{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-7/paragraph-12",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-7/paragraph-12.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/7/paragraph/12",
  "kind": "paragraph",
  "number": "12",
  "heading": null,
  "text": "Where—\n(a) the manufacturing authorisation relates to the assembly of an investigational medicinal product or EAMS medicinal product;\n(b) that investigational medicinal product or EAMS medicinal product is not manufactured by the holder of the authorisation; and\n(c) particulars as to the name and address of the manufacturer of, or of the person who imports, that investigational medicinal product or EAMS medicinal product had been given by the holder of the authorisation to the licensing authority,\nthe holder of the authorisation shall forthwith notify the licensing authority in writing of any changes in such particulars.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Sch. 7 Pt. 2 para. 12 inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 18(2)(f) (with reg. 19)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2004/1031/schedule/7/paragraph/12",
    "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."
}