV13 Type II - for the 10th and each subsequent 10 changes 4,362 4,500 18(2)
TVB3 Type IB - base fee (including the first 9 changes) 708 1,770 18(2)
TVB4 Type IB - for the 10th and each subsequent 10 changes 1,416 4,500 18(2)

Renewal of a pharmaceutical, immunological or biosimilar marketing authorisation

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
PR10 Renewal of MA 1,360 1,360 22(1)
PRP2 Exceptional Marketing Authorisation - 1st reassessment 305 305 22(2)
PRP3 Exceptional Marketing Authorisation - subsequent reassessment 1,360 1,360 22(2)

Mutual Recognition and Decentralised procedures

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
ECM5 Renewal where NI is CMS 1,225 1,225 23(b)

Veterinary homeopathic remedy

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
HA50 If all stocks and the formulation have already been assessed - not more than 5 stocks 160 160 24
HA60 If all stocks and the formulation have already been assessed - more than 5 stocks 375 375 24
HA30 If either all the stocks have already been assessed but there is a new formulation or if the formulation has already been assessed but 1 or more stocks have not already been assessed - not more than 5 stocks 455 455 24
HA40 If either all the stocks have already been assessed but there is a new formulation or if the formulation has already been assessed but 1 or more stocks have not already been assessed - more than 5 stocks 665 665 24
HA10 If the formulation and at least 1 of the stocks has not already been assessed - not more than 5 stocks 760 760 24
HA20 If the formulation and at least 1 of the stocks has not already been assessed - more than 5 stocks 985 985 24
HE10 If the product is already authorised for human use in the UK or for human or veterinary use in the UK or in another member state - not more than 5 stocks 160 160 24
HE20 If the product is already authorised for human use in the UK or for human or veterinary use in the UK or in another member state - more than 5 stocks 375 375 24
HR10 Renewal of a homeopathic remedy 320 0 25

Annual fees for marketing authorisations

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
YGAF1 Graded Annual Fee - % on turnover in the UK 0.67% 0.67% 26(2)
YFAF1 Fixed Annual Fee for each GB MA, NI MA and UK wide MA – turnover in the UK of authorised products equal to or greater than £230,000 230 230 26(2)
YFAF2 Fixed Annual Fee for each GB MA, NI MA and UK wide MA - turnover of authorised products less than £230,000 200 200 26(3)
  Failure to provide an audit certificate: Base fee 11,300 11,300 27(2)
  Failure to provide an audit certificate: Fee for each MA held 2,245 2,245 27(2)

Manufacturers authorisation

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
MA60 Application 3,040 3,040 28(a)
MA06 Application - Schedule 6 products 530 530 28(b)
MV60 Variation requiring scientific or pharmaceutical assessment 636 545 29(a)
MV62 Variation - change of ownership 443 380 29(b)
MV13 Variation - Schedule 6 products 210 180 29(c)
MV70 Variation not requiring scientific or pharmaceutical assessment 350 300 29(d)
MAU1 Autogenous vaccine - authorisation for each UK manufacturing site 3,435 3,435 30(1)a
MAU2 Autogenous vaccine - authorisation for each non-UK manufacturing site 3,270 3,270 30(1)b
MAS1 Autogenous vaccine - single batch 1,635 1,635 30(3)
MAV1 Autogenous vaccine - variation requiring inspection - UK site 3,435 3,435 30(1)a
MAV3 Autogenous vaccine - variation requiring inspection - non-UK site 3,270 3,270 30(1)b
MAV2 Autogenous vaccine - variation not requiring inspection 305 305 30(4)
MF60 Annual Fee - other than autogenous vaccines 550 495 31(1)
YGAF3 Annual Fee - autogenous vaccines - % of turnover in the UK in previous calendar year 0.67% 0.67% 31(2)
N/A Annual fee - Schedule 6 products no fee no fee 31(3)

Specific batch control

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
BC10 Authorisation to release a product under specific batch control 560 560 51 (a)
BC15 Additional batches at application where all subsequent batches affected by same issue - per additional batch 100 455 51(b)
BC81A Submission of results of tests carried out on a batch of immunological products prior to release on to the UK markets 80 80 52

Manufacturing site inspections

If a site is inspected for more than 1 type of authorisation at the same time, the inspection fee payable is the highest inspection fee plus 50% of any other applicable inspection fees.

