{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-eu-exit-regulations-2019/regulation-26",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-eu-exit-regulations-2019/regulation-26.json",
  "legislation": "uksi/2019/744",
  "legislation_title": "The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019",
  "legislation_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-eu-exit-regulations-2019",
  "path": "regulation/26",
  "kind": "regulation",
  "number": "26",
  "heading": "Insertion of Schedule 13 (transitional provisions in relation to EU Exit)",
  "text": "After Schedule 12 insert—\n“SCHEDULE 13\nTransitional provisions relating to EU Exit\nRegulation 56\nList of countries for the purpose of the definition of “marketing authorization” on IP completion day (regulation 2A)\n1 (1) For the purpose of regulation 2A, during the transitional period, the licensing authority must include each EEA State in the list referred to in paragraph (1) of that regulation.\n(2) Notwithstanding regulation 2A(3), the licensing authority must not, before the end of the transitional period, remove an EEA State from the list referred to in regulation 2A(1).\n(3) In this paragraph, “transitional period” is the period of two years beginning with IP completion day.\nList of countries where a sponsor of a clinical trial, or their legal representative, may be established on IP completion day (regulation 3(11A))\n2 (1) For the purpose of regulation 3, the licensing authority must include each EEA State in the list referred to in paragraph (11A) of that regulation.\n(2) Notwithstanding regulation 3(11C), the licensing authority must not, before the end of the transitional period, remove an EEA State from the list referred to in regulation 3(11A).\n(3) In this paragraph, “transitional period” is the period of two years beginning with IP completion day.\nImport of investigational medicinal products into Great Britain from EEA States during the transitional period\n3 (1) The condition in regulation 13(2)(b) and the restriction in regulation 36(1) do not apply to an investigational medicinal product that is imported into Great Britain from an EEA State before the end of the transitional period, provided that the production batch of investigational medicinal products of which the product is a part has been checked and certified by a qualified person pursuant to Article 13(3) and (4) of the Directive.\n(2) In this paragraph, “transitional period” is the period of one year beginning with IP completion day.\nApproved country for import list on IP completion day (regulation 43A)\n4 (1) For the purpose of regulation 43A, during the transitional period, the licensing authority must include each EEA State in the list referred to in paragraph (1) of that regulation.\n(2) Notwithstanding regulation 43A(3), the licensing authority must not, before the end of the transitional period, remove an EEA State from the list referred to in regulation 43A(1).\n(3) In this paragraph, “transitional period” is the period of two years beginning with IP completion day.”.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 26 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. 1 para. 10(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 26 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. 1 para. 10(b)(i)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in reg. 26 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. 1 para. 10(b)(ii)"
    },
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 26 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/2019/744/regulation/26",
    "retrieved_at": "2026-10-28T22:42:33.457024+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."
}