{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-8/paragraph-19",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-8/paragraph-19.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "schedule/8/paragraph/19",
  "kind": "paragraph",
  "number": "19",
  "heading": null,
  "text": "Where an authorisation for the medicinal product to be placed on the market has been granted by , in the case of a medicinal product for sale or supply in Northern Ireland, a member State or by a country other than an EEA State, or in the case of a medicinal product for sale or supply in Great Britain, by a country other than the United Kingdom or by the European Commission—\n(a) a copy of that authorisation;\n(b) a summary of the safety data, including the data contained in the periodic safety update reports, where available; and\n(c) any suspected adverse reaction reports.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Sch. 8 para. 19 substituted (31.12.2020) by S.I. 2019/775, reg. 50(4) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 38(c))"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/schedule/8/paragraph/19",
    "retrieved_at": "2026-10-29T01:24:34.993203+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."
}