Guidance
Exceptional marketing authorisation - pharmaceutical
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/exceptional-marketing-authorisation-pharmaceutical
1. Provisional exceptional marketing authorisation pharmaceutical
| Fee code | Description | Fee from 01/10/13 | VMR 2013 SCH 7 Para |
|---|---|---|---|
| J1130 | Base fee | 12,015 | 12 |
| K113-080 | Additional fee if any of the target species is food-producing | 3,905 | 12 |
| K113-090 | Each active ingredient not previously included in a veterinary medicinal product authorised in the UK; food producing | 5,850 | 12 |
| K113-100 | Each active ingredient not previously included in a veterinary medicinal product authorised in the UK; non-food producing | 4,910 | 12 |
| K113-150 | Each additional pack type | 710 | 12 |
| K113-160 | Each additional active ingredient; food-producing | 5,955 | 12 |
| K113-170 | Each additional active ingredient; non-food-producing | 3,800 | 12 |
| K113-180 | Each additional target species; food-producing | 2,965 | 12 |
| K113-190 | Each additional target species; non-food-producing | 1,485 | 12 |
| K113-210 | Each additional recommended route of administration; food-producing | 2,185 | 12 |
| K113-220 | Each additional recommended route of administration; non food-producing | 710 | 12 |
| K113-110 | Simultaneous applications: fee for each additional product in the application | 2,895 | 12 |
| J3110 | Conversion of an exceptional marketing authorisation to full MA | 3,000 | 14 |
2. Limited exceptional pharmaceutical marketing authorisation
| Fee Code | Description | Fee from 01/10/13 | VMR 2013 SCH 7 Para |
|---|---|---|---|
| J1150 | Base fee | 6,765 | 12 |
| K115-080 | Additional fee if any of the target species is food-producing | 1,952 | 12 |
| K115-090 | Each active ingredient not previously included in a veterinary medicinal product authorised in the UK; food producing | 3,732 | 12 |
| K115-100 | Each active ingredient not previously included in a veterinary medicinal product authorised in the UK; non-food producing | 3,262 | 12 |
| K115-150 | Each additional pack type | 370 | 12 |
| K115-160 | Each additional active ingredient; food-producing | 3,232 | 12 |
| K115-170 | Each additional active ingredient; non-food-producing | 2,155 | 12 |
| K115-180 | Each additional target species; food-producing | 1,985 | 12 |
| K115-190 | Each additional target species; non-food-producing | 1,247 | 12 |
| K115-210 | Each additional recommended route of administration; food-producing | 1,347 | 12 |
| K115-220 | Each additional recommended route of administration; non food-producing | 608 | 12 |
| K115-110 | Simultaneous applications: fee for each additional product in the application | 1,447 | 12 |
| N/A | Conversion of an exceptional marketing authorisation to full MA | 3,000 | 14 |