Variations to Marketing Authorisations (MAs) or Veterinary Homeopathic Remedies (VHRs)
Published 16 May 2024
Applies to Northern Ireland
© Crown copyright 2024
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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) |