{
  "url": "https://openlegislation.uk/draft-veterinary-medicines-amendment-etc-regulations-2024/regulation-171",
  "json_url": "https://openlegislation.uk/draft-veterinary-medicines-amendment-etc-regulations-2024/regulation-171.json",
  "legislation": "ukdsi/2024/9780348258523",
  "legislation_title": "The Veterinary Medicines (Amendment etc.) Regulations 2024",
  "legislation_url": "https://openlegislation.uk/draft-veterinary-medicines-amendment-etc-regulations-2024",
  "path": "regulation/171",
  "kind": "regulation",
  "number": "171",
  "heading": "Amendment to paragraph 17",
  "text": "In paragraph 17 (application for variation to marketing authorisation under national or mutual recognition procedure)—\n(a) in sub-paragraph (1) omit “18, 19 or”;\n(b) for the table substitute—\n“\nType of variations\nFee (£)\nSingle variations; one change for each product\nVariation – standard\n2,895\nUnless the variation is—\n(a) a change of route of administration, or the addition of a new one, of—\n(i)\nan immunological product, or a pharmaceutical product for a non-food-producing animal\n5,390\n(ii)\na pharmaceutical product for a food-producing animal\n7,135\n(b) a change of bioavailability\n8,415\n(c) a change of active substance, where the change is to—\n(i)\nuse a different biologically active substance with a slightly different molecular structure\n8,415\n(ii)\nmodify the vector used to produce the antigen or the source material, including a new master cell bank from a different source\n8,415\n(d) a change of pharmacokinetics\n8,415\nSimultaneous application falling within (a) to (d): fee for each additional product in the application\n1,465\nVariation – reduced\n885\nVariation - no assessment\n455\nGrouped variations\nVariation – standard led\nFor the first nine changes\n6,280\nFor each subsequent group of five or fewer changes\n2,250\nVariation – reduced led:\nFor the first nine changes\n1,770\nFor each subsequent group of five or fewer changes\n2,250\n”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2024/9780348258523/regulation/171",
    "retrieved_at": "2026-10-30T14:41:23.789053+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."
}