{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-11/paragraph-10",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-11/paragraph-10.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "schedule/11/paragraph/10",
  "kind": "paragraph",
  "number": "10",
  "heading": null,
  "text": "(1) After receiving the appropriate committee's report under paragraph 7 or 8 or notification under paragraph 9 the licensing authority must—\n(a) decide whether to grant or renew the UK marketing authorisation, certificate of registration or traditional herbal registration;\n(b) decide whether to grant or renew the authorisation, certificate or registration in accordance with the application; ...\n(c) decide whether to proceed with its proposal to revoke, vary or suspend the authorisation, certificate or registration ; or\n(d) decide whether to proceed with its proposal to decide that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation,\nas the case may be.\n(2) If the appropriate committee has given a report under paragraph 7 or 8, the licensing authority must take the report into account in making its decision.\n(3) The licensing authority must notify the applicant or holder of—\n(a) its decision; and\n(b) any advice given to it by the appropriate committee and the reasons for that advice.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Word in Sch. 11 para. 10(1)(b) omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 63(2D)(a) (as inserted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(3); 2020 c. 1, Sch. 5 para. 1(1))"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Sch. 11 para. 10(1)(d) and word inserted (31.12.2020) by S.I. 2019/775, reg. 63(2D)(b) (as inserted by The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/1385), reg. 1, Sch. 1 para. 7(3); 2020 c. 1, Sch. 5 para. 1(1))"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/schedule/11/paragraph/10",
    "retrieved_at": "2026-10-29T01:24:34.993203+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."
}