{
  "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.2/division-3",
  "json_url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.2/division-3.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/G/division/1.2/division/3",
  "kind": "division",
  "number": null,
  "heading": "Possibility of referring to the SmPC",
  "text": "Table 1: Content of the simplified IMPD\n(S: Data relating to the active substance; P: Data relating to the investigational medicinal product; A: Additional information on Facilities and Equipment, Adventitious Agents Safety Evaluation, Novel Excipients, and Solvents for Reconstitution and Diluents)\nTypes of previous assessment\nQuality data\nNon-clinical data\nClinical data\nThe investigational medicinal product is authorised or has a marketing authorisation in an ICH country and is used in the clinical trial:\n—\nwithin the conditions of the SmPC\nSmPC\n—\noutside the conditions of the SmPC\nSmPC\nIf appropriate\nIf appropriate\n—\nafter modification (for example blinding)\nP+A\nSmPC\nSmPC\nAnother pharmaceutical form or strength of the investigational medicinal product is authorised or has a marketing authorisation in an ICH country and the investigational medicinal product is supplied by the marketing authorisation holder\nSmPC+P+A\nYes\nYes\nThe investigational medicinal product is not authorised and has no marketing authorisation in an ICH country but the active substance is contained in an authorised medicinal product, and\n—\nis supplied by the same manufacturer\nSmPC+P+A\nYes\nYes\n—\nis supplied by another manufacturer\nSmPC+S+P+A\nYes\nYes\nThe investigational medicinal product was subject to a previous clinical trial application and authorised in the Member State concerned and has not been modified, and\n—\nno new data are available since last amendment to the clinical trial application,\nReference to previous submission\n—\nnew data are available since last amendment to the clinical trial application,\nNew data\nNew data\nNew data\n—\nis used under different conditions\nIf appropriate\nIf appropriate\nIf appropriate",
  "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/G/division/1.2/division/3",
    "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."
}