{
  "url": "https://openlegislation.uk/human-fertilisation-and-embryology-act-1990/schedule-3A/paragraph-3A",
  "json_url": "https://openlegislation.uk/human-fertilisation-and-embryology-act-1990/schedule-3A/paragraph-3A.json",
  "legislation": "ukpga/1990/37",
  "legislation_title": "Human Fertilisation and Embryology Act 1990",
  "legislation_url": "https://openlegislation.uk/human-fertilisation-and-embryology-act-1990",
  "path": "schedule/3A/paragraph/3A",
  "kind": "paragraph",
  "number": "3A",
  "heading": null,
  "text": "In relation to Northern Ireland, licence conditions shall require such—\n(a) systems to report, investigate, register and transmit information about serious adverse events and serious adverse reactions, and\n(b) accurate, rapid and verifiable procedures for recalling from distribution any product which may be related to a serious adverse event or serious adverse reaction,\nto be in place as are necessary to secure compliance with the requirements of Article 11 (notification of serious adverse events and reactions) of the first Directive and Article 5 (notification of serious adverse reactions) and Article 6 (notification of serious adverse events) of the third Directive.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 3A inserted (25.5.2007 for certain purposes, otherwise 5.7.2007) by The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 (S.I. 2007/1522), regs 1, 30"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Sch. 3A para. 3A and cross-heading inserted (31.12.2020) by S.I. 2019/482, reg. 2(17)(ba) (as substituted by The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1307), regs. 1, 16(b))"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukpga/1990/37/schedule/3A/paragraph/3A",
    "retrieved_at": "2026-10-29T09:42:58.103804+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."
}