{
  "url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-158",
  "json_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-158.json",
  "legislation": "ukdsi/2019/9780111179185",
  "legislation_title": "The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019",
  "legislation_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2019",
  "path": "regulation/158",
  "kind": "regulation",
  "number": "158",
  "heading": "Amendment of regulation 198 (post-authorisation safety studies: general provisions)",
  "text": "(1) Regulation 198 is amended as follows.\n(2) In paragraph (2), for “competent authorities of the EEA States in which the study is conducted” substitute “licensing authority”.\n(3) In paragraph (3)—\n(a) in sub-paragraph (c), for “relevant competent authorities” substitute “licensing authority”;\n(b) in sub-paragraph (d), for “competent authorities of the EEA States in which the study was conducted” substitute “the licensing authority if the study is conducted in the United Kingdom”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2019/9780111179185/regulation/158",
    "retrieved_at": "2026-10-30T15:01:32.040145+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."
}