{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-10/paragraph-5",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-10/paragraph-5.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "schedule/10/paragraph/5",
  "kind": "paragraph",
  "number": "5",
  "heading": null,
  "text": "(1) The applicant must submit data as to the efficacy of the product.\n(2) The data must consist of at least one the following—\n(a) study reports in relation to the product;\n(b) published scientific literature; or\n(c) the results of investigations (commonly known as homoeopathic provings) consisting of the administration of a substance to a human subject to ascertain the symptoms it produces.\n(3) The applicant must include with the data—\n(a) a table of contents; and\n(b) an evaluation of the data, including an explanation of how the data establishes that the product has a recognised level of efficacy in the therapeutic indication for which authorisation is sought.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/schedule/10/paragraph/5",
    "retrieved_at": "2026-10-29T01:24:34.993203+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."
}