{
  "url": "https://openlegislation.uk/veterinary-medicines-regulations-2006/schedule-7/paragraph-6",
  "json_url": "https://openlegislation.uk/veterinary-medicines-regulations-2006/schedule-7/paragraph-6.json",
  "legislation": "uksi/2006/2407",
  "legislation_title": "The Veterinary Medicines Regulations 2006",
  "legislation_url": "https://openlegislation.uk/veterinary-medicines-regulations-2006",
  "path": "schedule/7/paragraph/6",
  "kind": "paragraph",
  "number": "6",
  "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: The following fees are in addition to the base fee—\n910\n1,800\n1,800\n2,320\n460\nQuality assessment (if quality data are assessed):\n3,810\n3,230\n2,710\n3,470\n1,810\nSafety assessment (if safety data are assessed):\n3,810\n3,030\n1,030\n1,330\n1,810\nEfficacy assessment (if efficacy data are assessed):\n3,810\n3,030\n1,030\n1,330\n1,810\nEcotoxicology assessment (if ecotoxicology data are assessed):\n640\n520\n320\n410\n390\nAdditional fee if any of the target species is a food-producing animal (not payable if neither safety data nor ecotoxicology data are assessed):\n3,740\n3,420\n2,070\n2,650\n1,350\nReduced by—\nif no safety data are assessed:\n2,100\n2,100\n1,290\n1,650\n640\nif no ecotoxicology data are assessed:\n990\n760\n290\n370\n290\nAdditional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom—\nfood-producing animal:\n7,170\n6,330\n5,610\n7,200\n2,520\nnon-food-producing animal:\n6,260\n5,620\n5,360\n6,870\n2,200\nAdditional fee for each additional pack type:\n720\n720\n590\n740\n330\nReduced by—\nif no quality data are assessed:\n350\n350\n350\n450\n120\nif no safety data are assessed:\n180\n180\n120\n150\n60\nif no efficacy data are assessed:\n60\n60\n60\n70\n60\nif no ecotoxicity data are assessed:\n60\n60\n—\n—\n60\nAdditional fee for each additional active ingredient (food-producing animal):\n6,210\n5,870\n3,880\n4,960\n2,000\nReduced by—\nif no quality data are assessed:\n1,400\n1,400\n1,400\n1,790\n470\nif no safety data are assessed:\n2,630\n2,630\n1,580\n2,020\n820\nif no efficacy data are assessed:\n880\n700\n530\n670\n290\nif no ecotoxicity data are assessed:\n700\n580\n—\n—\n230\nAdditional fee for each additional active ingredient (non-food-producing animal):\n4,140\n3,940\n3,110\n3,960\n1,430\nReduced by—\nif no quality data are assessed:\n1,400\n1,400\n1,400\n1,790\n470\nif no safety data are assessed:\n1,400\n1,400\n880\n1,120\n470\nif no efficacy data are assessed:\n880\n700\n530\n670\n290\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):\n3,820\n3,430\n2,330\n2,980\n1,240\nReduced by—\nif no quality data are assessed:\n180\n180\n180\n220\n60\nif no safety data are assessed:\n1,400\n1,400\n880\n1,120\n470\nif no efficacy data are assessed:\n1,750\n1,400\n1,050\n1,350\n530\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):\n2,400\n2,010\n1,490\n1,900\n780\nReduced by—\nif no quality data are assessed:\n180\n180\n180\n220\n60\nif no safety data are assessed:\n180\n180\n120\n150\n60\nif no efficacy data are assessed:\n1,750\n1,400\n1,050\n1,350\n530\nif no ecotoxicity data are assessed:\n60\n60\n—\n—\n60\nAdditional fee for each additional recommended route of administration (food-producing animal):\n2,590\n2,390\n1,560\n1,980\n910\nReduced by—\nif no safety data are assessed:\n1,400\n1,400\n880\n1,120\n470\nif no efficacy data are assessed:\n880\n700\n530\n670\n290\nif no ecotoxicity data are assessed:\n60\n60\n—\n—\n60\nAdditional fee for each additional recommended route of administration (non- food-producing animal):\n1,170\n970\n720\n910\n390\nReduced by—\nif no safety data are assessed:\n180\n180\n120\n150\n60\nif no efficacy data are assessed:\n880\n700\n530\n670\n290\nSimultaneous applications: fee for each additional product in the application:\n2,780\n2,780\n2,780\n3,560\n1,610",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "I",
      "label": "I1",
      "text": "Sch. 7 para. 6 in force at 1.10.2006, see reg. 1"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2006/2407/schedule/7/paragraph/6",
    "retrieved_at": "2026-10-29T04:22:09.984208+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."
}