Guidance
Grouped variation applications
Published 16 May 2024
Applies to Northern Ireland
© Crown copyright 2024
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This publication is available at https://www.gov.uk/government/publications/fees-applied-to-veterinary-medicine-authorisation-applications-in-northern-ireland/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
1. National
| Fee code | Description | Fee from 01/10/13 | VMR 2013 SCH 7 Para |
|---|---|---|---|
| TV11G | Type II: first 9 changes [now referred to as a Variation Requiring Assessment (VRA) – standard / extended] | 2,181 | 17(4) |
| TV11X | Type II: 10th and each subsequent 10 changes [now referred to as a Variation Requiring Assessment (VRA) – standard / extended] | 4,362 | 17(4) |
| TVB1G | Type IB: first 9 changes [now referred to as a Variation Requiring Assessment (VRA) – reduced] | 708 | 17(4) |
| TVB2G | Type IB: 10th and each subsequent 10 changes [now referred to as a Variation Requiring Assessment (VRA) – reduced] | 1,416 | 17(4) |
2. Mutually recognised NI MAs
| Fee code | Description | Fee from 01/10/13 | VMR 2013 SCH 7 Para |
|---|---|---|---|
| EVC21 | Type II: first 9 changes [now referred to as a Variation Requiring Assessment (VRA) – standard / extended] | 3,768 | 17(4) |
| EVC22 | Type II: 10th and each subsequent 10 changes [now referred to as a Variation Requiring Assessment (VRA) – standard / extended] | 2,700 | 17(4) |
| EVCB1 | Type IB: first 9 changes[now referred to as a Variation Requiring Assessment (VRA) – reduced] | 1,062 | 17(4) |
| EVCB2 | Type IB: 10th and each subsequent 10 changes [now referred to as a Variation Requiring Assessment (VRA) – reduced] | 2,700 | 17(4) |
3. 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: 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: 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: first 9 changes [now referred to as a Variation Requiring Assessment (VRA) – reduced] | 2,650 | 18(3) |
| EVR32 | Involving nationally authorised products: Type IB: 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: 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: 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: first 9 changes [now referred to as a Variation Requiring Assessment (VRA) – reduced] | 954 | 18(4) |
| EVR33 | Involving mutually recognised products: Type IB: 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) |
4. Veterinary homeopathic remedy
| Fee code | Description | Fee from 01/10/13 | VMR 2013 SCH 7 Para |
|---|---|---|---|
| HA50 | If all stocks and the formulation have already been assessed; not more than 5 stocks | 160 | 24 |
| HA60 | If all stocks and the formulation have already been assessed; more than 5 stocks | 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 | 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 | 24 |
| HA10 | If the formulation and at least 1 of the stocks has not already been assessed; not more than 5 stocks | 760 | 24 |
| HA20 | If the formulation and at least 1 of the stocks has not already been assessed; more than 5 stocks | 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 | 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 | 24 |
| HR10 | Renewal | 320 | 25 |