{
  "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-VI/division-B/division-6",
  "json_url": "https://openlegislation.uk/eu-regulation-2014-536/annex-VI/division-B/division-6.json",
  "legislation": "eur/2014/536",
  "legislation_title": "Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2014-536",
  "path": "annex/VI/division/B/division/6",
  "kind": "division",
  "number": "6",
  "heading": "The following particulars shall appear on the immediate and the outer packaging:",
  "text": "(a) name of the main contact;\n(b) name of the medicinal product, followed by its strength and pharmaceutical form;\n(c) statement of the active substances expressed qualitatively and quantitatively per dosage unit;\n(d) batch or code number identifying the contents and packaging operation;\n(e) clinical trial reference code allowing identification of the clinical trial site, investigator and subject;\n(f) directions for use (reference may be made to a leaflet or other explanatory document intended for the subject or person administering the product);\n(g) ’For clinical trial use only’ or similar wording;\n(h) the storage conditions; and\n(i) period of use (expiry date or retest date as applicable).",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2014/536/annex/VI/division/B/division/6",
    "retrieved_at": "2026-11-01T14:47:39.363123+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."
}