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 Pounds Sterling (£).
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, some 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.
New GB MA and national only NI MA
| 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 |
New GB MA and mutually recognised MA with NI as CMS
| Fee code |
Description |
Fee from 01/01/2021 |
| 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 |
Variations: GB MA and national NI MA
| Fee code |
Description |
Reduced fee for NI application from 01/01/2021 |
| NI03 |
Type IA [now referred to as a Variation Not Requiring Assessment (VNRA)]: parallel submission of identical Type I A changes to identical national GB MA and NI MAs. The full fee is charged for the application to the GB MA plus a reduced fee for the application to the NI MA |
273 |
| NI04 |
Type IB [now referred to as a Variation Requiring Assessment (VRA) -reduced]: parallel submission of identical Type IB changes to identical national GB MA and NI MAs. The full fee is charged for the application to the GB MA plus reduced fee for the application to the NI MA. |
273 |
| NI05 |
Type II [now referred to as a Variation Requiring Assessment (VRA) – standard / extended]: parallel submission of identical Type II changes to identical national GB MA and NI MAs. The full fee is charged for the application to the GB MA plus reduced fee for the application to the NI MA. |
273 |
Variations: GB MA and mutually recognised NI MA
| Fee code |
Description |
Reduced fee for NI applications from 01/01/2021 |
| NI06 |
Type II [now referred to as a Variation Requiring Assessment (VRA – standard / extended: parallel submission of identical Type II changes to identical national GB MA and mutually recognised NI MA. The full fee in respect of the application for the GB MA plus reduced fee for the application to the mutually recognised NI MA |
531 |
The full CMS fee in respect of VNRA and VRA – reduced, will apply to mutually recognised NI MAs.
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.
| Fee Code |
Description |
Fee from 01/01/21 |
| MRL01 |
New MRL |
15,000 |
| MRL02 |
MRL (extensions/amendments) |
5,390 |
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 marketing authorisation -pharmaceutical
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 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 marketing authorisations - immunological or biosimilar
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 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 Marketing Authorisations (MAs) or Veterinary Homeopathic Remedies (VHRs)
For ease of reference, we have included in the tables below new terminology to describe variations, which are now ‘variations not requiring assessment (VNRA)’ and ‘variations requiring assessment (VRA)’.
We have updated the guidance Variations to a veterinary Marketing Authorisation or Homeopathic Remedy which explains these changes.
Single variation applications
The extension fee will continue to apply to these changes that are included in the list of Variations Requiring Assessment in published guidance.
Single applications are for one change per MA. However, a single change being made to the terms of several MAs that don’t meet the definition of a ‘product range’ will be applied for as separate applications, can be considered a ‘grouped’ variation for fee purposes.
National
| 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 for an immunological product, or pharmaceutical product for a 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 for a pharmaceutical product for a 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 – change of bioavailability or change of pharmacokinetics |
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 |
Type II - now referred to as Variations Requiring Assessment (VRA) – standard / extended) |
1,504 |
2,895 |
17(4) |
| TVB1 |
Type IB - now referred to as Variations Requiring Assessment (VRA) – reduced |
530 |
885 |
17(4) |
| TVA1 |
Type IA - now referred to as Variations Not Requiring Assessment (VNRA) |
400 |
455 |
17(4) |
Mutually recognised NI MAs:
| 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 for an immunological product, or pharmaceutical product for a 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 for a pharmaceutical product for a 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 – change of bioavailability or change of pharmacokinetics |
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 |
Type II [now referred to as Variations Requiring Assessment (VRA) – standard / extended] |
1,872 |
1,872 |
17(4) |
| ENB1 |
Type IB [now referred to as Variations Requiring Assessment (VRA) - reduced] |
531 |
531 |
17(4) |
| ENA1 |
Type IA [now referred to as Variations Not Requiring Assessment (VNRA)] |
273 |
273 |
17(4) |
Grouped variation applications
Each change per MA is counted as a ‘change’; therefore, if you are applying for 3 changes to 6 MAs these count as 18 changes for fee purposes.
