{
  "url": "https://openlegislation.uk/medicines-advisory-bodies-no-2-regulations-2005/schedule-5/part-3/paragraph-12",
  "json_url": "https://openlegislation.uk/medicines-advisory-bodies-no-2-regulations-2005/schedule-5/part-3/paragraph-12.json",
  "legislation": "uksi/2005/2754",
  "legislation_title": "The Medicines (Advisory Bodies) (No. 2) Regulations 2005",
  "legislation_url": "https://openlegislation.uk/medicines-advisory-bodies-no-2-regulations-2005",
  "path": "schedule/5/part/3/paragraph/12",
  "kind": "paragraph",
  "number": "12",
  "heading": "Right to be heard by person appointed in relation to marketing authorisation applications or proposals made before 30th October 2005",
  "text": "(1) This paragraph applies where, before 30th October 2005—\n(a) the Medicines Commission have reported findings and advice to the licensing authority under paragraph 8(3) of Schedule 2 to the Marketing Authorization Regulations; and\n(b) the licensing authority have not notified the applicant or holder of—\n(i) that advice; or\n(ii) the confirmation or alteration of their decision under paragraph 7 of Schedule 2 to those regulations.\n(2) The licensing authority shall give notice to the applicant or holder of—\n(i) the Medicines Commission’s advice and the reasons for it;\n(ii) the confirmation or alteration of their decision.\n(3) The applicant or holder may, within the time allowed—\n(a) notify the licensing authority that he wishes to appear before and be heard by a person appointed by the licensing authority; or\n(b) make written representations to the licensing authority.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2005/2754/schedule/5/part/3/paragraph/12",
    "retrieved_at": "2026-10-29T04:49:26.804880+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."
}