{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-10/part-1/paragraph-5",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-10/part-1/paragraph-5.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/10/part/1/paragraph/5",
  "kind": "paragraph",
  "number": "5",
  "heading": null,
  "text": "(1) Section 23 of the Act (special provisions as to the effect of manufacturer’s licence) shall be amended as follows.\n(2) In subsection (1)—\n(a) omit “clinical trials and”;\n(b) for paragraph (b), substitute the following paragraph—\n“(b) the products are manufactured or assembled to the order of—\n(i) a person who is the holder of such a product licence, or\n(ii) if the products are to be used for the purposes of a clinical trial, the sponsor of that trial,”.\n(3) After subsection (5), insert the following subsection—\n“(6) In this section, “clinical trial” and “sponsor”, in relation to a clinical trial, have the meaning given by Clinical Trials Regulations.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "M",
      "label": "M1",
      "text": "Section 23 of the Act has effect as if any reference in subsection (1) to a product licence included a reference to a marketing authorization; see regulation 9(1) of the 1994 Regulations."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2004/1031/schedule/10/part/1/paragraph/5",
    "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."
}