{
  "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-2/paragraph-10",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-2/paragraph-10.json",
  "legislation": "uksi/1994/3144",
  "legislation_title": "The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994",
  "legislation_url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994",
  "path": "schedule/2/paragraph/10",
  "kind": "paragraph",
  "number": "10",
  "heading": "Person appointed to hear representations",
  "text": "Any notification given under paragraph 9—\n(a) in a case falling within sub-paragraph (a), (b) or (c) of that paragraph, shall state the advice of the Medicines Commission or of the appropriate committee and the reasons stated by the Medicines Commission or the committee for giving that advice;\n(b) in a case falling within sub-paragraph (d) of that paragraph (whether it also falls within any of the other sub-paragraphs of that paragraph or not), shall include a statement of the proposals of the licensing authority and of the reasons for them.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [
    {
      "type": "am (1.1.2010)",
      "affecting": "uksi/2009/2820",
      "affecting_title": "The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2009"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2009/3222",
      "affecting_title": "The Medicines (Products for Human Use) (Amendments to Fees for Variations) Regulations 2009"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2004/3224",
      "affecting_title": "The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004"
    },
    {
      "type": "substituted",
      "affecting": "uksi/2005/2754",
      "affecting_title": "The Medicines (Advisory Bodies) (No. 2) Regulations 2005"
    },
    {
      "type": "word substituted",
      "affecting": "uksi/2005/2754",
      "affecting_title": "The Medicines (Advisory Bodies) (No. 2) Regulations 2005"
    },
    {
      "type": "substituted",
      "affecting": "uksi/2005/1094",
      "affecting_title": "The Medicines (Advisory Bodies) Regulations 2005"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002"
    }
  ],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1994/3144/schedule/2/paragraph/10",
    "retrieved_at": "2026-10-29T13:21:07.489272+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."
}