{
  "url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-126",
  "json_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-126.json",
  "legislation": "ukdsi/2020/9780348213980",
  "legislation_title": "The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020",
  "legislation_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020",
  "path": "schedule/2/paragraph/126",
  "kind": "paragraph",
  "number": "126",
  "heading": null,
  "text": "In regulation 158 (amendment of regulation 198 (post-authorisation safety studies: general provisions))—\n(a) in paragraph (2), for “for “competent authorities” to the end substitute—\n“—\n(a) “the competent authorities” to the end becomes sub-paragraph (a);\n(b) in sub-paragraph (a), at the end insert “and the licensing authority, where the product is subject to a marketing authorisation, traditional herbal registration or Article 126a authorisation for sale or supply in Northern Ireland;”\n(c) after sub-paragraph (a) insert—\n“(b) the licensing authority, where the product is subject to a marketing authorisation or traditional herbal registration for sale or supply in Great Britain only.”.”;\n(b) in paragraph (3)—\n(i) in sub-paragraph (a) for “for “relevant competent authorities” to the end substitute—\n“(i) “for “the relevant competent authorities” substitute—\n“—\n(i) the relevant competent authorities and the licensing authority, where paragraph (2)(a) applies;\n(ii) the licensing authority where paragraph (2)(b) applies,”\n(ii) “any new information” to the end becomes full-out words;”; and\n(ii) in sub-paragraph (b) for “for “competent authorities” to the end substitute—\n“—\n(i) “the competent authorities of the EEA States in which the study was conducted” becomes paragraph (i);\n(ii) in paragraph (i), after “the study was conducted” insert “and the licensing authority, where paragraph (2)(a) applies;”\n(iii) after paragraph (i) insert—\n“(ii) the licensing authority, where paragraph (2)(b) applies,”;\n(iv) “before the end of the period” to the end becomes full-out words.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2020/9780348213980/schedule/2/paragraph/126",
    "retrieved_at": "2026-10-30T14:48:26.477695+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."
}