{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-6/paragraph-6",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-6/paragraph-6.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "schedule/6/paragraph/6",
  "kind": "paragraph",
  "number": "6",
  "heading": null,
  "text": "Where the holder of a manufacturer's licence distributes by way of wholesale dealing any exempt advanced therapy medicinal product manufactured or assembled pursuant to the licence that person must comply with—\n(a) the requirements of paragraphs 15, 16, 18 and 19; and\n(b) the guidelines on good distribution practice published by the European Commission in accordance with Article 84 of the 2001 Directive;\nas if that person were the holder of a wholesale dealer's licence.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/schedule/6/paragraph/6",
    "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."
}