{
  "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-2/paragraph-12",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-2/paragraph-12.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/12",
  "kind": "paragraph",
  "number": "12",
  "heading": "Right to be heard by a person appointed or to make further representations",
  "text": "(1) Where the applicant or holder gives notice under paragraph 11 of his wish to appear before and be heard by a person appointed for the purpose by the licensing authority, the licensing authority shall make that appointment and—\n(a) the person so appointed shall not, except with the consent of the applicant or holder, be an officer or servant of any of the Ministers specified in paragraphs (a) and (b) of section 1(1) of the Act;\n(b) if the applicant or holder so requests, the hearing shall be in public; and\n(c) if the applicant or holder so requests, the licensing authority shall furnish to him a copy of the report of the person so appointed.\n(2) The licensing authority shall take into account the report of the person appointed and decide whether to renew the authorization, revoke, vary or suspend the authorization or confirm or alter its decision, as the case may be.",
  "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/12",
    "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."
}