{
  "url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-119",
  "json_url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-119.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/119",
  "kind": "regulation",
  "number": "119",
  "heading": "Amendment of regulation 135 (revocation, variation and suspension of traditional herbal registration)",
  "text": "(1) Regulation 135 is amended as follows.\n(1A) For paragraph (6) substitute—\n“(6) Condition E is that the holder of the registration has ceased to be established in—\n(a) the United Kingdom; or\n(b) in relation to a THR(NI), either the United Kingdom or the European Union,\nin accordance with the requirements of these Regulations.”.\n(2) In paragraph (7)(b), after “states other than EEA states” insert “/ countries other than approved countries for import”.\n(3) In paragraph (8)(a) omit “other than the United Kingdom”.\n(4) In paragraph (9), in sub-paragraph (b), at the beginning insert “in the case of a THR(NI) or THR(UK),”.\n(4A) After paragraph (10A) insert—\n“(10B) Condition K 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(5) Omit paragraph (11).",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 119(1A) inserted (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. 91(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 119(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. 91(b)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Reg. 119(3) 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. 91(c)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Words in reg. 119(4) 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. 91(d)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Reg. 119(4A) inserted (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. 91(e)"
    },
    {
      "type": "M",
      "label": "M1",
      "text": "Regulation 135 was amended by S.I. 2013/1855."
    },
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 119 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/119",
    "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."
}