Guidance

New 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/new-marketing-authorisation-pharmaceutical

1. Full national pharmaceutical applications

Fee code Description Fee from 01/10/13 VMR 2013 SCH 7 Para
J1010 Base Fee 13,530 7
K101-080 Food-producing target species 3,905 7
K101-090 Each active ingredient not previously included in a veterinary medicinal product authorised in the UK; food-producing 7,465 7
K101-100 Each active ingredient not previously included in a veterinary medicinal product authorised in the UK; non-food producing 6,525 7
K101-150 Each additional pack type 740 7
K101-160 Each additional active ingredient; food-producing 6,465 7
K101-170 Each additional active ingredient; non-food-producing 4,310 7
K101-180 Each additional target species; food-producing 3,970 7
K101-190 Each additional target species; non-food-producing 2,495 7
K101-210 Each additional recommended route of administration; food-producing 2,695 7
K101-220 Each additional recommended route of administration; non-food-producing 1,215 7
K101-300 Simultaneous applications: fee for each additional product in the application 2,895 7

2. Bibliographic national pharmaceutical applications

Fee code Description Fee from 01/10/13 VMR 2013 SCH 7 Para
J1020 Base fee 12,115 7
K102-080 Food-producing target species 3,585 7
K102-090 Each active ingredient not previously included in a veterinary medicinal product authorised in the UK; food producing 6,595 7
K102-100 Each active ingredient not previously included in a veterinary medicinal product authorised in the UK; non-food producing 5,855 7
K102-150 Each additional pack type 740 7
K102-160 Each additional active ingredient; food-producing 6,125 7
K102-170 Each additional active ingredient; non-food-producing 4,105 7
K102-180 Each additional target species; food-producing 3,565 7
K102-190 Each additional target species; non-food-producing 2,090 7
K102-210 Each additional recommended route of administration; food-producing 2,490 7
K102-220 Each additional recommended route of administration; non-food-producing 1,010 7
K102-300 Simultaneous applications: fee for each additional product in the application 2,895 7

3. Pharmacologically-equivalent product – national MAs - UK authorised reference product

Fee code Description Fee from 01/10/13 VMR 2013 SCH 7 Para
J1030 Base fee 7,195 7
K103-080 Food-producing target species 2,155 7
K103-090 Each active ingredient not previously included in a veterinary medicinal product authorised in the UK - food producing animal 5,885 7
K103-100 For each active ingredient not previously included in a veterinary medicinal product authorised in the UK; non-food producing 5,590 7
K103-150 Each additional pack type 605 7
K103-160 Each additional active ingredient; food-producing 4,040 7
K103-170 Each additional active ingredient - non-food-producing 3,235 7
K103-180 Each additional target species - food-producing 2,425 7
K103-190 Each additional target species - non-food-producing 1,550 7
K103-210 Each additional recommended route of administration; food-producing 1,620 7
K103-220 Each additional recommended route of administration; non-food-producing 740 7
K103-300 Simultaneous applications: fee for each additional product in the application 2,895 7

4. Pharmacologically‐equivalent product – mutually recognised MAs ‐ EU authorised reference product (NI only)

Fee code Description Fee from 01/10/13 VMR 2013 SCH 7 Para
J1040 Base fee 9,220 7
K104-080 Food-producing target species 2,760 7
K104-090 Each active ingredient not previously included in a veterinary medicinal product authorised in the UK; food producing 7,495 7
K104-100 Each active ingredient not previously included in a veterinary medicinal product authorised in the UK; non-food producing 7,155 7
K104-150 Each additional pack type 775 7
K104-160 Each additional active ingredient; food-producing 5,165 7
K104-170 Each additional active ingredient; non-food-producing 4,135 7
K104-180 Each additional target species; food-producing 3,100 7
K104-190 Each additional target species; non-food-producing 1,980 7
K104-210 Each additional recommended route of administration; food-producing 2,070 7
K104-220 Each additional recommended route of administration; non-food-producing 945 7
K104-300 Simultaneous applications: fee for each additional product in the application 3,705 7

5. Decentralised or Mutual Recognition (NI CMS)

Fee code Description Fee from 01/10/13 VMR 2013 SCH 7 Para
J1050 Base Fee 6,515 7
K105-080 Food-producing target species 1,415 7
K105-090 Each active ingredient not previously included in a veterinary medicinal product authorised in the UK; food producing 2,630 7
K105-100 Each active ingredient not previously included in a veterinary medicinal product authorised in the UK; non-food producing 2,295 7
K105-150 Each additional pack type 330 7
K105-160 Each additional active ingredient; food-producing 2,085 7
K105-170 Each additional active ingredient; non-food-producing 1,475 7
K105-180 Each additional target species; food-producing animal (max 2 additional species) 1,280 7
K105-190 Each additional target species; non-food-producing (max 2 additional species) 805 7
K105-210 Each additional recommended route of administration; food-producing 940 7
K105-220 Each additional recommended route of administration; non-food-producing 405 7
K105-300 Simultaneous applications: fee for each additional product in the application 1,685 7
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