{
  "url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-no-2-regulations-2021/regulation-18",
  "json_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-no-2-regulations-2021/regulation-18.json",
  "legislation": "ukdsi/2021/9780348228755",
  "legislation_title": "The Human Medicines (Amendment etc.) (EU Exit) (No. 2) Regulations 2021",
  "legislation_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-no-2-regulations-2021",
  "path": "regulation/18",
  "kind": "regulation",
  "number": "18",
  "heading": "Amendment of regulation 201 (submission and evaluation of final study reports for required studies)",
  "text": "(1) Regulation 201 is amended as follows.\n(2) For paragraph (2)(a), substitute—\n“(a) the licensing authority; and”\n(3) For paragraph (2)(b), substitute—\n“(b) where the authorisation is a UKMA(NI) or UKMA(UK) and the study was conducted in an EEA State, the Pharmacovigilance Risk Assessment Committee,”\n(4) Omit paragraph (3).",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Regulation 201 was amended by S.I. 2019/775 (as amended by S.I. 2020/1488)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2021/9780348228755/regulation/18",
    "retrieved_at": "2026-10-30T14:46:28.800050+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."
}