{
  "url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/schedule-2A/paragraph-1",
  "json_url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/schedule-2A/paragraph-1.json",
  "legislation": "uksi/2019/775",
  "legislation_title": "The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019",
  "legislation_url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019",
  "path": "schedule/2A/paragraph/1",
  "kind": "paragraph",
  "number": "1",
  "heading": null,
  "text": "After Schedule 8B to the Human Medicines Regulations 2012, insert—\n“SCHEDULE 8C\nMaterial to accompany an application for a UK marketing authorisation under the unfettered access route\nRegulation 50(1)\n1. A copy of the application submitted in connection with the granting of the EU marketing authorisation or UKMA(NI) which authorises the sale or supply of the medicinal product in Northern Ireland.\n2. A copy of all material submitted in support of the application for the EU marketing authorisation or UKMA(NI) which authorises the sale or supply of the medicinal product in Northern Ireland.\n3. A copy of the EU marketing authorisation or UKMA(NI) which authorises the sale or supply of the medicinal product in Northern Ireland.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 2A inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 190"
    },
    {
      "type": "I",
      "label": "I1",
      "text": "Sch. 2A para. 1 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2019/775/schedule/2A/paragraph/1",
    "retrieved_at": "2026-10-28T22:42:14.621781+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."
}