{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-15",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-15.json",
  "legislation": "uksi/2008/552",
  "legislation_title": "The Medicines (Products for Human Use-Fees) Regulations 2008",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008",
  "path": "schedule/1/paragraph/15",
  "kind": "paragraph",
  "number": "15",
  "heading": "Marketing authorizations",
  "text": "Subject to paragraphs 17 to 19 and 26 to 28, the fee payable under regulation 18(1) in connection with an application for a variation of a marketing authorization of a kind described in column 1 of the following table is—\n(a) if the application is an eCTD format application, the fee specified in the corresponding entry in column 2 of that table;\n(b) if the application is not an eCTD format application, the fee specified in the corresponding entry in column 3 of that table.\nFees for applications for variations of marketing authorizations\nColumn 1\nKind of application\nColumn 2\nFee payable if in eCTD format\nColumn 3\nFee payable for application not in eCTD format\n1. Application where, for the purposes of Commission Regulation (EC) No. 1084/2003, the United Kingdom is the reference Member State as defined in Article 3.4 of that Regulation\n(a)\nType IA Application\n£278\n£292\n(b)\nType IB Application\n£556\n£583\n(c)\nType II Application\n£900\n£944\n(d)\nType II Complex Variation Application\n£14,586\n£15,298\n(e)\nExtended Type II Complex Variation Application\n£36,290\n£38,062\n2. Other variation applications\n(a)\nBROMI Self Certification Application\n£176\n£178\n(b)\nType IA Application\n£180\n£188\n(c)\nBROMI Type 1A Application\n£180\n£188\n(d)\nType 1B Application\n£280\n£296\n(e)\nBROMI Type 1B Application\n£280\n£296\n(f)\nType II Application\n£744\n£778\n(g)\nType II Complex Variation Application\n£8,412\n£8,824\n(h)\nExtended Type II Complex\nVariation Application\n£25,962\n£27,228\n(i)\nReclassification variation\nApplication\n£8,264\n£8,666",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2008/552/schedule/1/paragraph/15",
    "retrieved_at": "2026-10-29T03:35:25.906399+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."
}