{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-10/part-2/paragraph-6",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/schedule-10/part-2/paragraph-6.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/2/paragraph/6",
  "kind": "paragraph",
  "number": "6",
  "heading": null,
  "text": "(1) The Medicines (Labelling) Regulations 1976 shall be amended as follows.\n(2) In regulation 1 (citation and scope) , after “apply”, insert “ or a medicinal product which is an investigational medicinal product within the meaning of the Medicines for Human Use (Clinical Trials) Regulations 2003 ”.\n(3) In regulation 2 (commencement), in paragraph (b), in sub-paragraph (i), omit “, clinical trial certificate”.\n(4) Omit regulation 6 (clinical trials).\n(5) In regulation 10 (surgical materials), omit the words from “, except that” to the end.\n(6) In regulation 16 (provisions in licences, clinical trial certificates and animal test certificates)—\n(a) in paragraph (1), for “a clinical trial certificate or animal test certificate ” substitute “ an animal test certificate ”;\n(b) in paragraph (2), omit “, clinical trial certificate”.\n(7) Omit Schedule 2 (particulars required in the labelling of containers and packages of medicinal products for clinical trials).",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "M",
      "label": "M1",
      "text": "S.I. 1976/1726; the Regulations were revoked in so far as they relate to the labelling of containers and packages of medicinal products for administration in certain medicinal tests on animals by S.I. 1996/2194."
    },
    {
      "type": "M",
      "label": "M2",
      "text": "As amended by S.I. 1994/3144."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2004/1031/schedule/10/part/2/paragraph/6",
    "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."
}