{
  "url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2019/schedule-8/paragraph-16",
  "json_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2019/schedule-8/paragraph-16.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": "schedule/8/paragraph/16",
  "kind": "paragraph",
  "number": "16",
  "heading": "Amendment of the Branded Health Service Medicines (Costs) Regulations 2018",
  "text": "(1) The Branded Health Service Medicines (Costs) Regulations 2018 are amended as follows.\n(2) In regulation 1(2) (interpretation)—\n(a) in the definition of “marketing authorisation” insert “UK” before “marketing” and re-insert the definition at the appropriate place;\n(b) in the definition of “marketing authorisation holder” insert “UK” before “marketing” in and re-insert the definition at the appropriate place;\n(c) omit the definition of “parallel distributed presentation”;\n(d) in paragraph (b) of the definition of “relevant medicine” insert “UK” before “marketing authorisation”; and\n(e) in the definition of “supplementary protection certificate” omit from “means” to the end and insert “has the meaning given by section 128B(2) of the Patents Act 1977”.\n(3) In regulation 3 (payment scheme)—\n(a) in paragraph (3)(a), insert “UK” before “marketing authorisation holder”;\n(b) omit paragraph (4)(c).\n(4) In regulation 9 (new presentation)—\n(a) in paragraph (10)—\n(i) in sub-paragraph (a), insert at the beginning “in relation to a product in respect of which there is a converted EU marketing authorisation”,\n(ii) in sub-paragraph (b), for “Article 21” to the end substitute “regulation 64(6) of the 2012 Regulations”; and\n(b) in paragraph (12), insert before the definition of “licensing authority”—\n““converted EU marketing authorisation” has the meaning given in paragraph 6(1) and (2) of Schedule 33A to the 2012 Regulations;”.\n(5) In regulation 21 (sales report), omit paragraph (1)(h).\n(6) In regulation 22 (presentation report), omit sub-paragraph (h).",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "S.I. 2018/345."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2019/9780111179185/schedule/8/paragraph/16",
    "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."
}