{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-11/paragraph-5",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-11/paragraph-5.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/5",
  "kind": "paragraph",
  "number": "5",
  "heading": null,
  "text": "(1) If the appropriate committee is consulted under paragraph 2(1) it may give a provisional opinion that on grounds relating to safety, quality or efficacy—\n(a) it may be unable to advise the licensing authority to grant or renew the UK marketing authorisation or traditional herbal registration;\n(b) it may be unable to advise the licensing authority to grant the authorisation or registration unless—\n(i) it contains terms other than those in the application, or\n(ii) it is granted subject to conditions; or\n(c) it may have to advise the licensing authority to revoke, vary or suspend the authorisation or registration.\n(2) If the Commission is consulted under paragraph 2(2), it may give a provisional opinion that, on grounds relating to safety or quality—\n(a) it may be unable to advise the licensing authority to grant or renew the certificate of registration;\n(b) it may be unable to advise the licensing authority to grant the certificate unless—\n(i) it contains terms other than those in the application, or\n(ii) it is granted subject to conditions; or\n(c) it may have to advise the licensing authority to revoke, vary or suspend the certificate.\n(2A) If the appropriate committee is consulted under paragraph 2(2A), it may give a provisional opinion that it may be unable to advise the licensing authority to decide that the orphan criteria are met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation.\n(3) The appropriate committee must notify the applicant for the grant or renewal , the applicant intending to demonstrate that the orphan criteria are met in relation to a medicinal product, or (as the case may be) the holder of the authorisation, certificate or registration in writing of its provisional opinion.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 11 para. 5(2A) inserted (31.12.2020) by S.I. 2019/775, reg. 63(2C)(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": "Words in Sch. 11 para. 5(3) inserted (31.12.2020) by S.I. 2019/775, reg. 63(2C)(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/5",
    "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."
}