{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2006/regulation-8",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2006/regulation-8.json",
  "legislation": "uksi/2006/1928",
  "legislation_title": "The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006",
  "legislation_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2006",
  "path": "regulation/8",
  "kind": "regulation",
  "number": "8",
  "heading": "Amendment of regulation 13 of the principal Regulations",
  "text": "In regulation 13 of the principal Regulations (supply of investigational medicinal products for the purpose of clinical trials), in paragraph (2), in sub-paragraph (b), for head (i) substitute—\n“(i) the product has been manufactured, assembled or imported—\n(aa) in accordance with the terms of a manufacturing authorisation,\n(bb) in accordance with the terms of an authorisation referred to in Article 13 of the Directive granted by a competent authority of an EEA State other than the United Kingdom, or\n(cc) in the case of assembly only, under the exemption in regulation 37, and”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2006/1928/regulation/8",
    "retrieved_at": "2026-10-29T04:25:32.359836+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."
}