{
  "url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-139",
  "json_url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-139.json",
  "legislation": "uksi/2019/775",
  "legislation_title": "The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019",
  "legislation_url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019",
  "path": "regulation/139",
  "kind": "regulation",
  "number": "139",
  "heading": "Amendment of regulation 177 (application of Part and interpretation)",
  "text": "(1) Regulation 177 is amended as follows.\n(2) After paragraph (1) insert—\n“(1A) Schedule 12A applies in relation to medicinal products that are the subject of a UKMA(GB) ora THR(GB).”.\n(3) In paragraph (2)—\n(a) after “this Part” insert “ and Schedule 12A ”;\n(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(4) In paragraph (3)—\n(a) for “Schedule 33” substitute “ Schedules 12A and 33 ”;\n(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(6) In paragraph (5)—\n(a) for “Schedule 33” substitute “Schedules 33 and 33A”;\n(b) in paragraph (c) of the definition of “relevant post-authorisation safety study”, omit “and”; and\n(c) after that definition, insert—\n““signal” means, in relation to a UKMA(GB) or THR(GB), information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, which is judged to be of sufficient likelihood to justify verificatory action; and”.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 139(2) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 107(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Reg. 139(3)(b) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 107(b)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Reg. 139(3)(c) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 107(b)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Reg. 139(4)(b) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 107(c)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Reg. 139(4)(c) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 107(c)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Reg. 139(5) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 107(d)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Reg. 139(6) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 107(e)"
    },
    {
      "type": "M",
      "label": "M1",
      "text": "Regulation 177 was amended by S.I. 2013/1855 and 2014/1878."
    },
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 139 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2019/775/regulation/139",
    "retrieved_at": "2026-10-28T22:42:14.621781+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."
}