For non-UK sites only, travel and subsistence costs and, if applicable, translation costs are payable in addition to the inspection fee.

Immunological site inspections - UK sites

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
SS40 Super site 24,071 26,745 33
SS10 Major site 16,785 18,650 33
SS20 Standard site 6,661 6,055 33
SS30 Minor site 4,757 5,285 33
SO33 Autogenous Vaccine Site Inspection 3,435 3,435 30(1)a

Immunological site inspections – non-UK sites

Travel & subsistence costs are payable in addition to these fees.

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
SS40A Super site 22,867 25,480 33
SS10A Major site 15,946 17,760 33
SS20A Standard site 6,327 5,765 33
SS30A Minor site 4,519 5,035 33
SO33A Autogenous Vaccine Site Inspection 3,270 3,270 30(1)b

Pharmaceutical site inspections - UK sites

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
SS91 Super site - Sterile 23,324 25,915 34
SS61 Major site - Sterile 13,010 14,455 34
SS71 Standard site - Sterile 8,244 9,160 34
SS81 Minor site - Sterile 5,022 4,565 34
SO91 Super site - non-sterile 14,180 15,755 35
SO61 Major site - non-sterile 8,325 9,250 35
SO71 Standard site - non-sterile 6,854 7,615 35
SO81 Minor site - non-sterile 3,789 4,210 35
SA91 Super site - Assembly of products only 11,025 12,250 36
SA61 Major site - Assembly of products only 5,949 6,610 36
SA71 Standard site - Assembly of products only 4,917 4,470 36
SA81 Minor site - Assembly of products only 2,035 1,850 36
SO34 Standard site - Schedule 6 products only 5,055 4,595 35
SO32 Minor site - Schedule 6 products only 2,728 2,480 35

Pharmaceutical site inspections – non-UK sites

Travel & subsistence costs are payable in addition to these fees.

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
SS91A Super site - Sterile 22,157 24,680 34
SS61A Major site - Sterile 12,359 13,770 34
SS71A Standard site - Sterile 7,832 8,725 34
SS81A Minor site - Sterile 4,770 4,350 34
SO91A Super site - non-sterile 13,471 15,015 35
SO61A Major site - non-sterile 7,909 8,810 35
SO71A Standard site - non-sterile 6,511 7,250 35
K105-080 Minor site - non-sterile 3,600 4,010 35
K105-090 Super site - Assembly of products only 10,474 11,665 36
SA61A Major site - Assembly of products only 5,652 6,295 36
SA71A Standard site - Assembly of products only 4,671 4,255 36
SA81A Minor site - Assembly of products only 1,933 1,760 36
SO34A Standard site - Schedule 6 products only 4,802 4,380 35
SO32A Minor site - Schedule 6 products only 2,592 2,365 35

Test sites, Blood Banks, Stem Cells

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
SS47 Test site inspection - UK site 3,344 3,040 37
SS47A Test site inspection - non-UK site 3,177 2,900 37
BBA1 Blood bank - authorisation to operate - first inspection 3,113 2,830 38(1)a
BBA5 Blood bank - subsequent inspection - UK site 3,113 2,970 38(1)b(i)
BBA5A Blood bank - subsequent inspection - non-UK site 2,966 2,830 38(1)b(ii)
N/A Variation of a blood bank authorisation 320 305 38(3)
BSC1 Stem Cell product - authorisation 3,427 3,270 38(2)
BSC2 Stem Cell product - subsequent inspection - UK site 3,092 3,435 38(2)
BSV1 Stem Cell product - variation 320 305 38(3)

