Guidance

Grouped variation applications

Updated 4 July 2024

Applies to Northern Ireland

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