{
  "url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-2/paragraph-7",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-marketing-authorisations-etc-regulations-1994/schedule-2/paragraph-7.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/7",
  "kind": "paragraph",
  "number": "7",
  "heading": "Licensing Authority’s decision",
  "text": "(1) In the case of an application for the grant of an authorization the licensing authority shall then (subject to the following provisions of this Schedule) either grant or refuse the application and may grant it with provisions otherwise than in accordance with the application.\n(2) In the case of an application of the renewal of an authorization the licensing authority shall either renew the authorization (whether or not in accordance with the application) or decide that it is still minded to refuse it.\n(3) In the case of a proposal to revoke, suspend or vary an authorization the licensing authority shall decide whether or not to proceed further with the proposal.\n(4) The licensing authority shall give notice to the applicant or holder of the advice given to it by the appropriate committee or the Medicines Commission, of the reasons for that advice, and of its decision made in accordance with sub-paragraphs (1), (2) or (3) above.",
  "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/7",
    "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."
}