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
National:
| Fee code |
Description |
Fee from 01/10/13 |
Fee from 01/10/11 |
VMR 2013 SCH 7 Para |
| TV11G |
Type II - for the first 9 changes [now referred to as a Variation Requiring Assessment (VRA) – standard / extended] |
2,181 |
6,280 |
17(4) |
| TV11X |
Type II - for the 10th and each subsequent 10 changes [now referred to as a Variation Requiring Assessment (VRA) – standard / extended] |
4,362 |
4,500 |
17(4) |
| TVB1G |
Type IB - for the first 9 changes [now referred to as a Variation Requiring Assessment (VRA) – reduced] |
708 |
1,770 |
17(4) |
| TVB2G |
Type IB - for the 10th and each subsequent 10 changes [now referred to as a Variation Requiring Assessment (VRA) – reduced] |
1,416 |
4,500 |
17(4) |
Mutually recognised NI MAs:
| Fee code |
Description |
Fee from 01/10/13 |
Fee from 01/10/11 |
VMR 2013 SCH 7 Para |
| EVC21 |
Type II - for the first 9 changes [now referred to as a Variation Requiring Assessment (VRA) – standard / extended] |
3,768 |
3,768 |
17(4) |
| EVC22 |
Type II - for the 10th and each subsequent 10 changes [now referred to as a Variation Requiring Assessment (VRA) – standard / extended] |
2,700 |
2,700 |
17(4) |
| EVCB1 |
Type IB - for the first 9 changes[now referred to as a Variation Requiring Assessment (VRA) – reduced] |
1,062 |
1,062 |
17(4) |
| EVCB2 |
Type IB - for the 10th and each subsequent 10 changes [now referred to as a Variation Requiring Assessment (VRA) – reduced] |
2,700 |
2,700 |
17(4) |
Workshare variation applications
Each change per MA is counted as a ‘change’; therefore, if you are applying for 3 changes to 6 MAs these count as 18 changes for fee purposes.
| Fee code |
Description |
Fee from 01/10/13 |
VMR 2013 SCH 7 Para |
| EVR29 |
Involving nationally authorised products: Type II - for the first 9 changes [now referred to as a Variation Requiring Assessment (VRA) – standard / extended] |
6,030 |
18(3) |
| EVR30 |
Involving nationally authorised products: Type II - for the 10th and each subsequent 10 changes [now referred to as a Variation Requiring Assessment (VRA) – standard / extended] |
4,500 |
18(3) |
| EVR31 |
Involving nationally authorised products: Type IB - for the first 9 changes [now referred to as a Variation Requiring Assessment (VRA) – reduced] |
2,650 |
18(3) |
| EVR32 |
Involving nationally authorised products: Type IB - for the 10th and each subsequent 10 changes [now referred to as a Variation Requiring Assessment (VRA) – reduced] |
4,500 |
18(3) |
| EVC23 |
Involving mutually recognised products: Type II - for the first 9 changes [now referred to as a Variation Requiring Assessment (VRA) – standard / extended] |
3,372 |
18(4) |
| EVCC2 |
Involving mutually recognised products: Type II - for the 10th and each subsequent 10 changes [now referred to as a Variation Requiring Assessment (VRA) – standard / extended] |
2,700 |
18(4) |
| EVCB3 |
Involving mutually recognised products: Type IB - for the first 9 changes [now referred to as a Variation Requiring Assessment (VRA) – reduced] |
954 |
18(4) |
| EVR33 |
Involving mutually recognised products: Type IB - for the 10th and each subsequent 10 changes [now referred to as a Variation Requiring Assessment (VRA) – reduced] |
2,700 |
18(4) |
| EVRE1 |
Fee per nationally authorised or mutually recognised MA included in a workshare application involving centrally authorised products |
455 |
18(5) |
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 |
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60 |