{
  "url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-7/paragraph-17",
  "json_url": "https://openlegislation.uk/veterinary-medicines-regulations-2007/schedule-7/paragraph-17.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/17",
  "kind": "paragraph",
  "number": "17",
  "heading": "Application for a variation to a marketing authorisation that has been issued in other member States",
  "text": "(1) In this paragraph the types of variation are those specified in Commission Regulation (EC) 1084/2003.\n(2) An applicant must make a separate application for a variation for each change in the marketing authorisation (unless a change is a direct consequence of the first change).\n(3) The fee is in accordance with the following table.\nVariations\nType of variation\nUK is the reference member State (£)\nUK is a concerned member State (£)\nType II variation:\n5,125\n3,075\nIf a marketing authorisation holder applies for a Type II variation for a number of marketing authorisations, and—\nall the applications have identical supporting data\nall the changes are identical\nall the applications are submitted at the same time\nthe fee payable is—\n– for the first variation:\n5,125\n3,075\n– for each subsequent variation:\n675\n450\nIf a marketing authorisation holder—\napplies for a Type II variation to correct the Summary of Product Characteristics or product literature or where variations are required for simple text layout changes\nthe change is not a result of safety concerns\nno new studies are required to support the change\nno other aspects of the dossier are changed\nthe fee payable is:\n1,305\n870\nChanges to details of the marketing authorisation holder’s pharmacovigilance system (no other changes to the dossier):\n1,305\n870\nType 1A variation:\n675\n450\nType 1B variation:\n1,305\n870\nIf a marketing authorisation holder applies for a Type 1B variation for a number of marketing authorisations, and—\nall the applications have identical supporting data\nall the changes are identical\nall the applications are submitted at the same time\nthe fee payable is—\n– for the first variation\n1,305\n675\n– for each subsequent variation\n870\n450",
  "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/17",
    "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."
}