{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-13/paragraph-3",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-13/paragraph-3.json",
  "legislation": "uksi/2004/1031",
  "legislation_title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
  "legislation_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004",
  "path": "schedule/13/paragraph/3",
  "kind": "paragraph",
  "number": "3",
  "heading": "Import of investigational medicinal products into Great Britain from EEA States during the transitional period",
  "text": "(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.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 13 inserted (31.12.2020) by The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744), regs. 1, 26 (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 1 para. 10; 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2004/1031/schedule/13/paragraph/3",
    "retrieved_at": "2026-10-29T05:28:03.775386+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."
}