{
  "url": "https://openlegislation.uk/veterinary-medicines-regulations-2005/schedule-7/paragraph-20",
  "json_url": "https://openlegislation.uk/veterinary-medicines-regulations-2005/schedule-7/paragraph-20.json",
  "legislation": "uksi/2005/2745",
  "legislation_title": "The Veterinary Medicines Regulations 2005",
  "legislation_url": "https://openlegislation.uk/veterinary-medicines-regulations-2005",
  "path": "schedule/7/paragraph/20",
  "kind": "paragraph",
  "number": "20",
  "heading": "Application for a variation",
  "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) and the appropriate fee is payable for each application.\n(3) If an applicant applies for an extension of a marketing authorisation as specified in Annex II to Commission Regulation (EC) No. 1084/2003—\n(a) if the applicant applies for a United Kingdom marketing authorisation the fee is the same as the fee for the application for a national marketing authorisation, plus any fees payable for any mutual recognition procedure; or\n(b) if the applicant uses the decentralised procedure, the fee is the same as the fee for a marketing authorisation using the decentralised procedure.\n(4) Other fees are in accordance with the following table—\nVariations\nType of variation\nRMS\nCMS\nFee(£)\nFee(£)\nType II variation\n10,125\n2,540\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\nfor the first variation\n10,125\n2,540\nfor each subsequent variation\n1,675\n330\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 lay out 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\n2,705\n355\nType 1A variation\n1,675\n330\nType 1B variation\n2,705\n355\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\n2,705\n355\nfor each subsequent variation\n1,675\n330\nNote: the RMS fee is payable when the United Kingdom acts as the reference member State and the CMS fee is payable when the United Kingdom acts as the concerned member State.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2005/2745/schedule/7/paragraph/20",
    "retrieved_at": "2026-10-29T04:49:34.048072+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."
}