{
  "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-7/paragraph-7",
  "json_url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-7/paragraph-7.json",
  "legislation": "uksi/2007/2539",
  "legislation_title": "The Veterinary Medicines Regulations 2007",
  "legislation_url": "https://openlegislation.uk/veterinary-medicines-regulations-2007",
  "path": "schedule/7/paragraph/7",
  "kind": "paragraph",
  "number": "7",
  "heading": "Fees for specified pharmaceutical applications",
  "text": "The following table sets out the fees relating to a pharmaceutical veterinary medicinal product for—\n(a) a national application for a marketing authorisation that is—\n(i) a full application under Part 1 of Schedule 1;\n(ii) a bibliographic application; or\n(iii) an application based on pharmacological equivalence;\n(b) an application for a marketing authorisation using the decentralised procedure where the United Kingdom is a concerned member State;\n(c) an application for the mutual recognition of a product authorised in another member State.\nFees for specified pharmaceutical applications\nPharmacologically Equivalent national application\nMenu\nFull national application under Part 1 of Schedule 1 (£)\nBibliographic national application (£)\nReference product authorised in UK (£)\nReference product not authorised in UK (£)\nDecentralised application where the UK is a concerned member State or recognition of a product authorised in another member State (£)\nBase Fee:\n930\n1,860\n1,860\n2,380\n460\nThe following fees are in addition to the base fee:\nQuality assessment (if quality data are assessed):\n3,900\n3,320\n2,790\n3,560\n1,860\nSafety assessment (if safety data are assessed):\n3,900\n3,120\n1,060\n1,360\n1,860\nEfficacy assessment (if efficacy data are assessed):\n3,900\n3,120\n1,060\n1,360\n1,860\nEcotoxicology assessment:(if ecotoxicology data are assessed):\n660\n530\n330\n420\n400\nAdditional fee if any of the target species is a food-producing animal (not payable if neither safety data nor ecotoxicology data are assessed):\n3,850\n3,520\n2,120\n2,710\n1,390\nReduced by— if no safety data are assessed:\n2,160\n2,160\n1,320\n1,690\n660\nif no ecotoxicology data are assessed:\n1,020\n780\n300\n380\n300\nAdditional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom—\nfood-producing animal:\n7,350\n6,500\n5,770\n7,370\n2,590\nnon-food-producing animal:\n6,430\n5,770\n5,510\n7,030\n2,260\nAdditional fee for each additional pack type:\n730\n730\n600\n760\n330\nReduced by— if no quality data are assessed:\n360\n360\n360\n460\n120\nif no safety data are assessed:\n180\n180\n120\n150\n60\nif no efficacy data are assessed:\n60\n60\n60\n80\n60\nif no ecotoxicity data are assessed:\n60\n60\n–\n–\n60\nAdditional fee for each additional active ingredient(food-producing animal):\n6,360\n6,030\n3,980\n5,090\n2,060\nReduced by— if no quality data are assessed:\n1,440\n1,440\n1,440\n1,840\n480\nif no safety data are assessed:\n2,690\n2,690\n1,620\n2,070\n840\nif no efficacy data are assessed:\n900\n720\n540\n690\n300\nif no ecotoxicity data are assessed:\n720\n600\n–\n–\n240\nAdditional fee for each additional active ingredient(non-food-producing animal):\n4,250\n4,050\n3,180\n4,070\n1,460\nReduced by— if no quality data are assessed:\n1,440\n1,440\n1,440\n1,840\n480\nif no safety data are assessed:\n1,440\n1,440\n900\n1,150\n480\nif no efficacy data are assessed:\n900\n720\n540\n690\n300\nif no ecotoxicity data are assessed:\n60\n60\n–\n–\n60\nAdditional fee if there is more than one target species, for each additional species (food-producing animal):\n3,910\n3,520\n2,390\n3,050\n1,260\nReduced by— if no quality data are assessed:\n180\n180\n180\n230\n60\nif no safety data are assessed:\n1,440\n1,440\n900\n1,150\n480\nif no efficacy data are assessed:\n1,800\n1,440\n1,080\n1,380\n540\nif no ecotoxicity data are assessed:\n120\n120\n–\n–\n60\nAdditional fee if there is more than one target species, for each additional species (non- food-producing animal):\n2,460\n2,060\n1,530\n1,950\n800\nReduced by— if no quality data are assessed:\n180\n180\n180\n230\n60\nif no safety data are assessed:\n180\n180\n120\n150\n60\nif no efficacy data are assessed:\n1,800\n1,440\n1,080\n1,380\n540\nif no ecotoxicity data are assessed:\n60\n60\n–\n–\n60\nAdditional fee for each additional recommended route of administration(food-producing animal):\n2,650\n2,460\n1,590\n2,040\n930\nReduced by— if no safety data are assessed:\n1,440\n1,440\n900\n1,150\n480\nif no efficacy data are assessed:\n900\n720\n540\n690\n300\nif no ecotoxicity data are assessed:\n60\n60\n–\n–\n60\nAdditional fee for each additional recommended route of administration(non- food-producing animal):\n1,190\n1,000\n730\n930\n400\nReduced by— if no safety data are assessed:\n180\n180\n120\n150\n60\nif no efficacy data are assessed:\n900\n720\n540\n690\n300\nSimultaneous applications: fee for each additional product in the application:\n2,850\n2,850\n2,850\n3,640\n1,660",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2007/2539/schedule/7/paragraph/7",
    "retrieved_at": "2026-10-29T03:44:29.692897+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}