{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-6/paragraph-10",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-6/paragraph-10.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/6/paragraph/10",
  "kind": "paragraph",
  "number": "10",
  "heading": null,
  "text": "Where the application relates to an MM investigational medicinal product, the application for each product must be accompanied by a dossier which includes, as a minimum, the following:\n(a) a description and means of identification of each modular unit at which manufacture or assembly of the MM investigational medicinal product is to take place;\n(b) the location of each unit at which manufacturing or assembly of the MM investigational medicinal product is to take place;\n(c) the location of each site at which operations related to the manufacture or assembly of the MM investigational medicinal product are to take place;\n(d) a description of the process by which the proposed holder of the authorisation will approve new modular units;\n(e) a description of the processes by which the proposed holder of the authorisation will initiate, suspend and cease manufacturing or assembly of the product at a modular unit;\n(f) a description of the manufacturing, assembly and product release processes to take place at each modular unit;\n(g) a description of the arrangements for supervision and control by the proposed holder of the authorisation of the manufacture or assembly operations at each modular unit;\n(h) a description of the arrangements for reporting of suspected adverse reactions from modular units to the MM (IMP) control site;\n(i) the name and contact details of the person at the MM (IMP) control site who is to be contacted in respect of manufacturing or assembly operations under the authorisation;\n(j) the name and contact details of the person to be contacted in respect of manufacturing or assembly operations at each modular unit;\n(k) the name and contact details of the person at the MM (IMP) control site who is to be contacted in respect of quality operations under the authorisation;\n(l) the name and contact details of the person to be contacted in respect of quality operations at each modular unit; and\n(m) a description of the processes by which the proposed holder of the authorisation will review and amend the MM (IMP) master file for the product.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 6 paras. 10, 11 inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 51(5)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2004/1031/schedule/6/paragraph/10",
    "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."
}