{
  "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-7/paragraph-12",
  "json_url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-7/paragraph-12.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/12",
  "kind": "paragraph",
  "number": "12",
  "heading": "Application for a provisional marketing authorisation (pharmaceutical)",
  "text": "The fee for an application for a provisional marketing authorisation for a pharmaceutical product is in accordance with the following table.\nFees for a provisional marketing authorisation for a pharmaceutical product\nMenu\nFee (£)\nBase Fee:\n930\nThe following fees are in addition to the base fee:\nQuality assessment (if quality data are assessed):\n3,900\nSafety assessment (if safety data are assessed):\n3,900\nEfficacy assessment (if efficacy data are assessed):\n2,420\nEcotoxicology assessment (if ecotoxicology data are assessed):\n660\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\nAdditional fee for each active ingredient not previously included in a veterinary medicinal product authorised in the United Kingdom—\nfood-producing animal:\n5,770\nnon-food-producing animal:\n4,840\nAdditional fee for each additional pack type:\n700\nAdditional fee for each additional active ingredient (food-producing animal):\n5,860\nAdditional fee for each additional active ingredient (non-food-producing animal):\n3,750\nAdditional fee if there is more than one target species, for each additional species (food-producing animal):\n2,920\nAdditional fee if there is more than one target species, for each additional species (non- food-producing animal):\n1,460\nAdditional fee for each additional recommended route of administration (food-producing animal):\n2,160\nAdditional fee for each additional recommended route of administration (non-food-producing animal):\n700\nSimultaneous applications—fee for each additional product in the application:\n2,850",
  "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/12",
    "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."
}