Veterinary Medicines Directorate
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 |