{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-33A/paragraph-4",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-33A/paragraph-4.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "schedule/33A/paragraph/4",
  "kind": "paragraph",
  "number": "4",
  "heading": "Qualified persons and approved country for batch testing list on IP completion day (Schedule 7)",
  "text": "(1) Sub-paragraph (2) applies to a person who—\n(a) is acting as a qualified person immediately before IP completion day; and\n(b) satisfies the requirements of Part 1 of Schedule 7 (qualification requirements for qualified persons) immediately before IP completion day as they had effect at that time.\n(2) The person is to be treated on and after IP completion day as continuing to satisfy the requirements of Part 1 of Schedule 7 if the person would otherwise fail to do so as a result of amendments made to that Part by the EU Exit Regulations.\n(3) For the purposes of paragraph 14(1)(b) of Schedule 7 (obligations of qualified person), for the transitional period, the licensing authority is deemed to have made appropriate arrangements with—\n(a) each EEA State;\n(b) Australia;\n(c) Canada;\n(d) Israel;\n(e) Japan;\n(f) New Zealand;\n(g) Switzerland; and\n(h) the United States of America,\nand the licensing authority must, on IP completion day, publish a list that includes those countries under paragraph 14(3) of Schedule 7.\n(4) The licensing authority may, in respect of any country specified in sub-paragraph (3)(b) to (h), include that country in the list subject to a condition or restriction as provided for in paragraph 14(4) of Schedule 7, insofar as that condition or restriction was reflected in the appropriate arrangements that existed immediately before IP completion day under Article 51(2) of the 2001 Directive.\n(5) The licensing authority must not, before the end of the transitional period, exercise its powers under paragraph 14(6) of Schedule 7 to remove an EEA State from the list it publishes.\n(6) In this regulation, “the transitional period” is the period of two years beginning with IP completion day.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 33A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 7 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 193); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/schedule/33A/paragraph/4",
    "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."
}