{
  "url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/schedule-8/paragraph-16",
  "json_url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/schedule-8/paragraph-16.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": "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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(4) In regulation 9 (new presentation)—\n(a) in paragraph (10)—\n(i) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(ii) in sub-paragraph (b), after “Article 21” insert “or regulation 64(6) of the 2012 Regulations”; and\n(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 8 para. 16(2)(a)-(d) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 194(d)(i)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Sch. 8 para. 16(3) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 194(d)(ii)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Sch. 8 para. 16(4)(a)(i) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 194(d)(iii)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Sch. 8 para. 16(4)(a)(ii) 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. 194(d)(iv)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Sch. 8 para. 16(4)(b) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 194(d)(v)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Sch. 8 para. 16(5) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 194(d)(vi)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Sch. 8 para. 16(6) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 194(d)(vii)"
    },
    {
      "type": "M",
      "label": "M1",
      "text": "S.I. 2018/345."
    },
    {
      "type": "I",
      "label": "I1",
      "text": "Sch. 8 para. 16 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/schedule/8/paragraph/16",
    "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."
}