{
  "url": "https://openlegislation.uk/human-medicines-amendment-regulations-2013/regulation-18",
  "json_url": "https://openlegislation.uk/human-medicines-amendment-regulations-2013/regulation-18.json",
  "legislation": "uksi/2013/1855",
  "legislation_title": "The Human Medicines (Amendment) Regulations 2013",
  "legislation_url": "https://openlegislation.uk/human-medicines-amendment-regulations-2013",
  "path": "regulation/18",
  "kind": "regulation",
  "number": "18",
  "heading": "Amendment of regulation 84",
  "text": "In regulation 84 (EU marketing authorisations: failure to provide information as to safety etc), in paragraph (2) for “16(4)” substitute “16(3a)”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Article 16(4) of Regulation (EC) No 726/2004 was re-numbered as Article 16(3a) by virtue of the Corrigendum (OJ L 348, 31.12.2010, p1) to Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicines for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medical Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2013/1855/regulation/18",
    "retrieved_at": "2026-10-29T00:46:46.454767+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."
}