{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-35",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-35.json",
  "legislation": "nisr/2012/134",
  "legislation_title": "The Medicines (Products for Human Use) (Fees) Regulations 2012",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012",
  "path": "schedule/2/paragraph/35",
  "kind": "paragraph",
  "number": "35",
  "heading": "Marketing authorizations",
  "text": "(1) Subject to paragraphs 36 to 39 and 46 to 48, the fee payable under regulation 18(1) in connection with an application for a variation to the terms of a marketing authorization of a kind described in column 1 of the appropriate table is the fee specified in the corresponding entry in column 2 of the appropriate table.\n(2) In sub-paragraph (1), the appropriate table is—\n(a) in respect of an application for a variation of a marketing authorization which is within the scope of EC Regulation No. 1234/2008, Table 1;\n(b) in respect of a UK national variation application, Table 2;\n(c) in respect of a reclassification variation application, Table 3.\n(3) In Table 1, “reference authority” has the meaning given in Article 20(2)(b) of EC Regulation No. 1234/2008.\n(4) In Table 2, “UK national variation application” means a variation to a notification of, or an application for, a variation to the terms of a marketing authorization which is not within the scope of EC Regulation No. 1234/2008 and which—\n(a) is a change set out in the document entitled “UK National MA Variations Guidance” published by the licensing authority and available on its website on 30th November 2009; and\n(b) complies with the procedures and conditions to be fulfilled as set out in that document,\nand the expressions “National Type 1B Application”, “National Type II Application”, “National Type II Complex Variation Application”, “National Type II Extended Complex Variation Application”, “National Type IB Minor Variation Group Application”, “National Type II Major Variation Group Application” and “National Type II Major Variation Complex Group Application” shall be interpreted accordingly.\nTable 1\nFees for applications for variations of marketing authorizations falling within the scope of EC Regulation No. 1234/2008\nColumn 1\nKind of variation\nColumn 2\nFee payable\n1. Application for a single kind variation\n(a)\nType IB Application where—\n(i)\nthe UK is a concerned Member State\n£300\n(ii)\nthe UK is the reference Member State or the licensing authority is the reference authority for work sharing\n£594\n(b)\nType II Application where—\n(i)\nthe UK is a concerned Member State\n£794\n(ii)\nthe UK is the reference Member State or the licensing authority is the reference authority for work sharing\n£962\n(c)\nType II Complex Variation Application where—\n(i)\nthe UK is a concerned Member State\n£8,981\n(ii)\nthe UK is the reference Member State or the licensing authority is the reference authority for work sharing\n£15,571\n(d)\nExtended Type II Complex Variation Application where—\n(i)\nthe UK is a concerned Member State\n£27,716\n(ii)\nthe UK is the reference Member State or the licensing authority is the reference authority for work sharing\n£38,744\n2. Applications for a Group\n(a)\nMinor Variation (Type IB) Group Application where—\n(i)\nthe UK is a concerned Member State\n£672\n(ii)\nthe UK is the reference Member State or the licensing authority is the reference authority for work sharing\n£1,324\n(b)\nMajor Variation (Type II) Group Application where—\n(i)\nthe UK is a concerned Member State\n£1,786\n(ii)\nthe UK is the reference Member State or the licensing authority is the reference authority for work sharing\n£2,158\n(c)\nMajor Variation (Type II) Complex Group Application where—\n(i)\nthe UK is a concerned Member State\n£9,738\n(ii)\nthe UK is the reference Member State or the licensing authority is the reference authority for work sharing\n£16,465\n(d)\nMajor Variation (Type II) Extended Complex Group Application where—\n(i)\nthe UK is a concerned Member State\n£28,401\n(ii)\nthe UK is the reference Member State or the licensing authority is the reference authority for work sharing\n£39,693\nTable 2\nFees for UK national variation applications\nColumn 1\nKind of national variation\nColumn 2\nFee payable\n1. National Type 1B Application\n£300\n2. National Type II Application\n£794\n3. National Type II Complex Variation Application\n£8,981\n4. National Type II Extended Complex Variation Application\n£27,716\n5. National Type IB Minor Variation Group Application\n£672\n6. National Type II Major Variation Group Application\n£1,786\n7. National Type II Major Variation Complex Group Application\n£9,738\n8. National Type II Major Variation Extended Complex Group Application\n£28,401\nTable 3\nFees for reclassification variation applications\nColumn 1\nKind of reclassification variation\nColumn 2\nFee payable\nApplication falling within the category described in—\n(a)\nparagraph 15(a)\n£12,961\n(b)\nparagraph 15(b)\n£8,822",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "See Article 1 of the Regulation."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "A copy of the guidance can be downloaded from the licensing authority’s website at www.mhra.gov.uk or obtained by writing to the licensing authority at 151 Buckingham Palace Road, London, SW1W 9SZ or by sending an email to info@mhra.gsi.gov.uk."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/nisr/2012/134/schedule/2/paragraph/35",
    "retrieved_at": "2026-10-29T01:16:38.443269+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."
}