{
  "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-E/division-29",
  "json_url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-E/division-29.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/I/division/E/division/29",
  "kind": "division",
  "number": "29",
  "heading": null,
  "text": "For a multinational clinical trial where the medicinal product to be used in each Member State concerned is authorised at national level, and the SmPC varies among Member States concerned, the sponsor shall choose one SmPC for the whole clinical trial. This SmPC shall be the one best suited to ensure patient safety.",
  "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/I/division/E/division/29",
    "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."
}