{
  "url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-no-2-regulations-2021/regulation-16",
  "json_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-no-2-regulations-2021/regulation-16.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/16",
  "kind": "regulation",
  "number": "16",
  "heading": "Amendment of regulation 199 (submission of draft study protocols for required studies)",
  "text": "(1) Regulation 199 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 is to be conducted in an EEA State, the Pharmacovigilance Risk Assessment Committee,”.\n(4) Omit paragraph (3).\n(5) In paragraph (4), for “paragraphs (2) and 3(a)” substitute “paragraph (2)(a)”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Regulation 199 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/16",
    "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."
}