{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/schedule-1/part-II/paragraph-1",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/schedule-1/part-II/paragraph-1.json",
  "legislation": "uksi/1995/1116",
  "legislation_title": "The Medicines (Products for Human Use — Fees) Regulations 1995",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995",
  "path": "schedule/1/part/II/paragraph/1",
  "kind": "paragraph",
  "number": "1",
  "heading": "Marketing authorizations",
  "text": "(1) Subject to paragraphs 2, 3 and 4, the fee payable under regulation 4(a) in connection with an application for a marketing authorization of a kind described in Column 1 of the following Table shall be the fee specified in the corresponding entry in Column 2 of that Table—\nTABLE\nColumn 1\nColumn 2\nKind of application\nFee payable\n1 Major application\n(a) in respect of any such application to which Section G of Part 4 of the Annex to Council Directive 75/318/EEC applies\n1 (a) £20,165\n(b) which is a decentralised incoming application\n1 (b) £50,365\n(c) in any other case\n1 (c) £71,950\n2 Complex application\n(a) which is a decentralised incoming application\n2 (a) £10,305\n(b) in any other case\n2 (b) £14,725\n3 Standard application\n(a) which is a decentralised incoming application\n3 (a) £4,255\n(b) in any other case\n3 (b) £6,080\n4 Simple application\n4 £1,710\n5 Application for a marketing authorization (parallel import)\n5 £1,700\n6 Change of ownership application\n6 £790\n(2) Each reference in paragraphs 3 and 4 to an amount payable under paragraph 1 in respect of an application refers to the amount payable under that paragraph in respect of an application of the kind in question.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ No. L147, 9.6.75, p. 1. The Annex was replaced by the Annex to Council Directive 91/507/EEC (OJ No. L270, 26.9.91, p. 32)."
    }
  ],
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  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1995/1116/schedule/1/part/II/paragraph/1",
    "retrieved_at": "2026-10-29T13:10:38.932521+00:00"
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  "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."
}