Guidance

Variations to Marketing Authorisations (MAs) or Veterinary Homeopathic Remedies (VHRs)

Updated 4 July 2024

Applies to Northern Ireland

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.

1. 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.

2. National

Fee code Description Fee from 01/10/13 VMR 2013 SCH 7 Para
K501-240 Extension: change of strength or potency or the addition of a new strength or potency 6,670 17(4)
K501-250 Extension: change of pharmaceutical form or the addition of a new pharmaceutical form 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; non-food producing 5,390 17(4)
K501-270 Extension: change of route of administration or the addition of a new one for a pharmaceutical product; food-producing 7,135 17(4)
K501-280 Extension: change or addition; food producing 9,620 17(4)
K501-300 Extension: change of active substance 8,415 17(4)
K501-310 Extension: change of bioavailability or change of pharmacokinetics 8,415 17(4)
K501-504 Extension: Simultaneous application: fee for each additional product in the application 2,895 17(4)
TV11 Type II - now referred to as Variations Requiring Assessment (VRA) – standard / extended) 1,504 17(4)
TVB1 Type IB - now referred to as Variations Requiring Assessment (VRA) – reduced 530 17(4)
TVA1 Type IA - now referred to as Variations Not Requiring Assessment (VNRA) 400 17(4)

3. Mutually recognised NI MAs

Fee code Description Fee from 01/10/13 VMR 2013 SCH 7 Para
K502-240 Extension: change of strength or potency or the addition of a new strength or potency 1,998 17(4)
K502-250 Extension: change of pharmaceutical form or the addition of a new pharmaceutical form 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; non-food producing 1,737 17(4)
K502-270 Extension: change of route of administration or the addition of a new one for a pharmaceutical product; food-producing 2,058 17(4)
K502-280 Extension: change or addition; food producing species 2,547 17(4)
K502-300 Extension: change of active substance 2,301 17(4)
K502-310 Extension: change of bioavailability or change of pharmacokinetics 2,301 17(4)
K502-504 Extension: Simultaneous application: fee for each additional product in the application 1,011 17(4)
ECV1 Type II [now referred to as Variations Requiring Assessment (VRA) – standard / extended] 1,872 17(4)
ENB1 Type IB [now referred to as Variations Requiring Assessment (VRA) - reduced] 531 17(4)
ENA1 Type IA [now referred to as Variations Not Requiring Assessment (VNRA)] 273 17(4)