{
  "url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-158",
  "json_url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-158.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": "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),\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(3) In paragraph (3)—\n(a) in sub-paragraph (c),\n(i) “for “the relevant competent authorities” substitute—\n“(i) “for “the relevant competent authorities” substitute—\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;”\n(b) in sub-paragraph (d),\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": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 158(2) substituted (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. 126(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 158(3)(a)(i) substituted (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. 126(b)(i)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in reg. 158(3) substituted (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. 126(b)(ii)"
    },
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 158 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/regulation/158",
    "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."
}