{
  "url": "https://openlegislation.uk/unlicensed-medicinal-products-for-human-use-transmissible-spongiform-encephalopathies-safety-regulations-2003/regulation-6",
  "json_url": "https://openlegislation.uk/unlicensed-medicinal-products-for-human-use-transmissible-spongiform-encephalopathies-safety-regulations-2003/regulation-6.json",
  "legislation": "uksi/2003/1680",
  "legislation_title": "The Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003",
  "legislation_url": "https://openlegislation.uk/unlicensed-medicinal-products-for-human-use-transmissible-spongiform-encephalopathies-safety-regulations-2003",
  "path": "regulation/6",
  "kind": "regulation",
  "number": "6",
  "heading": "Records of evidence of compliance",
  "text": "(1) The designated record-keeper for an unlicensed product shall, if materials to which the TSE Guideline applies were used in the course of the manufacture of that product—\n(a) establish records in English that demonstrate that the product has been manufactured in accordance with the TSE Guideline; and\n(b) keep those records available for the appropriate Minister for a period of five years from the date on which he imports or markets the product, or for a period of one year from the expiry date for the product, whichever is the longer.\n(2) For the purposes of paragraph (1)—\n(a) a person is the designated record-keeper for an unlicensed product—\n(i) if he is the person who imports the product, or\n(ii) if the product has been manufactured or assembled in the United Kingdom, if he is the person who manufactured or assembled the product in the United Kingdom;\n(b) if materials used in the course of the manufacture of an unlicensed product may be materials to which the TSE Guideline applies, they shall be deemed to be materials to which the TSE Guideline applies, unless the designated record-keeper for the unlicensed product is able to demonstrate that they are not materials to which the TSE Guideline applies.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 6 in force at 30.7.2003, see reg. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2003/1680/regulation/6",
    "retrieved_at": "2026-10-29T06:18:33.650829+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."
}