Wholesale Dealer’s authorisation

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
WA30 Application – turnover in the UK is more than or equal to £35,000 1,745 1,760 39(1)(a)
WA40 Application - turnover in the UK is less than £35,000 or AVM-GSL, homeopathic or Schedule 6 products only 785 785 39(1)(b)/(c)
WV30 Variation requiring scientific or pharmaceutical assessment 515 515 40(a)
WV31 Variation only involving change of ownership 430 430 40(b)
WV32 Variation not requiring scientific or pharmaceutical assessment 300 300 40(c)
WF30 Annual Fee – turnover in the UK is more than or equal to £35,000 483 330 41(1)a
WF31 Annual Fee - turnover in the UK is less than £35,000 or AVM-GSL, or homeopathic remedies 315 215 41(1)b
WF32 Annual Fee -Schedule 6 products only 215 215 41(1)c
WIL10 Inspection - AVM-GSL, homeopathic remedies 1,442 830 42(b)(i)
WIL10 Inspection - turnover in the UK in previous calendar year is less than £35,000 1,442 830 42(b)(ii)
WIJ10 Inspection - Schedule 6 products only 830 830 42(c)
WI01 Inspection - Otherwise 3,058 1,760 42(a)
WDIC1 Wholesale Dealers Import Certificate* 1,320 760 50(1)

*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.

Feedingstuffs

Where more than 1 of the activities below is carried out at 1 premises, only 1 fee (the highest) is payable.

No fee is payable under sub-paragraph (1) in respect of an establishment where specified feed additives are manufactured if a veterinary medicinal product intended to be incorporated into feedingstuffs is manufactured at that establishment in accordance with a manufacturing authorisation.

Great Britain

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
FDA1 Category 1 - Application for the approval of establishment manufacturing a specified feed additive 70 975 43(1)
FDR1 Category 1 - Renewal - Annual Fee 70 975 43(2)
FDN1 Category 1 - Inspection 1,810 - 44
FDA2 Category 2 - Application for the approval of an establishment to manufacture a premixture 70 615 43(1)
FDR2 Category 2 - Renewal - Annual Fee 70 615 43(2)
FDN2 Category 2 - Inspection 1,090 - 44
FDA3 Category 3 - Application for the approval of an establishment to manufacture feedingstuffs, using specified feed additives or veterinary medicinal products directly at any concentration, or using premixtures or specified feed additive complementary feedingstuffs 70 615 43(1)
FDR3 Category 3 - Renewal - Annual Fee 70 615 43(2)
FDN3 Category 3 - Inspection 1,090 - 44
FDA4 Category 4 - Application for the approval of an establishment to manufacture feedingstuffs for placing on the market using a veterinary medicinal product or premixture where the concentration of veterinary medicinal product in the feedingstuffs is 2kg per tonne or more 70 415 43(1)
FDR4 Category 4 - Renewal - Annual Fee 70 415 43(2)
FDN4 Category 4 - Inspection 961 - 44
FDA5 Category 5 - Application for the approval of an establishment to manufacture feedingstuffs using premixtures or specified feed additive complementary feedingstuffs containing specified feed additives when the feedingstuffs are to be placed on the market 70 205 43(1)
FDR5 Category 5 - Renewal - Annual Fee 70 205 43(2)
FDN5 Category 5 - Inspection 405 - 44
FDA6 Category 6 - Application for the approval of an establishment to manufacture feedingstuffs for the manufacturer’s own use using a veterinary medicinal product or premixture where the concentration of veterinary medicinal product in the feedingstuffs is 2kg per tonne or more 70 150 43(1)
FDR6 Category 6 - Renewal - Annual Fee 70 150 43(2)
FDN6 Category 6 - Inspection 320 - 44
FDA7 Category 7 - Application for the approval of an establishment to manufacture feedingstuffs using premixtures containing specified feed additives when the feedingstuffs are to be used by the person manufacturing the feedingstuffs 70 130 43(1)
FDR7 Category 7 - Renewal - Annual Fee 70 130 43(2)
FDN7 Category 7 - Inspection 240 - 44
FDA8 Category 8 - Application for approval as a distributor of specified feed additives, premixtures or feedingstuffs containing specified feed additives, or premixtures or feedingstuffs containing veterinary medicinal products 70 145 43(1)
FDR8 Category 8 - Renewal - Annual Fee 70 145 43(2)
FDN8 Category 8 - Inspection 227 - 44

