Guidance

Exceptional marketing authorisation - pharmaceutical

Updated 4 July 2024

Applies to Northern Ireland

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