{
  "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-B/division-7",
  "json_url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-B/division-7.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/B/division/7",
  "kind": "division",
  "number": "7",
  "heading": "However, in the cover letter it is not necessary to reproduce information already contained in the EU application form, with the following exceptions:",
  "text": "(a) specific features of the clinical trial population, such as subjects not able to give informed consent, minors and pregnant or breastfeeding women;\n(b) whether the clinical trial involves the first administration of a new active substance to humans;\n(c) whether scientific advice relating to the clinical trial or the investigational medicinal product has been given by the Agency, a Member State or a third country;\n(d) whether the clinical trial is part or is intended to be part of a Paediatric Investigation Plan (PIP) as referred to in Title II, Chapter 3, of Regulation (EC) No 1901/2006 (if the Agency has already issued a decision on the PIP, the cover letter contains the link to the decision of the Agency on its website);\n(e) whether investigational medicinal products or auxiliary medicinal products are a narcotic, psychotropic or radiopharmaceutical;\n(f) whether the investigational medicinal products consist of or contain a genetically-modified organism or organisms;\n(g) whether the sponsor has obtained an orphan designation for the investigational medicinal product for an orphan condition;\n(h) a comprehensive list, including the regulatory status, of all investigational medicinal products and a list of all auxiliary medicinal products; and\n(i) a list of medical devices which are to be investigated in the clinical trial but which are not part of the investigational medicinal product or products, together with a statement as to whether the medical devices are CE-marked for the intended use.",
  "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/B/division/7",
    "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."
}