{
  "url": "https://openlegislation.uk/draft-human-medicines-amendment-regulations-2026/regulation-6",
  "json_url": "https://openlegislation.uk/draft-human-medicines-amendment-regulations-2026/regulation-6.json",
  "legislation": "ukdsi/2026/9780348278958",
  "legislation_title": "The Human Medicines (Amendment) Regulations 2026",
  "legislation_url": "https://openlegislation.uk/draft-human-medicines-amendment-regulations-2026",
  "path": "regulation/6",
  "kind": "regulation",
  "number": "6",
  "heading": "Amendment of regulation 19",
  "text": "(1) Regulation 19 (exemptions from requirement for wholesale dealer's licence) is amended as follows.\n(2) In paragraph (4A)—\n(a) in the opening words—\n(i) for “vaccination or immunisation against coronavirus or influenza virus” substitute “vaccination against an infectious disease”, and\n(ii) after “the person distributing the medicinal product”, insert “(Person A)”;\n(b) in sub-paragraph (b)—\n(i) after “relevant arrangements” insert “(Person B)”, and\n(ii) at the end, omit “and”;\n(c) at the end of sub-paragraph (c), insert “and”; and\n(d) after sub-paragraph (c), insert—\n“(d) conditions A and B in paragraphs (4E) and (4F) are met.”\n(3) Omit paragraph (4B).\n(4) For paragraph (4D), substitute—\n“(4E) Condition A is that supply between Person A and Person B is agreed with the body making the arrangements to supply the medicinal product and the distribution occurs in exceptional circumstances, which are such that Person A and Person B are satisfied, having made appropriate enquiries, that—\n(a) there is an urgent public health need for a patient to have administered to them the medicinal product on a particular occasion that the distribution would facilitate;\n(b) there is no other way that the patient could receive treatment with the medicinal product without undue delay; and\n(c) there is no suitable alternative medicinal product that the patient could receive treatment with without undue delay.\n(4F) Condition B is that the medicinal product remains in its manufacturer’s original outer packaging, and is stored and transported, in accordance with the terms of its marketing authorisation.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Paragraphs (4A), (4B) and (4D) were inserted by S.I. 2020/1125 and S.R. 2020/349 and paragraph (4D) has been amended by S.I. 2024/344 and S.R. 2024/68."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2026/9780348278958/regulation/6",
    "retrieved_at": "2026-10-30T14:37:58.296902+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."
}