Northern Ireland

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
N/A Category 1 - Application for the approval of an establishment to manufacture a specified feed additive and the subsequent annual fee (no fee is payable for premises that already have a manufacturing authorisation relating to veterinary medicinal products for incorporating into feedingstuffs) 545 520 45(1)
N/A Category 2 - Application for the approval of an establishment to manufacture a premixture and the subsequent annual fee 435 415 45(1)
N/A Category 3 - Application for the approval of an establishment to manufacture feedingstuffs, using specified feed additives or veterinary medicinal products directly at any concentration, or using premixtures, and the subsequent annual fee 435 415 45(1)
N/A Category 4 - Application for the approval of an establishment to manufacture feedingstuffs for placing on the market using a veterinary medicinal product or premixture where the concentration of veterinary medicinal product in the feedingstuffs in 2kg per tonne or more, and the subsequent annual fee 320 305 45(1)
N/A Category 5 - Application for the approval of an establishment to manufacture feedingstuffs using premixtures containing specified feed additives when the feedingstuffs are to be placed on the market, and the subsequent annual fee 170 160 45(1)
N/A Category 6 - Application for the approval of an establishment to manufacture feedingstuffs for the manufacturer’s own use using a veterinary medicinal product or premixture where the concentration of veterinary medicinal product in the feedingstuffs is 2kg per tonne or more, and the subsequent annual fee 131 125 45(1)
N/A Category 7 - Application for the approval of an establishment to manufacture feedingstuffs using premixtures from specified feed additives when the feedingstuffs are to be used by the person manufacturing the feedingstuffs, and the subsequent annual fee 110 105 45(1)
N/A Category 8 - Application for approval as a distributor of specified feed additives, premixtures or feedingstuffs containing specified feed additives, or premixtures or feedingstuffs containing veterinary medicinal products, and the subsequent annual fee 70 65 45(1)

Testing of samples

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
N/A The fee for testing a sample required to be submitted by the Secretary of State is the full economic cost of the test - - 47

Inspection improvement notices

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
N/A The full economic cost of any inspection necessary as a result of the issue of an improvement notice is payable by the person on whom the notice was served - - 59

Approval of premises for supply by Suitably Qualified Persons

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
1601 Approval of premises 265 265 46(1)(a)
SQPAM Subsequent annual fee 185 185 46(2)(a)
1607 Approval of premises - horses only 145 145 46(1)(b)(i)
SQPAJ Subsequent annual fee - horses only 95 95 46(2)(b)(i)
1604 Approval of premises - horses and companion animals only 145 145 46(1)(b)(i)
SQPAS Subsequent annual fee - horses and companion animals only 95 95 46(2)(b)(i)
1610 Approval of premises - companion animals only 110 110 46(1)(b)(ii)
SQPAC Subsequent annual fee - companion animals only 70 70 46(2)(b)(ii)

Veterinary surgeon’s practice inspection

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
PI01 Inspection 350 250 57(1)

Special Import and Export certificates

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
SIC1 Special Import Certificate (SIC) - postal application - product authorised in another country 15 15 49(1)a
N/A Special Import Certificate (SIC) - online application no fee no fee 49(3)
WDIC1 Wholesale Dealers Import Certificate* 1,320 760 50(1)
XPC1 Export Certificate (each) 30 30 53
XPC2 Export Certificate certified copy of each original 15 15 53

*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.

Appeal to the Veterinary Products Committee

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
VA30 The fee for an appeal to the Veterinary Products Committee 1,500 - 55

Referral to an appointed person

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
N/A The appellant is liable for the full economic cost of a referral, subject to a maximum of £5,000. These fees are refunded if the decision is reversed - - 56

Non-payment of fees

Fee code Description Fee from 01/10/13 Fee from 01/10/11 VMR 2013 SCH 7 Para
N/A Where any fee (other than any fee relating to a manufacturing authorisation or wholesale dealer’s authorisation) is not paid, the Secretary of State may, after giving 1 month’s written warning, suspend the processing of any application from the person who has not paid the fee     60
Published 6 January 2021