{
  "url": "https://openlegislation.uk/veterinary-medicines-regulations-2006/schedule-7/paragraph-14",
  "json_url": "https://openlegislation.uk/veterinary-medicines-regulations-2006/schedule-7/paragraph-14.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/14",
  "kind": "paragraph",
  "number": "14",
  "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:\n8,990\n2,220\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 the fee payable is—\nfor the first variation:\n8,990\n2,220\nfor each subsequent variation:\n1,555\n440\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 the fee payable is:\n2,455\n475\nType 1A variation:\n1,555\n440\nType 1B variation:\n2,455\n475\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—\nfor the first variation:\n2,455\n475\nfor each subsequent variation:\n1,555\n440",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "I",
      "label": "I1",
      "text": "Sch. 7 para. 14 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/14",
    "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."
}