{
  "url": "https://openlegislation.uk/eu-regulation-2014-536/article-36",
  "json_url": "https://openlegislation.uk/eu-regulation-2014-536/article-36.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": "article/36",
  "kind": "article",
  "number": "36",
  "heading": "Notification of the start of a clinical trial and of the end of the recruitment of subjects",
  "text": "1. The sponsor shall notify each Member State concerned of the start of a clinical trial in relation to that Member State through the EU portal.\nThat notification shall be made within 15 days from the start of the clinical trial in relation to that Member State.\n2. The sponsor shall notify each Member State concerned of the first visit of the first subject in relation to that Member State through the EU portal.\nThat notification shall be made within 15 days from the first visit of the first subject in relation to that Member State.\n3. The sponsor shall notify each Member State concerned of the end of the recruitment of subjects for a clinical trial in that Member State through the EU portal.\nThat notification shall be made within 15 days from the end of the recruitment of subjects. In case of re-start of recruitment, paragraph 1 shall apply.",
  "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/article/36",
    "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."
}