{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-110",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-110.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/110",
  "kind": "regulation",
  "number": "110",
  "heading": "Revocation, variation and suspension of certificate of registration",
  "text": "(1) The licensing authority may revoke, vary or suspend a certificate of registration if any of the following conditions are met.\n(2) Condition A is that the licensing authority thinks that—\n(a) the product to which the certificate relates is harmful;\n(b) the risks of the product to the health of patients or of the public outweigh any beneficial effects of the product; or\n(c) the product's qualitative or quantitative composition is not as described in the application for the certificate or the material supplied with it.\n(3) Condition B is that the licensing authority thinks that the application or the material accompanying it is incorrect.\n(4) Condition C is that the licensing authority thinks that there has been a breach of—\n(a) a term of the certificate; or\n(b) a requirement imposed by Chapter 1 of Part 13 (packaging and leaflets).\n(5) Condition D is that the licensing authority thinks that a condition to which the certificate is subject by virtue of regulation 105 (conditions of certificate or registration) has not been fulfilled.\n(6) Condition E is that the licensing authority thinks that the holder of the certificate has not complied with regulation 115(1) to (3) (requirements to provide information).\n(7) Condition F is that the holder of the certificate has ceased to be established in—\n(a) the United Kingdom; or\n(b) in relation to a COR(NI), either the United Kingdom or the European Union,\nin accordance with the requirements of these Regulations.\n(8) Condition G is that—\n(a) the holder applies to vary the certificate; and\n(b) the licensing authority thinks that the application should be granted.\n(8A) Condition H is that the manufacture and control of the product to which the certificate relates is not in compliance with the particulars provided under regulation 103(8)(c) and (d).\n(8B) Condition I is that the licensing authority thinks that the revocation, variation or suspension is necessary or expedient in light of the Protocol on Ireland/Northern Ireland in the withdrawal agreement.\n(9) Schedule 11 makes provision about advice and representations in relation to a proposal to revoke, vary or suspend a certificate of registration, other than a proposal to vary a certificate on the application of its holder.\n(10) This regulation is subject to regulation 111 (certificates granted under Chapter 4 of Title III of the 2001 Directive).",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 110(7)(a)(b) substituted for words in reg. 110(7) (31.12.2020) by S.I. 2019/775, reg. 102(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 80(a))"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Reg. 110(8A) inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 19"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Reg. 110(8B) inserted (31.12.20200 by S.I. 2019/775, reg. 102(2A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 80(b))"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/110",
    "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."
}